A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Ceramic On Metal
* Device: Metal on Metal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceramic On Metal<br>This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup. | Device: Ceramic On Metal<br>* Ceramic on Metal articulation using M2a-38™ mm cup<br>|
| Active Comparator: Metal on Metal<br>This arm utilizes the metal on metal articulation using M2a-38™ mm cup. | Device: Metal on Metal<br>* Metal on Metal articulation using M2a-38™ mm cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Clinical Success (CCS) Rate as defined in the protocol |  | 6 weeks, 6 months, annually up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score |  | 6 weeks, 6 months, annually up to 10 years | 
| Womac Score |  | 6 weeks, 6 months, annually up to 10 years | 
| Metal Ion concentrations in blood and urine |  | 6 weeks, 6 months, annually up to 10 years | 
| Measurement of cellular markers in blood |  | 6 weeks, 6 months, annually up to 10 years | 
| Complications |  | Any Time | 
| Survivorship |  | Any Time |