Anterior Cruciate Ligament InjuryNCT03433170
Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction
A study testing Quadrupled semitendinosus graft and ST-Gracilis graft in people with Anterior Cruciate Ligament Injury, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial summary
Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Quadrupled semitendinosus graft and ST-Gracilis graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteColombia
- Study dates
- 20 Jan 2018to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old.
Who cannot join
- Multiligament injuries. Re-ruptures of the ACL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Quadrupled semitendinosus graft, ST-Gracilis graft
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrupled semitendinosus graftProcedure or surgery
Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
ST-Gracilis graftProcedure or surgery
Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
| Study group | Role | What they receive |
|---|---|---|
| Quadrupled semitendinosus graft | Experimental | Autologous quadrupled semitendinosus graft is used to reconstruct the ACL injury Receives: Procedure: Quadrupled semitendinosus graft |
| ST-Gracilis graft | Active comparator | Both gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury Receives: Procedure: ST-Gracilis graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstrings Strength
Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.
Measured: 6 months
Secondary outcomes (2)
Anterior cruciate ligament rerupture
New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination.
Measured: 24 months
ACL laxity
Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start20 Jan 2018
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Martinez, Fundacion Clinica Valle del Lili
- Investigators
- Juan P Martinez, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433170
- Sponsor's protocol ID
- STX4
- Status last verified
- Oct 2022
- First submitted
- 27 Jan 2018
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41018256
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03433170
- Acronym / sponsor ID
- STX4
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrupled semitendinosus graft | Experimental | Procedure: Quadrupled semitendinosus graftAutologous quadrupled semitendinosus graft is used to reconstruct the ACL injury |
| ST-Gracilis graft | Active comparator | Procedure: ST-Gracilis graftBoth gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old.
Key exclusion criteria (1 listed)
- Multiligament injuries. Re-ruptures of the ACL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrupled semitendinosus graftQuadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia. | Procedure or surgery | Quadrupled semitendinosus graft |
| ST-Gracilis graftUse of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia. | Procedure or surgery | ST-Gracilis graft |
Primary outcome
Hamstrings Strength
Time frame: 6 months
Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons.
2 secondary outcomes
Anterior cruciate ligament rerupture
Time frame: 24 months
ACL laxity
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 41018256Martinez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Martinez, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadrupled semitendinosus graft and ST-Gracilis graft in people with Anterior Cruciate Ligament Injury, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstrings Strength (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.