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

• ClinicalTrials.gov Identifier: NCT02397278
• Recruitment Status: Completed
• First Posted: March 24, 2015
• Results First Posted: August 5, 2021
• Last Update Posted: August 5, 2021
• Sponsor: University of Colorado, Denver
• Collaborator: Terumo BCT
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteochondritis Dissecans	Drug: Platelet rich plasma (PRP)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Arm 1- Conservative Treatment Arm 2- PRP Injections
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: March 2015
• Actual Primary Completion Date: January 8, 2020
• Actual Study Completion Date: January 8, 2020

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI [ Time Frame: 6 months ]
   Measured by dGEMRIC MRI

Secondary Outcome Measures :

1. Improvement in Pain, Performance and Overall Function: IKDC [ Time Frame: 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.
2. Improvement in Pain, Performance and Overall Function: KOOS, Baseline [ Time Frame: 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.
3. Improvement in Pain, Performance and Overall Function: KOOS, 6 Months [ Time Frame: 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.
4. Improvement in Pain, Performance and Overall Function: KOOS, 12 Months [ Time Frame: 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 Outcome Measures:

1. dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction. [ Time Frame: 6 months ]
   Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Colorado

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Terumo BCT

Investigators

• Principal Investigator: Michael Fadell, MD; Children's Hospital Colorado

  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:

Study Protocol and Statistical Analysis Plan  [PDF] November 28, 2017

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02397278
• Other Study ID Numbers: 13-2797
• First Posted: March 24, 2015
• Results First Posted: August 5, 2021
• Last Update Posted: August 5, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Osteochondritis; Osteochondritis Dissecans; Osteochondrosis; Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Connective Tissue Diseases