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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04684160
• Other study ID #: CUKorea MB
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Awareness
• Joint Diseases
• Osteoarthritis, Knee

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