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

Study Overview

• Status: Unknown
• Conditions: Knee Ligament Injury
• Intervention / Treatment: Device: Anterior Cruciate Ligament Reconstruction

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

Study Locations

• France
  • Loire
    • Saint-Étienne, Loire, France, 42100
      • Recruiting
      • Centre ORTHEO
      • Contact: François-Xavier FV VERDOT, M.D.; Phone Number: 0477490986; Email: fxverdot@ortheo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and precise description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the Polylactic Interference Screw	Before surgery until 7 months post-surgery
Change in the patients recovery	Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery	2 months post-surgery

Collaborators and Investigators

• Sponsor: Biomatlante
• Collaborators: Atlanstat
• Investigators: Principal Investigator: François-Xavier FV VERDOT, M.D., Centre ORTHEO

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Anticipated): October 5, 2021
• Study Completion (Anticipated): October 5, 2021

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Reconstruction; Knee Ligament Injury; Knee Ligament Rupture; Knee Ligament Reconstruction
• Other Study ID Numbers: 2018-A03207-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No