Study of Meniscal Allografts
Summary
Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.
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 which will be used are taken on dead donors and then frozen with respect of 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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Total or Subtotal Meniscectomy Sequelae
Intervention
Meniscal Allograft, Control arm
Location
Hôpital Avicenne - Service de Chirurgie orthopédique
Bobigny
Ile de France
France
93009
Status
Not yet recruiting
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01059409
- Information obtained from ClinicalTrials.gov on July 15, 2010
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