Anterior Cruciate Ligament RuptureNCT06664047
Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
A study testing OTT ACLR and ACLR LET in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injuries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the over-the-top (OTT) anterior cruciate ligament (ACL) reconstruction (ACL-R) technique with the anteromedial ACL-R + lateral extraarticular tenodesis (LET). It aims to provide valuable insights into two different surgical approaches aimed at enhancing knee stability. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Tear
- What is being tested?
- OTT ACLR and ACLR LET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 1 Nov 2028
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of an isolated anterior cruciate ligament (ACL) tear (isolated ligament injury).
- Age between 18 and 50 years.
- No previous history of surgery on the same knee.
- MRI and CT scans performed at the end of the first postoperative year.
Who cannot join
- Presence of additional ligamentous injury (e.g., posterior cruciate ligament or collateral ligament) along with the ACL tear.
- Incomplete clinical scores.
- History of previous surgery on the same knee.
- Presence or history of infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiological and Clinical Outcomes of Over-the-Top ACL Reconstruction vs. Anteromedial ACL Reconstruction With Additional Lateral Extraarticular Tenodesis: A Prospectively Randomized Controlled Trial
This study aims to compare the over-the-top (OTT) anterior cruciate ligament (ACL) reconstruction (ACL-R) technique with the anteromedial ACL-R + lateral extraarticular tenodesis (LET). It aims to provide valuable insights into two different surgical approaches aimed at enhancing knee stability. The over-the-top ACL-R technique, which involves routing the graft over the posterior aspect of the lateral femoral condyle, is known for its simplicity and ability to preserve the anatomical footprint of the ACL. Although a non-anatomical reconstruction, the OTT technique has shown comparable clinical results and good return to sports (RTS) ratios when compared to the conventional ACLR alone. It is also favored in revision surgeries or when there is difficulty accessing the femoral tunnel through conventional approaches. However, concerns regarding its ability to fully restore rotational stability persist, especially in high-demand athletes.
In contrast, the anteromedial portal technique for ACL-R, combined with LET, has gained popularity due to its effectiveness in controlling both anterior tibial translation and rotational instability. LET augments the intra-articular reconstruction by providing additional restraint against pivot shifts, which can be critical in patients with high-risk profiles for re-injury, such as those participating in pivoting sports. Comparing these two approaches in terms of clinical outcomes, graft integrity, rotational control, and return-to-sport rates with a prospectively randomized controlled trial will help clarify their roles in contemporary ACL surgery and could guide surgeons in choosing the most appropriate method based on patient-specific factors.
Read the detailed description
Anterior cruciate ligament reconstruction (ACLR) is one of the most commonly performed procedures in orthopedic sports medicine, aimed at restoring knee stability, facilitating return to activities, and preventing secondary injuries to the cartilage and menisci. Improved understanding of knee joint anatomy and biomechanics has led to advancements in surgical techniques, and modern 'anatomic' techniques have shown favorable outcomes in most patients. However, despite technical advancements, ACL reconstruction techniques still fail to fully restore normal knee biomechanics, particularly with regard to tibial rotation, leaving some patients with residual instability. Additionally, the rate of return to high-level sports has been reported as low as 63% at two years.
Residual anterolateral subluxation, as measured by the pivot shift test, is a clinical indicator of internal rotation laxity and is associated with poor outcomes and low patient satisfaction. Such altered kinematics may contribute further to the development of osteoarthritis (OA). The inability of traditional ACLR to reliably restore normal tibial rotational kinematics could be one reason for this outcome.
Lateral extra-articular tenodesis (LET) is performed alongside ACLR to control anterolateral rotational instability in knees with ACL deficiency. Recent studies have shown that this procedure reduces the risk of ACL graft re-rupture, better restores knee joint kinematics, and improves return-to-sport rates. ACLR and LET procedures are now routinely performed in many centers.
