Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT
NCT ID: NCT02642692
Last Updated: 2021-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-06-30
2020-12-31
Brief Summary
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Detailed Description
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The 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.
Between 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".
The 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.
Both groups of patients will receive the same physical therapy protocol. Data will be evaluated with the SPSS software for Windows (version 13.0).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patellar Tendon Graft
Kind of graft that will be used for acl reconstruction
Patellar Tendon graft
Acl reconstruction with patellar tendon graft
Hamstring Graft
Kind of graft that will be used for acl reconstruction
Hamstring Graft
Acl reconstruction with hamstring graft
Interventions
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Patellar Tendon graft
Acl reconstruction with patellar tendon graft
Hamstring Graft
Acl reconstruction with hamstring graft
Eligibility Criteria
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Inclusion Criteria
* skeletally mature patients with closed physis
* no previous surgery on the affected knee (except for arthroscopic meniscectomy)
* less than 1 year from injury
* no associated ligament injuries (except for the medial collateral ligament grade I and II)
* soccer players.
Exclusion Criteria
* degenerative changes in arthroscopy or image exams
* those who play soccer less than 4 times / week
14 Years
40 Years
ALL
No
Sponsors
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Faculdade de Ciências Médicas da Santa Casa de São Paulo
OTHER
Responsible Party
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Luiz Gabriel Betoni Guglielmetti
MD, Master, Phd
Principal Investigators
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luiz G guglielmetti, MD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Ciencias Medicas da Santa Casa de São Paulo
Locations
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Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo
São Paulo, , Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16373713.1.0000.5479
Identifier Type: -
Identifier Source: org_study_id
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