Osteochondritis Dissecans
Conditions
Brief summary
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.
Interventions
Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
Sponsors
Terumo BCT
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Arm 1- Conservative Treatment Arm 2- PRP Injections
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female age 10 - 17 inclusive with open physis confirmed by MRI 2. Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery. 3. The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal. 4. Patients with Di Paola stage 1 or 2 lesions
Exclusion criteria
1. Patients with polyarticular disease. 2. Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL). Only those patients with a positive history of blood disorders will have a Complete Blood Count (CBC) performed a week prior to inclusion in the study. 3. Patients who had intra-articular treatment with steroids within 3 months 4. Patients who are pregnant or nursing at the time of consent. 5. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis) 6. Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish) 7. Patients who had previous knee surgery 8. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments. 9. Chronic use of NSAID (defined as taking non-steroidal anti-inflammatory drug) regularly every week for the last 6 months), steroids or chemotherapy drugs 10. Treatment with NSAIDs within 15 days prior to randomization in this study 11. Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects. 12. Patients with a prolongation of bleeding time, e.g. those receiving anticoagulant drug therapy 13. Patients with a contraindication to MRI including: patients with cardiac pacemaker or non-approved intracranial vascular clip, and those with orthopedic hardware as the resulting artifact can complicate interpretation 14. Patients with acute or chronic renal failure 15. Patients with a previous anaphylactic reaction to gadolinium enhanced MRI. 16. Patients with Di Paola stage 3 or 4 lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI | 6 months | Measured by dGEMRIC MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Pain, Performance and Overall Function: IKDC | Baseline, 6 months, 12 months | 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. |
| Improvement in Pain, Performance and Overall Function: KOOS, Baseline | 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. |
| Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | 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. |
| Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction. | 6 months | Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Deemed ineligible following surgery | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Platelet Rich Plasma (PRP) | Conventional Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 7 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.6 years | 12 years | 11.335 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 8 Participants |
| Region of Enrollment United States | 15 participants | 7 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
Primary
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI
Measured by dGEMRIC MRI
Time frame: 6 months
Population: 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.
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.
Time frame: Baseline, 6 months, 12 months
Population: Not all participants were available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: IKDC | Baseline | 48 score on a scale | Standard Deviation 21 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: IKDC | Month 6 | 86 score on a scale | Standard Deviation 21 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: IKDC | Month 12 | 84 score on a scale | Standard Deviation 18 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: IKDC | Baseline | 52 score on a scale | Standard Deviation 34 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: IKDC | Month 6 | 84 score on a scale | Standard Deviation 20 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: IKDC | Month 12 | 90 score on a scale | Standard Deviation 9 |
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.
Time frame: 12 Months
Population: Not all participants were available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Pain Subscale | 85.9 score on a scale | Standard Deviation 16.4 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Sport Subscale | 75.6 score on a scale | Standard Deviation 30.8 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Symptoms Subscale | 92.9 score on a scale | Standard Deviation 5 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Quality of Life Subscale | 56.9 score on a scale | Standard Deviation 24.2 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Activities of Daily Living Subscale | 90.5 score on a scale | Standard Deviation 13.1 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Quality of Life Subscale | 75.0 score on a scale | Standard Deviation 14.4 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Pain Subscale | 93.8 score on a scale | Standard Deviation 8.3 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Activities of Daily Living Subscale | 99.2 score on a scale | Standard Deviation 1.3 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Sport Subscale | 91.7 score on a scale | Standard Deviation 14.4 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 12 Months | Symptoms Subscale | 94.0 score on a scale | Standard Deviation 10.3 |
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.
Time frame: 6 Months
Population: Not all participants were available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Symptoms Subscale | 84.6 score on a scale | Standard Deviation 5.4 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Sport Subscale | 88.1 score on a scale | Standard Deviation 29.2 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Activities of Daily Living Subscale | 95.8 score on a scale | Standard Deviation 10.2 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Quality of Life Subscale | 68.1 score on a scale | Standard Deviation 22.6 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Pain Subscale | 90.6 score on a scale | Standard Deviation 15.6 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Quality of Life Subscale | 53.1 score on a scale | Standard Deviation 32.5 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Pain Subscale | 91.4 score on a scale | Standard Deviation 10.6 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Symptoms Subscale | 89.3 score on a scale | Standard Deviation 12.3 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Activities of Daily Living Subscale | 96.6 score on a scale | Standard Deviation 3.9 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, 6 Months | Sport Subscale | 69.6 score on a scale | Standard Deviation 40.6 |
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.
Time frame: Baseline
Population: Not all participants were available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Symptoms Subscale | 67.3 score on a scale | Standard Deviation 24.7 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Sport Subscale | 23.8 score on a scale | Standard Deviation 21.1 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Activities of Daily Living Subscale | 70.1 score on a scale | Standard Deviation 24.5 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Quality of Life Subscale | 43.1 score on a scale | Standard Deviation 19.9 |
| Platelet Rich Plasma (PRP) | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Pain Subscale | 56.8 score on a scale | Standard Deviation 21.6 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Quality of Life Subscale | 28.3 score on a scale | Standard Deviation 20.3 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Pain Subscale | 50.0 score on a scale | Standard Deviation 24.6 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Symptoms Subscale | 65.0 score on a scale | Standard Deviation 17 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Activities of Daily Living Subscale | 60.7 score on a scale | Standard Deviation 25.2 |
| Conventional Therapy | Improvement in Pain, Performance and Overall Function: KOOS, Baseline | Sport Subscale | 30.7 score on a scale | Standard Deviation 42.2 |
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
Time frame: 6 months