The over-the-top (OTT) ACL reconstruction technique involves passing the graft over the superomedial edge of the lateral femoral condyle and securing it to the lateral femoral cortex. The proposed advantages of this technique include its safety, ease of use, reproducibility, low cost, and compatibility with all graft types and fixation methods. Additionally, the OTT technique can be used to reinforce ACL remnants, thus minimizing technical challenges encountered during anatomic reconstruction procedures. These challenges include difficulty visualizing the femoral placement, mismatches between tibial and femoral tunnels, reliance on clock-face systems for femoral tunnel positioning, and instrument impingement during excessive knee flexion.
Currently, there is limited literature comparing the outcomes of OTT and anatomic ACLR techniques, and no studies compare the OTT and ACLR + LET procedures.
The aim of this study is to compare the clinical and radiological outcomes, as well as return-to-sport rates, between patients undergoing the Over-the-Top ACL Reconstruction technique and those undergoing the Anteromedial ACL Reconstruction technique with Lateral Extra-Articular Tenodesis.
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Tear
- Being tested
- OTT ACLR, ACLR LET
- Keywords
- Anterior cruciate ligament rupture, Over-the-top reconstruction, Lateral extra-articular tenodesis
- 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.
OTT ACLRProcedure or surgery
Patients in this group will undergo a reconstruction with the OTT technique which includes an intra-articular component and an extra-articular one, functioning as a LET.
ACLR LETProcedure or surgery
Patients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band.
| Study group | Role | What they receive |
|---|---|---|
| OTT ACLR | Active comparator | Patients in this group will undergo a reconstruction with the OTT technique which includes an intra-articular component and an extra-articular one, functioning as a LET. Receives: Procedure: OTT ACLR |
| ACLR LET | Active comparator | Patients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band. Receives: Procedure: ACLR LET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-rupture
Re-rupture prevalence detected on MRI (yes/no)
Measured: Postoperative 1.st year
Tibial tunnel widening
Tibial tunnel diameter measured at the widest point on axial CT scans (number, mm)
Measured: Postoperative 1.st year
Tegner Activity Scale
minimum value:0, maximum value 10, higher values mean better outcome
Measured: Postoperative 1.st year
Knee Score ve Knee Injury & Osteoarthritis Outcome (KOOS)
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Postoperative 1.st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start24 Oct 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Prospectively Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enejd Veizi, MD, Ankara City Hospital Bilkent
- Investigators
- Enejd Veizi, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664047
- Sponsor's protocol ID
- TADEB-1-24-645
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucidi GA, Roberti di Sarsina T, Zaffagnini S. Editorial Commentary: The Number One Cause of Anterior Cruciate Ligament Reconstruction Graft Failure Is a Misplaced Femoral Tunnel: Over-the-Top Technique Plus Lateral Extra-Articular Tenodesis Is Recommended. Arthroscopy. 2024 Feb;40(2):435-437. doi: 10.1016/j.arthro.2023.07.021.
PubMed 38296446Zaffagnini S, Lucidi GA, Macchiarola L, Agostinone P, Neri MP, Marcacci M, Grassi A. The 25-year experience of over-the-top ACL reconstruction plus extra-articular lateral tenodesis with hamstring tendon grafts: the story so far. J Exp Orthop. 2023 Apr 1;10(1):36. doi: 10.1186/s40634-023-00599-8.
PubMed 37005946Kamei G, Nakamae A, Nakata K, Nekomoto A, Tsuji S, Hashiguchi N, Ishikawa M, Adachi N. Comparison of clinical outcomes between anterior cruciate ligament reconstruction with over-the-top route procedure and anatomic single-bundle reconstruction in pediatric patients. J Pediatr Orthop B. 2023 Mar 1;32(2):178-184. doi: 10.1097/BPB.0000000000001008. Epub 2023 Dec 15.
PubMed 36700965Bonanzinga T, Grassi A, Altomare D, Lucidi GA, Macchiarola L, Zaffagnini S, Marcacci M. High return to sport rate and few re-ruptures at long term in professional footballers after anterior cruciate ligament reconstruction with hamstrings. Knee Surg Sports Traumatol Arthrosc. 2022 Nov;30(11):3681-3688. doi: 10.1007/s00167-022-06944-1. Epub 2022 Apr 22.
