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Study of Meniscal Allografts (ERAM)

This study is currently recruiting participants.
Verified December 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01059409
First received: January 28, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Meniscectomy Sequelae
 Procedure: Meniscal Allograft
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • "Function" Subscale in the Koos Scale (area under the curve) [ Time Frame: 2 years follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical criteria: pain, quality of life, professional activity [ Time Frame: At 2 years follow-up ] [ Designated as safety issue: Yes ]
  • Post operative and late complications [ Time Frame: At 2 years follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meniscal Allograft Procedure: Meniscal Allograft
Meniscal Allograft

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059409

Contacts
Contact: Patricia THOREUX, MD,PhD 33(1) 48-95-58-11 patricia.thoreux@avc.aphp.fr

Locations
France
Hôpital Avicenne - Service de Chirurgie orthopédique Not yet recruiting
Bobigny, Ile de France, France, 93009
Contact: Patricia THOREUX, MD,PhD     33(1)48-95-58-11     patricia.thoreux@avc.aphp.fr    
Principal Investigator: Patricia THOREUX, MD, PhD            
POTEL Jean-François, Clinique Medipole Garonne Recruiting
Toulouse, France, 31036
Contact: Jean-François POTEL, MD-PhD     +33 (0) 6 07 37 71 47     jf.potel@wanadoo.fr    
Contact: Christophe JAVOIS, MD     33(0) 6.80.57.81.02     christophe.javois@yahoo.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Patricia THOREUX, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01059409     History of Changes
Other Study ID Numbers: P070309 / IC0705
Study First Received: January 28, 2010
Last Updated: December 11, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Meniscal Allografts
Osteoarthritis

ClinicalTrials.gov processed this record on June 17, 2013