Cementless New Alumina-zirconia Ceramic Bearing Total Hip Arthroplasty (THA) in Asian Patients
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|ClinicalTrials.gov Identifier: NCT00935519|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2009
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Hip||Device: 4th generation ceramic bearing composite ceramic bearing||Not Applicable|
Total hip arthroplasty (THA) using a metal-on-polyethylene articulation has become one of the most effective procedures for the surgical treatment for end-stage hip disease.
However, polyethylene wear debris-induced osteolysis has been postulated to cause/contribute to the aseptic loosening of a THA, and hence, is regarded to be an important factor in its in vivo longevity.
In the third generation of ceramic manufacturing, many improvements, such as hot isostatic pressing, laser marking, and non destructive proof-testing for all ceramic components, have been introduced. This third generation ceramic component has high purity, high density, and small grain size, and, therefore, has a very high potential for resisting crack propagation, which may culminate in its fracture. In spite of this, a number of substantial concerns, such as ceramic fracture, impingement-associated fatigue failure, wear, and osteolysis after long-term follow-up, persist with the use of ceramics in THA.
In addition, the third generation ceramic articulation is associated with an increased incidence of dislocation because ceramic liners with elevated rim and extended-long-neck ceramic heads are not available.
However, new alumina-zirconia composites bearing implants (4th generation ceramic bearing) affords various options such as large head and thin liner, which may decrease the ceramic fracture rate and dislocation rate and improve the longevity of THA. In addition, large head can improve the range of motion and possible traditional cross-legged sitting position of Koreans without impingement between the neck and liner rim.
So far, the patients who are underwent THA using 28 mm femoral head diameter complains limitation of range of motion and feeling impingement sensation at sitting on the floor with their legs crossed. There have been increasing complaints especially from Korean patients regarding the difficulties associated with carrying out their daily activities, whose life style involves sitting on the floor with their legs crossed. Therefore, large head of new alumina-zirconia composites bearing implants(4th generation ceramic bearing) expects increasing satisfaction of Korean patients.
This is the first study, to our knowledge, of an evaluation of clinical outcome of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing and the functional outcome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cementless New Alumina-zirconia(4th Generation Ceramic Bearing) Composite Ceramic Bearing Total Hip Arthroplasty (THA) in Asian Patients : a 5 Year Minimum Follow-up Study|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2030|
|Estimated Study Completion Date :||December 2030|
Survival rate of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 5 years follow-up.
Device: 4th generation ceramic bearing composite ceramic bearing
THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 5 years follow-up.
Other Name: delta ceramic
- Survival rate of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 5 years follow-up. [ Time Frame: up to 5 years ]
- The performance in patients younger than 50 years at 5 years follow up [ Time Frame: Follow-up evaluations will be performed at six weeks; at three, six, nine, and twelve months and every six 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. [ Time Frame: Follow-up evaluations will be performed at six weeks; at three, six, nine, and twelve months and every six months thereafter. ]
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): NCT00935519
|Korea, Republic of|
|Seoul national University Bundang Hospital|
|Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||Kyung-Hoi Koo, professor||Seoul National University Bundang Hospital|