Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee

Study Overview
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Brief Summary
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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.

Official Title
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Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee: Does it Help? A Clinical and Magnetic Resonance Imaging (MRI) Study.

Conditions
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Osteochondritis Dissecans

Intervention / Treatment
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* Drug: Platelet rich plasma (PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 10 - 17 inclusive with open physis confirmed by MRI Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery. The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal. Patients with Di Paola stage 1 or 2 lesions Exclusion Criteria: Patients with polyarticular disease. 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. Patients who had intra-articular treatment with steroids within 3 months Patients who are pregnant or nursing at the time of consent. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis) Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish) Patients who had previous knee surgery Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments. Chronic use of NSAID (defined as taking non-steroidal anti-inflammatory drug) regularly every week for the last 6 months), steroids or chemotherapy drugs Treatment with NSAIDs within 15 days prior to randomization in this study Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects. Patients with a prolongation of bleeding time, e.g. those receiving anticoagulant drug therapy 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 Patients with acute or chronic renal failure Patients with a previous anaphylactic reaction to gadolinium enhanced MRI. Patients with Di Paola stage 3 or 4 lesions

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1- Conservative Treatment Arm 2- PRP Injections
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelet rich plasma (PRP)<br>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. | Drug: Platelet rich plasma (PRP)<br>* Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.<br>* Other names: autologous PRP;|
| No Intervention: Conventional therapy<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI | Measured by dGEMRIC MRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |