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| ID | Type | Description | Link |
|---|---|---|---|
| IND Exemption 123189 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Hospital for Special Surgery, New York | OTHER |
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Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after patients return to full activity and can place them at considerable risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic interventions to prevent muscle atrophy is needed to advance the care of patients who suffer from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an important role in promoting muscle growth and protecting muscle from atrophy. While GH therapy has shown promise in protecting immobilized muscle from various models of disuse atrophy, it remains unknown whether GH can help to restore strength and protect against the loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe return to play of patients that suffer ACL tears, and help to prevent the long-term OA and reduction in quality of life that occur after these traumatic knee injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Active Comparator | Somatropin of rDNA origin |
|
| Placebo | Placebo Comparator | A placebo vehicle that contains somatropin diluent but no active hormone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 wks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Normative Isokinetic Extension (Nm) at Pre-op (Baseline) | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher L Mendias, PhD, ATC | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24081158 | Background | Boesen AP, Dideriksen K, Couppe C, Magnusson SP, Schjerling P, Boesen M, Kjaer M, Langberg H. Tendon and skeletal muscle matrix gene expression and functional responses to immobilisation and rehabilitation in young males: effect of growth hormone administration. J Physiol. 2013 Dec 1;591(23):6039-52. doi: 10.1113/jphysiol.2013.261263. Epub 2013 Sep 30. | |
| 19470622 |
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Recruitment completed at the University of Michigan Sports Medicine Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin | Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period. |
| FG001 | Placebo | A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 20 subjects who began the study, 19 were included in the baseline analysis. One subject who withdrew from the study was not included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin | Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at 26 wks post-op |
|
1-3 weeks pre-op to 25 weeks post-op
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somatropin | Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | General disorders | Systematic Assessment |
Please consult the full manuscript or contact the study PI for any questions about study results. Additional clinical trials must be conducted before definitive conclusions can be made.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Mendias | Hopsital For Special Surgery and University of Michigan | 212-249-2373 | mendiasc@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2019 | Sep 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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|
| Placebo | Drug | A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period. |
|
| at pre-op (baseline) |
| Normative Isokinetic Flexion (Nm) at Pre-op (Baseline) | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 weeks post-op |
| Normative Isometric Extension (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Normative Isometric Extension (Nm) at 26 Weeks Post-op | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 weeks post-op |
| Normative Isometric Flexion (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Normative Isometric Flexion (Nm) at 26 Weeks Post-op | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 weeks post-op |
| Absolute Isokinetic Extension (Nm) at Pre-op (Baseline) | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Absolute Isokinetic Extension (Nm) at 26 wk Post-op | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 wk post-op |
| Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline) | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 weeks post-op |
| Absolute Isometric Extension (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Absolute Isometric Extension (Nm) at 26 Weeks Post-op | Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 weeks post-op |
| Absolute Isometric Flexion (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | at pre-op (baseline) |
| Absolute Isometric Flexion (Nm) at 26 Weeks Post-op | Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | at 26 weeks post-op |
| VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline) | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59. | at pre-op (baseline) |
| VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59. | at 26 weeks post-op |
| VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline) | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47. | at pre-op (baseline) |
| VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47. | at 26 weeks post-op |
| International Knee Document Committee (IKDC) at Pre-op (Baseline) | The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function. | at pre-op (baseline) |
| International Knee Documentation Committee (IKDC) up to 26 wk Post-op | The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function. | up to 26 wk post-op |
| The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op | KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at 26 weeks post-op |
| KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline) | KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at pre-op (baseline) |
| KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op | KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at 26 weeks post-op |
| KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline) | KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at pre-op (baseline) |
| KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op | KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at 26 weeks post-op |
| KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline) | KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at pre-op (baseline) |
| KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op | KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. | at 26 weeks post-op |
| KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline) | KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. | at pre-op (baseline) |
| KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op | KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at 26 weeks post-op |
| KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline) | KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | at pre-op (baseline) |
| Absolute Quadriceps Volume (L) at Pre-op (Baseline) | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at pre-op (baseline) |
