Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal Injection of Platelet-rich Plasma (PRP) (COMPARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion
• Intervention / Treatment: Procedure: Intra-meniscal injection of platelet-rich plasma

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Department of Radiology, Croix-Rousse Hospital, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with symptomatic non-surgical meniscal injury treated with percutaneous intravenous injection of platelet-rich plasma (PRP)

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving platelet rich plasma; The group is composed of patients receiving an intra-meniscal injection of platelet-rich plasma, under echographic control, for isolated meniscal lesion.	Procedure: Intra-meniscal injection of platelet-rich plasma; Intra-meniscal injection of platelet-rich plasma under echographic control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of International Knee Documentation Committee (IKDC) score	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.	Between 0 and 6 months post injection

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CRC_GHN_2019_006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No