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NCT Number: NCT02511158

French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)

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.

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Arthritis Joint Diseases Knee Injuries Leg Injuries Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Wounds and Injuries

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Médico-Chirurgical Paris V (CMCV)

Paris, 75005, France

Location status: Recruiting

Location contact

Antoine Gerometta, MD

SUB_INVESTIGATOR

Nicolas Lefevre, MD

SUB_INVESTIGATOR

Serge Herman, MD

PRINCIPAL_INVESTIGATOR

Shahnaz Klouche, MD

CONTACT

[email protected]

+628350478

Yoann Bohu, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient refusal

Treatment and study plan

Ligament of the knee reconstruction

Procedure

Reconstruction of ligaments of the knee by autografts

Primary outcomes

  1. Number of re-tear

    Time frame: 2 years

Secondary outcomes

  1. International Knee Documentation Committee score

    Time frame: 2 years

  2. Lyshom score

    Time frame: 2 years

  3. Tegner score

    Time frame: 2 years

  4. Knee injury and Osteoarthritis Outcome Score

    Time frame: 2 years

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shahnaz Klouche, MD

CONTACT

[email protected]

+33628350478

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery

Acronym: FAST

Important dates

Study start
2012
Primary completion
2032
Study completion
2052
First posted
Jul 29, 2015
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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