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

NCT ID: NCT03866824

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-12-04

Brief Summary

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).

Conditions

DEGENERATIVE MENISCAL LESIONS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRP group

Group Type: EXPERIMENTAL

injection of Platelet Enhanced Plasma(PRP)

Intervention Type: DRUG

intra-articular injection

RMI

Intervention Type: DEVICE

A CONTROL RMI at 1 year follow-up.

reference treatment

Group Type: ACTIVE_COMPARATOR

injection of corticosteroids

Intervention Type: DRUG

intra-articular injection

RMI

Intervention Type: DEVICE

A CONTROL RMI at 1 year follow-up.

Interventions

injection of Platelet Enhanced Plasma(PRP)

intra-articular injection

Intervention Type: DRUG

injection of corticosteroids

intra-articular injection

Intervention Type: DRUG

RMI

A CONTROL RMI at 1 year follow-up.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean-olivier ARNAUD

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2018-A02497-48

Identifier Type: OTHER

Identifier Source: secondary_id

2018-55

Identifier Type: -

Identifier Source: org_study_id