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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116051
• Other study ID #: 200330159
• Status: Completed
• Phase: N/A
• First received: June 26, 2005
• Last updated: July 6, 2009
• Start date: September 2004
• Est. completion date: April 2006

Study information

• Verified date: July 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Acetabular implant, Monoblock cup

Locations

Country	Name	City	State
Denmark	Orthopaedic Center, Aarhus University Hospital,	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital, Aarhus University Hospital, Zimmer, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular component migration evaluated by RSA
Secondary	BMD in the surrounding bone of the acetabular implant