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

2019-10-16 10:39:32 | BioPortfolio


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

Study Design


Knee Ligament Injury


Anterior Cruciate Ligament Reconstruction


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2019-10-16T10:39:32-0400

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Medical and Biotech [MESH] Definitions

Rebuilding of the ANTERIOR CRUCIATE LIGAMENT to restore functional stability of the knee. AUTOGRAFTING or ALLOGRAFTING of tissues is often used.

Rebuilding of the POSTERIOR CRUCIATE LIGAMENT to restore functional stability of the knee.

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