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

The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Composite Interference Scres 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 CIS, 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:

1. Objective IKDC score (clinical evaluation)
2. Subjective IKDS score (functional evaluation)
3. Safety (report of any adverse event)
4. 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
  • Paca
    • Marseille, Paca, France, 13008
      • Recruiting
      • Clinique Juge
      • Contact: Jaafar JS SBIHI, M.D.; Phone Number: 0811632282; Email: j.sbihi13@gmail.com
      • Contact: Nathalie NR RICHARDET, CRA; Phone Number: 0811632282; Email: nathalie.richardet@icos13.com
      • Principal Investigator: Jaafar JS SBIHI, M.D.

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 ACL 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 froù 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 surgey / 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 surgey / 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 Composite Interference Screw	Before surgery until 7 months post-surgery
Change in the patients recovery	Record of recovery informations	2 months post-surgery

Collaborators and Investigators

• Sponsor: Biomatlante
• Collaborators: Atlanstat
• Investigators: Principal Investigator: Jaafar JS SBIHI, M.D., Clinique Juge

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2019
• Primary Completion (ANTICIPATED): August 23, 2021
• Study Completion (ANTICIPATED): August 23, 2021

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (ACTUAL): September 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Anterior cruciate ligament reconstruction; Knee ligament injury; Anterior cruciate ligament rupture; Knee ligament rupture; Knee ligament reconstruction
• Other Study ID Numbers: 2018-A03211-54

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