Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: April 13, 2010
Last updated: July 20, 2015
Last verified: July 2015
The primary objectives of this clinical study include:
- Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.
- Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing.
- Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years.
- Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.
||Observational Model: Cohort
Time Perspective: Prospective
||Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
Primary Outcome Measures:
- Dislocation [ Time Frame: 12 month postop ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical Outcomes including Harris Hip Score, UCLA and WOMAC [ Time Frame: 12 months, 18 months and 30 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
This study will evaluate incidence of dislocation and short-term clinical outcome on patients who undergo large diameter 4th generation ceramic bearing total hip Arthroplasty ("THA") in comparison to historical data on 3rd generation CoC THA (28mm) patients. Specifically the study intends to address the following research topics:
- The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
- The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
- The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
- Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
- Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
- The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients indicated for total hip arthroplasty
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01103882
|Hallym University Hospital
|Anyang, Korea, Republic of |
|Seoul National University Bundang Hospital
|Bundang, Korea, Republic of |
|Masan, Korea, Republic of |
|Chung-Ang University Hospital
|Seoul, Korea, Republic of |
||Woon-Hwa Jung, M.D.
||Murup Hospital, Masan, Korea
||Yong-Chan Ha, M.D., Ph.D.
||hung-Ang University Hosptial, Chung-Ang University College of Medicine
||Yong-Kyun Lee, M.D., Ph.D.
||Seoul National University Bundang Hospital
||Tae-Young Kim, M.D.
||Hallym University Hospital
ClinicalTrials.gov processed this record on May 26, 2016
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2010
||July 20, 2015
||Korea: Institutional Review Board