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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: Hamstring Graft; Procedure: Patellar Tendon graft

• Registration Number: NCT02642692
• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

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).

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-25
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hamstring Graft	Hamstring Graft	Kind of graft that will be used for acl reconstruction
Patellar Tendon Graft	Patellar Tendon graft	Kind of graft that will be used for acl reconstruction

Primary Outcome Measures

Name	Time	Method
Cincinnati Knee Rating System	2 years	It is a subjective score

Secondary Outcome Measures

Name	Time	Method
rerupture	2 years
International Knee Documentantion Committee (IKDC) score	2 years

Trial Locations

Locations (1)

Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo; 🇧🇷 Sao Paulo, Brazil