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NCT Number: NCT05219396

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Balance Gait Proprioception

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University

Taichung, 406040, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee arthroplasty

Device

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

Primary outcomes

  1. Knee joint proprioception

    Time frame: Pre-operation

    Degrees

  2. Knee joint proprioception

    Time frame: Post-operation 6 weeks

    Degrees

  3. Knee joint proprioception

    Time frame: Post-operation 3 months

    Degrees

  4. Postural stability index

    Time frame: Pre-operation

    Degrees

  5. Postural stability index

    Time frame: Post-operation 6 weeks

    Degrees

  6. Postural stability index

    Time frame: Post-operation 3 months

    Degrees

  7. Angle of foot during walking

    Time frame: Pre-operation

    Degrees

  8. Angle of foot during walking

    Time frame: Post-operation 6 weeks

    Degrees

  9. Angle of foot during walking

    Time frame: Post-operation 3 months

    Degrees

  10. Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC

    Time frame: Pre-operation

    Scoring from 0 to 100, and higher scores mean a better outcome.

  11. Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC

    Time frame: Post-operation 6 weeks

    Scoring from 0 to 100, and higher scores mean a better outcome.

  12. Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC

    Time frame: Post-operation 3 months

    Scoring from 0 to 100, and higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Feb 2, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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