A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty (MagnumCRCT)
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|ClinicalTrials.gov Identifier: NCT01247038|
Recruitment Status : Terminated (Biomet's focus has changed and we no longer expect further developments)
First Posted : November 24, 2010
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Metal on ceramic articulation Device: Metal-on-Metal||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||January 2011|
|Actual Primary Completion Date :||July 10, 2015|
|Actual Study Completion Date :||July 10, 2015|
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
Metal on Metal articulation
Other Name: Magnum
- 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
- Composite Clinical Score (CCS) rate at 2 years post operative [ Time Frame: 2 years post operatively ]
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
|Bosnia and Herzegovina|
|Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"|
|Banja Luka, Bosnia and Herzegovina|
|Parktown, South Africa|