PubMed 35451640
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Clinical Outcomes of Over-the-Top ACL Reconstruction vs. Anteromedial ACL Reconstruction With Additional Lateral Extraarticular Tenodesis: A Prospectively Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06664047
- Acronym / sponsor ID
- TADEB-1-24-645
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Tear
- Keywords
- Anterior cruciate ligament rupture, Over-the-top reconstruction, Lateral extra-articular tenodesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 29 Oct 2024 (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 aims to compare the over-the-top (OTT) anterior cruciate ligament (ACL) reconstruction (ACL-R) technique with the anteromedial ACL-R + lateral extraarticular tenodesis (LET). It aims to provide valuable insights into two different surgical approaches aimed at enhancing knee stability. The over-the-top ACL-R technique, which involves routing the graft over the posterior aspect of the lateral femoral condyle, is known for its simplicity and ability to preserve the anatomical footprint of the ACL. Although a non-anatomical reconstruction, the OTT technique has shown comparable clinical results and good return to sports (RTS) ratios when compared to the conventional ACLR alone. It is also favored in revision surgeries or when there is difficulty accessing the femoral tunnel through conventional approaches. However, concerns regarding its ability to fully restore rotational stability persist, especially in high-demand athletes.
In contrast, the anteromedial portal technique for ACL-R, combined with LET, has gained popularity due to its effectiveness in controlling both anterior tibial translation and rotational instability. LET augments the intra-articular reconstruction by providing additional restraint against pivot shifts, which can be critical in patients with high-risk profiles for re-injury, such as those participating in pivoting sports. Comparing these two approaches in terms of clinical outcomes, graft integrity, rotational control, and return-to-sport rates with a prospectively randomized controlled trial will help clarify their roles in contemporary ACL surgery and could guide surgeons in choosing the most appropriate method based on patient-specific factors.
Detailed description
Anterior cruciate ligament reconstruction (ACLR) is one of the most commonly performed procedures in orthopedic sports medicine, aimed at restoring knee stability, facilitating return to activities, and preventing secondary injuries to the cartilage and menisci. Improved understanding of knee joint anatomy and biomechanics has led to advancements in surgical techniques, and modern 'anatomic' techniques have shown favorable outcomes in most patients. However, despite technical advancements, ACL reconstruction techniques still fail to fully restore normal knee biomechanics, particularly with regard to tibial rotation, leaving some patients with residual instability. Additionally, the rate of return to high-level sports has been reported as low as 63% at two years.
Residual anterolateral subluxation, as measured by the pivot shift test, is a clinical indicator of internal rotation laxity and is associated with poor outcomes and low patient satisfaction. Such altered kinematics may contribute further to the development of osteoarthritis (OA). The inability of traditional ACLR to reliably restore normal tibial rotational kinematics could be one reason for this outcome.
Lateral extra-articular tenodesis (LET) is performed alongside ACLR to control anterolateral rotational instability in knees with ACL deficiency. Recent studies have shown that this procedure reduces the risk of ACL graft re-rupture, better restores knee joint kinematics, and improves return-to-sport rates. ACLR and LET procedures are now routinely performed in many centers.
The over-the-top (OTT) ACL reconstruction technique involves passing the graft over the superomedial edge of the lateral femoral condyle and securing it to the lateral femoral cortex. The proposed advantages of this technique include its safety, ease of use, reproducibility, low cost, and compatibility with all graft types and fixation methods. Additionally, the OTT technique can be used to reinforce ACL remnants, thus minimizing technical challenges encountered during anatomic reconstruction procedures. These challenges include difficulty visualizing the femoral placement, mismatches between tibial and femoral tunnels, reliance on clock-face systems for femoral tunnel positioning, and instrument impingement during excessive knee flexion.
Currently, there is limited literature comparing the outcomes of OTT and anatomic ACLR techniques, and no studies compare the OTT and ACLR + LET procedures.
