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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04684160
Other study ID # CUKorea MB
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 19, 2016
Est. completion date December 31, 2022

Study information

Verified date December 2020
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Fixed-bearing TKA

Mobile-bearing TKA


Locations

Country Name City State
Korea, Republic of The Catholic University of Korea Seoul St Mary's hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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