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Trial record 31 of 88 for:    Recruiting, Not yet recruiting, Available Studies | "Anterior Cruciate Ligament"

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

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ClinicalTrials.gov Identifier: NCT02511158
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Shahnaz Klouche, 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.

Condition or disease Intervention/treatment
Rupture of Anterior Cruciate Ligament Osteoarthritis Procedure: Ligament of the knee reconstruction

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 [Patient Registry]
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery
Study Start Date : September 2012
Estimated Primary Completion Date : September 2032
Estimated Study Completion Date : September 2052

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Ligament of the knee reconstruction
    Reconstruction of ligaments of the knee by autografts


Primary Outcome Measures :
  1. Number of re-tear [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511158


Contacts
Contact: Shahnaz Klouche, MD +33628350478 klouche_shahnaz@yahoo.fr

Locations
France
Centre Médico-Chirurgical Paris V (CMCV) Recruiting
Paris, France, 75005
Contact: Shahnaz Klouche, MD    +628350478    klouche_shahnaz@yahoo.fr   
Principal Investigator: Serge Herman, MD         
Sub-Investigator: Nicolas Lefevre, MD         
Sub-Investigator: Yoann Bohu, MD         
Sub-Investigator: Antoine Gerometta, MD         
Sponsors and Collaborators
Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahnaz Klouche, Physician responsible of clinical research, Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport
ClinicalTrials.gov Identifier: NCT02511158     History of Changes
Other Study ID Numbers: CMC2012
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Shahnaz Klouche, Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport:
Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament

Additional relevant MeSH terms:
Osteoarthritis
Rupture
Anterior Cruciate Ligament Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries