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

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.

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.

Study Overview

• Status: Completed
• Conditions: Osteochondritis Dissecans
• Intervention / Treatment: Drug: Platelet rich plasma (PRP)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Terumo BCT
• Investigators: Principal Investigator: Michael Fadell, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Cartilage Diseases; Osteochondrosis; Osteochondritis; Osteochondritis Dissecans
• Other Study ID Numbers: 13-2797

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No