Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses

Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee; Arthropathy of Knee; Joint Awareness
• Intervention / Treatment: Device: Fixed-bearing TKA; Device: Mobile-bearing TKA

Detailed Description

Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with knee joint advanced osteoarthritis
• Age over 55 years old
• Scheduled to undergo primary total knee arthroplasty

Exclusion Criteria:

• Post-traumatic or inflammatory osteoarthritis
• Those who undertook previous ligamentous surgery
• Those who do not understand and give answers to a survey

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixed-bearing group	Device: Fixed-bearing TKA
Experimental: Mobile-bearing group	Device: Mobile-bearing TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forgotten joint score	Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100	Postoperative 3 years
Crepitus	Any grating, crackling or popping sensation around knee when moving a joint	Postoperative 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forgotten joint score	Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100	Postoperative 5 years
Crepitus	Any grating, crackling or popping sensation around knee when moving a joint	Postoperative 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Knee Society Score (KSS) at 3 and 5 years	Patient-reported Outcome measure; The lower, the worse. Range: 0-200	Preoperative and Postoperative 3, 5 years
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 years	Patient-reported Outcome measure; The higher, the worse. Range: 0-96	Preoperative and Postoperative 3, 5 years
Central Sensitization Index (CSI)	Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100	Postoperative 3 years
Central Sensitization Index (CSI)	Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100	Postoperative 5 years
Radiological outcomes	Measurements of radiological angles	Postoperative 3 years
Radiological outcomes	Measurements of radiological angles	Postoperative 5 years

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Study Chair: Yong In, M.D., Ph.D., Seoul St. Mary'S Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CUKorea MB

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