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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208364
First received: September 13, 2005
Last updated: October 8, 2012
Last verified: October 2012

September 13, 2005
October 8, 2012
April 2004
October 2014   (final data collection date for primary outcome measure)
Kaplan-Meier survivorship calculated at the 5 year time point. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00208364 on ClinicalTrials.gov Archive Site
  • Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiological analysis [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Metal ion analysis in whole blood [ Time Frame: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Post-traumatic Arthritis
  • Collagen Disorders
  • Avascular Necrosis
  • Traumatic Femoral Fractures
  • Nonunion of Femoral Fractures
  • Congenital Hip Dysplasia
  • Slipped Capital Femoral Epiphysis
Device: Pinnacle Acetabular Cup System
A cementless acetabular cup with metal liner for use in total hip replacement
Pinnacle Acetabular Cup System
A cementless acetabular cup with metal liner for use in total hip replacement
Intervention: Device: Pinnacle Acetabular Cup System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
October 2024
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects undergoing revision hip replacement.

iii) Women who are pregnant.

iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

vi) Subjects who are currently involved in any injury litigation claims.

Additional Exclusion Criteria for Subjects Having Blood Analysis:

  1. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
  2. Subjects with an occupational exposure to cobalt or chromium.
  3. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
  4. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
  5. Subjects who are undergoing a simultaneous bilateral total hip replacement.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United Kingdom
 
NCT00208364
CT01/11
No
DePuy International
DePuy International
Not Provided
Not Provided
DePuy International
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP