NCT01247038

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Metal on ceramic articulation	Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup
DEVICE	Metal-on-Metal	Metal on Metal articulation

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-07-10
• Completion: 2015-07-10
• First posted: 2010-11-24
• Last updated: 2017-06-21

Locations

2 sites across 2 countries: Bosnia and Herzegovina, South Africa