Study of Meniscal Allografts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.

Conditions
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Meniscectomy Sequelae

Intervention / Treatment
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* Procedure: Meniscal Allograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meniscal Allograft<br> | Procedure: Meniscal Allograft<br>* Meniscal Allograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function Subscale in the Koos Scale (area under the curve) | Koos Scale | 2 years follow up | 

Secondary Outcome Measures

| Outcome Measure | 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 | At 2 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meniscal Allografts, Osteoarthritis