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

Zimmer Biomet

Status

Terminated

Conditions

Osteoarthritis

Treatments

Device: Metal on ceramic articulation

Device: Metal-on-Metal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01247038

Biomet UK Healthcare Ltd (Other Identifier)

BMETEU.CR.EU33

Details and patient eligibility

About

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).

Full 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.

Enrollment

130 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary total hip replacement
Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
Patients preoperative Harris hip score < 80 points
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

Patient preoperative Harris hip score > 80 points
Pre-existing metal implants
Patients with significant co-morbidity - ASSA IV - V
Dementia and inability to understand and follow instructions
Neurological conditions affecting movement
Women younger than 45 years old
Presence of symptomatic arthritis in other lower limb joints
Patients requiring smaller than 38mm and larger than 60mm diameter femoral heads
Patients taking NSAIDs and / all drugs that will affect bone metabolism