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

Meniscus Lesion Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966638
• Other study ID #: CRC_GHN_2019_006
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2020
• Est. primary completion date: April 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

Procedure:
• Intra-meniscal injection of platelet-rich plasma
Intra-meniscal injection of platelet-rich plasma under echographic control

Locations

Country	Name	City	State
France	Department of Radiology, Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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