Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 119 for:    ZIRCONIUM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935519
Recruitment Status : Active, not recruiting
First Posted : July 9, 2009
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Kyung-Hoi Koo, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Device: 4th generation ceramic bearing composite ceramic bearing Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ceramic bearing
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Korea, Republic of
Seoul national University Bundang Hospital
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kyung-Hoi Koo, professor Seoul National University Bundang Hospital

Layout table for additonal information
Responsible Party: Kyung-Hoi Koo, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00935519     History of Changes
Other Study ID Numbers: SNU 09-01
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by Kyung-Hoi Koo, Seoul National University Bundang Hospital:
total hip arthroplasty, ceramic, survival