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

Sponsor
Ramsay Générale de Santé (Other)
Overall Status
Recruiting
CT.gov ID
NCT05123456
Collaborator
European Clinical Trial Experts Network (Other), Private Hospital Jean Mermoz (Other)
180
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20
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiography
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
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
Actual Study Start Date :
Apr 15, 2020
Actual Primary Completion Date :
Apr 15, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Assessment of the prevalence of femoro-tibial osteoarthritis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital privé Jean Mermoz Lyon France 69008

Sponsors and Collaborators

  • Ramsay Générale de Santé
  • European Clinical Trial Experts Network
  • Private Hospital Jean Mermoz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramsay Générale de Santé
ClinicalTrials.gov Identifier:
NCT05123456
Other Study ID Numbers:
  • 2018-A02447-48
First Posted:
Nov 17, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021