Clinical Trial: A Comparison of Two Surface Materials (Tantalum versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty

This study is currently recruiting patients.

Sponsors and Collaborators: University of Aarhus
Aalborg Hospital
Zimmer
Information provided by: University of Aarhus

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

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Acetabular component migration evaluated by RSA
Secondary Outcomes: BMD in the surrounding bone of the acetabular implant
Expected Total Enrollment:  50

Study start: September 2004;  Expected completion: January 2009
Last follow-up: January 2006;  Data entry closure: January 2008

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   -   70 Years,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00116051

Thomas Baad-Hansen, MD      89497781  Ext. 45    baadhansen@dadlnet.dk

Denmark
      Orthopaedic Center, Aarhus University Hospital,, Aarhus,  8000,  Denmark; Recruiting
Thomas Baad-Hansen, MD.  89497781  Ext. 45    baadhansen@dadlnet 
Thomas Baad-Hansen, MD,  Sub-Investigator
Kjeld Søballe, MD. Prof.,  Principal Investigator
Søren Kold, MD. Phd.,  Sub-Investigator
Poul Torben Nielsen, MD.,  Sub-Investigator
Poul Hedevang, MD,  Sub-Investigator

Study chairs or principal investigators

Kjeld Søballe, MD., Prof.,  Principal Investigator,  Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark   

More Information

Study ID Numbers:  200330159
Record last reviewed:  June 2004
Last Updated:  June 30, 2005
Record first received:  June 26, 2005
ClinicalTrials.gov Identifier:  NCT00116051
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-07-05

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