Posterior Cruciate Ligament TearNCT04954482
Anatomical and Biomechanical Study of Combined Reconstruction in III° Posterior Cruciate Ligament Injury
An observational study of Posterior Cruciate Ligament Tear, run by Peking University Third Hospital at 1 site in China.
Trial summary
To establish a III°PCL injury model on fresh cadaver knee specimens, and to define the pathological and anatomical connotation of III°PCL injury by using anatomical methods. To explore and establish combined reconstruction techniques, including PCL reconstruction combined with injury repair and reconstruction, and to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posterior Cruciate Ligament Tear
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2017to 23 Jun 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There were no sports injuries such as knee ligament rupture and meniscus injury.
Who may be able to join
- no sports injuries such as knee ligament rupture and meniscus injury specimens
Who cannot join
- sports injuries such as knee ligament rupture and meniscus injury specimens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical and Biomechanical Study of Combined Reconstruction in the Treatment of III° Posterior Cruciate Ligament Injury
To establish a III°PCL injury model on fresh cadaver knee specimens, and to define the pathological and anatomical connotation of III°PCL injury by using anatomical methods.
To explore and establish combined reconstruction techniques, including PCL reconstruction combined with injury repair and reconstruction, and to explore the role of combined reconstruction techniques in maintaining knee stability through biomechanical experiments.
Read the detailed description
Objective: (1) To establish a III°PCL injury model on fresh cadaver knee specimens, and to define the pathological and anatomical connotation of III°PCL injury by using anatomical methods.
(2) To explore and establish combined reconstruction techniques, including PCL reconstruction combined with injury repair and reconstruction, and to explore the role of combined reconstruction techniques in maintaining knee stability through biomechanical experiments.
Design: ① The subjects of this study were fresh cadaver knee specimens.
- Sample size:
A Anatomical study of injury model, planning 6 cases. B. Exploration of treatment methods for complicated injuries. 8 cases of specimens are planned to be used. According to the pathological and anatomical content of III°PCL injury (IKDC standard), the repair and reconstruction techniques of combined injury were designed. Arthroscopic transtibial single-bundle PCL reconstruction technique was used in all the reconstruction of PCL. Using the robotic arm or universal sensor test system as the biomechanical test platform, Biomechanical tests were carried out on the experimental specimens, and the results were compared to determine the shortcomings of the new PCL reconstruction, according to which the surgical procedures were improved, and then the biomechanical tests were carried out. After repeated technical improvement (4 cycles, 2 specimens per cycle), the new PCL reconstruction technique was finally determined.
C To investigate the effect of new PCL reconstruction in maintaining the stability of knee joint, 8 cases were treated with a specimen plan. Biomechanical tests were performed on each specimen in its intact state, post-traumatic state (after the establishment of the III°PCL injury model), and post-traumatic state (after the application of the new PCL reconstruction technology) using the robotic arm/universal sensor test system.
Outcome evaluation: The biomechanical characteristics of knee specimens under different conditions were measured, compared and statistically analyzed, and the conclusions were drawn.
Statistical Methods:
- Multivariate linear analysis model and Bonferroni multiple comparison were used to compare the kinematics changes of knee joints under various loading conditions and knee flexion angles under the condition of knee joint integrity, III°PCL injury, PCL reconstruction, and combined injury treatment.
- Univariate repeated measure ANOVA was used to compare the knee joint integrity, III°PCL injury, the stability of the knee joint after PCL reconstruction, and the stability of the knee joint after combined injury treatment (including the back drawer test and stress radiograph measurement).
- Conditions
- Posterior Cruciate Ligament Tear
- Being tested
- No Intervention
- Keywords
- posterior cruciate ligament, biomechanics, Combined reconstruction technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an observation study, with no intervention
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | The included specimens were used to establish a new posterior fork reconstruction procedure. Receives: Other: No Intervention | |
| The validation group | The included specimens were used to validate the new posterior fork reconstruction procedure. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance of posterior displacement of the tibia
The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Measured: On the day of enrollment.
Secondary outcomes (4)
Internal rotation angle of the tibia
The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Measured: On the day of enrollment.
External rotation angle of the tibia
The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Measured: On the day of enrollment.
Tibia varus Angle
The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Measured: On the day of enrollment.
