Cementless New Alumina-zirconia Ceramic Bearing Total Hip Arthroplasty (THA) in Asian Patients

NCT ID: NCT00935519

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2023-12-31

Brief Summary

This study will evaluate a midterm clinical and radiologic outcome patients who undergo new alumina-zirconia composite ceramic bearing THA.

Detailed Description

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.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ceramic bearing

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.

Group Type: OTHER

4th generation ceramic bearing composite ceramic bearing

Intervention Type: DEVICE

THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 10 years follow-up.

Interventions

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 10 years follow-up.

Intervention Type: DEVICE

Other Intervention Names

delta ceramic

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyung-Hoi Koo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyung-Hoi Koo, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

SNU 09-01

Identifier Type: -

Identifier Source: org_study_id