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

This study is currently recruiting participants.
Verified November 2012 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01247038
First received: November 22, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  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 Phase
Osteoarthritis
 Device: Ceramic on metal articulating bearing surface
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Metal ion concentration in blood and urine [ Time Frame: 2 years post operatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: November 2022
Estimated Primary Completion Date: November 2022 (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: Ceramic on metal articulating bearing surface
Ceramic-on-metal articulation against metal-on-metal articulation using the same Recap Acetabular cup
Other Name: MagnumC
Active Comparator: Metal-on-metal Device: Ceramic on metal articulating bearing surface
Ceramic-on-metal articulation against metal-on-metal articulation using the same Recap Acetabular cup
Other Name: MagnumC

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247038

Contacts
Contact: Lipalo Mokete, Dr (+27)114884911 lipalo@hotmail.com

Locations
Bosnia and Herzegovina
Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic" Active, not recruiting
Banja Luka, Bosnia and Herzegovina
South Africa
Johannesburg Hospital Recruiting
Parktown, South Africa
Contact: Lipalo Mokete, Dr            
Sponsors and Collaborators
Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01247038     History of Changes
Other Study ID Numbers: BMETEU.CR.EU33.11, Biomet UK Healthcare Ltd
Study First Received: November 22, 2010
Last Updated: November 8, 2012
Health Authority: South Africa: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013