Radiological and Clinical Outcomes of Over-the-Top ACL Reconstruction vs. Anteromedial ACL Reconstruction With Additional Lateral Extraarticular Tenodesis: A Prospectively Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Re-rupture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
OTT ACLR
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.
干预措施: OTT ACLR (Procedure)
ACLR LET
Patients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band.
干预措施: ACLR LET (Procedure)
结局指标
主要结局
Re-rupture
时间窗: Postoperative 1.st year
Re-rupture prevalence detected on MRI (yes/no)
Tibial tunnel widening
时间窗: Postoperative 1.st year
Tibial tunnel diameter measured at the widest point on axial CT scans (number, mm)
Tegner Activity Scale
时间窗: Postoperative 1.st year
minimum value:0, maximum value 10, higher values mean better outcome
Knee Score ve Knee Injury & Osteoarthritis Outcome (KOOS)
时间窗: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
次要结局
未报告次要终点
研究者
Enejd Veizi, MD
Assistant Professor
Ankara City Hospital Bilkent
