French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)

Recruiting

• Conditions: Rupture of Anterior Cruciate Ligament; Osteoarthritis

• Registration Number: NCT02511158
• Lead Sponsor: Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

Brief Summary

In this study we will examine patients who have undergone anterior cruciate and/or posterior cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury, contralateral tear and functional outcomes at least two years after surgery.

Detailed Description

The purpose of this study is to identify the rate of re tear two year after ligament reconstruction of the knee. The second objective is to assess the osteoarthritis of the knee at 20 years follow-up.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27
• Primary Completion: 2032-09
• Study Completion: 2052-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

• One ligament or multi-ligaments tear of the knee
• Surgery reconstruction with any technique

Exclusion Criteria

• Patient refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of re-tear	2 years

Secondary Outcome Measures

Name	Time	Method
Tegner score	2 years
International Knee Documentation Committee score	2 years
Knee injury and Osteoarthritis Outcome Score	2 years
joint line space measurement on comparative standard radiograph at 30 degree of flexion before surgery and at the final follow-up (Schuss view)	20 years
Lyshom score	2 years

Trial Locations

Locations (1)

Centre Médico-Chirurgical Paris V (CMCV); 🇫🇷 Paris, France