An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

Phase 4TerminatedNCT01134445

DePuy International42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia

Interventions

DePuy Proxima™ HipDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis. Exclusion Criteria: * Subjects with active local or systemic infection * Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. * Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s). * Subjects with Charcot's or Paget's disease. * Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur. * Subjects with severe osteoporosis. * Subjects with previous proximal femoral fractures. * 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, hemi-arthroplasty or hip resurfacing * Subjects who have previously undergone osteotomy or arthrodesis 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

Locations (4)

Hospital Belle Isle

Metz, France

Hospital de Santo Antonio

Porto, Portugal

Hospital Clinic Barcelona

Barcelona, Spain

Pilgrim Hospital

Boston, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 5yrs post surgery

Secondary Outcomes

Annual Kaplan-Meier survivorship calculations

Time frame: 1yr post-surgery

Harris Hip Score

Time frame: 6mths post-surgery

Oxford Hip Score

Time frame: 3mths post-surgery

UCLA Activity Score

Time frame: 3mths post-surgery

Hip Outcome Score

Time frame: 3mths post-surgery

EuroQol EQ-5D

Time frame: 3mths post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 2yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 3yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 4yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 6yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 7yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 8yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 9yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 10yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 11yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 12yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 13yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 14yrs post-surgery

Annual Kaplan-Meier survivorship calculations

Time frame: 15yrs post-surgery

Harris Hip Score

Time frame: 1yr post-surgery

Harris Hip Score

Time frame: 2yrs post-surgery

Harris Hip Score

Time frame: 5yrs post-surgery

Harris Hip Score

Time frame: 10yrs post-surgery

Harris Hip Score

Time frame: 15yrs post-surgery

Radiographic Analysis

Time frame: 3mths post-surgery

Radiographic Analysis

Time frame: 6mths post-surgery

Radiographic Analysis

Time frame: 1yr post-surgery

Radiographic Analysis

Time frame: 2yrs post-surgery

Radiographic Analysis

Time frame: 5yrs post-surgery

Radiographic Analysis

Time frame: 10yrs post-surgery

Radiographic Analysis

Time frame: 15 yrs post-surgery

Oxford Hip Score

Time frame: 6mths post-surgery

Oxford Hip Score

Time frame: 1yr post-sugery

UCLA Activity Score

Time frame: 6mths post-surgery

UCLA Activity Score

Time frame: 1yr post-surgery

Hip Outcome Score

Time frame: 6mths post-surgery

Hip Outcome Score

Time frame: 1yr post-surgery

EuroQol EQ-5D

Time frame: 6mths post-surgery

EuroQol EQ-5D

Time frame: 1yr post-surgery

Oxford Hip Score

Time frame: 2yrs post-surgery

Oxford Hip Score

Time frame: 3yrs post-surgery

Oxford Hip Score

Time frame: 4yrs post-surgery

Oxford Hip Score

Time frame: 5yrs post-surgery

Oxford Hip Score

Time frame: 6yrs post-surgery

Oxford Hip Score

Time frame: 7yrs post-surgery

Oxford Hip Score

Time frame: 8yrs post-surgery

Oxford Hip Score

Time frame: 9yrs post surgery

Oxford Hip Score

Time frame: 10yrs post-surgery

Oxford Hip Score

Time frame: 11yrs post-surgery

Oxford Hip Score

Time frame: 12yrs post-surgery

Oxford Hip Score

Time frame: 13yrs post-sugery

Oxford Hip Score

Time frame: 14yrs post-surgery

Oxford Hip Score

Time frame: 15yrs post-surgery

UCLA Activity Score

Time frame: 2yrs post-surgery

UCLA Activity Score

Time frame: 3yrs post-surgery

UCLA Activity Score

Time frame: 4yrs post-surgery

UCLA Activity Score

Time frame: 5yrs post-surgery

UCLA Activity Score

Time frame: 6yrs post-surgery

UCLA Activity Score

Time frame: 7yrs post-surgery

UCLA Activity Score

Time frame: 8yrs post-surgery

UCLA Activity Score

Time frame: 9yrs post-surgery

UCLA Activity Score

Time frame: 10yrs post-surgery

UCLA Activity Score

Time frame: 11yrs post-surgery

UCLA Activity Score

Time frame: 12yrs post-surgery

UCLA Activity Score

Time frame: 13yrs post-surgery

UCLA Activity Score

Time frame: 14yrs post-surgery

UCLA Activity Score

Time frame: 15yrs post-surgery

Hip Outcome Score

Time frame: 2yrs post-surgery

Hip Outcome Score

Time frame: 3yrs post-surgery

Hip Outcome Score

Time frame: 4yrs post-surgery

Hip Outcome Score

Time frame: 5yrs post-surgery

Hip Outcome Score

Time frame: 6yrs post-surgery

Hip Outcome Score

Time frame: 7yrs post-surgery

Hip Outcome Score

Time frame: 8yrs post-surgery

Hip Outcome Score

Time frame: 9yrs post-surgery

Hip Outcome Score

Time frame: 10yrs post-surgery

Hip Outcome Score

Time frame: 11yrs post-surgery

Hip Outcome Score

Time frame: 12yrs post-surgery

Hip Outcome Score

Time frame: 13yrs post-surgery

Hip Outcome Score

Time frame: 14yrs post-surgery

Hip Outcome Score

Time frame: 15yrs post-surgery

EuroQol EQ-5D

Time frame: 2yrs post-surgery

EuroQol EQ-5D

Time frame: 3yrs post-surgery

EuroQol EQ-5D

Time frame: 4yrs post-surgery

EuroQol EQ-5D

Time frame: 5yrs post-surgery

EuroQol EQ-5D

Time frame: 6yrs post-surgery

EuroQol EQ-5D

Time frame: 7yrs post-surgery

EuroQol EQ-5D

Time frame: 8yrs post-surgery

EuroQol EQ-5D

Time frame: 9yrs post-surgery

EuroQol EQ-5D

Time frame: 10yrs post-surgery

EuroQol EQ-5D

Time frame: 11yrs post-surgery

EuroQol EQ-5D

Time frame: 12yrs post-surgery

EuroQol EQ-5D

Time frame: 13yrs post-surgery

EuroQol EQ-5D

Time frame: 14yrs post-surgery

EuroQol EQ-5D

Time frame: 15yrs post-surgery

Data from ClinicalTrials.gov

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