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| Name | Class |
|---|---|
| Terumo BCT | INDUSTRY |
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This study plans to learn more about ways to treat a joint problem in the knee called Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to determine whether the injections lead to improvements in pain, performance of activities of daily living, improvements is sports activities and overall function and symptoms reduction. The investigators will compare PRP treatment to conservative therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma (PRP) | Active Comparator | Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
|
| Conventional therapy | No Intervention | Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma (PRP) | Drug | Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI | Measured by dGEMRIC MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Pain, Performance and Overall Function: IKDC | Measured by the Pediatric IKDC survey results. The International Knee Documentation Committee questionnaire measures knee function, Scores range from 1-100, with higher scores indicating a better outcome. | Baseline, 6 months, 12 months |
| Improvement in Pain, Performance and Overall Function: KOOS, Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction. | Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fadell, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet Rich Plasma (PRP) | Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy. |
| FG001 | Conventional Therapy | Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet Rich Plasma (PRP) | Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI | Measured by dGEMRIC MRI | This outcome measure for post-contrast dGEMRIC studies was not collected. The protocol was amended to include non-contrast studies due to difficulty recruiting patients. | Posted | 6 months |
|
12 Months
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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 | Platelet Rich Plasma (PRP) | Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy. |
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The 12 month time point for primary and secondary outcome measures was mistakenly omitted from the original registration. This has been corrected to align with the currently approved protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Fadell II | Stanford University | 3037241111 | mfadell@stanford.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 | Nov 28, 2017 | Jul 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Arm 1- Conservative Treatment Arm 2- PRP Injections
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|
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome. |
| Baseline |
| Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome. | 6 Months |
| Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome. | 12 Months |
| BG001 | Conventional Therapy | Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Conventional Therapy | Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
|
| Secondary | Improvement in Pain, Performance and Overall Function: IKDC | Measured by the Pediatric IKDC survey results. The International Knee Documentation Committee questionnaire measures knee function, Scores range from 1-100, with higher scores indicating a better outcome. | Not all participants were available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months |
|
|
|
| Other Pre-specified | dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction. | Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results | Not Posted | 6 months | Participants |
| Secondary | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome. | Not all participants were available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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|
|
| Secondary | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome. | Not all participants were available for analysis. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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|
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| Secondary | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome. | Not all participants were available for analysis. | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Conventional Therapy | Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. | 0 | 8 | 0 | 8 | 0 | 8 |
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| Month 12 |
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| Activities of Daily Living Subscale |
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| Sport Subscale |
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| Quality of Life Subscale |
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| Activities of Daily Living Subscale |
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| Sport Subscale |
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| Quality of Life Subscale |
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| Activities of Daily Living Subscale |
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| Sport Subscale |
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| Quality of Life Subscale |
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