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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05219396
Other study ID # CMUH110-REC2-235
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 120
Est. completion date December 31, 2023
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Taiwan China Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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