Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2016
CompletedFirst Submitted
Initial submission to the registry
December 16, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 24, 2020
December 1, 2020
6.2 years
December 16, 2020
December 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Forgotten joint score
Postoperative 5 years
Crepitus
Postoperative 5 years
Other Outcomes (6)
Change from baseline Knee Society Score (KSS) at 3 and 5 years
Preoperative and Postoperative 3, 5 years
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 years
Preoperative and Postoperative 3, 5 years
Central Sensitization Index (CSI)
Postoperative 3 years
- +3 more other outcomes
Study Arms (2)
Fixed-bearing group
ACTIVE COMPARATORMobile-bearing group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed with knee joint advanced osteoarthritis
- Age over 55 years old
- Scheduled to undergo primary total knee arthroplasty
You may not qualify if:
- Post-traumatic or inflammatory osteoarthritis
- Those who undertook previous ligamentous surgery
- Those who do not understand and give answers to a survey
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea Seoul St Mary's hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yong In, M.D., Ph.D.
Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2020
First Posted
December 24, 2020
Study Start
October 19, 2016
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
December 24, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share