Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433170
• Other study ID #: STX4
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: Fundacion Clinica Valle del Lili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Fundacion Valle del Lili	Cali	Valle

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamstrings Strength	Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.	6 months
Secondary	Anterior cruciate ligament rerupture	New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination.	24 months
Secondary	ACL laxity	Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz).	24 months