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

Primary Purpose

Osteochondritis Dissecans

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma (PRP)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteochondritis Dissecans

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Platelet rich plasma (PRP)

Conventional therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 24, 2015
Last Updated
July 14, 2021
Sponsor
University of Colorado, Denver
Collaborators
Terumo BCT
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1. Study Identification

Unique Protocol Identification Number
NCT02397278
Brief Title
Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Terumo BCT

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondritis Dissecans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1- Conservative Treatment Arm 2- PRP Injections
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma (PRP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Platelet rich plasma (PRP)
Other Intervention Name(s)
autologous PRP
Intervention Description
Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
Primary Outcome Measure Information:
Title
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI
Description
Measured by dGEMRIC MRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in Pain, Performance and Overall Function: IKDC
Description
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.
Time Frame
Baseline, 6 months, 12 months
Title
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Description
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.
Time Frame
Baseline
Title
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Description
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.
Time Frame
6 Months
Title
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Description
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.
Time Frame
12 Months
Other Pre-specified Outcome Measures:
Title
dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction.
Description
Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fadell, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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