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A Multi-Centre Study to Assess the Long-Term Survivorship and Performance of the DePuy PROXIMA™ Hip in Subjects Requiring a Total Hip Replacement
This study is currently recruiting participants.
Verified by DePuy International, April 2008
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208455
  Purpose

A post-market surveillance study to evaluate survivorship, and clinical and radiological performance of the DePuy PROXIMA™ hip


Condition Intervention Phase
Primary Osteoarthritis
Secondary Osteoarthritis
Avascular Necrosis
Developmental Dysplasia of the Hip
Device: DePuy Proxima™ Hip
Phase IV

MedlinePlus related topics: Osteoarthritis Osteonecrosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated at the five-year time-point [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annual Kaplan-Meier survivorship calculations, Harris Hip Score, Oxford Hip score, Radiographic analysis. [ Time Frame: Annual ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2005
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DePuy Proxima™ Hip
    A short, anatomic, cementless femoral stem for use in total hip arthroplasty
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208455

Contacts
Contact: Michael Borroff, B.Sc., M.Sc. +44 113 387 7800 ext 7910 mborroff@dpygb.jnj.com

Locations
Germany
Asklepios Klinikum Active, not recruiting
Bad Abbach, Germany
Italy
Ospedale San Pietro Active, not recruiting
Rome, Italy
Spain
Arnau de Vilanova Active, not recruiting
Valencia, Spain
United Kingdom
North Bristol NHS Trust Recruiting
Bristol, United Kingdom
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael Borroff, B.Sc., M.Sc. DePuy International Ltd.
  More Information

Responsible Party: DePuy International ( Michael Borroff )
Study ID Numbers: CT03/09
Study First Received: September 13, 2005
Last Updated: April 22, 2008
ClinicalTrials.gov Identifier: NCT00208455  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Study placed in the following topic categories:
Osteonecrosis
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Necrosis
Musculoskeletal Diseases
Arthritis
Neoplasm Metastasis
Congenital Abnormalities
Hip dislocation
Hip Dislocation, Congenital

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009