Status:
COMPLETED
Taperloc Versus Taplerloc Microplasty
Lead Sponsor:
Ingemar Ivarsson
Collaborating Sponsors:
Biomet U.K. Ltd.
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between...
Detailed Description
Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study. Periprosthetic bone loss...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with primary osteoarthritis of the hip scheduled for THA.
- Suitable anatomy for both stems
- Willingness and ability to follow study-protocol
- Exclusion Criteria
- Malignancy or metastatic bone disease.
- Any other disease severely affecting bone and mineral metabolism
- Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
- Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
- Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
- Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
- Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00757107
Start Date
October 1 2011
End Date
June 1 2015
Last Update
March 14 2016
Active Locations (1)
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1
University hospital of Linkoping
Linköping, Sweden, 581 85