Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

NCT03433170 | Completed DMC

• 1 other identifier: STX4
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (1)

• Hamstrings Strength

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

  6 months

Secondary Outcomes (2)

• Anterior cruciate ligament rerupture

  24 months

• ACL laxity

  24 months

Study Arms (2)

Quadrupled semitendinosus graft

EXPERIMENTAL

Autologous quadrupled semitendinosus graft is used to reconstruct the ACL injury

Procedure: Quadrupled semitendinosus graft

ST-Gracilis graft

ACTIVE COMPARATOR

Both gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury

Procedure: ST-Gracilis graft

Interventions

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.

Quadrupled semitendinosus graft

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.

ST-Gracilis graft

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Multiligament injuries. Re-ruptures of the ACL.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (1)

• Martinez-Cano JP, Gallego A, Cuadros J, Ibarra L, Mejia FM, Velasquez-Hammerle MV, Martinez-Rondanelli A. Similar results with quadrupled semitendinosus and semitendinosus-gracilis graft in anterior cruciate ligament reconstruction: A randomised controlled trial with 2-year follow-up. J Exp Orthop. 2025 Sep 24;12(3):e70399. doi: 10.1002/jeo2.70399. eCollection 2025 Jul.

  PMID: 41018256 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Juan P Martinez, MD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 14, 2018
• Study Start: January 20, 2018
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: September 19, 2025

Record last verified: 2022-10

Locations

CO (1)