Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
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|ClinicalTrials.gov Identifier: NCT01103882|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2010
Last Update Posted : March 21, 2017
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.
|Condition or disease|
|Arthropathy of Hip|
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.
|Study Type :||Observational|
|Estimated Enrollment :||277 participants|
|Official Title:||Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||May 2017|
- Dislocation [ Time Frame: 12 month postop ]
- Clinical Outcomes including Harris Hip Score, UCLA and WOMAC [ Time Frame: 12 months, 18 months and 30 months ]
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): NCT01103882
|Korea, Republic of|
|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|
|Principal Investigator:||Woon-Hwa Jung, M.D.||Murup Hospital, Masan, Korea|
|Principal Investigator:||Yong-Chan Ha, M.D., Ph.D.||Chung-Ang University Hosptial, Chung-Ang University College of Medicine|
|Principal Investigator:||Yong-Kyun Lee, M.D., Ph.D.||Seoul National University Bundang Hospital|
|Principal Investigator:||Tae-Young Kim, M.D.||Hallym University Hospital|