Study of Meniscal Allografts (ERAM)

August 31, 2020 updated by: Assistance Publique - Hôpitaux de Paris

The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31036
        • POTEL Jean-François, Clinique Medipole Garonne
    • Ile De France
      • Bobigny, Ile De France, France, 93009
        • Hôpital Avicenne - Service de Chirurgie orthopédique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meniscal Allograft
Procedure: Meniscal Allograft
Meniscal Allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Function" Subscale in the Koos Scale (area under the curve)
Time Frame: 2 years follow up
Koos Scale
2 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical criteria: pain, quality of life, professional activity
Time Frame: At 2 years follow-up
Pain, quality of life, professional activity
At 2 years follow-up
Post operative and late complications
Time Frame: At 2 years follow-up
Post operative complications
At 2 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Patricia THOREUX, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P070309 / IC0705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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