Status:
COMPLETED
A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
Detailed Description
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the c...
Eligibility Criteria
Inclusion
- Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
- Patients preoperative Harris Hip Score \<= 70 points
- Patients aged over 18 and under 75
- Patients with limited co-morbidity - ASA I-III
- Patients with normal urea and electrolyte levels and creatinine levels
- Patients must be able to understand instructions and be willing to return for follow-up
- Patients willing to provide blood and urine samples for metal ion analysis at follow up
Exclusion
- Patients preoperative Harris Hip Score \> 70 points
- Previous prosthetic hip surgery
- Patients with significant co-morbidity - ASA IV - V
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Existing metal implant or fixation device
- Pregnancy
- Presence of symptomatic arthritis in other lower limb joints
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00754520
Start Date
May 1 2009
End Date
December 1 2021
Last Update
October 2 2024
Active Locations (3)
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1
Central Finland Central Hospital
Jyväskylä, Finland
2
Kymenlaakso Central Hospital
Kotka, Finland
3
North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA