search
Back to results

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

Primary Purpose

ACL, Anterior Curciate Ligament, Anterolateral Ligament

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiography
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for ACL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital privé Jean MermozRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient operated with isolated ACL knee reconstruction

Patient operated with ACL and ALL knee reconstruction

Arm Description

Outcomes

Primary Outcome Measures

Assessment of the prevalence of femoro-tibial osteoarthritis
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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2021
Last Updated
November 9, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network, Private Hospital Jean Mermoz
search

1. Study Identification

Unique Protocol Identification Number
NCT05123456
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network, Private Hospital Jean Mermoz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, Anterior Curciate Ligament, Anterolateral Ligament, Knee Injuries, ALL

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient operated with isolated ACL knee reconstruction
Arm Type
Experimental
Arm Title
Patient operated with ACL and ALL knee reconstruction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Radiography
Intervention Description
Comparative X-ray of the single knee at 30 ° flexion.
Primary Outcome Measure Information:
Title
Assessment of the prevalence of femoro-tibial osteoarthritis
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Hopital privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand SONNERY COTTET, Dr
Phone
+33 (0)4 37 53 00 24
Email
sonnerycottet@aol.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs