Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02642692
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2015-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2015-12-25', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cincinnati Knee Rating System', 'timeFrame': '2 years', 'description': 'It is a subjective score'}], 'secondaryOutcomes': [{'measure': 'rerupture', 'timeFrame': '2 years'}, {'measure': 'International Knee Documentantion Committee (IKDC) score', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACL reconstruction', 'Single bundle', 'Clinical results', 'Soccer players'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'referencesModule': {'references': [{'pmid': '10424213', 'type': 'BACKGROUND', 'citation': 'Corry IS, Webb JM, Clingeleffer AJ, Pinczewski LA. Arthroscopic reconstruction of the anterior cruciate ligament. A comparison of patellar tendon autograft and four-strand hamstring tendon autograft. Am J Sports Med. 1999 Jul-Aug;27(4):444-54. doi: 10.1177/03635465990270040701.'}, {'pmid': '8198189', 'type': 'BACKGROUND', 'citation': 'Aglietti P, Buzzi R, Zaccherotti G, De Biase P. Patellar tendon versus doubled semitendinosus and gracilis tendons for anterior cruciate ligament reconstruction. Am J Sports Med. 1994 Mar-Apr;22(2):211-7; discussion 217-8. doi: 10.1177/036354659402200210.'}, {'pmid': '10210074', 'type': 'BACKGROUND', 'citation': 'Carter TR, Edinger S. Isokinetic evaluation of anterior cruciate ligament reconstruction: hamstring versus patellar tendon. Arthroscopy. 1999 Mar;15(2):169-72. doi: 10.1053/ar.1999.v15.0150161.'}, {'pmid': '22048746', 'type': 'BACKGROUND', 'citation': 'Mascarenhas R, Tranovich MJ, Kropf EJ, Fu FH, Harner CD. Bone-patellar tendon-bone autograft versus hamstring autograft anterior cruciate ligament reconstruction in the young athlete: a retrospective matched analysis with 2-10 year follow-up. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1520-7. doi: 10.1007/s00167-011-1735-2. Epub 2011 Nov 3.'}, {'pmid': '20532868', 'type': 'BACKGROUND', 'citation': 'Walden M, Hagglund M, Werner J, Ekstrand J. The epidemiology of anterior cruciate ligament injury in football (soccer): a review of the literature from a gender-related perspective. Knee Surg Sports Traumatol Arthrosc. 2011 Jan;19(1):3-10. doi: 10.1007/s00167-010-1172-7. Epub 2010 Jun 9.'}, {'pmid': '8197541', 'type': 'BACKGROUND', 'citation': 'Fink C, Hoser C, Benedetto KP, Judmaier W. [(Neuro)muscular changes in the knee stabilizing muscles after rupture of the anterior cruciate ligament]. Sportverletz Sportschaden. 1994 Mar;8(1):25-30. doi: 10.1055/s-2007-993449. German.'}, {'pmid': '34604426', 'type': 'DERIVED', 'citation': 'Guglielmetti LGB, Salas VER, Jorge PB, Severino FR, Duarte A, de Oliveira VM, Cury RPL. Prospective and Randomized Clinical Evaluation of Hamstring Versus Patellar Tendon Autograft for Anterior Cruciate Ligament Reconstruction in Soccer Players. Orthop J Sports Med. 2021 Sep 24;9(9):23259671211028168. doi: 10.1177/23259671211028168. eCollection 2021 Sep.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players.', 'detailedDescription': 'A number of techniques for ACL reconstruction have been proposed and tested, and most surgeons now prefer autografts with the patellar tendon or semitendinosus tendon. The functional outcome after ACL reconstruction with the patellar or semitendinosus tendon has been a recent area of interest. Soccer is the most popular sport worldwide with more than 260 million active players, and it is hard to say if patellar tendon or semitendinosus grafts have different outcomes.\n\nThe purpose of this study was to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players. The hypothesis of this study was that hamstring autograft ACL reconstruction would provide no statistically significant differences in patient-reported outcome scores, postoperative level of sports function, and harvest-site morbidity when compared with patellar tendon autograft .The Cincinnati Knee Rating System (CKRS) was chosen as the primary outcome. As secondary outcome, reruptures.\n\nBetween march 2016 and march 2017, 60 soccer players will be operated. The investigators consider as soccer players those who play more than 4 times a week. Once included in the study, they will be randomized in two groups: "hamstring group" and "patellar tendon group".\n\nThe final clinical evaluation with two years. For both groups, the technique is the same, the fixation of the grafts with metal interference screws. Femoral tunnel will be drilled with outside-in technique. The tibial tunnel with conventional 55 degrees guide.\n\nBoth groups of patients will receive the same physical therapy protocol. Data will be evaluated with the SPSS software for Windows (version 13.0).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral ACL lesion\n* skeletally mature patients with closed physis\n* no previous surgery on the affected knee (except for arthroscopic meniscectomy)\n* less than 1 year from injury\n* no associated ligament injuries (except for the medial collateral ligament grade I and II)\n* soccer players.\n\nExclusion Criteria:\n\n* morbid obesity\n* degenerative changes in arthroscopy or image exams\n* those who play soccer less than 4 times / week'}, 'identificationModule': {'nctId': 'NCT02642692', 'briefTitle': 'Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Hamstrings X Patellar Tendon for Anterior Cruciate Ligament Reconstruction in Soccer Players - RCT', 'orgStudyIdInfo': {'id': '16373713.1.0000.5479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patellar Tendon Graft', 'description': 'Kind of graft that will be used for acl reconstruction', 'interventionNames': ['Procedure: Patellar Tendon graft']}, {'type': 'EXPERIMENTAL', 'label': 'Hamstring Graft', 'description': 'Kind of graft that will be used for acl reconstruction', 'interventionNames': ['Procedure: Hamstring Graft']}], 'interventions': [{'name': 'Patellar Tendon graft', 'type': 'PROCEDURE', 'description': 'Acl reconstruction with patellar tendon graft', 'armGroupLabels': ['Patellar Tendon Graft']}, {'name': 'Hamstring Graft', 'type': 'PROCEDURE', 'description': 'Acl reconstruction with hamstring graft', 'armGroupLabels': ['Hamstring Graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01221020', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'luiz G guglielmetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Ciencias Medicas da Santa Casa de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Master, Phd', 'investigatorFullName': 'Luiz Gabriel Betoni Guglielmetti', 'investigatorAffiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}}}}