Study of Meniscal Allografts (ERAM)
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 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.|
- "Function" Subscale in the Koos Scale (area under the curve) [ Time Frame: 2 years follow up ] [ Designated as safety issue: No ]
- 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 ]
|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)|
|Experimental: Meniscal Allograft||
Procedure: Meniscal Allograft
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059409
|Hôpital Avicenne - Service de Chirurgie orthopédique|
|Bobigny, Ile de France, France, 93009|
|POTEL Jean-François, Clinique Medipole Garonne|
|Toulouse, France, 31036|
|Principal Investigator:||Patricia THOREUX, MD,PhD||Assistance Publique - Hôpitaux de Paris|