Study of Meniscal Allografts (ERAM)
|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
|Condition or disease||Intervention/treatment||Phase|
|Meniscectomy Sequelae||Procedure: Meniscal Allograft||Phase 3|
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)|
|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|
|Experimental: Meniscal Allograft||
Procedure: Meniscal Allograft
- "Function" Subscale in the Koos Scale (area under the curve) [ Time Frame: 2 years follow up ]
- Clinical criteria: pain, quality of life, professional activity [ Time Frame: At 2 years follow-up ]
- Post operative and late complications [ Time Frame: At 2 years follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|