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

Not Applicable

Completed

• Conditions: Osteochondritis Dissecans
• Interventions: Drug: Platelet rich plasma (PRP)

• Registration Number: NCT02397278
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-24
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-24
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Status Verified: 2021-07
• Results First Submitted: 2021-07-14
• Results First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Results First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma (PRP)	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.

Primary Outcome Measures

Name	Time	Method
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI	6 months	Measured by dGEMRIC MRI

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States