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

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

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.

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.

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