NCT00208351

A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement

Clinical and Radiographic Evaluation to Compare a Polished and Non-polished Collared Stem and a Polished and Non Polished Collarless Stem in Primary Total Hip Replacement

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Conditions

• Osteoarthritis
• Post-traumatic Arthritis
• Collagen Disorder
• Avascular Necrosis
• Traumatic Femoral Fractures
• Nonunion of Femoral Fractures
• Congenital Hip Dysplasia
• Slipped Capital Femoral Epiphysis

Interventions

Type	Name	Description
DEVICE	Ultima LX Collared Stem - Non-Polished/Blasted Finished	A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
DEVICE	Ultima LX Collared Stem - Polished Finished	A collared polished finished cementless femoral component for use in total hip replacement.
DEVICE	Ultima LX Collarless Stem - Non-Polished/Blasted Finished	A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
DEVICE	Ultima LX Collarless Stem - Polished finished	A collarless polished finished cementless femoral component for use in total hip replacement.

Timeline

• Start date: 1997-05-01
• Primary completion: 2004-11-01
• Completion: 2015-03-01
• First posted: 2005-09-21
• Last updated: 2016-05-11

Locations

1 site across 1 country: United Kingdom