Back to resultsA Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty (MagnumCRCT)
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Metal on ceramic articulation
Metal-on-Metal
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
- Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
- Johannesburg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metal on ceramic articulation
Metal-on-metal
Arm Description
The arm consists of patients with Ceramic femoral heads articulating with metal acetabular cups
The arm consists of patients with Metal femoral heads articulating with metal acetabular cups
Outcomes
Primary Outcome Measures
Metal ion concentration in blood and urine
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01247038
Brief Title
A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty
Acronym
MagnumCRCT
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Biomet's focus has changed and we no longer expect further developments
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 10, 2015 (Actual)
Study Completion Date
July 10, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metal on ceramic articulation
Arm Type
Experimental
Arm Description
The arm consists of patients with Ceramic femoral heads articulating with metal acetabular cups
Arm Title
Metal-on-metal
Arm Type
Active Comparator
Arm Description
The arm consists of patients with Metal femoral heads articulating with metal acetabular cups
Intervention Type
Device
Intervention Name(s)
Metal on ceramic articulation
Other Intervention Name(s)
MagnumC
Intervention Description
Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup
Intervention Type
Device
Intervention Name(s)
Metal-on-Metal
Other Intervention Name(s)
Magnum
Intervention Description
Metal on Metal articulation
Primary Outcome Measure Information:
Title
Metal ion concentration in blood and urine
Description
Metal ion concentration will be determined from patients blood and urine at prescribed intervals
Time Frame
2 years post operatively
Secondary Outcome Measure Information:
Title
Composite Clinical Score (CCS) rate at 2 years post operative
Time Frame
2 years post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
City
Banja Luka
Country
Bosnia and Herzegovina
Facility Name
Johannesburg Hospital
City
Parktown
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty
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