Anterior Cruciate Ligament (ACL)NCT07418476
Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction
A study testing ACL Reconstruction and TARS-Augmented ACL Reconstruction in people with Anterior Cruciate Ligament (ACL), run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to compare standard anterior cruciate ligament (ACL) reconstruction using hamstring autograft with ACL reconstruction augmented using the Tape Active Reconstruction System (TARS). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL)
- What is being tested?
- ACL Reconstruction and TARS-Augmented ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 1 Jul 2027
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 44 years
- Diagnosis of complete ACL rupture confirmed by clinical examination and imaging
- Planned primary single-bundle anatomic ACL reconstruction using hamstring autograft
- Intact contralateral knee
- Provision of written informed consent
Who cannot join
- Cartilage lesions grade 2 or higher according to the Outerbridge classification
- Combined ligament injuries or inflammatory arthritis
- Tibial slope greater than 12 degrees
- Advanced knee laxity
- Revision ACL reconstruction
- Requirement for additional surgical procedures during the same operation
- Inability to comply with follow-up protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Standard Anterior Cruciate Ligament Reconstruction and Tape Active Reconstruction System (TARS)-Augmented Reconstruction: A Prospective Randomized Controlled Study
This study is designed to compare standard anterior cruciate ligament (ACL) reconstruction using hamstring autograft with ACL reconstruction augmented using the Tape Active Reconstruction System (TARS). Eligible patients aged 18 to 44 years with a complete ACL rupture will be prospectively enrolled and randomized in a 1:1 ratio into two study groups. Participants will be evaluated preoperatively and postoperatively at regular follow-up visits, with the final assessment performed at 12 months after surgery. Outcome assessments will include patient-reported outcome measures, objective clinical examination of knee stability, instrumented laxity measurements, and radiological evaluation.
Read the detailed description
Anterior cruciate ligament reconstruction is one of the most commonly performed procedures in sports orthopaedic surgery. Although standard hamstring autograft reconstruction provides good clinical outcomes, residual anterior knee laxity and graft failure remain concerns, particularly in young and active patients. Augmentation using the Tape Active Reconstruction System (TARS) has been introduced as an adjunct technique intended to share load with the graft during the early healing phase and potentially improve postoperative stability.
The aim of this study is to evaluate whether ACL reconstruction augmented using TARS results in superior clinical, functional, and radiological outcomes compared with standard ACL reconstruction alone. The study will prospectively collect demographic, clinical, functional, and imaging data and analyze the relationship between surgical technique and postoperative outcomes. Patients will be evaluated preoperatively and at 12 months postoperatively. Assessments will include objective knee stability testing using the KT-1000 arthrometer, clinical examination (Lachman and pivot shift tests), functional outcome scores, and radiological evaluation. Magnetic resonance imaging (MRI), including T2 mapping sequences, will be performed at 1 year to evaluate graft maturation, and integration.
- Conditions
- Anterior Cruciate Ligament (ACL)
- Being tested
- ACL Reconstruction, TARS-Augmented ACL Reconstruction
- Keywords
- anterior cruciate ligament, suture tape augmentation, t2 mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL ReconstructionProcedure or surgery
ACL reconstruction using semitendinosus tendon autograft
TARS-Augmented ACL ReconstructionProcedure or surgery
Arthroscopic single-bundle ACL reconstruction using a quadrupled semitendinosus tendon autograft was performed with additional Tape Active Reconstruction System (TARS) augmentation. High-strength suture tape was applied to provide load sharing during early rehabilitation. The postoperative rehabilitation protocol was identical to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Standard ACL Reconstruction | Active comparator | Patients will undergo single-bundle anatomic ACL reconstruction using a quadrupled hamstring (semitendinosus) autograft. Femoral and tibial fixation will be performed using adjustable cortical suspension devices according to standard surgical techniques. Receives: Procedure: ACL Reconstruction |
| TARS-Augmented ACL Reconstruction | Experimental | Patients will undergo the same standard ACL reconstruction procedure with augmentation using the Tape Active Reconstruction System (TARS). Within the TARS technique, high-strength suture tape is applied to provide load sharing and graft protection during the early rehabilitation period. Receives: Procedure: TARS-Augmented ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side to side difference in anterior tibial translation (mm)
Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer.
Measured: Preoperative and 12 months postoperatively
Secondary outcomes (3)
International Knee Documentation Committee (IKDC) Score
Patient reported outcome measures of symptoms, sports activity \& knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Measured: 12 months
Marx Activity Rating Scale
Patient-reported outcome measure of participation in high-demand sports activities, assessing the frequency of running, cutting, decelerating, and pivoting movements. Scores range from 0 to 16, with 0 indicating no participation in these activities and 16 indicating very frequent participation in pivoting and impact activities.
Measured: 12 months
Radiological assessment using MRI for graft maturation and integration
Graft maturation was assessed using MRI with T2 mapping sequences, and T2 values were measured at intra-articular graft regions using standardized regions of interest. Graft integration was assessed according to the Ge et al. grading system (Grade 1-3) based on the quality of graft-bone interface integration
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 posted18 Feb 2026
- Study start28 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (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 Anterior Cruciate Ligament (ACL)Studies 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
- Model description
- Prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418476
- Sponsor's protocol ID
- OMUKAEK 2025/436
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith PA, Daniel AV, Stensby JD, Cook CS, Wijdicks CA. Quadriceps Tendon Autograft ACL Reconstruction With Suture Tape Augmentation: Safe Results Based on Minimum 2-Year Follow-up MRI. Orthop J Sports Med. 2024 Apr 11;12(4):23259671241239275. doi: 10.1177/23259671241239275. eCollection 2024 Apr.
