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Insufficient number of patients included compared to the expected duration of inclusion.
sponsor's decision
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meniscal Allograft | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meniscal Allograft | Procedure | Meniscal Allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Function" Subscale in the Koos Scale (area under the curve) | Koos Scale | 2 years follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical criteria: pain, quality of life, professional activity | Pain, quality of life, professional activity | At 2 years follow-up |
| Post operative and late complications | Post operative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia THOREUX, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| POTEL Jean-François, Clinique Medipole Garonne | Toulouse | 31036 | France | |||
| Hôpital Avicenne - Service de Chirurgie orthopédique |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| At 2 years follow-up |
| Bobigny |
| Île-de-France Region |
| 93009 |
| France |