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.
Read more: http://www.clinicaltrials.gov/ct2/show/NCT01247038?cond=%22Arthritis%22&lup_s=10/31/2013&lup_d=30
