Anatomical and Biomechanical Study of Combined Reconstruction in III° Posterior Cruciate Ligament Injury

Completed

• Conditions: Posterior Cruciate Ligament Tear
• Interventions: Other: No Intervention

• Registration Number: NCT04954482
• Lead Sponsor: Peking University Third Hospital

Brief 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 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 Timeline

• Study Start: 2017-04-11
• Primary Completion: 2019-06-23
• Study Completion: 2019-06-23
• Status Verified: 2021-07
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Last Update Submitted: 2021-07-05
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• no sports injuries such as knee ligament rupture and meniscus injury specimens

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Exclusion Criteria

• sports injuries such as knee ligament rupture and meniscus injury specimens

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The validation group	No Intervention	The included specimens were used to validate the new posterior fork reconstruction procedure.
The experimental group	No Intervention	The included specimens were used to establish a new posterior fork reconstruction procedure.

Primary Outcome Measures

Name	Time	Method
The distance of posterior displacement of the tibia	On the day of enrollment.	The robotic arm/universal sensor test system was used as the test platform to test the specimens .

Secondary Outcome Measures

Name	Time	Method
Tibial valgus Angle	On the day of enrollment.	The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Internal rotation angle of the tibia	On the day of enrollment.	The robotic arm/universal sensor test system was used as the test platform to test the specimens .
External rotation angle of the tibia	On the day of enrollment.	The robotic arm/universal sensor test system was used as the test platform to test the specimens .
Tibia varus Angle	On the day of enrollment.	The robotic arm/universal sensor test system was used as the test platform to test the specimens .

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China