Study of Meniscal Allografts

NCT ID: NCT01059409

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Meniscectomy Sequelae

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meniscal Allograft

Group Type EXPERIMENTAL

Meniscal Allograft

Intervention Type PROCEDURE

Meniscal Allograft

Interventions

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Meniscal Allograft

Meniscal Allograft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia THOREUX, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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POTEL Jean-François, Clinique Medipole Garonne

Toulouse, , France

Site Status

Hôpital Avicenne - Service de Chirurgie orthopédique

Bobigny, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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P070309 / IC0705

Identifier Type: -

Identifier Source: org_study_id

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