NCT04076956

Brief Summary

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. 1.Objective IKDC score (clinical evaluation)
  2. 2.Subjective IKDS score (functional evaluation)
  3. 3.Safety (report of any adverse event)
  4. 4.Follow-up of the patient's recovery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

August 28, 2019

Last Update Submit

February 3, 2025

Conditions

Knee Ligament Injury

Keywords

Knee ligament injuryAnterior cruciate ligament ruptureAnterior cruciate ligament reconstructionKnee ligament ruptureKnee 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 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 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 ReconstructionDEVICE

Reconstruction of the Anterior Cruciate Ligament using an interference screw

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique JUGE

Marseille, PACA, 13008, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Jaafar JS SBIHI, M.D.

    Clinique Juge

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 28, 2019

First Posted

September 4, 2019

Study Start

August 23, 2019

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)