Meniscectomy Sequelae
Conditions
Keywords
Meniscal Allografts, Osteoarthritis
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.
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.
Interventions
PROCEDUREMeniscal Allograft
Meniscal Allograft
Sponsors
Ministry of Health, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Function Subscale in the Koos Scale (area under the curve) | 2 years follow up | Koos Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical criteria: pain, quality of life, professional activity | At 2 years follow-up | Pain, quality of life, professional activity |
| Post operative and late complications | At 2 years follow-up | Post operative complications |
Countries
France
Outcome results
None listed