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Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial
Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. It is intended to specially evaluate if by using only the semitendinosus (ST) tendon, the strength of the limb for hamstrings is affected different compared to using both gracilis and ST.
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.
Age
15 - No limit years
Sex
ALL
Healthy Volunteers
No
Fundacion Valle del Lili
Cali, Valle del Cauca Department, Colombia
Start Date
January 20, 2018
Primary Completion Date
June 30, 2022
Completion Date
July 31, 2022
Last Updated
September 19, 2025
42
ACTUAL participants
Quadrupled semitendinosus graft
PROCEDURE
ST-Gracilis graft
PROCEDURE
Lead Sponsor
Fundacion Clinica Valle del Lili
NCT07475351
NCT07419750
Data Source & Attribution
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