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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Patellar Tendon graft
Hamstring Graft
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring ACL reconstruction, Single bundle, Clinical results, Soccer players

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patellar Tendon Graft

Hamstring Graft

Arm Description

Kind of graft that will be used for acl reconstruction

Kind of graft that will be used for acl reconstruction

Outcomes

Primary Outcome Measures

Cincinnati Knee Rating System
It is a subjective score

Secondary Outcome Measures

rerupture
International Knee Documentantion Committee (IKDC) score

Full Information

First Posted
December 25, 2015
Last Updated
August 23, 2021
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02642692
Brief Title
Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT
Official Title
Hamstrings X Patellar Tendon for Anterior Cruciate Ligament Reconstruction in Soccer Players - RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
ACL reconstruction, Single bundle, Clinical results, Soccer players

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patellar Tendon Graft
Arm Type
Experimental
Arm Description
Kind of graft that will be used for acl reconstruction
Arm Title
Hamstring Graft
Arm Type
Experimental
Arm Description
Kind of graft that will be used for acl reconstruction
Intervention Type
Procedure
Intervention Name(s)
Patellar Tendon graft
Intervention Description
Acl reconstruction with patellar tendon graft
Intervention Type
Procedure
Intervention Name(s)
Hamstring Graft
Intervention Description
Acl reconstruction with hamstring graft
Primary Outcome Measure Information:
Title
Cincinnati Knee Rating System
Description
It is a subjective score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
rerupture
Time Frame
2 years
Title
International Knee Documentantion Committee (IKDC) score
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
luiz G guglielmetti, MD
Organizational Affiliation
Faculdade de Ciencias Medicas da Santa Casa de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01221020
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10424213
Citation
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.
Results Reference
background
PubMed Identifier
8198189
Citation
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.
Results Reference
background
PubMed Identifier
10210074
Citation
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.
Results Reference
background
PubMed Identifier
22048746
Citation
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.
Results Reference
background
PubMed Identifier
20532868
Citation
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.
Results Reference
background
PubMed Identifier
8197541
Citation
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.
Results Reference
background
PubMed Identifier
34604426
Citation
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.
Results Reference
derived

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

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