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

NCT04122677 | Completed

• 1 other identifier: 2018-A03207-48
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Ligament Injury

Keywords

Knee Ligament Injury; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Reconstruction; Knee Ligament Rupture; Knee Ligament Reconstruction

Outcome Measures

Primary Outcomes (2)

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

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

  4 months before surgery / 7 months post-surgery

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

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

  4 months before surgery / 7 months post-surgery

Secondary Outcomes (2)

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

  Before surgery until 7 months post-surgery

• Change in the patients recovery

  2 months post-surgery

Interventions

Anterior Cruciate Ligament Reconstruction DEVICE

Reconstruction of the Anterior Cruciate Ligament using an interference screw.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria. The study population is composed of 56 patients according to the protocol.

You may qualify if:

• 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

You may not qualify if:

• History of ligament, meniscal surgery or fracture of the affected knee
• Pregnancy of breastfeeding women

Sponsors & Collaborators

• Biomatlante: lead
• Atlanstat: collaborator

Study Sites (1)

Centre ORTHEO

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

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• François-Xavier FV VERDOT, M.D.

  Centre ORTHEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 10, 2019
• Study Start: November 14, 2019
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)