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

NCT03966638 | Completed

• 1 other identifier: CRC_GHN_2019_006
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Lesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Intra-meniscal injection of platelet-rich plasma PROCEDURE

Intra-meniscal injection of platelet-rich plasma under echographic control

Patients receiving platelet rich plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69004, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 29, 2019
• Study Start: November 1, 2017
• Primary Completion: April 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)