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

NCT04122677 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2025-02-04

No results posted yet for this study

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

Conditions

  • Knee Ligament Injury

Interventions

DEVICE

Anterior Cruciate Ligament Reconstruction

Reconstruction of the Anterior Cruciate Ligament using an interference screw.

Sponsors & Collaborators

  • Atlanstat

    collaborator INDUSTRY

  • Biomatlante

    lead INDUSTRY

Principal Investigators

  • François-Xavier FV VERDOT, M.D. · Centre ORTHEO

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2022-12-21
Completion
2022-12-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04122677 on ClinicalTrials.gov