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Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT03433170
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Pablo Martinez, 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Procedure: Quadrupled semitendinosus graft Procedure: ST-Gracilis graft Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Hamstrings Strength [ Time Frame: 6 months ]
    Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.


Secondary Outcome Measures :
  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).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433170


Contacts
Contact: Juan P Martinez, MD 5723319090 jpmartinezc@gmail.com

Locations
Colombia
Fundacion Valle del Lili Recruiting
Cali, Valle, Colombia
Contact: Juan P Martinez, Md    5723319090      
Principal Investigator: Juan P Martinez, MD         
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
Principal Investigator: Juan P Martinez, MD Fundacion Clinica Valle del Lili

Responsible Party: Juan Pablo Martinez, Orthopaedic Surgeon, Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT03433170     History of Changes
Other Study ID Numbers: STX4
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries