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
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedFirst Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedNovember 17, 2021
November 1, 2021
1 year
November 9, 2021
November 9, 2021
Conditions
Outcome Measures
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.
1 day
Study Arms (2)
Patient operated with isolated ACL knee reconstruction
EXPERIMENTALPatient operated with ACL and ALL knee reconstruction
EXPERIMENTALInterventions
Comparative X-ray of the single knee at 30 ° flexion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
- Private Hospital Jean Mermozcollaborator
Study Sites (1)
Hopital privé Jean Mermoz
Lyon, 69008, France
Related Publications (1)
Shatrov J, Freychet B, Hopper GP, Coulin B, El Helou A, An JS, Vieira TD, Sonnery-Cottet B. Radiographic Incidence of Knee Osteoarthritis After Isolated ACL Reconstruction Versus Combined ACL and ALL Reconstruction: A Prospective Matched Study From the SANTI Study Group. Am J Sports Med. 2023 Jun;51(7):1686-1697. doi: 10.1177/03635465231168899. Epub 2023 May 8.
PMID: 37154412DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 17, 2021
Study Start
April 15, 2020
Primary Completion
April 15, 2021
Study Completion
December 15, 2021
Last Updated
November 17, 2021
Record last verified: 2021-11