search
Back to results

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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pinnacle Acetabular Cup System
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Cementless, Metal-on-Metal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy. Subjects with an occupational exposure to cobalt or chromium. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations. Subjects who are undergoing a simultaneous bilateral total hip replacement.

Sites / Locations

  • Ospedale Riuniti Di Bergamo
  • Royal Orthopaedic Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pinnacle Acetabular Cup System

Arm Description

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

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the 5 year time point.

Secondary Outcome Measures

Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
Harris Hip score
Oxford Hip score
Radiological analysis
Metal ion analysis in whole blood

Full Information

First Posted
September 13, 2005
Last Updated
October 6, 2016
Sponsor
DePuy International
search

1. Study Identification

Unique Protocol Identification Number
NCT00208364
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early due to business reasons
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
Keywords
Hip, Cementless, Metal-on-Metal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pinnacle Acetabular Cup System
Arm Type
Other
Arm Description
A cementless acetabular cup with metal liner for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Pinnacle Acetabular Cup System
Intervention Description
A cementless acetabular cup with metal liner for use in total hip replacement
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculated at the 5 year time point.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
Time Frame
Annually
Title
Harris Hip score
Time Frame
6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Title
Oxford Hip score
Time Frame
6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Title
Radiological analysis
Time Frame
6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Title
Metal ion analysis in whole blood
Time Frame
pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy. Subjects with an occupational exposure to cobalt or chromium. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations. Subjects who are undergoing a simultaneous bilateral total hip replacement.
Facility Information:
Facility Name
Ospedale Riuniti Di Bergamo
City
Bergamo
Country
Italy
Facility Name
Royal Orthopaedic Hospital
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs