Skip to main content
OpenTrials
Completed

NCT Number: NCT02397278

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteochondritis Dissecans Bone Diseases Musculoskeletal Diseases Osteochondritis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients with polyarticular disease.
  • 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.
  • 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

Treatment and study plan

Platelet Rich Plasma (PRP)

Drug

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

Other names: autologous PRP

Primary outcomes

  1. Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI

    Time frame: 6 months

    Measured by dGEMRIC MRI

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Terumo BCT

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2015
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.