Status:
ACTIVE_NOT_RECRUITING
Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty
Lead Sponsor:
Danderyd Hospital
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Total Hip Arthroplasty
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-lin...
Eligibility Criteria
Inclusion
- Primary osteoarthritis of the hip
- Willingness and ability to follow study-protocol
Exclusion
- Inflammatory arthritis or secondary osteoarthritis.
- Type C (stove pipe) femur
- Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
- Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
- Ongoing oestrogen treatment
- Not suited for the study for other reason (surgeons preference)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02254980
Start Date
February 1 2013
End Date
October 1 2026
Last Update
February 7 2019
Active Locations (1)
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1
Orthopaedic department, Danderyd Hospital
Stockholm, Sweden, 18288