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NCT05123456 Clinical 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

Knee Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05123456
Other study ID # 2018-A02447-48
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2020
Est. completion date December 15, 2021

Study information
Verified date November 2021
Source Ramsay Générale de Santé
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Radiography
Comparative X-ray of the single knee at 30 ° flexion.

Locations
Country Name City State
France Hopital privé Jean Mermoz Lyon

Sponsors (3)
Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network, Private Hospital Jean Mermoz

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 day
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