Study of Meniscal Allografts (ERAM)

This study is ongoing, but not recruiting participants.
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: January 28, 2010
Last updated: October 7, 2015
Last verified: October 2015
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: September 2010
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01059409

Hôpital Avicenne - Service de Chirurgie orthopédique
Bobigny, Ile de France, France, 93009
POTEL Jean-François, Clinique Medipole Garonne
Toulouse, France, 31036
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Principal Investigator: Patricia THOREUX, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01059409     History of Changes
Other Study ID Numbers: P070309 / IC0705
Study First Received: January 28, 2010
Last Updated: October 7, 2015
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Meniscal Allografts
Osteoarthritis processed this record on November 27, 2015