Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total hip replacement, Spectron and Taperloc
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis focused on measuring THR, reversed hybrid, wear
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis
- Indication for THR
Exclusion Criteria:
- Significant anatomical abnormalities
- Rheumatoid artheritis, dysplasia, fracture sequela
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00526539
First Posted
September 6, 2007
Last Updated
July 3, 2011
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00526539
Brief Title
Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
5. Study Description
Brief Summary
Total hip replacement is a very cost effective procedure to enhance life quality in a group of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions (1). Historically, many different principles have been used from the first resurfacings to cemented and uncemented total hip replacements as we know them today. In 2000, 28 different femoral stems and 26 different acetabular components were in regular use in Norway. There are several well-documented cemented acetabular components, but no such uncemented cup. On the femoral side there are several well-documented stems both cemented and uncemented. (2).
From the late 1990's a reverse hybrid (uncemented stem and cemented cup) is being more frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is increasing. (1). This technique is solely based on experience and the fact that one combines the better of two principles (cemented and uncemented). There is no scientific evidence that this technique is as good or better than a cemented THR.
One of the potential problems with hydroxyapatite coated components is that it is suspected that it may increase wear due to the particle theory. (3,4). There are no prospective randomised controlled RSA and DXA studies that conclude on this matter. This is such a study and our hypothesis is that there is no difference in wear or osteolysis between the methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
THR, reversed hybrid, wear
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Total hip replacement, Spectron and Taperloc
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis
Indication for THR
Exclusion Criteria:
Significant anatomical abnormalities
Rheumatoid artheritis, dysplasia, fracture sequela
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, professor, MD, Ph.D
Organizational Affiliation
Ullevål University Hospital, N-0407 Oslo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Einar Lindalen, MD
Organizational Affiliation
Lovisenberg Hospital, N- 0440 Oslo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?
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