| Absolute Quadricep Volume (L) at 26 Week Post-op | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at 26 week post-op |
| Absolute Hamstring Volume (L) at Pre-op (Baseline) | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at pre-op (baseline) |
| Absolute Hamstring Volume (L) at 26 Weeks Post-op | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at 26 weeks post-op |
| Normalized Quadriceps Volume (L) at Pre-op (Baseline) | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at pre-op (baseline) |
| Normalized Quadriceps Volume (L) at 26 Weeks Post-op | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at 26 weeks post-op |
| Normalized Hamstring Volume (L) at Pre-op (Baseline) | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at pre-op (baseline) |
| Normalized Hamstring Volume (L) at 26 Weeks Post-op | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | at 26 weeks post-op |
| Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op | IGF1 was measured from serum using an IMMULITE 2000 system (Siemens). | Area under the curve between -1 and 5 weeks post-op |
| Myostatin at -1 and 5 Weeks Post-op | Myostatin was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. | Area under the curve between -1 and 5 weeks post-op |
| MMP3 at -1 and 5 Weeks Post-op | Matrix metalloproteinase-3 (MMP3) was measured from serum using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. | Area under the curve between -1 and 5 weeks post-op |
| Hyaluronic Acid at -1 and 5 Weeks Post-op | Hyaluronic acid was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. | Area under the curve between -1 and 5 weeks post-op |
| Surya S, Horowitz JF, Goldenberg N, Sakharova A, Harber M, Cornford AS, Symons K, Barkan AL. The pattern of growth hormone delivery to peripheral tissues determines insulin-like growth factor-1 and lipolytic responses in obese subjects. J Clin Endocrinol Metab. 2009 Aug;94(8):2828-34. doi: 10.1210/jc.2009-0638. Epub 2009 May 26. |
| 23739685 | Background | Mendias CL, Lynch EB, Davis ME, Sibilsky Enselman ER, Harning JA, Dewolf PD, Makki TA, Bedi A. Changes in circulating biomarkers of muscle atrophy, inflammation, and cartilage turnover in patients undergoing anterior cruciate ligament reconstruction and rehabilitation. Am J Sports Med. 2013 Aug;41(8):1819-26. doi: 10.1177/0363546513490651. Epub 2013 Jun 5. |
| 18158071 | Background | Gelato M, McNurlan M, Freedland E. Role of recombinant human growth hormone in HIV-associated wasting and cachexia: pathophysiology and rationale for treatment. Clin Ther. 2007 Nov;29(11):2269-88. doi: 10.1016/j.clinthera.2007.11.004. |
| 32452208 | Derived | Mendias CL, Enselman ERS, Olszewski AM, Gumucio JP, Edon DL, Konnaris MA, Carpenter JE, Awan TM, Jacobson JA, Gagnier JJ, Barkan AL, Bedi A. The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial. Am J Sports Med. 2020 Jul;48(8):1916-1928. doi: 10.1177/0363546520920591. Epub 2020 May 26. |
| BG001 | Placebo | A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Isokinetic Knee Strength (Nm) | Mean | Standard Deviation | Newton Meters |
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| OG001 | Placebo | A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period. |
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| Secondary | Normative Isokinetic Extension (Nm) at Pre-op (Baseline) | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Normative Isokinetic Flexion (Nm) at Pre-op (Baseline) | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb. | Posted | Mean | 90% Confidence Interval | Nm | at 26 weeks post-op |
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| Secondary | Normative Isometric Extension (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Normative Isometric Extension (Nm) at 26 Weeks Post-op | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb. | Posted | Mean | 90% Confidence Interval | Nm | at 26 weeks post-op |
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| Secondary | Normative Isometric Flexion (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Normative Isometric Flexion (Nm) at 26 Weeks Post-op | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb. | Posted | Mean | 90% Confidence Interval | Nm | at 26 weeks post-op |
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| Secondary | Absolute Isokinetic Extension (Nm) at Pre-op (Baseline) | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups. | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Absolute Isokinetic Extension (Nm) at 26 wk Post-op | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups. | Posted | Mean | 90% Confidence Interval | Nm | at 26 wk post-op |
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| Secondary | Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline) | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups. | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups. | Posted | Mean | 90% Confidence Interval | Nm | at 26 weeks post-op |
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| Secondary | Absolute Isometric Extension (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Absolute Isometric Extension (Nm) at 26 Weeks Post-op | Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups. | Posted | Mean | 90% Confidence Interval | Nm | at 26 weeks post-op |
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| Secondary | Absolute Isometric Flexion (Nm) at Pre-op (Baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm). | Posted | Mean | 90% Confidence Interval | Nm | at pre-op (baseline) |
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| Secondary | Absolute Isometric Flexion (Nm) at 26 Weeks Post-op | Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. | A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups. | Posted | Mean | 90% Confidence Interval | Nm | at 26 weeks post-op |
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| Secondary | VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline) | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59. | A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | T-score | at pre-op (baseline) |
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| Secondary | VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59. | A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | T-score | at 26 weeks post-op |
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| Secondary | VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline) | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47. | A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | T-score | at pre-op (baseline) |
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| Secondary | VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47. | A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | T-score | at 26 weeks post-op |
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| Secondary | International Knee Document Committee (IKDC) at Pre-op (Baseline) | The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function. | A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint. | Posted | Mean | 90% Confidence Interval | score on a scale | at pre-op (baseline) |
