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

Condition(s) targeted: Osteoarthritis

Intervention: Ceramic on Metal articulation using M2a-38™ mm cup (Device); Metal on Metal articulation using M2a-38™ mm cup (Device)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Biomet U.K. Ltd.

Official(s) and/or principal investigator(s):
G. Stranks, FRCS, Principal Investigator, Affiliation: North Hampshire Hospital
M Pesola, Principal Investigator, Affiliation: Central Finland Central Hospital
M Manninen, Principal Investigator, Affiliation: Kymenlaakso Central Hospital

Overall contact:
David Stephenson, Phone: +44 1793 645 229, Email: david.stephenson@biometeurope.com

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.

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: Composite Clinical Success (CCS) Rate as defined in the protocol

Secondary outcome:

Oxford Hip Score

Womac Score

Metal Ion concentrations in blood and urine

Measurement of cellular markers in blood

Complications

Survivorship

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 composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

David Stephenson, Phone: +44 1793 645 229, Email: david.stephenson@biometeurope.com

Central Finland Central Hospital, Jyvaskyla, Finland

Kymenlaakso Central Hospital, Kotka, Finland

North Hampshire Hospital, Basingstoke RG24 9NA, United Kingdom

Starting date: September 2008
Ending date: May 2020
Last updated: September 16, 2008