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
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.
- 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