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Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT

Hamstrings X Patellar Tendon for Anterior Cruciate Ligament Reconstruction in Soccer Players - RCT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02642692
Enrollment
60
Registered
2015-12-30
Start date
2015-06-30
Completion date
2020-12-31
Last updated
2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Keywords

ACL reconstruction, Single bundle, Clinical results, Soccer players

Brief summary

The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players.

Detailed description

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. 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).

Interventions

PROCEDUREPatellar Tendon graft

Acl reconstruction with patellar tendon graft

PROCEDUREHamstring Graft

Acl reconstruction with hamstring graft

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* unilateral ACL lesion * 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

* morbid obesity * degenerative changes in arthroscopy or image exams * those who play soccer less than 4 times / week

Design outcomes

Primary

MeasureTime frameDescription
Cincinnati Knee Rating System2 yearsIt is a subjective score

Secondary

MeasureTime frame
rerupture2 years
International Knee Documentantion Committee (IKDC) score2 years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026