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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage.
During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage.
This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not.
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.
Recent developments in the treatment of articular cartilage defects have resulted in several techniques that involve the stimulation of native cellular components for the purpose of differentiation and proliferation in the cartilage defect. Techniques of interest for this study are the use of microfracture combined with platelet rich plasma (PRP), and a recently developed augmentation of the microfracture procedure-BioCartilage.
The microfracture procedure is performed with PowerPick. During the procedure, a patient with focal cartilage defect undergoes arthroscopic debridement of the defect before microfracture is used to create holes in the subchondral plate in order to provide access to mesenchymal stem cells (MSCs). To complete this marrow stimulating procedure (MSP), the microfractured region is filled with PRP harvested intraoperatively from the patient. A fibrin glue is then used to cover the defect and hold the PRP repair in place.
This basic MSP has been shown to regenerate cartilage tissue and improve joint function. Microfracture treatments using PRP are "shown to have good to excellent short-term outcomes in appropriately indicated patients" (Abrams, Mall, Fortier, Roller, & Cole, 2013), however successful long-term outcomes have not been demonstrated in the literature.
BioCartilage, a novel therapy developed by Arthrex Inc, is implemented as an augmentation of the basic approach of using microfracture and PRP. All aspects of the procedure, as well as indications for the procedure, are the same as the basic MSP described above, except the PRP is combined with BioCartilage powder, which acts as a scaffolding for cellular growth. BioCartilage is an FDA approved augmentation of microfracture treatment with PRP, and the powder itself contains no living cells.
Animal models using BioCartilage have provided data that supports the assertion that the BioCartilage augmentation may improve outcomes for patients who receive it; however there is currently no published human clinical outcomes data available for using BioCartilage (Abrams et al., 2013).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSP with BioCartilage | Patients receiving marrow stimulating procedure with BioCartilage adjunct. | ||
| MSP without BioCartilage | Patients receiving marrow stimulating procedure without BioCartilage. |
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| Measure | Description | Time Frame |
|---|---|---|
| MRI Repair Tissue Comparison | The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups. | 1 year post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form-12 Health Survey (SF-12) | The 12-item Short Form Survey (SF-12) is a general health questionnaire. The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
| Measure | Description | Time Frame |
|---|---|---|
| Marx Activity Rating Scale | The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a minimum score of 0 and a maximum of 16 points, with a higher score indicating more frequent participation. |
Inclusion Criteria:
I. Inclusion in the study will be considered when all of the following conditions are met:
Exclusion Criteria:
II. Exclusion from the study will be determined by any one of the following conditions being met:
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Patients recruited from Missouri Orthopaedic Institute's patient population.
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| Name | Affiliation | Role |
|---|---|---|
| James P Stannard, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Orthopaedic Institute | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512974 | Derived | Shah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090. |
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6 Subjects were intra-operative screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | MSP With BioCartilage | Patients receiving marrow stimulating procedure with BioCartilage adjunct. |
| FG001 | MSP Without BioCartilage | Patients receiving marrow stimulating procedure without BioCartilage. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There are six subjects who failed to meet intra-operative criteria for study participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | MSP Without BioCartilage | Patients receiving marrow stimulating procedure without BioCartilage. |
| BG001 | MSP With BioCartilage | Patients receiving marrow stimulating procedure with BioCartilage adjunct. |
| 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 | MRI Repair Tissue Comparison | The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups. | There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group. | Posted | Count of Participants | Participants | 1 year post-operatively |
|
The time period for collection of adverse events is 2 years post intervention.
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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 | MSP With BioCartilage | Patients receiving marrow stimulating procedure with BioCartilage adjunct. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Project Analyst | University of Missouri | 573-882-7583 | jonesvicki@health.missouri.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 23, 2015 | Jul 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Approximately 2 years |
| Approximately 2 years |
| Knee Injury and Osteoarthritis Outcomes Score (KOOS) | The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment. | Approximately 2 years |
| International Knee Documentation Committee (IKDC) Subjective Portion | The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function. | Approximately 2 years |
| Number of Participants Who Were Able To Return To Return to Work or Sports Activity | This is a two question survey administered to subjects that obtains subjective data "Yes / No" regarding whether the subject has been able to return to work or sports activity since surgery. | Approximately 2 years |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| BMI (Body Mass Index) | Mean | Full Range | kg/m^2 |
|
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
| OG001 | MSP Without BioCartilage | Patients receiving marrow stimulating procedure without BioCartilage. |
|
|
|
| Secondary | Short Form-12 Health Survey (SF-12) | The 12-item Short Form Survey (SF-12) is a general health questionnaire. The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group. | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 years |
|
|
|
|
| Other Pre-specified | Marx Activity Rating Scale | The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a minimum score of 0 and a maximum of 16 points, with a higher score indicating more frequent participation. | There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group. | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 years |
|
|
|
|
| Other Pre-specified | Knee Injury and Osteoarthritis Outcomes Score (KOOS) | The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment. | There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group. | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 years |
|
|
|
|
| Other Pre-specified | International Knee Documentation Committee (IKDC) Subjective Portion | The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function. | There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group. | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 years |
|
|
|
|
| Other Pre-specified | Number of Participants Who Were Able To Return To Return to Work or Sports Activity | This is a two question survey administered to subjects that obtains subjective data "Yes / No" regarding whether the subject has been able to return to work or sports activity since surgery. | There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group. | Posted | Count of Participants | Participants | Approximately 2 years |
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | MSP Without BioCartilage | Patients receiving marrow stimulating procedure without BioCartilage. | 0 | 5 | 0 | 5 | 0 | 5 |
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