Study of Meniscal Allografts

Not Applicable

Terminated

• Conditions: Meniscectomy Sequelae
• Interventions: Procedure: Meniscal Allograft

• Registration Number: NCT01059409
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.

Detailed Description

Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.

The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.

The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.

Study Timeline

• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Study Start: 2010-09
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age from 18 on
• Previous total or subtotal meniscectomy
• Medical insurance
• Female patients have to be under contraceptive treatment
• Sign consent form

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Exclusion Criteria

• Age < 18 years
• Pregnant or breast-feeding woman
• Need of a simultaneous frontal osteotomy
• Inflammatory disease
• Septic background
• Psychiatric background
• Understanding difficulties or problems for follow-up
• No consent
• No medical insurance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meniscal Allograft	Meniscal Allograft	-

Primary Outcome Measures

Name	Time	Method
"Function" Subscale in the Koos Scale (area under the curve)	2 years follow up	Koos Scale

Secondary Outcome Measures

Name	Time	Method
Clinical criteria: pain, quality of life, professional activity	At 2 years follow-up	Pain, quality of life, professional activity
Post operative and late complications	At 2 years follow-up	Post operative complications

Trial Locations

Locations (2)

POTEL Jean-François, Clinique Medipole Garonne; 🇫🇷 Toulouse, France

Hôpital Avicenne - Service de Chirurgie orthopédique; 🇫🇷 Bobigny, Ile De France, France