Osteoarthritis, Knee Clinical Trial
Official title:
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Verified date | December 2020 |
Source | The Catholic University of Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | The Catholic University of Korea Seoul St Mary's hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Radiological outcomes | Measurements of radiological angles | Postoperative 3 years | |
Other | Radiological outcomes | Measurements of radiological angles | Postoperative 5 years | |
Primary | 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 | |
Primary | Crepitus | Any grating, crackling or popping sensation around knee when moving a joint | Postoperative 3 years | |
Secondary | 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 | |
Secondary | Crepitus | Any grating, crackling or popping sensation around knee when moving a joint | Postoperative 5 years |
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