Overview

This trial is active, not recruiting.

Condition meniscectomy sequelae
Treatment meniscal allograft
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Ministry of Health, France
Start date September 2010
End date September 2017
Trial size 120 participants
Trial identifier NCT01059409, P070309 / IC0705

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
meniscal allograft
Meniscal Allograft

Primary Outcomes

Measure
"Function" Subscale in the Koos Scale (area under the curve)
time frame: 2 years follow up

Secondary Outcomes

Measure
Clinical criteria: pain, quality of life, professional activity
time frame: At 2 years follow-up
Post operative and late complications
time frame: At 2 years follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.
Principal investigator Patricia THOREUX, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.