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Study of Meniscal Allografts (ERAM)

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ClinicalTrials.gov Identifier: NCT01059409
Recruitment Status : Unknown
Verified May 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2010
Last Update Posted : May 10, 2016
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Meniscectomy Sequelae Procedure: Meniscal Allograft Phase 3

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : September 2010
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Meniscal Allograft Procedure: Meniscal Allograft
Meniscal Allograft



Primary Outcome Measures :
  1. "Function" Subscale in the Koos Scale (area under the curve) [ Time Frame: 2 years follow up ]

Secondary Outcome Measures :
  1. Clinical criteria: pain, quality of life, professional activity [ Time Frame: At 2 years follow-up ]
  2. Post operative and late complications [ Time Frame: At 2 years follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059409


Locations
France
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
Investigators
Principal Investigator: Patricia THOREUX, MD,PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01059409     History of Changes
Other Study ID Numbers: P070309 / IC0705
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

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