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

NCT06891430 | Not Yet Recruiting

• 1 other identifier: 24765-4-01
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Anterior Cruciate Ligament Tear

Keywords

tunnel widening; Anterior Cruciate Ligament; double-bundle reconstruction; single-bundle reconstruction

Outcome Measures

Primary Outcomes (1)

• tunnel widening

  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.

  From two days postoperatively to two years postoperatively

Secondary Outcomes (4)

• Return to sport

  Follow-up more than two years postoperatively.

• IKDC 2000

  Recorded preoperatively and at follow-up more than two years postoperatively.

• Lyholm score

  Recorded preoperatively and at follow-up more than two years postoperatively.

• Tegner

  From two days postoperatively to two years postoperatively

Study Arms (3)

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.

Procedure: Procedure: Anatomical Single-Bundle ACL Reconstruction

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.

Procedure: Procedure: Central Axial Single-Bundle ACL Reconstruction

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.

Procedure: Procedure: Double-Bundle ACL Reconstruction

Interventions

Procedure: Anatomical Single-Bundle ACL Reconstruction PROCEDURE

Patients undergo anatomical single-bundle ACL reconstruction with femoral and tibial tunnel drilling.

ASBR Group

Procedure: Central Axial Single-Bundle ACL Reconstruction PROCEDURE

Patients undergo central axial single-bundle ACL reconstruction with optimized tunnel positioning.

CASBR Group

Procedure: Double-Bundle ACL Reconstruction PROCEDURE

Patients undergo double-bundle ACL reconstruction targeting AMB and PLB footprints.

DBR Group

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 24, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03