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

NCT ID: NCT05123456

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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ACL Anterior Curciate Ligament Anterolateral Ligament Knee Injuries ALL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patient operated with isolated ACL knee reconstruction

Group Type EXPERIMENTAL

Radiography

Intervention Type PROCEDURE

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

Patient operated with ACL and ALL knee reconstruction

Group Type EXPERIMENTAL

Radiography

Intervention Type PROCEDURE

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

Interventions

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Radiography

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Private Hospital Jean Mermoz

UNKNOWN

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital privé Jean Mermoz

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bertrand SONNERY COTTET, Dr

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37154412 (View on PubMed)

Other Identifiers

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2018-A02447-48

Identifier Type: -

Identifier Source: org_study_id