French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST) (FAST)

July 24, 2020 updated by: Shahnaz Klouche, Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75005
        • Recruiting
        • Centre Médico-Chirurgical Paris V (CMCV)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of re-tear
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
International Knee Documentation Committee score
Time Frame: 2 years
2 years
Lyshom score
Time Frame: 2 years
2 years
Tegner score
Time Frame: 2 years
2 years
Knee injury and Osteoarthritis Outcome Score
Time Frame: 2 years
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)
Time Frame: 20 years
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2032

Study Completion (Anticipated)

September 1, 2052

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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