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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Cartilage Degeneration
• Intervention / Treatment: Diagnostic test: gait testing, functional MRI

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Shuang Ren; Phone Number: +8617610252992; Email: xixishuang123@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thirty patients with ACL rupture undergoing ACL reconstruction surgery at the Institute of Sports Medicine, Peking University Third Hospital would be included in the study cohort were included, A total of 30 healthy volunteers with no history of musculoskeletal system injury or surgery in bilateral lower extremities would be included

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers; gait testing and MRI at baseline for healthy volunteers	Diagnostic test: gait testing, functional MRI; diagnostic tests including the gait testing and functional MRI
ACL-deficient patients; gait testing and MRI at pre-operation, 6 months post-operation, 1 year post-operation, 2 years post-operation	Diagnostic test: gait testing, functional MRI; diagnostic tests including the gait testing and functional MRI

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Shuang Ren, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (ACTUAL): July 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: functional MRI; anterior cruciate ligament reconstruction; sports biomechanics; joint loading; cartilage degeneration
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: M2019434

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