A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
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Details and patient eligibility
About
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.
Full 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 composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
213 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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