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Completed

NCT Number: NCT02642692

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

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

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Key information

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo

São Paulo, 01221020, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patellar Tendon graft

Procedure

Acl reconstruction with patellar tendon graft

Hamstring Graft

Procedure

Acl reconstruction with hamstring graft

Primary outcomes

  1. Cincinnati Knee Rating System

    Time frame: 2 years

    It is a subjective score

Secondary outcomes

  1. rerupture

    Time frame: 2 years

  2. International Knee Documentantion Committee (IKDC) score

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2015
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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