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Completed

NCT Number: NCT00116051

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

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

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Center, Aarhus University Hospital,

Aarhus, 8000, Denmark

About this study

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:

  • less migration of the acetabulum component, as evaluated by RSA;
  • increased BMD in the bone surrounding acetabulum components;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetabular implant, Monoblock cup

Device

Primary outcomes

  1. Acetabular component migration evaluated by RSA

Secondary outcomes

  1. BMD in the surrounding bone of the acetabular implant

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Zimmer Biomet

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jun 27, 2005
Registry last updated
Jul 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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