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

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ClinicalTrials.gov Identifier: NCT04684160
Recruitment Status : Active, not recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Arthropathy of Knee Joint Awareness Device: Fixed-bearing TKA Device: Mobile-bearing TKA Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Actual Study Start Date : October 19, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fixed-bearing group Device: Fixed-bearing TKA
Experimental: Mobile-bearing group Device: Mobile-bearing TKA


Outcome Measures
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Primary Outcome Measures :
  1. Forgotten joint score [ Time Frame: Postoperative 3 years ]
    Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100

  2. Crepitus [ Time Frame: Postoperative 3 years ]
    Any grating, crackling or popping sensation around knee when moving a joint


Secondary Outcome Measures :
  1. Forgotten joint score [ Time Frame: Postoperative 5 years ]
    Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100

  2. Crepitus [ Time Frame: Postoperative 5 years ]
    Any grating, crackling or popping sensation around knee when moving a joint


Other Outcome Measures:
  1. Change from baseline Knee Society Score (KSS) at 3 and 5 years [ Time Frame: Preoperative and Postoperative 3, 5 years ]
    Patient-reported Outcome measure; The lower, the worse. Range: 0-200

  2. Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 years [ Time Frame: Preoperative and Postoperative 3, 5 years ]
    Patient-reported Outcome measure; The higher, the worse. Range: 0-96

  3. Central Sensitization Index (CSI) [ Time Frame: Postoperative 3 years ]
    Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100

  4. Central Sensitization Index (CSI) [ Time Frame: Postoperative 5 years ]
    Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100

  5. Radiological outcomes [ Time Frame: Postoperative 3 years ]
    Measurements of radiological angles

  6. Radiological outcomes [ Time Frame: Postoperative 5 years ]
    Measurements of radiological angles


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684160


Locations
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Korea, Republic of
The Catholic University of Korea Seoul St Mary's hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Chair: Yong In, M.D., Ph.D. Seoul St. Mary's Hospital
More Information
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Responsible Party: Yong In, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT04684160    
Other Study ID Numbers: CUKorea MB
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases