Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Cincinnati Knee Rating System [2 years]
It is a subjective score
Secondary Outcome Measures
- rerupture [2 years]
- International Knee Documentantion Committee (IKDC) score [2 years]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo | Sao Paulo | Brazil | 01221020 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Carter TR, Edinger S. Isokinetic evaluation of anterior cruciate ligament reconstruction: hamstring versus patellar tendon. Arthroscopy. 1999 Mar;15(2):169-72.
- 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.
- 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. German.
- 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.
- Waldén M, Hägglund 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. Review.
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