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A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DePuy Proxima™ Hip
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 Arthroplasty, Replacement, Hip, Conservative, Anatomic, Cementless

Eligibility Criteria

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

Inclusion Criteria: i) Male or female subjects between 18 and 70 years of age. 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 agree to return to the hospital for all the required post-operative follow-ups. iv) Subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the DePuy PROXIMA™ hip femoral prosthesis. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long term participation and follow-up in this study. ii) Women who are pregnant. iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s). v) Subjects who are currently involved in any injury litigation claims. vi) Subjects for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip. 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

  • Asklepios Klinikum
  • Ospedale San Pietro
  • Arnau de Vilanova
  • North Bristol NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DePuy Proxima™ Hip

Arm Description

A short, anatomic, cementless femoral component for use in total hip arthroplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
June 23, 2017
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00208455
Brief Title
A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
Official Title
An Uncontrolled, Multi-Centre, Prospective, Post Marketing Surveillance Study to Monitor the Long Term Survivorship of the DePuy PROXIMA™ Hip in Subjects Requiring a Total Hip Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
DePuy discontinued this product in 2013, the clinical program was reviewed and this Study was closed.
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 2013 (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 DePuy PROXIMA™ hip 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 undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

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, Avascular Necrosis, Traumatic Femoral Fractures, Congenital Hip Dysplasia
Keywords
Arthroplasty, Replacement, Hip, Conservative, Anatomic, 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
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DePuy Proxima™ Hip
Arm Type
Other
Arm Description
A short, anatomic, cementless femoral component for use in total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
DePuy Proxima™ Hip
Intervention Description
A short, anatomic, cementless femoral component for use in total hip arthroplasty
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculated at the five-year time-point
Time Frame
5 yrs
Secondary Outcome Measure Information:
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
Annually
Title
Harris Hip Score
Time Frame
6mths, 1yr, 2yrs, 5yrs, 7 yrs, 10yrs and 15 yrs post-surgery
Title
Radiographic analysis
Time Frame
6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Title
Oxford Hip score
Time Frame
6mths, and annually 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 between 18 and 70 years of age. 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 agree to return to the hospital for all the required post-operative follow-ups. iv) Subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the DePuy PROXIMA™ hip femoral prosthesis. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long term participation and follow-up in this study. ii) Women who are pregnant. iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s). v) Subjects who are currently involved in any injury litigation claims. vi) Subjects for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip. 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
Asklepios Klinikum
City
Bad Abbach
Country
Germany
Facility Name
Ospedale San Pietro
City
Rome
Country
Italy
Facility Name
Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
North Bristol NHS Trust
City
Bristol
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

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