FAST - French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study

Head :
Klouche Shahnaz, Chirurgie orthopédique
Lefevre Nicolas, Chirurgie orthopédique

Last update : 10/17/2016 | Version : 1 | ID : 73368

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study
Sign or acronym FAST
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CPP IDFVI - CNIL N°1556375 - NCT02511158
General Aspects
Medical area Physical medicine and rehabilitation
Radiology and medical imaging
Traumatology
Pathology (details) Rupture of Anterior Cruciate Ligament of the Knee
Keywords Anterior Cruciate Ligament; ACL Reconstruction; Sport injuries
Collaborations
Participation in projects, networks and consortia No
Funding
Funding status Private
Details Fond de Dotation pour la Recherche Clinique en orthopédie et pathologie du sport
Governance of the database
Sponsor(s) or organisation(s) responsible Fond de Dotation pour la Recherche Clinique en orthopédie et pathologie du sport
Organisation status Private
Presence of scientific or steering committees No
Scientific investigator(s) (Contact)
Name of the director Klouche
Surname Shahnaz
Address 23 rue Brochant
75017 PARIS
Phone +33628350478
Email klouche_shahnaz@yahoo.fr
Unit Chirurgie orthopédique
Organization Fonds Dotation pour la Recherche Clinique en orthopédie et pathologie du sport
Name of the director Lefevre
Surname Nicolas
Address 23 rue Brochant
75017 PARIS
Phone + 33 (1) 40 79 40 36
Email docteurlefevre@sfr.fr
Unit Chirurgie orthopédique
Organization Fonds Dotation pour la Recherche Clinique en orthopédie et pathologie du sport
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health care professionals
Database recruitment is is made on the basis of: Another treatment or procedure
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria
Database objective
Main objective 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.
Inclusion criteria Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria:
• One ligament or multi-ligaments tear of the knee
• Surgery reconstruction with any technique
Population type
Age Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2012
Date of last collection (YYYY or MM/YYYY) 2032
Size of the database
Size of the database (number of individuals) [10 000-20 000[ individuals
Details of the number of individuals 500 persons per year
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Administrative data
Clinical data (detail) Direct physical measures
Details of collected clinical data Peroperative data , objective scores of the knee (IKDC, range of motion)
Declarative data (detail) Internet self-questionnaire
Details of collected declarative data Level
Paraclinical data (detail) GNRB, MRI
Biological data (detail) None
Presence of a biobank No
Health parameters studied Health event/morbidity
Quality of life/health perception
Quality of life/perceived health (detail) Psychological factors involved in the ability to return to sport (ACL-RSI scale)
Procedures
Data collection method Internet (e-CRF and self-questionnaires) on websurvey software
Quality procedure(s) used Automatic and scheduled checking (monthly)
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Monitoring by contact with the referring doctor
Links to administrative sources No
Promotion and access
Promotion
Link to the document doi: 10.1007/s00167-013-2384-4
Description Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Validity of GNRB® arthrometer compared to Telos™ in the assessment of partial anterior cruciate ligament tears. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):285-90.
Link to the document doi: 10.1007/s00167-013-2511-2
Description Lefevre N, Naouri JF, Bohu Y, Klouche S, Herman S. Sensitivity and specificity of bell-hammer tear as an indirect sign of partial anterior cruciate ligament rupture on magnetic resonance imaging. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1112-8.
Link to the document doi: 10.1007/ s00167-014-2942-4
Description Bohu Y, Klouche S, Lefevre N, Webster K, Herman S. Translation, cross-cultural adaptation and validation of the French version of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1192-6
Link to the document doi: 10.1016/j.otsr.2014.03.024
Description Lefevre N, Bohu Y, de Pamphilis O, Klouche S, Devaux C, Herman S. Outpatient surgery feasibility in anterior cruciate ligament reconstruction: a prospective comparative assessment. Orthop Traumatol Surg Res. 2014 Sep;100(5):521-6
Link to the document doi: 10.1016/j.otsr.2014.07.036
Description Lefevre N, Klouche S, de Pamphilis O, Devaux C, Herman S, Bohu Y. Postoperative discomfort after outpatient anterior cruciate ligament reconstruction: a prospective comparative study. Orthop Traumatol Surg Res. 2015 Apr;101(2):163-6
Link to the document doi: 10.1177/0363546516660075
Description Return to Sport After Primary and Revision Anterior Cruciate Ligament Reconstruction: A Prospective Comparative Study of 552 Patients From the FAST Cohort. Am J Sports Med. 2016 Aug 16
Link to the document Doi : 10.1016/j.otsr.2016.07.011
Description 1. Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Oct 3
Access
Presence of document that lists variables and coding procedures Yes
Terms of data access (charter for data provision, format of data, availability delay) Access to data is restricted to medical director of clinical research program, surgeons and clinical research assitants of the "Fond de Dotation pour la Recherche Clinique en orthopédie et pathologie du sport"
Access to aggregated data No access
Access to individual data No access

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