Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL

November 9, 2021 updated by: Ramsay Générale de Santé
The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Recruiting
        • Hopital Prive Jean Mermoz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent an isolated Anterior Cruciate Ligament (ACL) reconstruction or a combined ACL and anterolateral ligament reconstruction (Extra Articular Plasty) between January 1, 2011 and March 31, 2012.
  • Patients affiliated or beneficiaries of a social security scheme
  • Patients who have given their express consent.

Exclusion Criteria:

  • Patients with pediatric ACL reconstruction technique
  • Patients with a complex associated gesture such as osteotomy or ligamentoplasty other than extra articular plastic surgery.
  • Contraindication to a radio control (pregnancy)
  • Patient's refusal to participate in the study
  • Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient operated with isolated ACL knee reconstruction
Procedure: Radiography
Comparative X-ray of the single knee at 30 ° flexion.
Experimental: Patient operated with ACL and ALL knee reconstruction
Procedure: Radiography
Comparative X-ray of the single knee at 30 ° flexion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the prevalence of femoro-tibial osteoarthritis
Time Frame: 1 day
The prevalence of femoro-tibial osteoarthritis will be assessed by the percentage of patients with cartilage damage to the femoro-tibial compartments on a single X-ray of the face compared to 30 °of flexion.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network
Private Hospital Jean Mermoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02447-48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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