Anterior Cruciate Ligament RuptureNCT04957797
Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study
A study testing round tunnel and flat tunnel in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- round tunnel and flat tunnel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intact knee with no previous injures
Who cannot join
- those with ligamentous injury or a limited range of motion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking university third hospital
Beijing, Beijing Municipality, 100191
yingfang ao, M.D., 13910125935, aoyingfang@163.com
About this study
Official title: Anatomic and Biomechanical Investigation on Anterior Cruciate Ligament: A Cadaveric Study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- round tunnel, flat tunnel
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
round tunnelProcedure or surgery
reamed with round tunnel
flat tunnelProcedure or surgery
reamed with flat tunnel
| Study group | Role | What they receive |
|---|---|---|
| ROT-Group | Other | reamed with round tunnel Receives: Procedure: round tunnel |
| FLT-Group | Experimental | reamed with flat tunnel Receives: Procedure: flat tunnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: within 1 hour after surgery
varus and valgus
10-Nm varus and valgus torques at 15°, 30°of knee flexion
Measured: 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
Measured: within 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Mar 2019
- Primary completion1 Mar 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingfang ao, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957797
- Sponsor's protocol ID
- M2019056
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic and Biomechanical Investigation on Anterior Cruciate Ligament: A Cadaveric Study
- ClinicalTrials.gov ID
- NCT04957797
- Acronym / sponsor ID
- M2019056
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ROT-Group | Other | Procedure: round tunnelreamed with round tunnel |
| FLT-Group | Experimental | Procedure: flat tunnelreamed with flat tunnel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- intact knee with no previous injures
Key exclusion criteria (1 listed)
- those with ligamentous injury or a limited range of motion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| round tunnelreamed with round tunnel | Procedure or surgery | ROT-Group |
| flat tunnelreamed with flat tunnel | Procedure or surgery | FLT-Group |
Primary outcome
simulated pivot-shift test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 1 hour after surgery
10-Nm varus and valgus torques at 15°, 30°of knee flexion
average percentage of ACL tibial footprint coverage
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yingfang ao, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing round tunnel and flat tunnel in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiahao zhang, M.D. (13001108061, jiahaozhang_pkmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
simulated pivot-shift test (time frame: within 1 hour after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.