The Comparison of Proprioception and Gait Function Among Different Rotational Designs in Knee Arthroplasty

The symptoms of knee osteoarthritis include knee joint pain, impaired proprioception, and etc. Knee arthroplasty is commonly recommended for the patient with severe knee osteoarthritis to relieve pain and regain function. But the effects of arthroplasty on the proprioception and gait performance, which were related to the risk of falling, were not fully understood. Recently, the concept of enhancing the rotational movement has been introduced into the design of the knee joint prosthesis for mimicking the kinematic performance of the healthy knee. However, study on the functional performance after using these rotational designed arthroplasties was still scarce. So, the purpose of this study aims to evaluate the differences in the proprioception, balance function and gait performance among different designs of the knee arthroplasties with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design. This study is divided into the retrospective and prospective parts.

Investigators will enroll the patients who already replaced their knee joint by one of the above knee arthroplasties for the retrospective part; other patients who plans to receive one of the above knee arthroplasties, twenty participants for each design and each part. The assessment of proprioception, balance function and gait performance will be performed before the knee arthroplasty, and followed at the post-surgery time points of six weeks and three months. The one-way ANOVA will be used to compare the group differences in the retrospective part, and the two-way mixed model ANOVA for the prospective part.

Ultimately, the results of this study could help to have better knowledge of the treatment effects from the different designed knee arthroplasties.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Gait; Proprioception; Balance
• Intervention / Treatment: Device: Knee arthroplasty

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 406040
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Out patient department

Description

Inclusion Criteria:

• Diagnosed as knee joint osteoarthritis and will receive knee joint arthroplasty.

Exclusion Criteria:

• Already receiving a knee joint arthroplasty surgery
• Can not walk independently for 20 m
• Can not stand for 5 min
• With neurological degenerative disease
• Lower limb received any surgery within recent 2 years

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mobile bearing (MB)	Device: Knee arthroplasty; Your knee should be replaced with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design protheses.
medial congruent (MC)	Device: Knee arthroplasty; Your knee should be replaced with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design protheses.
posterior stabilized (PS)	Device: Knee arthroplasty; Your knee should be replaced with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design protheses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee joint proprioception	Degrees	Pre-operation
Knee joint proprioception	Degrees	Post-operation 6 weeks
Knee joint proprioception	Degrees	Post-operation 3 months
Postural stability index	Degrees	Pre-operation
Postural stability index	Degrees	Post-operation 6 weeks
Postural stability index	Degrees	Post-operation 3 months
Angle of foot during walking	Degrees	Pre-operation
Angle of foot during walking	Degrees	Post-operation 6 weeks
Angle of foot during walking	Degrees	Post-operation 3 months
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC	Scoring from 0 to 100, and higher scores mean a better outcome.	Pre-operation
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC	Scoring from 0 to 100, and higher scores mean a better outcome.	Post-operation 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC	Scoring from 0 to 100, and higher scores mean a better outcome.	Post-operation 3 months

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): December 24, 2024

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: proprioception; knee arthroplasty; rotational design; balance function; gait performance
• Other Study ID Numbers: CMUH110-REC2-235

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