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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397278
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020


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.



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 [ Time Frame: 6 months ]
    Measured by the Pediatric IKDC and KOOS survey results


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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397278


Contacts
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Contact: Emily Palmeri 720-777-8513 emily.palmeri@childrenscolorado.org
Contact: Michael Fadell, MD 720-777-6047 michael.fadell@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Michael Fadell, MD    720-777-6047    michael.fadell@childrenscolorado.org   
Contact: Emily Palmeri, BS    720-777-8513    emily.palmeri@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Terumo BCT
Investigators
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Principal Investigator: Michael Fadell, MD Children's Hospital Colorado
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02397278    
Other Study ID Numbers: 13-2797
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteochondritis
Osteochondritis Dissecans
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases