Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study

NCT04957797 | Unknown DMC

• 1 other identifier: M2019056
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (5)

• 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 flexion

  within 1 hour after surgery

• simulated KT-2000 arthrometer

  134-N anterior tibial load simulates a KT-2000 arthrometer at 0°, 15°, 30°, 60°, and 90°of knee flexion

  within 1 hour after surgery

• internal and external rotation

  5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90° of knee flexion

  within 1 hour after surgery

• varus and valgus

  10-Nm varus and valgus torques at 15°, 30°of knee flexion

  within 1 hour after surgery

• 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

Study Arms (2)

ROT-Group

OTHER

reamed with round tunnel

Procedure: round tunnel

FLT-Group

EXPERIMENTAL

reamed with flat tunnel

Procedure: flat tunnel

Interventions

round tunnel PROCEDURE

reamed with round tunnel

ROT-Group

flat tunnel PROCEDURE

reamed with flat tunnel

FLT-Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• intact knee with no previous injures

You may not qualify if:

• those with ligamentous injury or a limited range of motion

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• yingfang ao, M.D.

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

jiahao zhang, M.D.

CONTACT

13001108061; jiahaozhang_pkmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nine matched-paired fresh frozen human cadaveric knees were randomly distributed into two groups: Flat-tunnel (FLT) group and round-tunnel (ROT) group. One knee from each pair was reamed with flat tunnel, while the contralateral knee was reamed with round tunnel.

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 12, 2021
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: December 31, 2022
• Last Updated: July 12, 2021

Record last verified: 2021-06

Locations

CN (1)