The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04968665
• Other study ID #: M2019434
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Shuang Ren
• Phone: +8617610252992
• Email: xixishuang123[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration

Description:

Cartilage degeneration in the medial tibiofemoral joint is common after anterior cruciate ligament reconstruction (ACLR), which may develop into knee osteoarthritis (disability rate 21.3%). Alterations in joint biomechanical properties play an important role in cartilage degeneration after ACLR. However, the mechanism remains unclear.

Our research studied the joint kinematics and kinetics properties after ACLR and found significant changes in biomechanics in the ACLR knees. Therefore, this study will combine longitude biochemical changes in the cartilage to explore how the alterations in biomechanics would influence biochemical changes in the joint cartilage.

This study will explore the joint biomechanical properties during functional activities by motion analysis, the effects of biomechanical properties on cartilage stress distribution by finite element analysis, the long-term biochemical changes in the joint cartilage by functional MRI. This study will establish prediction models for cartilage biomechanical changes in the mid-term based on joint biomechanical properties in the early stage after ACLR, and cartilage biomechanical changes in the long-term based on joint biomechanical properties in the mid-term after ACLR. The study aims to clarify the mechanism of cartilage degeneration after ACLR and search biomechanical risk factors, in order to provide methods for clinical prevention of cartilage degeneration after ACLR.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Unilateral ACL rupture of the knee

Exclusion Criteria:

concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Cartilage Degeneration

Intervention

Diagnostic Test:
• gait testing, functional MRI
diagnostic tests including the gait testing and functional MRI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee T1 rho value	knee T1 rho value by functional MRI	On the day of enrollment.
Primary	knee T1 rho value	knee T1 rho value by functional MRI	At 6 months post operation.
Primary	knee T1 rho value	knee T1 rho value by functional MRI	At 12 months post operation.
Primary	knee T1 rho value	knee T1 rho value by functional MRI	At 2 years post operation.
Primary	knee T2 value	knee T1 rho value by functional MRI	On the day of enrollment.
Primary	knee T2 value	knee T1 rho value by functional MRI	At 6 months post operation.
Primary	knee T2 value	knee T1 rho value by functional MRI	At 12 months post operation.
Primary	knee T2 value	knee T1 rho value by functional MRI	At 2 years post operation.
Primary	knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	On the day of enrollment.
Primary	knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 6 months post operation.
Primary	knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 12 months post operation.
Primary	knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 2 years post operation.
Primary	knee moments	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	On the day of enrollment.
Primary	knee moments	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 6 months post operation.
Primary	knee moments	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 12 months post operation.
Primary	knee moments	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 2 years post operation.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	On the day of enrollment.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 6 months post operation.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 12 months post operation.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 2 years post operation.
Primary	knee rotation angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	On the day of enrollment.
Primary	knee rotation angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 6 months post operation.
Primary	knee rotation angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 12 months post operation.
Primary	knee rotation angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 2 years post operation.