NCT03433170

Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fundacion Clinica Valle del Lili · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anterior Cruciate Ligament Injury

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-01-20
• Primary completion: 2022-06-30
• Completion: 2022-07-31
• First posted: 2018-02-14
• Last updated: 2025-09-19

Locations

1 site across 1 country: Colombia