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

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

Summary

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

Conditions

Knee Ligament Injury

Intervention

Anterior Cruciate Ligament Reconstruction

Status

Not yet recruiting

Source

Biomatlante

Results (where available)

View Results

Links

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

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PubMed Articles [8950 Associated PubMed Articles listed on BioPortfolio]

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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.

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Sprain or tear injuries to the ANTERIOR CRUCIATE LIGAMENT of the knee.

A strong ligament of the knee that originates from the posteromedial portion of the lateral condyle of the femur, passes anteriorly and inferiorly between the condyles, and attaches to the depression in front of the intercondylar eminence of the tibia.

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