Back to resultsA Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
Primary Purpose
Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bi-Metric femoral implant (titanium versus cobalt-chromium)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring RSA, Osteoarthritis, Hip arthroplasty, DEXA, Titanium, Cobalt chromium, Bone cement
Eligibility Criteria
Inclusion Criteria: Primary osteoarthritis of the hip Spinal anesthesia Informed written consent Exclusion Criteria: Neuromuscular disease in the affected leg Vascular disease in the affected leg Fracture sequelae in the affected hip Weight over 100 kg Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period
Sites / Locations
- Orthopaedic Department, Ribe County Hospital
Outcomes
Primary Outcome Measures
Migration of femoral components evaluated by RSA
Secondary Outcome Measures
Periprosthetic BMD changes evaluated by DEXA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00120952
Brief Title
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
Official Title
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
Brief Summary
In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
RSA, Osteoarthritis, Hip arthroplasty, DEXA, Titanium, Cobalt chromium, Bone cement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Bi-Metric femoral implant (titanium versus cobalt-chromium)
Primary Outcome Measure Information:
Title
Migration of femoral components evaluated by RSA
Secondary Outcome Measure Information:
Title
Periprosthetic BMD changes evaluated by DEXA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary osteoarthritis of the hip
Spinal anesthesia
Informed written consent
Exclusion Criteria:
Neuromuscular disease in the affected leg
Vascular disease in the affected leg
Fracture sequelae in the affected hip
Weight over 100 kg
Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe, MD, DMSc
Organizational Affiliation
Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopaedic Department, Ribe County Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
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