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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04684160
Enrollment
100
Registered
2020-12-24
Start date
2016-10-19
Completion date
2022-12-31
Last updated
2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Joint Awareness, Osteoarthritis, Knee

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.

Interventions

DEVICEFixed-bearing TKA

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Forgotten joint scorePostoperative 3 yearsQuestionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
CrepitusPostoperative 3 yearsAny grating, crackling or popping sensation around knee when moving a joint

Secondary

MeasureTime frameDescription
Forgotten joint scorePostoperative 5 yearsQuestionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
CrepitusPostoperative 5 yearsAny grating, crackling or popping sensation around knee when moving a joint

Other

MeasureTime frameDescription
Change from baseline Knee Society Score (KSS) at 3 and 5 yearsPreoperative and Postoperative 3, 5 yearsPatient-reported Outcome measure; The lower, the worse. Range: 0-200
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 yearsPreoperative and Postoperative 3, 5 yearsPatient-reported Outcome measure; The higher, the worse. Range: 0-96
Central Sensitization Index (CSI)Postoperative 3 yearsQuestionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100
Radiological outcomesPostoperative 3 yearsMeasurements of radiological angles

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026