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

A Multicentre Prospective Randomised Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic on Metal and Metal on Metal Large Diameter Femoral Heads, 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 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).

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Metal on ceramic articulation; Device: Metal-on-Metal

Detailed 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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina
    • Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
• South Africa
  • Parktown, South Africa
    • Johannesburg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metal on ceramic articulation; The arm consists of patients with Ceramic femoral heads articulating with metal acetabular cups	Device: Metal on ceramic articulation; Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup; Other Names: MagnumC
Active Comparator: Metal-on-metal; The arm consists of patients with Metal femoral heads articulating with metal acetabular cups	Device: Metal-on-Metal; Metal on Metal articulation; Other Names: Magnum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metal ion concentration in blood and urine	Metal ion concentration will be determined from patients blood and urine at prescribed intervals	2 years post operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Composite Clinical Score (CCS) rate at 2 years post operative	2 years post operatively

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 10, 2015
• Study Completion (Actual): July 10, 2015

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: BMETEU.CR.EU33; Biomet UK Healthcare Ltd (Other Identifier: Biomet UK Healthcare Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO