A Comparison of Two Surface Materials (Tantalum versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty - Article Degenerative Joint Disease; Osteoarthritis arthritis
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.
|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
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.
- 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.
- 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
Orthopaedic Center, Aarhus University Hospital,, Aarhus, 8000, Denmark; Recruiting
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
Kjeld Søballe, MD., Prof., Principal Investigator, Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
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