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

Phase 4

Terminated

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Avascular Necrosis; Traumatic Femoral Fractures
• Interventions: Device: DePuy Proxima™ Hip

• Registration Number: NCT00208455
• Lead Sponsor: DePuy International

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2012-09
• Study Completion: 2013-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DePuy Proxima™ Hip	DePuy Proxima™ Hip	A short, anatomic, cementless femoral component for use in total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship calculated at the five-year time-point	5 yrs

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Asklepios Klinikum; 🇩🇪 Bad Abbach, Germany

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Ospedale San Pietro; 🇮🇹 Rome, Italy

Arnau de Vilanova; 🇪🇸 Valencia, Spain