Study of Meniscal Allografts (ERAM)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Meniscectomy Sequelae

Treatments: Procedure: Meniscal Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT01059409

P070309 / IC0705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Meniscal Allograft

Experimental group

Treatment:

Procedure: Meniscal Allograft