Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Procedure: Quadrupled semitendinosus graft; Procedure: ST-Gracilis graft

• Registration Number: NCT03433170
• Lead Sponsor: Fundacion Clinica Valle del Lili

Brief 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.

Study Timeline

• Study Start: 2018-01-20
• Study First Submitted: 2018-01-27
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old.

Exclusion Criteria

• Multiligament injuries. Re-ruptures of the ACL.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadrupled semitendinosus graft	Quadrupled semitendinosus graft	Autologous quadrupled semitendinosus graft is used to reconstruct the ACL injury
ST-Gracilis graft	ST-Gracilis graft	Both gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury

Primary Outcome Measures

Name	Time	Method
Hamstrings Strength	6 months	Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.

Secondary Outcome Measures

Name	Time	Method
Anterior cruciate ligament rerupture	24 months	New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination.
ACL laxity	24 months	Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz).

Trial Locations

Locations (1)

Fundacion Valle del Lili; 🇨🇴 Cali, Valle, Colombia