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

Biomatlante

Status: Completed

Conditions: Knee Ligament Injury

Treatments: Device: Anterior Cruciate Ligament Reconstruction

Study type: Observational

Funder types: Industry

Identifiers

NCT04122677

2018-A03207-48

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design