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A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty

2014-09-25 15:08:23 | BioPortfolio

Summary

The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).

Description

This multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same Recap Acetabular cup.

The metal ion release will be evaluated at predetermined postoperative intervals during the first 36 months. A trial will be conducted as a clinical trial in accordance with the Medical Devices Directive 93/42/EEC (2002).

A total of 150 patients have to be recruited from the South African centre (2 groups)

The initial study assessment period will be 48 months; 24 months recruitment and 24 months follow-up. The follow-up reviews will be at 6 weeks, 6 months, 1 year, 2 years and 3 years. A 5 year and 10 year clinical review will also be carried out with all patients.

An assessment of incidences of adverse events and metal ion release concentrations will be made when all patients are at 6 months postoperatively.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Osteoarthritis

Intervention

Metal on ceramic articulation, Metal-on-Metal

Location

Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
Banja Luka
Bosnia and Herzegovina

Status

Active, not recruiting

Source

Biomet, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-25T15:08:23-0400

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