A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborators:
Aalborg Universityhospital
Aarhus University Hospital
Zimmer, Inc.
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00116051
First received: June 26, 2005
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

The purpose of this study is to compare two surface materials (tantalum versus titanium fiber mesh) of acetabular components in hip arthroplasty.


Condition Intervention
Osteoarthritis
Device: Acetabular implant, Monoblock cup

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Acetabular component migration evaluated by RSA

Secondary Outcome Measures:
  • BMD in the surrounding bone of the acetabular implant

Estimated Enrollment: 50
Study Start Date: September 2004
Estimated Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

In younger patients, acetabulum components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed. A new implant material (tantalum) has shown better properties than the implant material which is in use today (titanium). The advantages of tantalum implants are greater porosity, reduced stiffness and a higher friction coefficient than with titanium implants.

Hypothetically, the higher porosity of tantalum should enhance bone ingrowth due to better osteoconductivity in terms of:

  1. less migration of the acetabulum component, as evaluated by RSA;
  2. increased BMD in the bone surrounding acetabulum components;
  3. fewer postoperative complaints on the Harris Hip Score and visual analog scale scores.

The migration of acetabulum components will be evaluated by RSA. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary arthritis in the hip.
  • Patients with sufficient bone density to allow uncemented implantation of a femoral component.
  • Informed patient consent in writing.

Exclusion Criteria:

  • Patients with neuromuscular or vascular disease in the affected leg.
  • Patients found upon operation to be unsuited for uncemented acetabulum component.
  • Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
  • Patients with fracture sequelae.
  • Female patients of childbearing capacity.
  • Hip joint dysplasia.
  • Sequelae to previous hip joint disorder in childhood.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116051

Locations
Denmark
Orthopaedic Center, Aarhus University Hospital,
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aalborg Universityhospital
Aarhus University Hospital
Zimmer, Inc.
Investigators
Principal Investigator: Kjeld Søballe, MD., Prof. Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Professor Kjeld Soballe, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C
ClinicalTrials.gov Identifier: NCT00116051     History of Changes
Other Study ID Numbers: 200330159
Study First Received: June 26, 2005
Last Updated: July 6, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
RSA
DEXA
Osteoarthritis
Hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014