Knee Ligament Injury Clinical Trial
Official title:
Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions
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
n/a
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