ACL - Anterior Cruciate Ligament RuptureNCT07753707
Influence of the Different Types of Tibial Fixation in the Reconstruction of the Anterior Cruciate Ligament of the Knee: Osseous Integration, Ligament Maturation and Clinical Results.
A study testing Anterior cruciate ligament (ACL) reconstruction in people with ACL - Anterior Cruciate Ligament Rupture, run by Institut Català de Traumatologia i Medicina de l'Esport at 1 site in Spain.
Trial summary
Influence of different tibial fixation methods in anterior cruciate ligament (ACL) reconstruction: bone integration, graft maturation, and clinical outcomes. Primary Objective To assess whether any of the four tibial fixation techniques is superior in terms of: Graft-bone integration (CT/MRI), Graft maturation (MRI)… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Anterior cruciate ligament (ACL) reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years.
- Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.
Who cannot join
- Age ≥55 years.
- Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.
- Malpositioned tunnels (evaluated by MRI at 6 months postop).
- Previous knee surgery.
- Femoral or tibial deformities.
- Multiligament injuries.
- Note: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Influence of different tibial fixation methods in anterior cruciate ligament (ACL) reconstruction: bone integration, graft maturation, and clinical outcomes.
Primary Objective
Read more
To assess whether any of the four tibial fixation techniques is superior in terms of:
Graft-bone integration (CT/MRI),
Graft maturation (MRI),
Clinical outcomes (IKDC, Lysholm, Tegner scores; manual and instrumented knee stability with KT-1000 arthrometer).
Secondary Objectives
Compare clinical outcomes among groups (IKDC, Lysholm, Tegner).
Compare re-rupture rates and patient satisfaction.
Study Design
Prospective randomized trial.
The study will be registered in the international Clinical Trials registry.
Inclusion Criteria
Age ≥18 years.
Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.
Exclusion Criteria
Age ≥55 years.
Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.
Malpositioned tunnels (evaluated by MRI at 6 months postop).
Previous knee surgery.
Femoral or tibial deformities.
Multiligament injuries.
Note: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
Randomization
Patients meeting inclusion/exclusion criteria will be randomized (via Research Randomizer: https://www.randomizer.org/
) into 3 groups:
Group A (TORN): bioabsorbable interference screw, same diameter as the tunnel.
Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.
Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button/plate.
Sample size: 37 patients per group, 111 total.
Follow-up
Radiographic, CT, and MRI evaluation pre-op, at 15 days, and at 1 year post-op.
Clinical and radiological follow-up for 1 year.
Statistical Analysis
In the prospective phase, Student's t-test will be performed for comparison of pre- and postoperative variables. All variables will also be compared between groups and within groups (baseline vs. end of follow-up) using analysis of variance (ANOVA).
Linear regression models will be applied to test for potential significance that could be masked by confounding factors.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- Anterior cruciate ligament (ACL) reconstruction
- 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.
Anterior cruciate ligament (ACL) reconstructionProcedure or surgery
The three different types of tibial fixation in ACL reconstruction with Hamstring autograft:
Group A (TORN): bioabsorbable interference screw, same diameter as the tunnel.
Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.
Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button/plate.
| Study group | Role | What they receive |
|---|---|---|
| Group A (TORN): tibial graft fixation bioabsorbable interference screw, same diameter as the tunnel. | Active comparator | Not described Receives: Procedure: Anterior cruciate ligament (ACL) reconstruction |
| Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter. | Active comparator | Not described Receives: Procedure: Anterior cruciate ligament (ACL) reconstruction |
| Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button | Active comparator | Not described Receives: Procedure: Anterior cruciate ligament (ACL) reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACL Graft-bone integration (CT/MRI)
Graft-bone integration assessed by CT or MRI according to tunnel healing and bone incorporation.
Measured: 12 months
Graft maturation (MRI)
Graft maturation assessed on MRI using the Signal-to-Noise Quotient (SNQ).
Measured: 6-12 months
Secondary outcomes (3)
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Patient-reported knee function. Scores range from 0 to 100, with higher scores indicating better knee function.
Measured: 12 months
Tegner Activity Scale
Activity level assessed using the Tegner Activity Scale. Scores range from 0 to 10, with higher scores indicating higher activity levels.
Measured: 12 months
Side-to-side anterior knee laxity measured with KT-1000 arthrometer
Anterior tibial translation measured using a KT-1000 arthrometer. Lower side-to-side differences indicate better knee stability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start7 Jan 2023
- Primary completion31 Jan 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català de Traumatologia i Medicina de l'Esport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753707
- Sponsor's protocol ID
- LCA-INT-22
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mathew M, Dhollander A, Getgood A. Anterolateral Ligament Reconstruction or Extra-Articular Tenodesis: Why and When? Clin Sports Med. 2018 Jan;37(1):75-86. doi: 10.1016/j.csm.2017.07.011. Epub 2017 Oct 3.
