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

This study has been terminated.
(Biomet's focus has changed and we no longer expect further developments)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247038
First Posted: November 24, 2010
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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).

Condition Intervention
Osteoarthritis Device: Metal on ceramic articulation Device: Metal-on-Metal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Metal ion concentration in blood and urine [ Time Frame: 2 years post operatively ]
    Metal ion concentration will be determined from patients blood and urine at prescribed intervals


Secondary Outcome Measures:
  • Composite Clinical Score (CCS) rate at 2 years post operative [ Time Frame: 2 years post operatively ]

Enrollment: 130
Study Start Date: January 2011
Study Completion Date: July 10, 2015
Primary Completion Date: July 10, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Magnum

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247038


Locations
Bosnia and Herzegovina
Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
Banja Luka, Bosnia and Herzegovina
South Africa
Johannesburg Hospital
Parktown, South Africa
Sponsors and Collaborators
Zimmer Biomet
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01247038     History of Changes
Other Study ID Numbers: BMETEU.CR.EU33
Biomet UK Healthcare Ltd ( Other Identifier: Biomet UK Healthcare Ltd )
First Submitted: November 22, 2010
First Posted: November 24, 2010
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases


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