A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty |
- Acetabular component migration evaluated by RSA
- BMD in the surrounding bone of the acetabular implant
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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| Denmark | |
| Orthopaedic Center, Aarhus University Hospital, | |
| Aarhus, Denmark, 8000 | |
| Principal Investigator: | Kjeld Søballe, MD., Prof. | Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark |
More Information
No publications provided
| 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 |
| Study First Received: | June 26, 2005 |
| Last Updated: | July 6, 2009 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
RSA DEXA Osteoarthritis Hip arthroplasty |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013