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

NCT02397278 | Completed Results DMC

• 1 other identifier: 13-2797
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondritis Dissecans

Outcome Measures

Primary Outcomes (1)

• Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI

  Measured by dGEMRIC MRI

  6 months

Secondary Outcomes (4)

• Improvement in Pain, Performance and Overall Function: IKDC

  Baseline, 6 months, 12 months

• Improvement in Pain, Performance and Overall Function: KOOS, Baseline

  Baseline

• Improvement in Pain, Performance and Overall Function: KOOS, 6 Months

  6 Months

• Improvement in Pain, Performance and Overall Function: KOOS, 12 Months

  12 Months

Other Outcomes (1)

• dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction.

  6 months

Study Arms (2)

Platelet rich plasma (PRP)

ACTIVE COMPARATOR

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)

Conventional therapy

NO INTERVENTION

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.

Interventions

Platelet rich plasma (PRP) DRUG

Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.

Also known as: autologous PRP

Platelet rich plasma (PRP)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with polyarticular disease.
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Terumo BCT: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

The 12 month time point for primary and secondary outcome measures was mistakenly omitted from the original registration. This has been corrected to align with the currently approved protocol.

Results Point of Contact

• Title: Michael Fadell II
• Organization: Stanford University

mfadell@stanford.edu

3037241111

Study Officials

• Michael Fadell, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1- Conservative Treatment Arm 2- PRP Injections

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Locations

US (1)