Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 10:46 PM
Study NCT ID:
NCT02511158
Status:
RECRUITING
Last Update Posted:
2020-07-27
First Post:
2015-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2052-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of re-tear', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'International Knee Documentation Committee score', 'timeFrame': '2 years'}, {'measure': 'Lyshom score', 'timeFrame': '2 years'}, {'measure': 'Tegner score', 'timeFrame': '2 years'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '2 years'}, {'measure': 'joint line space measurement on comparative standard radiograph at 30 degree of flexion before surgery and at the final follow-up (Schuss view)', 'timeFrame': '20 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament'], 'conditions': ['Rupture of Anterior Cruciate Ligament', 'Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '25666422', 'type': 'RESULT', 'citation': '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. doi: 10.1016/j.otsr.2014.07.036. Epub 2015 Feb 7.'}, {'pmid': '25082774', 'type': 'RESULT', 'citation': '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. doi: 10.1016/j.otsr.2014.03.024. Epub 2014 Jul 28.'}, {'pmid': '24676789', 'type': 'RESULT', 'citation': '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. doi: 10.1007/s00167-014-2942-4. Epub 2014 Mar 28.'}, {'pmid': '23604176', 'type': 'RESULT', 'citation': '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. doi: 10.1007/s00167-013-2511-2. Epub 2013 Apr 21.'}, {'pmid': '23338663', 'type': 'RESULT', 'citation': 'Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Validity of GNRB(R) arthrometer compared to Telos in the assessment of partial anterior cruciate ligament tears. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):285-90. doi: 10.1007/s00167-013-2384-4. Epub 2013 Jan 22.'}, {'pmid': '30574516', 'type': 'RESULT', 'citation': 'Sadeqi M, Klouche S, Bohu Y, Herman S, Lefevre N, Gerometta A. Progression of the Psychological ACL-RSI Score and Return to Sport After Anterior Cruciate Ligament Reconstruction: A Prospective 2-Year Follow-up Study From the French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST). Orthop J Sports Med. 2018 Dec 17;6(12):2325967118812819. doi: 10.1177/2325967118812819. eCollection 2018 Dec.'}, {'pmid': '30481480', 'type': 'RESULT', 'citation': 'Bohu Y, Klouche S, Herman S, de Pamphilis O, Gerometta A, Lefevre N. Professional Athletes Are Not at a Higher Risk of Infections After Anterior Cruciate Ligament Reconstruction: Incidence of Septic Arthritis, Additional Costs, and Clinical Outcomes From the French Prospective Anterior Cruciate Ligament Study (FAST) Cohort. Am J Sports Med. 2019 Jan;47(1):104-111. doi: 10.1177/0363546518810527. Epub 2018 Nov 27.'}, {'pmid': '30473373', 'type': 'RESULT', 'citation': 'Raoul T, Klouche S, Guerrier B, El-Hariri B, Herman S, Gerometta A, Lefevre N, Bohu Y. Are athletes able to resume sport at six-month mean follow-up after anterior cruciate ligament reconstruction? Prospective functional and psychological assessment from the French Anterior Cruciate Ligament Study (FAST) cohort. Knee. 2019 Jan;26(1):155-164. doi: 10.1016/j.knee.2018.11.006. Epub 2018 Nov 22.'}, {'pmid': '27720193', 'type': 'RESULT', 'citation': '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 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.'}, {'pmid': '27530413', 'type': 'RESULT', 'citation': 'Lefevre N, Klouche S, Mirouse G, Herman S, Gerometta A, Bohu Y. 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. 2017 Jan;45(1):34-41. doi: 10.1177/0363546516660075. Epub 2016 Aug 20.'}, {'pmid': '38333967', 'type': 'DERIVED', 'citation': 'Moussa MK, Lefevre N, Valentin E, Coughlan A, Zgolli A, Gerometta A, Meyer A, Hardy A. Impact of Lateral Extra-Articular Procedure Augmentation on Rerupture Risk and Tegner Activity Scale Outcomes in Adolescent Anterior Cruciate Ligament: A Matched Comparative Study With a Minimum 2-Year Follow-up. Am J Sports Med. 2024 Mar;52(4):892-901. doi: 10.1177/03635465231223703. Epub 2024 Feb 9.'}, {'pmid': '32025764', 'type': 'DERIVED', 'citation': 'Bohu Y, Klouche S, Sezer HB, Herman S, Grimaud O, Gerometta A, Meyer A, Lefevre N. Vancomycin-soaked autografts during ACL reconstruction reduce the risk of post-operative infection without affecting return to sport or knee function. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2578-2585. doi: 10.1007/s00167-020-05879-9. Epub 2020 Feb 5.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One ligament or multi-ligaments tear of the knee\n* Surgery reconstruction with any technique\n\nExclusion Criteria:\n\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02511158', 'acronym': 'FAST', 'briefTitle': 'French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)', 'organization': {'class': 'OTHER', 'fullName': 'Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport'}, 'officialTitle': 'Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery', 'orgStudyIdInfo': {'id': 'CMC2012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ligament of the knee reconstruction', 'type': 'PROCEDURE', 'description': 'Reconstruction of ligaments of the knee by autografts'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Shahnaz Klouche, MD', 'role': 'CONTACT', 'email': 'klouche_shahnaz@yahoo.fr', 'phone': '+628350478'}, {'name': 'Serge Herman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicolas Lefevre, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yoann Bohu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antoine Gerometta, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Médico-Chirurgical Paris V (CMCV)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Shahnaz Klouche, MD', 'role': 'CONTACT', 'email': 'klouche_shahnaz@yahoo.fr', 'phone': '+33628350478'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician responsible of clinical research', 'investigatorFullName': 'Shahnaz Klouche', 'investigatorAffiliation': 'Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport'}}}}