search
Back to results

A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Withdrawn
Phase
Phase 4
Locations
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

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 a cementless acetabular component and a metal on polyethylene bearing. 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) Subjects undergoing simultaneous bilateral hip operation. iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily. v) Women who are pregnant. vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months. viii) Subjects who are currently involved in any injury litigation claims.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Pinnacle Acetabular System

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score
    Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score
    Kaplan-Meier survivorship

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 27, 2017
    Sponsor
    DePuy International
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00208429
    Brief Title
    A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-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 System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Site Principal Investigator became seriously ill, so study abandoned before the start of recruitment
    Study Start Date
    July 1, 2004 (Actual)
    Primary Completion Date
    July 1, 2009 (Anticipated)
    Study Completion Date
    July 1, 2019 (Anticipated)

    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 polyethylene-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.

    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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Pinnacle Acetabular System
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Pinnacle Acetabular System
    Primary Outcome Measure Information:
    Title
    Kaplan-Meier survivorship calculated at the five-year time-point.
    Time Frame
    5 yrs post surgery
    Secondary Outcome Measure Information:
    Title
    Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score
    Time Frame
    6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
    Title
    Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score
    Time Frame
    Annually up to 15 yrs post-surgery
    Title
    Kaplan-Meier survivorship
    Time Frame
    Annually up to 15 yrs 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 a cementless acetabular component and a metal on polyethylene bearing. 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) Subjects undergoing simultaneous bilateral hip operation. iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily. v) Women who are pregnant. vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months. viii) Subjects who are currently involved in any injury litigation claims.

    12. IPD Sharing Statement

    Learn more about this trial

    A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

    We'll reach out to this number within 24 hrs