Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction
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|ClinicalTrials.gov Identifier: NCT03433170|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injury||Procedure: Quadrupled semitendinosus graft Procedure: ST-Gracilis graft||Not Applicable|
Data checks programmed by a third party after inclusion of participant number 10, 20, 30 and 42. This includes source data verification.
Simple size calculations estimating a difference of 50% in strength improvement between both groups at the six months follow-up visit. 80% power and 5% alpha error.
Strength measured with dynamometer, laxity with ACL laxity tester and function with 3 scores: IKDC, Tegner-Lysholm and KOOS.
Missing data will be minimized by double checking when registering data. It might be necessary to increase sample size to 50 patients of intermediate analysis show it is necessary to find an statistically significant difference.
Trial could be stopped early if one intervention shows to be better in the intermediate analysis. These analysis will be conducted after the first 16 and 32 participants have been included.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial|
|Actual Study Start Date :||January 20, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Quadrupled semitendinosus graft
Autologous quadrupled semitendinosus graft is used to reconstruct the ACL injury
Procedure: Quadrupled semitendinosus graft
Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
Active Comparator: ST-Gracilis graft
Both gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury
Procedure: ST-Gracilis graft
Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
- Hamstrings Strength [ Time Frame: 6 months ]Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.
- Anterior cruciate ligament rerupture [ Time Frame: 24 months ]New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination.
- ACL laxity [ Time Frame: 24 months ]Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz).
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): NCT03433170
|Contact: Juan P Martinez, MDfirstname.lastname@example.org|
|Fundacion Valle del Lili||Recruiting|
|Cali, Valle, Colombia|
|Contact: Juan P Martinez, Md 5723319090|
|Principal Investigator: Juan P Martinez, MD|
|Principal Investigator:||Juan P Martinez, MD||Fundacion Clinica Valle del Lili|