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Status unknownNCT05123456Updated Nov 17, 2021

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

An interventional study of Radiography in ACL, Anterior Curciate Ligament and Anterolateral Ligament, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-17.

Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2020, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ACL
  • Anterior Curciate Ligament
  • Anterolateral Ligament
  • Knee Injuries
  • ALL
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 180 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Patient operated with isolated ACL knee reconstruction

    Procedure: Radiography

  • Experimental
    Patient operated with ACL and ALL knee reconstruction

    Procedure: Radiography

Interventions

  • ProcedureRadiography

    Comparative X-ray of the single knee at 30 ° flexion.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Hopital privé Jean Mermoz
    Lyon, 69008, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05123456
Lead sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network, Private Hospital Jean Mermoz
Responsible party
Sponsor
First posted
Nov 17, 2021
Start date
Apr 15, 2020
Primary completion
Apr 15, 2021
Completion
Dec 15, 2021 (estimated)
Last update
Nov 17, 2021

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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