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Completed

NCT Number: NCT03433170

Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quadrupled semitendinosus graft

Procedure

Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.

ST-Gracilis graft

Procedure

Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.

Primary outcomes

  1. Hamstrings Strength

    Time frame: 6 months

    Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.

Secondary outcomes

  1. Anterior cruciate ligament rerupture

    Time frame: 24 months

    New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination.

  2. ACL laxity

    Time frame: 24 months

    Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz).

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2018
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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