The Clinical Efficacy of Anterolateral Complex Augmentation in Patients With ACL Rupture Combined With Excessive Internal Tibial Rotation Subluxation: A Bidirectional Cohort Study

NCT06961292 | Enrolling By Invitation DMC

• 1 other identifier: M2024140; M2024141
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on preoperative MRI. The study population will consist of patients with primary ACL rupture, and high-risk individuals will be identified based on the presence of EIRTS on preoperative knee MRI. The exposure group will undergo ACLR combined with ALC augmentation, while the control group will receive standard ACLR. Observational indicators will include all baseline patient characteristics and postoperative clinical outcomes.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

anterior cruciate ligament; anterolateral complex; ateral extra-articular tenodesis; internal rotational tibial subluxation; tibiofemoral position; magnetic resonance imaging; bidirectional cohort study

Outcome Measures

Primary Outcomes (2)

• Graft Failure Rate

  Graft failure was identified based on physical examination findings and postoperative MRI scans at the designated follow-up time points.

  At 2 and 5 years postoperatively

• Return to Pivoting Sports: Rate and Time

  The rate and timing of return to pivoting sports were recorded at each follow-up time point.

  At 2 and 5 years postoperatively

Secondary Outcomes (4)

• Patient-Reported Outcome Measures

  At 2 and 5 years postoperatively

• Physical Examinations

  At 2 and 5 years postoperatively

• Muscle Strength

  At 2 and 5 years postoperatively

• MRI Measurements

  At 2 and 5 years postoperatively

Study Arms (2)

Control group

Patients who underwent primary anterior cruciate ligament reconstruction at our institution and met the following criteria: A. Inclusion Criteria: Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation \[IRTS\] \> 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study. B. Exclusion Criteria: Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery.

ALC augmentation group

Patients who underwent anterior cruciate ligament reconstruction combined with anterolateral complex augmentation using lateral extra-articular tenodesis (LET) and met the following criteria: A. Inclusion Criteria: Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation \[IRTS\] \> 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study. B. Exclusion Criteria: Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent primary anterior cruciate ligament reconstruction at our institution and fulfilled the predefined inclusion and exclusion criteria.

You may qualify if:

• Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation \[IRTS\] \> 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study.

You may not qualify if:

• Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)