Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study

NCT ID: NCT04957797

Last Updated: 2021-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ROT-Group

reamed with round tunnel

Group Type OTHER

round tunnel

Intervention Type PROCEDURE

reamed with round tunnel

FLT-Group

reamed with flat tunnel

Group Type EXPERIMENTAL

flat tunnel

Intervention Type PROCEDURE

reamed with flat tunnel

Interventions

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round tunnel

reamed with round tunnel

Intervention Type PROCEDURE

flat tunnel

reamed with flat tunnel

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* intact knee with no previous injures

Exclusion Criteria

* those with ligamentous injury or a limited range of motion
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yingfang ao, M.D.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking university third hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jiahao zhang, M.D.

Role: CONTACT

13001108061

Facility Contacts

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yingfang ao, M.D.

Role: primary

13910125935

Other Identifiers

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M2019056

Identifier Type: -

Identifier Source: org_study_id

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