Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions

Study Overview
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Brief Summary
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The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the PIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters: Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery

Official Title
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Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions

Conditions
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Knee Ligament Injury

Intervention / Treatment
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* Device: Anterior Cruciate Ligament Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute or chronic Anterior Cruciate Ligament deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons Males or females aged from 18 to 60 years No history of surgery on the affected knee Patients not under guardianship or judicial protection Signature of non opposition form (consent of the patient Exclusion Criteria: History of ligament, meniscal surgery or fracture of the affected knee Pregnancy of breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Anterior Cruciate Ligament Reconstruction|Reconstruction of the Anterior Cruciate Ligament using an interference screw.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the objective International Knee Documentation Committee score before and after surgery | Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal) | 4 months before surgery / 7 months post-surgery | 
| Change of the subjective International Knee Documentation Committee score before and after surgery | Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result) | 4 months before surgery / 7 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and precise description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the Polylactic Interference Screw | Before surgery until 7 months post-surgery | 
| Change in the patients recovery | Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery | 2 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Knee Ligament Rupture, Knee Ligament Reconstruction