MENIPREP Study: Evauation of the Effectiveness of Prp Injection in the Management of Degenerative Meniscal Lesions : Randomized Controlled Trial Double Blind Versus Reference Treatment" (MENIPREP)

Meniscal tissue has very limited intrinsic properties in terms of repair, given the low mitotic activity of chondrocytes and poor vascularization. Nevertheless, its capacity for regeneration, in vivo and in vitro, can be stimulated by the contribution of growth factors, as has been widely described in the medical and scientific literature. Platelet Enhanced Plasma (PRP) is an autologous biological product (that is, derived from the patient's blood) containing a growth factor concentrate. The contribution of these growth factors stimulates cartilage repair by stimulating neovascularization, collagen synthesis and activation of chondrocytes. Intra-articular injection PRP is an autologous biological product, now used in daily practice for the treatment of early osteoarthritic lesions.

The hypothesis of this work is that the injection of PRP in contact with LMD(Degenerative Meniscal Lesions) will improve the clinical symptomatology of our patients compared to reference treatment (intra-auricular injection of corticosteroids).

Study Overview

• Status: Completed
• Conditions: DEGENERATIVE MENISCAL LESIONS
• Intervention / Treatment: Drug: injection of Platelet Enhanced Plasma(PRP); Device: RMI; Drug: injection of corticosteroids

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Men and women aged 20 to 80

• MDD diagnosis objected to MRI (grade II/III)
• Joint pain for more than 3 month
• Absence of bone lesion or moderate knee osteoarthritis stage <2 on the Kellgren Laurence scale (objectified on radiography in schuss) in the 6 months prior to inclusion
• Axial deformity of the lower limbs less than or equal to 5 °
• Signed consent signed by the patient
• Ability to perform procedures as part of the follow-up (walk 50 steps on a flat surface and up / down stairs).
• Be affiliated to a health insurance scheme

Exclusion Criteria:

• Axial deformity> 5 °
• Ligament instability
• Major injuries or surgery of the target knee or lateral contralateral knee in the 12 months preceding the inclusion visit
• Ligament reconstruction in the 12 months prior to the inclusion visit
• Need a cane or assistance to move
• BMI> 35
• Thrombocytopenia <150 G / L
• Thrombocytosis> 450 G / L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP group	Drug: injection of Platelet Enhanced Plasma(PRP); intra-articular injection; Device: RMI; A CONTROL RMI at 1 year follow-up.
Active Comparator: reference treatment	Device: RMI; A CONTROL RMI at 1 year follow-up.; Drug: injection of corticosteroids; intra-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control by Magnetic Resonance Imaging (MIR)	To evaluate the evolution of the LMD compared to pretherapeutic images.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-completed questionnaire SF36	SF36 (The Short Form (36) Health Survey)	12 Months
self-completed questionnaire EVA score	EVA (analogical visual scale)	12 Months
self-completed questionnaire KOOS score	KOOS (Knee Injury and Osteoarthritis Outcome Score)	12 Months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: jean-olivier ARNAUD, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2018-55; 2018-A02497-48 (Other Identifier: IDRCB)

Drug and device information, study documents

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