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

NCT05219396 | Completed

• 1 other identifier: CMUH110-REC2-235
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee; Proprioception; Gait; Balance

Keywords

knee arthroplasty; rotational design; proprioception; balance function; gait performance

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (3)

mobile bearing (MB)

Device: Knee arthroplasty

medial congruent (MC)

Device: Knee arthroplasty

posterior stabilized (PS)

Device: Knee arthroplasty

Interventions

Knee arthroplasty DEVICE

Your knee should be replaced with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design protheses.

medial congruent (MC); mobile bearing (MB); posterior stabilized (PS)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Out patient department

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 2, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: December 24, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)