Tibial valgus Angle
The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Measured: On the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start11 Apr 2017
- Primary completion23 Jun 2019
- Study completion23 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Cruciate Ligament TearStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Ping, Peking University Third Hospital
- Investigators
- Ping Liu, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954482
- Sponsor's protocol ID
- M2017121
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Biomechanical Study of Combined Reconstruction in the Treatment of III° Posterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT04954482
- Acronym / sponsor ID
- M2017121
- Conditions
- Posterior Cruciate Ligament Tear
- Keywords
- posterior cruciate ligament, biomechanics, Combined reconstruction technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 23 Jun 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 8 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.
To establish a III°PCL injury model on fresh cadaver knee specimens, and to define the pathological and anatomical connotation of III°PCL injury by using anatomical methods.
To explore and establish combined reconstruction techniques, including PCL reconstruction combined with injury repair and reconstruction, and to explore the role of combined reconstruction techniques in maintaining knee stability through biomechanical experiments.
Detailed description
Objective: (1) To establish a III°PCL injury model on fresh cadaver knee specimens, and to define the pathological and anatomical connotation of III°PCL injury by using anatomical methods.
(2) To explore and establish combined reconstruction techniques, including PCL reconstruction combined with injury repair and reconstruction, and to explore the role of combined reconstruction techniques in maintaining knee stability through biomechanical experiments.
Design: ① The subjects of this study were fresh cadaver knee specimens.
- Sample size:
A Anatomical study of injury model, planning 6 cases. B. Exploration of treatment methods for complicated injuries. 8 cases of specimens are planned to be used. According to the pathological and anatomical content of III°PCL injury (IKDC standard), the repair and reconstruction techniques of combined injury were designed. Arthroscopic transtibial single-bundle PCL reconstruction technique was used in all the reconstruction of PCL. Using the robotic arm or universal sensor test system as the biomechanical test platform, Biomechanical tests were carried out on the experimental specimens, and the results were compared to determine the shortcomings of the new PCL reconstruction, according to which the surgical procedures were improved, and then the biomechanical tests were carried out. After repeated technical improvement (4 cycles, 2 specimens per cycle), the new PCL reconstruction technique was finally determined.
C To investigate the effect of new PCL reconstruction in maintaining the stability of knee joint, 8 cases were treated with a specimen plan. Biomechanical tests were performed on each specimen in its intact state, post-traumatic state (after the establishment of the III°PCL injury model), and post-traumatic state (after the application of the new PCL reconstruction technology) using the robotic arm/universal sensor test system.
Outcome evaluation: The biomechanical characteristics of knee specimens under different conditions were measured, compared and statistically analyzed, and the conclusions were drawn.
Statistical Methods:
- Multivariate linear analysis model and Bonferroni multiple comparison were used to compare the kinematics changes of knee joints under various loading conditions and knee flexion angles under the condition of knee joint integrity, III°PCL injury, PCL reconstruction, and combined injury treatment.
- Univariate repeated measure ANOVA was used to compare the knee joint integrity, III°PCL injury, the stability of the knee joint after PCL reconstruction, and the stability of the knee joint after combined injury treatment (including the back drawer test and stress radiograph measurement).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | – | Other: No InterventionThe included specimens were used to establish a new posterior fork reconstruction procedure. |
| The validation group | – | Other: No InterventionThe included specimens were used to validate the new posterior fork reconstruction procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There were no sports injuries such as knee ligament rupture and meniscus injury.
Key inclusion criteria (1 listed)
- no sports injuries such as knee ligament rupture and meniscus injury specimens
Key exclusion criteria (1 listed)
- sports injuries such as knee ligament rupture and meniscus injury specimens
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 |
|---|---|---|
| No InterventionThis is an observation study, with no intervention | Other | The experimental group, The validation group |
Primary outcome
The distance of posterior displacement of the tibia
Time frame: On the day of enrollment.
The robotic arm/universal sensor test system was used as the test platform to test the specimens .
4 secondary outcomes
Internal rotation angle of the tibia
Time frame: On the day of enrollment.
External rotation angle of the tibia
Time frame: On the day of enrollment.
Tibia varus Angle
Time frame: On the day of enrollment.
Tibial valgus Angle
Time frame: On the day of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Ping Liu, Doctor 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?
An observational study of Posterior Cruciate Ligament Tear, 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: finished, as of the sponsor's last update on 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance of posterior displacement of the tibia (time frame: On the day of enrollment.). 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 8 Jul 2021.