PubMed 29173559Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. doi: 10.1177/0363546507308939. Epub 2007 Nov 7.
PubMed 17989167
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Different Types of Tibial Fixation in the Reconstruction of the Anterior Cruciate Ligament of the Knee: Osseous Integration, Ligament Maturation and Clinical Results.
- ClinicalTrials.gov ID
- NCT07753707
- Acronym / sponsor ID
- LCA-INT-22
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Institut Català de Traumatologia i Medicina de l'EsportUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Aug 2026 (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.
Influence of different tibial fixation methods in anterior cruciate ligament (ACL) reconstruction: bone integration, graft maturation, and clinical outcomes.
Primary Objective
To assess whether any of the four tibial fixation techniques is superior in terms of:
Graft-bone integration (CT/MRI),
Graft maturation (MRI),
Clinical outcomes (IKDC, Lysholm, Tegner scores; manual and instrumented knee stability with KT-1000 arthrometer).
Secondary Objectives
Compare clinical outcomes among groups (IKDC, Lysholm, Tegner).
Compare re-rupture rates and patient satisfaction.
Study Design
Prospective randomized trial.
The study will be registered in the international Clinical Trials registry.
Inclusion Criteria
Age ≥18 years.
Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.
Exclusion Criteria
Age ≥55 years.
Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.
Malpositioned tunnels (evaluated by MRI at 6 months postop).
Previous knee surgery.
Femoral or tibial deformities.
Multiligament injuries.
Note: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
Randomization
Patients meeting inclusion/exclusion criteria will be randomized (via Research Randomizer: https://www.randomizer.org/
) into 3 groups:
Group A (TORN): bioabsorbable interference screw, same diameter as the tunnel.
Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.
Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button/plate.
Sample size: 37 patients per group, 111 total.
Follow-up
Radiographic, CT, and MRI evaluation pre-op, at 15 days, and at 1 year post-op.
Clinical and radiological follow-up for 1 year.
Statistical Analysis
In the prospective phase, Student's t-test will be performed for comparison of pre- and postoperative variables. All variables will also be compared between groups and within groups (baseline vs. end of follow-up) using analysis of variance (ANOVA).
Linear regression models will be applied to test for potential significance that could be masked by confounding factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (TORN): tibial graft fixation bioabsorbable interference screw, same diameter as the tunnel. | Active comparator | Procedure: Anterior cruciate ligament (ACL) reconstruction |
| Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter. | Active comparator | Procedure: Anterior cruciate ligament (ACL) reconstruction |
| Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button | Active comparator | Procedure: Anterior cruciate ligament (ACL) reconstruction |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age ≥18 years.
- Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.
Key exclusion criteria (7 listed)
- Age ≥55 years.
- Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.
- Malpositioned tunnels (evaluated by MRI at 6 months postop).
- Previous knee surgery.
- Femoral or tibial deformities.
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 |
|---|---|---|
| Anterior cruciate ligament (ACL) reconstructionThe three different types of tibial fixation in ACL reconstruction with Hamstring autograft: Group A (TORN): bioabsorbable interference screw, same diameter as the tunnel. Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter. Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button/plate. | Procedure or surgery | Group A (TORN): tibial graft fixation bioabsorbable interference screw, same diameter as the tunnel., Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter., Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button |
Primary outcome
ACL Graft-bone integration (CT/MRI)
Time frame: 12 months
Graft-bone integration assessed by CT or MRI according to tunnel healing and bone incorporation.
Graft maturation (MRI)
Time frame: 6-12 months
Graft maturation assessed on MRI using the Signal-to-Noise Quotient (SNQ).
3 secondary outcomes
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Time frame: 12 months
Tegner Activity Scale
Time frame: 12 months
Side-to-side anterior knee laxity measured with KT-1000 arthrometer
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 29173559Mathew M, Dhollander A, Getgood A. Anterolateral Ligament Reconstruction or Extra-Articular Tenodesis: Why and When? Clin Sports Med. 2018 Jan;37(1):75-86. doi: 10.1016/j.csm.2017.07.011. Epub 2017 Oct 3.
- Background: PubMed 17989167Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. doi: 10.1177/0363546507308939. Epub 2007 Nov 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cruciate ligament (ACL) reconstruction in people with ACL - Anterior Cruciate Ligament Rupture, run by Institut Català de Traumatologia i Medicina de l'Esport at 1 site in Spain.
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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
ACL Graft-bone integration (CT/MRI) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT07753707, which also lists 2 linked publications.
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 7 Aug 2026.