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A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement

NCT00208364 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2016-10-07

No results posted yet for this study

Summary

The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.

Conditions

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

Interventions

DEVICE

Pinnacle Acetabular Cup System

A cementless acetabular cup with metal liner for use in total hip replacement

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2014-10-31
Completion
2016-09-30

Countries

  • Italy
  • United Kingdom

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 NCT00208364 on ClinicalTrials.gov