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Clinical Trials/NCT03966638
NCT03966638
Completed
Not Applicable

Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal

Hospices Civils de Lyon1 site in 1 country40 target enrollmentNovember 1, 2017
ConditionsMeniscus Lesion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meniscus Lesion
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
1
Primary Endpoint
Variation of International Knee Documentation Committee (IKDC) score
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Meniscal lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy.

Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions.

PRP has been injected under ultrasound in tendons or intra-articularly for several years.

This technique of meniscal percutaneous injection of PRP is now carried out for more than 2 years in our hospital, with satisfactory preliminary results, without any complication.

All patients in our study received an intra-meniscal injection of PRP, under echographic control. They were evaluated clinically and by Magnetic Resonance Imaging (MRI) before and at 6 months of the injection.

The aim of the study is to evaluate the efficacy of intra-meniscal injection of PRP on the symptomatology of the patients (pain, sport activities and daily life) at 6 months post-treatment.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
November 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • isolated symptomatic meniscal lesion
  • lesion confirmed by MRI
  • grade II or III lesion touching the peripheral involvement of the middle segment,
  • lesion treated by percutaneous intra meniscal PRP's injection
  • IKDC score measured before injection and 6 months post-injection

Exclusion Criteria

  • other painful etiology of the knee
  • emergency surgical management (luxation, bucket handle) or not (indication validated by the surgeon, meniscectomy or meniscal suture)
  • impossibility to perform the procedure (non visible lesion, morphology of the patient, cutaneous infection, coagulation treatment in progress)

Outcomes

Primary Outcomes

Variation of International Knee Documentation Committee (IKDC) score

Time Frame: Between 0 and 6 months post injection

The variation of IKDC score between before injection and 6 months post-injection will be calculated. The IKDC score ranges from 0 to 100 and is interpreted as a measure of function with higher scores representing higher levels of function.

Study Sites (1)

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