A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty (MagnumCRCT)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
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|
- 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 ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247038
|Bosnia and Herzegovina|
|Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"|
|Banja Luka, Bosnia and Herzegovina|
|Parktown, South Africa|