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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

NCT00208351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2016-05-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Primary Completion
2004-11-30
Completion
2015-03-31

Countries

  • United Kingdom

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208351 on ClinicalTrials.gov