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

Completed

• Conditions: Knee Ligament Injury

• Registration Number: NCT04122677
• Lead Sponsor: Biomatlante

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Study Start: 2019-11-14
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of the objective International Knee Documentation Committee score before and after surgery	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)
Change of the subjective International Knee Documentation Committee score before and after surgery	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 Outcome Measures

Name	Time	Method
Number and precise description of any adverse event during the follow-up	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
Change in the patients recovery	2 months post-surgery	Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery

Trial Locations

Locations (1)

Centre ORTHEO; 🇫🇷 Saint-Étienne, Loire, France