CClinicalTrials.gg
CompletedNCT02642692Updated Aug 27, 2021

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

An interventional study of Patellar Tendon graft and Hamstring Graft in Anterior Cruciate Ligament Injuries, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to participants aged 14 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-08-27.

Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
14 Years to 40 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Anterior Cruciate Ligament Injuries

Keywords

  • ACL reconstruction
  • Single bundle
  • Clinical results
  • Soccer players
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's enrollment of 60 is close to the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 39 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 40 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • morbid obesity
  • degenerative changes in arthroscopy or image exams
  • those who play soccer less than 4 times / week
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Patellar Tendon Graft

    Kind of graft that will be used for acl reconstruction

    Procedure: Patellar Tendon graft

  • Experimental
    Hamstring Graft

    Kind of graft that will be used for acl reconstruction

    Procedure: Hamstring Graft

Interventions

  • ProcedurePatellar Tendon graft

    Acl reconstruction with patellar tendon graft

  • ProcedureHamstring Graft

    Acl reconstruction with hamstring graft

06

What researchers measure

Primary outcomes

  1. Cincinnati Knee Rating System

    It is a subjective score

    Time frame: 2 years

Secondary outcomes

  1. rerupture

    Time frame: 2 years

  2. International Knee Documentantion Committee (IKDC) score

    Time frame: 2 years

07

Study locations

1 site
  • Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo
    Sao Paulo, 01221020, Brazil
08

References and documents

Publications

  • 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. PubMed 10424213 ↗
  • 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. PubMed 8198189 ↗
  • 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. PubMed 10210074 ↗
  • 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. PubMed 22048746 ↗
  • 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. PubMed 20532868 ↗
  • 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. PubMed 8197541 ↗
  • 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. PubMed 34604426 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02642692
Lead sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible party
Luiz Gabriel Betoni Guglielmetti (MD, Master, Phd, Faculdade de Ciências Médicas da Santa Casa de São Paulo) — Principal investigator
First posted
Dec 30, 2015
Start date
Jun 2015
Primary completion
Dec 2020
Completion
Dec 2020
Last update
Aug 27, 2021

Study contacts

luiz G guglielmetti, MD
principal investigator · Faculdade de Ciencias Medicas da Santa Casa de São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion