- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116038
A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty
A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In younger patients femoral 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.
The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.
Theoretically, the greater porous surface of mid-coated implants should:
- Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
- Improve anchorage of the implant due to the higher friction coefficient
- Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. 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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aarhus, Denmark, 8000
- Orthopaedic Center, Aarhus University Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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migration of femoral components evaluated by RSA
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Secondary Outcome Measures
Outcome Measure |
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BMD in the surrounding bone tissue of femoral components
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kjeld Søballe, MD., Prof., Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20030192
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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