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The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unloader Bracing | Experimental | This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period. |
|
| Non-Bracing Arm | Active Comparator | This group will be randomly selected and assigned to wear no brace post-operatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unloader Bracing | Device | The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tegner Score (Clinical Outcome) | The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Dragoo, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unloader Bracing | This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period. |
| FG001 | Non-Bracing Arm | This group was randomly selected and assigned to wear no brace post-operatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the protocol were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Unloader Bracing | This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period. |
| BG001 | Non-Bracing Arm | This group was randomly selected and assigned to wear no brace post-operatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
Up to two years.
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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 | Unloader Bracing | This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Dragoo, MD | Stanford University | 650-721-3430 | jdragoo@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2011 | May 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2019 | May 29, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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|
| Non-Bracing | Device | Microfracture performed with no post-operative unloader bracing |
|
| 2 years |
| Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) | SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. | 2 years |
| Change From Baseline in Lysholm Score (Clinical Outcome) | The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. | 2 years |
| Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen. | 2 years |
| Change From Baseline in Cartilage Volume (Radiographic Outcome) | 2 years |
| Change From Baseline in Cartilage Thickness (Radiographic Outcome) | 2 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. | Mean | Standard Deviation | units on a scale |
|
| Tegner Score | The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport. | Mean | Standard Deviation | units on a scale |
|
| SF-12 Score | SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. | Mean | Standard Deviation | units on a scale |
|
| Lysholm Score | The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. | Mean | Standard Deviation | units on a scale |
|
| T2 Relaxation time | T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen. | Mean | Standard Deviation | milliseconds (ms) |
|
| Cartilage Volume | Negative values indicate that the reading was less than the reference zone for cartilage volume. | Mean | Standard Deviation | mm^3 |
|
| Cartilage Thickness | Negative values indicate that the reading was less than the reference zone for cartilage thickness. | Mean | Standard Deviation | mm |
|
| OG001 |
| Non-Bracing Arm |
This group was randomly selected and assigned to wear no brace post-operatively. |
|
|
|
| Secondary | Change From Baseline in Tegner Score (Clinical Outcome) | The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport. | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
|
|
|
| Secondary | Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) | SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
|
|
|
| Secondary | Change From Baseline in Lysholm Score (Clinical Outcome) | The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
|
|
|
| Secondary | Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen. | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | millisecond (ms) | 2 years |
|
|
|
|
| Secondary | Change From Baseline in Cartilage Volume (Radiographic Outcome) | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm^3 | 2 years |
|
|
|
|
| Secondary | Change From Baseline in Cartilage Thickness (Radiographic Outcome) | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm | 2 years |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Non-Bracing Arm | This group was randomly selected and assigned to wear no brace post-operatively. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Change at month 24 |
|
| 0.340 |
| Other |
| Difference between baseline and month 24. | Regression, Linear | 0.179 | Other |
| Change at month 24 |
|
| 0.958 |
| Other |
| Difference between baseline and month 24. | Regression, Linear | 0.634 | Other |
| Change at month 24 |
|
| 0.666 |
| Other |
| Difference between baseline and month 24. | Regression, Linear | 0.854 | Other |
| 0.414 |
| Other |
| 0.276 |
| Other |
| 0.091 |
| Other |