The aim of this study is to compare the clinical and radiological outcomes, as well as return-to-sport rates, between patients undergoing the Over-the-Top ACL Reconstruction technique and those undergoing the Anteromedial ACL Reconstruction technique with Lateral Extra-Articular Tenodesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospectively Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| OTT ACLR | Active comparator | Procedure: OTT ACLRPatients in this group will undergo a reconstruction with the OTT technique which includes an intra-articular component and an extra-articular one, functioning as a LET. |
| ACLR LET | Active comparator | Procedure: ACLR LETPatients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of an isolated anterior cruciate ligament (ACL) tear (isolated ligament injury).
- Age between 18 and 50 years.
- No previous history of surgery on the same knee.
- MRI and CT scans performed at the end of the first postoperative year.
Key exclusion criteria (4 listed)
- Presence of additional ligamentous injury (e.g., posterior cruciate ligament or collateral ligament) along with the ACL tear.
- Incomplete clinical scores.
- History of previous surgery on the same knee.
- Presence or history of infection.
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 |
|---|---|---|
| OTT ACLRPatients in this group will undergo a reconstruction with the OTT technique which includes an intra-articular component and an extra-articular one, functioning as a LET. | Procedure or surgery | OTT ACLR |
| ACLR LETPatients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band. | Procedure or surgery | ACLR LET |
Primary outcome
Re-rupture
Time frame: Postoperative 1.st year
Re-rupture prevalence detected on MRI (yes/no)
Tibial tunnel widening
Time frame: Postoperative 1.st year
Tibial tunnel diameter measured at the widest point on axial CT scans (number, mm)
Tegner Activity Scale
Time frame: Postoperative 1.st year
minimum value:0, maximum value 10, higher values mean better outcome
Knee Score ve Knee Injury & Osteoarthritis Outcome (KOOS)
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
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 29 Sep 2026.
- Background: PubMed 38296446Lucidi GA, Roberti di Sarsina T, Zaffagnini S. Editorial Commentary: The Number One Cause of Anterior Cruciate Ligament Reconstruction Graft Failure Is a Misplaced Femoral Tunnel: Over-the-Top Technique Plus Lateral Extra-Articular Tenodesis Is Recommended. Arthroscopy. 2024 Feb;40(2):435-437. doi: 10.1016/j.arthro.2023.07.021.
- Background: PubMed 37005946Zaffagnini S, Lucidi GA, Macchiarola L, Agostinone P, Neri MP, Marcacci M, Grassi A. The 25-year experience of over-the-top ACL reconstruction plus extra-articular lateral tenodesis with hamstring tendon grafts: the story so far. J Exp Orthop. 2023 Apr 1;10(1):36. doi: 10.1186/s40634-023-00599-8.
- Background: PubMed 36700965Kamei G, Nakamae A, Nakata K, Nekomoto A, Tsuji S, Hashiguchi N, Ishikawa M, Adachi N. Comparison of clinical outcomes between anterior cruciate ligament reconstruction with over-the-top route procedure and anatomic single-bundle reconstruction in pediatric patients. J Pediatr Orthop B. 2023 Mar 1;32(2):178-184. doi: 10.1097/BPB.0000000000001008. Epub 2023 Dec 15.
- Background: PubMed 35451640Bonanzinga T, Grassi A, Altomare D, Lucidi GA, Macchiarola L, Zaffagnini S, Marcacci M. High return to sport rate and few re-ruptures at long term in professional footballers after anterior cruciate ligament reconstruction with hamstrings. Knee Surg Sports Traumatol Arthrosc. 2022 Nov;30(11):3681-3688. doi: 10.1007/s00167-022-06944-1. Epub 2022 Apr 22.
- 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.
Enejd Veizi, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTT ACLR and ACLR LET in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injuries, run by Ankara City Hospital Bilkent 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 4 inclusion and 4 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 29 Sep 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?
Re-rupture (time frame: Postoperative 1.st year). The study lists 4 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 NCT06664047, which also lists 4 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 29 Sep 2026.