Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Procedure: flat tunnel; Procedure: round tunnel

• Registration Number: NCT04957797
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The present study was aimed to investigate the kinematics differences between round-tunnel (ROT) and flat-tunnel (FLT) techniques and compare the influence to the anterior root of lateral meniscus (ARLM ) in anterior cruciate ligament (ACL) reconstruction when using hamstring graft.

Detailed Description

Nine matched pairs of fresh-frozen cadaveric knees were evaluated for the kinematics of intact, ACL-sectioned, and either ROT or FLT reconstructed knees. The graft bundles for FLT technique were separately tensioned. A 6 degrees of freedom robotic system was used to assess knee laxity: (1) 134-N anterior tibial load at 0°, 15°, 30°, 60°, and 90°of knee flexion. (2) 10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30°. (3) 5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90°. (4) 10-Nm varus and valgus torques at 15°, 30°. Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-03-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• intact knee with no previous injures

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Exclusion Criteria

• those with ligamentous injury or a limited range of motion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLT-Group	flat tunnel	reamed with flat tunnel
ROT-Group	round tunnel	reamed with round tunnel

Primary Outcome Measures

Name	Time	Method
simulated pivot-shift test	within 1 hour after surgery	10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30° of knee flexion
simulated KT-2000 arthrometer	within 1 hour after surgery	134-N anterior tibial load simulates a KT-2000 arthrometer at 0°, 15°, 30°, 60°, and 90°of knee flexion
internal and external rotation	within 1 hour after surgery	5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90° of knee flexion
varus and valgus	within 1 hour after surgery	10-Nm varus and valgus torques at 15°, 30°of knee flexion
average percentage of ACL tibial footprint coverage	within 1 hour after surgery	Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning post-operation

Trial Locations

Locations (1)

Peking university third hospital; 🇨🇳 Beijing, Beijing, China