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A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

NCT00208468 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2016-10-07

No results posted yet for this study

Summary

This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.

Conditions

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

Interventions

DEVICE

European Hip

A cementless femoral component for use in total hip replacement

DEVICE

Zweymüller

A cementless femoral component for use in total hip replacement

DEVICE

CLS Spotorno

A 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
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2005-06-30
Completion
2015-03-31

Countries

  • Austria
  • Germany
  • Italy

Study Locations

More Related Trials

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 NCT00208468 on ClinicalTrials.gov