Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis

NCT06664047 | Recruiting

• 1 other identifier: TADEB-1-24-645
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• Re-rupture

  Re-rupture prevalence detected on MRI (yes/no)

  Postoperative 1.st year

• Tibial tunnel widening

  Tibial tunnel diameter measured at the widest point on axial CT scans (number, mm)

  Postoperative 1.st year

• Tegner Activity Scale

  minimum value:0, maximum value 10, higher values mean better outcome

  Postoperative 1.st year

• Knee Score ve Knee Injury & Osteoarthritis Outcome (KOOS)

  minimum value:0, maximum value 100, higher values mean better outcome

  Postoperative 1.st year

Study Arms (2)

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.

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.

Procedure: ACLR LET

Interventions

OTT ACLR PROCEDURE

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.

OTT ACLR

ACLR LET PROCEDURE

Patients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band.

ACLR LET

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 38296446 BACKGROUND

• Zaffagnini 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.

  PMID: 37005946 BACKGROUND

• Kamei 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.

  PMID: 36700965 BACKGROUND

• Bonanzinga 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.

  PMID: 35451640 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Enejd Veizi, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enejd Veizi, MD

CONTACT

+905439799959; dr.nad89@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospectively Randomized Controlled Trial

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)