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| Name | Class |
|---|---|
| Atlanstat | INDUSTRY |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cruciate Ligament Reconstruction | Device | Reconstruction of the Anterior Cruciate Ligament using an interference screw. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.
The study population is composed of 56 patients according to the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| François-Xavier FV VERDOT, M.D. | Centre ORTHEO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre ORTHEO | Saint-Étienne-de-Montluc | Pays de la Loire Region | 42100 | France |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2019 | Sep 30, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059549 | Anterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery |
| 2 months post-surgery |