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| Secondary | International Knee Documentation Committee (IKDC) up to 26 wk Post-op | The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function. | A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint. | Posted | Mean | 90% Confidence Interval | units on a scale | up to 26 wk post-op |
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| Secondary | The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op | KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at 26 weeks post-op |
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| Secondary | KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline) | KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at pre-op (baseline) |
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| Secondary | KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op | KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at 26 weeks post-op |
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| Secondary | KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline) | KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at pre-op (baseline) |
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| Secondary | KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op | KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at 26 weeks post-op |
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| Secondary | KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline) | KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at pre-op (baseline) |
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| Secondary | KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op | KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at 26 weeks post-op |
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| Secondary | KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline) | KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at pre-op (baseline) |
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| Secondary | KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op | KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at 26 weeks post-op |
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| Secondary | KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline) | KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures | A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects. | Posted | Mean | 90% Confidence Interval | score on a scale | at pre-op (baseline) |
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| Secondary | Absolute Quadriceps Volume (L) at Pre-op (Baseline) | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at pre-op (baseline) |
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| Secondary | Absolute Quadricep Volume (L) at 26 Week Post-op | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at 26 week post-op |
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| Secondary | Absolute Hamstring Volume (L) at Pre-op (Baseline) | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at pre-op (baseline) |
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| Secondary | Absolute Hamstring Volume (L) at 26 Weeks Post-op | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at 26 weeks post-op |
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| Secondary | Normalized Quadriceps Volume (L) at Pre-op (Baseline) | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at pre-op (baseline) |
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| Secondary | Normalized Quadriceps Volume (L) at 26 Weeks Post-op | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at 26 weeks post-op |
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| Secondary | Normalized Hamstring Volume (L) at Pre-op (Baseline) | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at pre-op (baseline) |
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| Secondary | Normalized Hamstring Volume (L) at 26 Weeks Post-op | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). | Scans were performed on a total of 19 participant at three time points throughout the study. | Posted | Mean | 90% Confidence Interval | Liters | at 26 weeks post-op |
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| Secondary | Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op | IGF1 was measured from serum using an IMMULITE 2000 system (Siemens). | Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC. | Posted | Mean | 90% Confidence Interval | ng*days/mL | Area under the curve between -1 and 5 weeks post-op |
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| Secondary | Myostatin at -1 and 5 Weeks Post-op | Myostatin was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. | Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC. | Posted | Mean | 90% Confidence Interval | ng*days/mL | Area under the curve between -1 and 5 weeks post-op |
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| Secondary | MMP3 at -1 and 5 Weeks Post-op | Matrix metalloproteinase-3 (MMP3) was measured from serum using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. | Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC. | Posted | Mean | 90% Confidence Interval | ng*days/mL | Area under the curve between -1 and 5 weeks post-op |
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| Secondary | Hyaluronic Acid at -1 and 5 Weeks Post-op | Hyaluronic acid was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. | Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC. | Posted | Mean | 90% Confidence Interval | ng*days/mL | Area under the curve between -1 and 5 weeks post-op |
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| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Placebo | A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period. | 0 | 9 | 0 | 9 | 5 | 9 |
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint pain (other than surgical knee) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Increased sweating | Blood and lymphatic system disorders | Systematic Assessment |
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| Tingling sensation/numbness | General disorders | Systematic Assessment |
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| Elevated alanine aminotransferase | General disorders | Systematic Assessment |
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| Elevated aspirate aminotransferase | General disorders | Systematic Assessment |
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| Temperature sensation fluctuations | General disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Reduced appetite | General disorders | Systematic Assessment |
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| Elevated blood glucose | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Injection site bruising | General disorders | Systematic Assessment |
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| Muscle spasms/cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |