search
Back to results

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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Terminated
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
Pinnacle™ Acetabular 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, Ceramic-on-Ceramic

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 effect 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.

vii) Subjects undergoing a simultaneous bilateral hip operation.

viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.

ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily

Sites / Locations

  • St Anne's University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ceramic-on-Ceramic

Arm Description

Pinnacle™ Acetabular System with ceramic liner

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship at the five-year period

Secondary Outcome Measures

Kaplan-Meier survivorship calculations
Harris Hip Score
Radiographic analysis
Oxford Hip score

Full Information

First Posted
March 30, 2009
Last Updated
October 6, 2016
Sponsor
DePuy International
search

1. Study Identification

Unique Protocol Identification Number
NCT00872222
Brief Title
A Single Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-ceramic 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 Ceramic-on-ceramic 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
January 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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 of the Pinnacle™ Cup with a ceramic-on-ceramic 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.

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, Ceramic-on-Ceramic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ceramic-on-Ceramic
Arm Type
Other
Arm Description
Pinnacle™ Acetabular System with ceramic liner
Intervention Type
Device
Intervention Name(s)
Pinnacle™ Acetabular System
Intervention Description
A cementless acetabular cup with ceramic liner for use in total hip replacement
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship at the five-year period
Time Frame
5yrs
Secondary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculations
Time Frame
Annually
Title
Harris Hip Score
Time Frame
6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Title
Radiographic analysis
Time Frame
6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Title
Oxford Hip score
Time Frame
3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs 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 effect 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. vii) Subjects undergoing a simultaneous bilateral hip operation. viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation. ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Facility Information:
Facility Name
St Anne's University Hospital
City
Brno
Country
Czech Republic

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs