Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injury
• Intervention / Treatment: Procedure: Quadrupled semitendinosus graft; Procedure: ST-Gracilis graft

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Valle
    • Cali, Valle, Colombia
      • Fundacion Valle del Lili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamstrings Strength	Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion Clinica Valle del Lili
• Investigators: Principal Investigator: Juan P Martinez, MD, Fundacion Clinica Valle del Lili

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 27, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: STX4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No