PubMed 38617885Kitchen BT, Mitchell BC, Cognetti DJ, Siow MY, Howard R, Carroll AN, Bastrom TP, Edmonds EW. Outcomes After Hamstring ACL Reconstruction With Suture Tape Reinforcement in Adolescent Athletes. Orthop J Sports Med. 2022 Apr 8;10(4):23259671221085577. doi: 10.1177/23259671221085577. eCollection 2022 Apr.
PubMed 35425845
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Anterior Cruciate Ligament Reconstruction and Tape Active Reconstruction System (TARS)-Augmented Reconstruction: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07418476
- Acronym / sponsor ID
- OMUKAEK 2025/436
- Conditions
- Anterior Cruciate Ligament (ACL)
- Keywords
- anterior cruciate ligament, suture tape augmentation, t2 mapping
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Feb 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.
This study is designed to compare standard anterior cruciate ligament (ACL) reconstruction using hamstring autograft with ACL reconstruction augmented using the Tape Active Reconstruction System (TARS). Eligible patients aged 18 to 44 years with a complete ACL rupture will be prospectively enrolled and randomized in a 1:1 ratio into two study groups. Participants will be evaluated preoperatively and postoperatively at regular follow-up visits, with the final assessment performed at 12 months after surgery. Outcome assessments will include patient-reported outcome measures, objective clinical examination of knee stability, instrumented laxity measurements, and radiological evaluation.
Detailed description
Anterior cruciate ligament reconstruction is one of the most commonly performed procedures in sports orthopaedic surgery. Although standard hamstring autograft reconstruction provides good clinical outcomes, residual anterior knee laxity and graft failure remain concerns, particularly in young and active patients. Augmentation using the Tape Active Reconstruction System (TARS) has been introduced as an adjunct technique intended to share load with the graft during the early healing phase and potentially improve postoperative stability.
The aim of this study is to evaluate whether ACL reconstruction augmented using TARS results in superior clinical, functional, and radiological outcomes compared with standard ACL reconstruction alone. The study will prospectively collect demographic, clinical, functional, and imaging data and analyze the relationship between surgical technique and postoperative outcomes. Patients will be evaluated preoperatively and at 12 months postoperatively. Assessments will include objective knee stability testing using the KT-1000 arthrometer, clinical examination (Lachman and pivot shift tests), functional outcome scores, and radiological evaluation. Magnetic resonance imaging (MRI), including T2 mapping sequences, will be performed at 1 year to evaluate graft maturation, and integration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard ACL Reconstruction | Active comparator | Procedure: ACL ReconstructionPatients will undergo single-bundle anatomic ACL reconstruction using a quadrupled hamstring (semitendinosus) autograft. Femoral and tibial fixation will be performed using adjustable cortical suspension devices according to standard surgical techniques. |
| TARS-Augmented ACL Reconstruction | Experimental | Procedure: TARS-Augmented ACL ReconstructionPatients will undergo the same standard ACL reconstruction procedure with augmentation using the Tape Active Reconstruction System (TARS). Within the TARS technique, high-strength suture tape is applied to provide load sharing and graft protection during the early rehabilitation period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 44 years
- Diagnosis of complete ACL rupture confirmed by clinical examination and imaging
- Planned primary single-bundle anatomic ACL reconstruction using hamstring autograft
- Intact contralateral knee
- Provision of written informed consent
Key exclusion criteria (7 listed)
- Cartilage lesions grade 2 or higher according to the Outerbridge classification
- Combined ligament injuries or inflammatory arthritis
- Tibial slope greater than 12 degrees
- Advanced knee laxity
- Revision ACL reconstruction
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 |
|---|---|---|
| ACL ReconstructionACL reconstruction using semitendinosus tendon autograft | Procedure or surgery | Standard ACL Reconstruction |
| TARS-Augmented ACL ReconstructionArthroscopic single-bundle ACL reconstruction using a quadrupled semitendinosus tendon autograft was performed with additional Tape Active Reconstruction System (TARS) augmentation. High-strength suture tape was applied to provide load sharing during early rehabilitation. The postoperative rehabilitation protocol was identical to the control group. | Procedure or surgery | TARS-Augmented ACL Reconstruction |
Primary outcome
Side to side difference in anterior tibial translation (mm)
Time frame: Preoperative and 12 months postoperatively
Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer.
3 secondary outcomes
International Knee Documentation Committee (IKDC) Score
Time frame: 12 months
Marx Activity Rating Scale
Time frame: 12 months
Radiological assessment using MRI for graft maturation and integration
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 14 Jul 2026.
- Background: PubMed 38617885Smith PA, Daniel AV, Stensby JD, Cook CS, Wijdicks CA. Quadriceps Tendon Autograft ACL Reconstruction With Suture Tape Augmentation: Safe Results Based on Minimum 2-Year Follow-up MRI. Orthop J Sports Med. 2024 Apr 11;12(4):23259671241239275. doi: 10.1177/23259671241239275. eCollection 2024 Apr.
- Background: PubMed 35425845Kitchen BT, Mitchell BC, Cognetti DJ, Siow MY, Howard R, Carroll AN, Bastrom TP, Edmonds EW. Outcomes After Hamstring ACL Reconstruction With Suture Tape Reinforcement in Adolescent Athletes. Orthop J Sports Med. 2022 Apr 8;10(4):23259671221085577. doi: 10.1177/23259671221085577. eCollection 2022 Apr.
- Individual participant dataSharing planned: No
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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 ACL Reconstruction and TARS-Augmented ACL Reconstruction in people with Anterior Cruciate Ligament (ACL), run by Samsun University at 1 site in Turkey (Türkiye).
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 5 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 14 Jul 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 Turkey (Türkiye). 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?
Side to side difference in anterior tibial translation (mm) (time frame: Preoperative and 12 months postoperatively). 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 NCT07418476, 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 14 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.