Cementless New Alumina-zirconia Ceramic Bearing Total Hip Arthroplasty (THA) in Asian Patients
1 other identifier
interventional
310
1 country
1
Brief Summary
This study will evaluate a midterm clinical and radiologic outcome patients who undergo new alumina-zirconia composite ceramic bearing THA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 2, 2022
January 1, 2022
14.6 years
July 7, 2009
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 10 years follow-up.
up to 10 years
Secondary Outcomes (2)
The performance in patients younger than 50 years at 10 years follow up
Follow-up evaluations will be performed at six weeks; at three, six, nine, and twelve months and every 12 months thereafter.
Evaluation between preoperative and postoperative of Harris hip score, UCLA activity score, WOMAC, and Subject satisfaction score at a minimum of 5 years follow-up.
Follow-up evaluations will be performed at six weeks; at three, six, nine, and twelve months and every 12 months thereafter.
Study Arms (1)
ceramic bearing
OTHERSurvival rate of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 10 years follow-up.
Interventions
THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 10 years follow-up.
Eligibility Criteria
You may qualify if:
- Subjects who have femoral head osteonecrosis
- Subjects who have primary or secondary osteoarthritis
- Subjects who have femoral neck fracture
- Subjects who have infection sequels
- Subjects who have rheumatoid arthritis or ankylosing spondylitis
- Subjects who have developmental dysplasia of the hip or acetabular dysplasia
You may not qualify if:
- Subjects who have active infection
- Subjects who have unstable medical illness
- Subjects who have rapidly progressive neurological disease
- Subjects who have revision surgery or bipolar endoprosthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Hoi Koo, professor
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 9, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 2, 2022
Record last verified: 2022-01