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

Osteochondritis Dissecans Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397278
• Other study ID #: 13-2797
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: January 8, 2020

Study information

• Verified date: July 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis Dissecans

Intervention

Drug:
• Platelet rich plasma (PRP)
Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Terumo BCT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction.	Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results	6 months
Primary	Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI	Measured by dGEMRIC MRI	6 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline
Secondary	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.	6 Months
Secondary	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.	12 Months