Back to resultsComparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Primary Purpose
Osteoarthritis, Knee, Arthropathy of Knee, Joint Awareness
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fixed-bearing TKA
Mobile-bearing TKA
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea Seoul St Mary's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fixed-bearing group
Mobile-bearing group
Arm Description
Outcomes
Primary Outcome Measures
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
Crepitus
Any grating, crackling or popping sensation around knee when moving a joint
Secondary Outcome Measures
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
Crepitus
Any grating, crackling or popping sensation around knee when moving a joint
Full Information
NCT ID
NCT04684160
First Posted
December 16, 2020
Last Updated
December 21, 2020
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04684160
Brief Title
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Official Title
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Arthropathy of Knee, Joint Awareness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed-bearing group
Arm Type
Active Comparator
Arm Title
Mobile-bearing group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fixed-bearing TKA
Intervention Type
Device
Intervention Name(s)
Mobile-bearing TKA
Primary Outcome Measure Information:
Title
Forgotten joint score
Description
Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
Time Frame
Postoperative 3 years
Title
Crepitus
Description
Any grating, crackling or popping sensation around knee when moving a joint
Time Frame
Postoperative 3 years
Secondary Outcome Measure Information:
Title
Forgotten joint score
Description
Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
Time Frame
Postoperative 5 years
Title
Crepitus
Description
Any grating, crackling or popping sensation around knee when moving a joint
Time Frame
Postoperative 5 years
Other Pre-specified Outcome Measures:
Title
Change from baseline Knee Society Score (KSS) at 3 and 5 years
Description
Patient-reported Outcome measure; The lower, the worse. Range: 0-200
Time Frame
Preoperative and Postoperative 3, 5 years
Title
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 years
Description
Patient-reported Outcome measure; The higher, the worse. Range: 0-96
Time Frame
Preoperative and Postoperative 3, 5 years
Title
Central Sensitization Index (CSI)
Description
Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100
Time Frame
Postoperative 3 years
Title
Central Sensitization Index (CSI)
Description
Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100
Time Frame
Postoperative 5 years
Title
Radiological outcomes
Description
Measurements of radiological angles
Time Frame
Postoperative 3 years
Title
Radiological outcomes
Description
Measurements of radiological angles
Time Frame
Postoperative 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong In, M.D., Ph.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Catholic University of Korea Seoul St Mary's hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
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