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

This study is currently recruiting participants.
Verified September 2016 by Luiz Gabriel Betoni Guglielmetti, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642692
First Posted: December 30, 2015
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Luiz Gabriel Betoni Guglielmetti, Faculdade de Ciências Médicas da Santa Casa de São Paulo
  Purpose
The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players.

Condition Intervention
Anterior Cruciate Ligament Injuries Procedure: Patellar Tendon graft Procedure: Hamstring Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hamstrings X Patellar Tendon for Anterior Cruciate Ligament Reconstruction in Soccer Players - RCT

Resource links provided by NLM:


Further study details as provided by Luiz Gabriel Betoni Guglielmetti, Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:
  • Cincinnati Knee Rating System [ Time Frame: 2 years ]
    It is a subjective score


Secondary Outcome Measures:
  • rerupture [ Time Frame: 2 years ]
  • International Knee Documentantion Committee (IKDC) score [ Time Frame: 2 years ]

Estimated Enrollment: 60
Study Start Date: June 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patellar Tendon Graft
Kind of graft that will be used for acl reconstruction
Procedure: Patellar Tendon graft
Acl reconstruction with patellar tendon graft
Experimental: Hamstring Graft
Kind of graft that will be used for acl reconstruction
Procedure: Hamstring Graft
Acl reconstruction with hamstring graft

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642692


Contacts
Contact: luiz G guglielmetti, MD +5511984152687 luizgbg@terra.com.br
Contact: pedro B Jorge, MD +55119976749615 pbj1980@hotmail.com

Locations
Brazil
Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo Recruiting
Sao Paulo, Brazil, 01221020
Contact: luiz B Guglielmetti, MD    +5511984152687    luizgbg@terra.com.br   
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Principal Investigator: luiz G guglielmetti, MD Faculdade de Ciencias Medicas da Santa Casa de São Paulo
  More Information

Publications:
Responsible Party: Luiz Gabriel Betoni Guglielmetti, MD, Master, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT02642692     History of Changes
Other Study ID Numbers: 16373713.1.0000.5479
First Submitted: December 25, 2015
First Posted: December 30, 2015
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Luiz Gabriel Betoni Guglielmetti, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
ACL reconstruction
Single bundle
Clinical results
Soccer players

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries