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OpenTrials
Completed

NCT Number: NCT04122677

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

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Key information

Conditions

Knee Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre ORTHEO

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior cruciate ligament reconstruction

Device

Reconstruction of the Anterior Cruciate Ligament using an interference screw.

Primary outcomes

  1. Change of the objective International Knee Documentation Committee score before and after surgery

    Time frame: 4 months before surgery / 7 months post-surgery

    Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal)

  2. Change of the subjective International Knee Documentation Committee score before and after surgery

    Time frame: 4 months before surgery / 7 months post-surgery

    Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result)

Secondary outcomes

  1. Number and precise description of any adverse event during the follow-up

    Time frame: Before surgery until 7 months post-surgery

    Record and description of any adverse event during the follow-up that reflects the safety of the Polylactic Interference Screw

  2. Change in the patients recovery

    Time frame: 2 months post-surgery

    Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery

Sponsors and collaborators

Lead sponsor

Biomatlante

Industry

Collaborators

  • Atlanstat

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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