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临床试验/NCT06891430
NCT06891430尚未招募不适用

Prognosis Analysis of Three Surgical Techniques for Arthroscopic Anterior Cruciate Ligament Reconstruction

Beijing Tsinghua Chang Gung Hospital0 个研究点目标入组 180 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
主要终点
tunnel widening

研究概览

简要总结

This study hypothesizes that the tunnel positioning and drilling direction in two single-bundle reconstruction techniques (Anatomical Single-Bundle Reconstruction, ASBR, and Central Axial Single-Bundle Reconstruction, CASBR) influence the biomechanical environment of the graft, thereby affecting graft remodeling and maturation, ultimately impacting postoperative outcomes. Studies have shown that the graft bending angle (GBA) is a critical factor affecting graft ligamentization. ASBR, with a higher GBA, may result in poorer graft maturation, while CASBR, with a lower GBA, may provide a more favorable biomechanical environment. Additionally, graft volume has been identified as an important factor influencing postoperative graft maturation. Therefore, this study also examines the double-bundle reconstruction (DBR) technique, which has a GBA similar to CASBR.

The Impact of Three Techniques on Graft Maturation Anatomical Single-Bundle Reconstruction (ASBR)

ASBR involves drilling a single tunnel at both the femoral and tibial ends, with the tunnel positioned at the center of the dense fiber area of the ACL footprint. The femoral tunnel is positioned at 90° knee flexion and drilled at 120°, while the tibial tunnel is positioned at 70° knee flexion. Due to the higher GBA in ASBR, the graft may experience greater bending stress during motion, leading to impaired graft maturation, limited ligamentization, and increased stress concentration around the tunnel, potentially causing tunnel widening.

Central Axial Single-Bundle Reconstruction (CASBR)

CASBR also involves drilling a single tunnel at both ends, but the tunnel is positioned in the posterior region of the dense fiber area of the ACL footprint, mimicking the central axis of the native ACL. The femoral tunnel is positioned at 90° knee flexion and drilled at 120°, while the tibial tunnel is positioned at 70° knee flexion. Compared to ASBR, CASBR's lower GBA results in more uniform graft stress distribution, promoting better graft maturation and reducing the risk of stress concentration and tunnel widening.

Double-Bundle Reconstruction (DBR)

DBR involves drilling two tunnels at both the femoral and tibial ends, targeting the dense fiber areas of the anterior medial bundle (AMB) and posterior lateral bundle (PLB) of the ACL footprint. The positioning of the PLB tunnel is similar to CASBR, while the AMB tunnel is located in the anterior region of the footprint. DBR provides a more anatomically accurate distribution of forces, leading to a more even biomechanical environment. However, the increased number of tunnels may complicate stress distribution.

Impact on Postoperative Outcomes ASBR, with its higher GBA, may lead to poor graft maturation and increased tunnel widening. CASBR, with a lower GBA, offers a more favorable biomechanical environment for graft maturation. While DBR ensures a more uniform force distribution, the additional tunnels may introduce complexities in stress distribution, potentially affecting postoperative recovery and return to sports (RTS).

详细描述

Hypothesis and Background This study hypothesizes that the tunnel positioning and drilling direction of two single-bundle reconstruction techniques influence the biomechanical environment of the graft, which may affect graft remodeling. Poor biomechanical environments could result in suboptimal graft maturation and worse return-to-sport (RTS) outcomes. Previous research has identified the graft bending angle (GBA) as a risk factor for graft ligamentization. Anatomical Single-Bundle Reconstruction (ASBR) is associated with a higher GBA, whereas Central Axial Single-Bundle Reconstruction (CASBR) has a relatively lower GBA. Recent studies have also highlighted the influence of graft volume on postoperative graft maturation. Therefore, this section further discusses ACL double-bundle reconstruction (DBR), which has a GBA similar to CASBR. The anatomical and directional terminologies used in this study are based on the ESSKA scientific seminar on ACL reconstruction held at Imperial College London.

Techniques Anatomical Single-Bundle Reconstruction (ASBR)

ASBR involves drilling single femoral and tibial tunnels, both positioned at the center of the dense fiber area of the native ACL footprint. This technique represents the anatomical location of the ACL.

Femoral Tunnel: Positioned arthroscopically through the anteromedial portal at 90° knee flexion, targeting the center of the ACL femoral footprint. A guidewire is used without a positioning device, and the femoral tunnel is drilled at 120° knee flexion.

Tibial Tunnel: Positioned arthroscopically through the anteromedial portal at 70° knee flexion using the Smith & Nephew tibial tunnel guide. The tibial tunnel is drilled at the center of the ACL tibial footprint, with angles adjusted to 55° relative to the horizontal plane and 30° medially from the sagittal plane.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • •Diagnosed with anterior cruciate ligament (ACL) rupture; Age between 18-50 years; All patients must have isolated anterior cruciate ligament (ACL) rupture; Knee joint degeneration < KL grade II, and intraoperative cartilage injury < ICRS grade III; All isolated ACL rupture patients must not have other ligament injuries; If accompanied by meniscus injury, the proportion of medial or lateral meniscus resection during surgery must not exceed 40%; The duration of the condition must be within one year after injury; No restriction on body weight; The cause of ACL rupture must be sports-related trauma or twisting injuries, excluding car accident injuries.

排除标准

  • •Patients with other surgical contraindications; Patients with poor compliance; Patients planning pregnancy; Patients deemed unsuitable for inclusion by the researchers.

研究组 & 干预措施

ASBR Group

Experimental

Description: Patients in this group will undergo anatomical single-bundle ACL reconstruction (ASBR). The femoral and tibial tunnels will be positioned at the center of the dense fiber area of the native ACL footprint. Graft fixation will be performed using EndoButton on the femoral side and bioabsorbable screws on the tibial side.

干预措施: Procedure: Anatomical Single-Bundle ACL Reconstruction (Procedure)

CASBR Group

Experimental

Description: Patients in this group will undergo central axial single-bundle ACL reconstruction (CASBR). The femoral and tibial tunnels will mimic the central axis of the native ACL, spanning the dense fiber structure from anteromedial to posterolateral. Graft fixation will follow the same protocol as the ASBR group.

干预措施: Procedure: Central Axial Single-Bundle ACL Reconstruction (Procedure)

DBR Group

Experimental

Description: Patients in this group will undergo ACL double-bundle reconstruction (DBR), with separate femoral and tibial tunnels for the anterior medial bundle (AMB) and posterior lateral bundle (PLB). Graft fixation will involve independent tensioning of AMB and PLB grafts at different knee flexion angles.

干预措施: Procedure: Double-Bundle ACL Reconstruction (Procedure)

结局指标

主要结局

tunnel widening

时间窗: From two days postoperatively to two years postoperatively

Tunnel widening is measured as the percentage change in cross-sectional area of the graft tunnel. Using CT and MRI, we measure the cross-sectional area perpendicular to the graft tunnel two days after surgery (baseline) and again during follow-up. The tunnel enlargement rate is calculated as: Tunnel Enlargement Rate = (Follow-up Tunnel Area - Postoperative Day 2 Tunnel Area) / Postoperative Day 2 Tunnel Area × 100% The measurement unit is percentage (%), with higher percentages indicating greater tunnel widening.

次要结局

  • Lyholm score(Recorded preoperatively and at follow-up more than two years postoperatively.)
  • Return to sport(Follow-up more than two years postoperatively.)
  • IKDC 2000(Recorded preoperatively and at follow-up more than two years postoperatively.)
  • Tegner(From two days postoperatively to two years postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

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