Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
round tunnel
flat tunnel
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture
Eligibility Criteria
Inclusion Criteria:
- intact knee with no previous injures
Exclusion Criteria:
- those with ligamentous injury or a limited range of motion
Sites / Locations
- Peking university third hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
ROT-Group
FLT-Group
Arm Description
reamed with round tunnel
reamed with flat tunnel
Outcomes
Primary Outcome Measures
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
simulated KT-2000 arthrometer
134-N anterior tibial load simulates a KT-2000 arthrometer at 0°, 15°, 30°, 60°, and 90°of knee flexion
internal and external rotation
5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90° of knee flexion
varus and valgus
10-Nm varus and valgus torques at 15°, 30°of knee flexion
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04957797
First Posted
June 27, 2021
Last Updated
July 4, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04957797
Brief Title
Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study
Official Title
Anatomic and Biomechanical Investigation on Anterior Cruciate Ligament: A Cadaveric Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROT-Group
Arm Type
Other
Arm Description
reamed with round tunnel
Arm Title
FLT-Group
Arm Type
Experimental
Arm Description
reamed with flat tunnel
Intervention Type
Procedure
Intervention Name(s)
round tunnel
Intervention Description
reamed with round tunnel
Intervention Type
Procedure
Intervention Name(s)
flat tunnel
Intervention Description
reamed with flat tunnel
Primary Outcome Measure Information:
Title
simulated pivot-shift test
Description
10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30° of knee flexion
Time Frame
within 1 hour after surgery
Title
simulated KT-2000 arthrometer
Description
134-N anterior tibial load simulates a KT-2000 arthrometer at 0°, 15°, 30°, 60°, and 90°of knee flexion
Time Frame
within 1 hour after surgery
Title
internal and external rotation
Description
5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90° of knee flexion
Time Frame
within 1 hour after surgery
Title
varus and valgus
Description
10-Nm varus and valgus torques at 15°, 30°of knee flexion
Time Frame
within 1 hour after surgery
Title
average percentage of ACL tibial footprint coverage
Description
Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning post-operation
Time Frame
within 1 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
intact knee with no previous injures
Exclusion Criteria:
those with ligamentous injury or a limited range of motion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jiahao zhang, M.D.
Phone
13001108061
Email
jiahaozhang_pkmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yingfang ao, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking university third hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yingfang ao, M.D.
Phone
13910125935
Email
aoyingfang@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study
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