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

Sponsor

DePuy International (Industry)

Overall Status

Terminated

CT.gov ID

NCT00208455

Collaborator

(none)

184

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia	Device: DePuy Proxima™ Hip	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

184 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: DePuy Proxima™ Hip A short, anatomic, cementless femoral component for use in total hip arthroplasty	Device: DePuy Proxima™ Hip A short, anatomic, cementless femoral component for use in total hip arthroplasty

Arm

Intervention/Treatment

Other: DePuy Proxima™ Hip

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

Device: DePuy Proxima™ Hip

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

Outcome Measures

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the five-year time-point [5 yrs]

Secondary Outcome Measures

Annual Kaplan-Meier survivorship calculations [Annually]
Harris Hip Score [6mths, 1yr, 2yrs, 5yrs, 7 yrs, 10yrs and 15 yrs post-surgery]
Radiographic analysis [6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery]
Oxford Hip score [6mths, and annually post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects between 18 and 70 years of age.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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.
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:

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.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
Subjects who are currently involved in any injury litigation claims.
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.
Subjects undergoing a simultaneous bilateral hip operation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
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