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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05219396
• Other study ID #: CMUH110-REC2-235
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Balance
• Gait
• Proprioception

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