ITMO public health
Last update : 10/17/2016 | Version : 1 | ID : 73368
| 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 |
| Scientific investigator(s) (Contact) | |
| Name of the director | Klouche |
| Surname | Shahnaz |
| Address |
23 rue Brochant 75017 PARIS |
| Phone | +33628350478 |
| 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 |
| docteurlefevre@sfr.fr | |
| Unit | Chirurgie orthopédique |
| Organization | Fonds Dotation pour la Recherche Clinique en orthopédie et pathologie du sport |
| 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 |
| 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 |
Access not yet planned |
| Access to individual data |
No access |
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