Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

Anatomic and Biomechanical Investigation on Anterior Cruciate Ligament: A Cadaveric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957797
• Other study ID #: M2019056
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: jiahao zhang, M.D.
• Phone: 13001108061
• Email: jiahaozhang_pkmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 31, 2022
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• intact knee with no previous injures

Exclusion Criteria:

• those with ligamentous injury or a limited range of motion

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• round tunnel
reamed with round tunnel
• flat tunnel
reamed with flat tunnel

Locations

Country	Name	City	State
China	Peking university third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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