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

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.

Study Overview

• Status: Completed
• Conditions: Posterior Cruciate Ligament Tear
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There were no sports injuries such as knee ligament rupture and meniscus injury.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The experimental group; The included specimens were used to establish a new posterior fork reconstruction procedure.	Other: No Intervention; This is an observation study, with no intervention
The validation group; The included specimens were used to validate the new posterior fork reconstruction procedure.	Other: No Intervention; This is an observation study, with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	On the day of enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal rotation angle of the tibia	The robotic arm/universal sensor test system was used as the test platform to test the specimens .	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 .	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 .	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 .	On the day of enrollment.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Ping Liu, Doctor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): June 23, 2019
• Study Completion (Actual): June 23, 2019

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: biomechanics; posterior cruciate ligament; Combined reconstruction technique
• Other Study ID Numbers: M2017121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No