Cemented Marathon/Corail Versus Pinnacle/Corail

Arthritis of the Hip Clinical Trial

Official title: Cemented Marathon/Corail Versus Pinnacle/Corail. Comparison of Polyethylene Wear, Component Migration and Periprosthetic Bone Mineral Density. A Randomised Study of 48 Hips Using Radiostereometry and Dual-energy X-ray Absorptiometry

Status Active, not recruiting

Clinical Trial Summary

A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:

1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and

2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana)

There will be a further in-group randomisation to a Corail femoral stem with or without a collar, creating a number of 4 study-groups in total.

The aims of the study are:

• To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)

• To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA)

• To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis of the Hip

• NCT number: NCT01693627
• Study type: Interventional
• Source: Haukeland University Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2012
• Completion date: January 2022