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

This study has been terminated.
(DePuy discontinued this product in 2013, the clinical program was reviewed and this Study was closed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208455
First Posted: September 21, 2005
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy International
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia Device: DePuy Proxima™ Hip Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated at the five-year time-point [ Time Frame: 5 yrs ]

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

Enrollment: 184
Study Start Date: February 2005
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208455


Locations
Germany
Asklepios Klinikum
Bad Abbach, Germany
Italy
Ospedale San Pietro
Rome, Italy
Spain
Arnau de Vilanova
Valencia, Spain
United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Sponsors and Collaborators
DePuy International
  More Information

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208455     History of Changes
Other Study ID Numbers: CT03/09
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by DePuy International:
Arthroplasty
Replacement
Hip
Conservative
Anatomic
Cementless

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fractures, Bone
Wounds and Injuries
Leg Injuries
Dislocations
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities