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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceramic On Metal

This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.

Group Type EXPERIMENTAL

Ceramic On Metal

Intervention Type DEVICE

Ceramic on Metal articulation using M2a-38™ mm cup

Metal on Metal

This arm utilizes the metal on metal articulation using M2a-38™ mm cup.

Group Type ACTIVE_COMPARATOR

Metal on Metal

Intervention Type DEVICE

Metal on Metal articulation using M2a-38™ mm cup

Interventions

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Ceramic On Metal

Ceramic on Metal articulation using M2a-38™ mm cup

Intervention Type DEVICE

Metal on Metal

Metal on Metal articulation using M2a-38™ mm cup

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No