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

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ClinicalTrials.gov Identifier: NCT00116051
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : July 7, 2009
Information provided by:

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

Condition or disease Intervention/treatment
Osteoarthritis Device: Acetabular implant, Monoblock cup

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
Study Start Date : September 2004
Primary Completion Date : April 2006
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Tantalum
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Acetabular component migration evaluated by RSA

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

Eligibility Criteria

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00116051

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

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
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by University of Aarhus:
Hip arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases