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:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208455
First received: September 13, 2005
Last updated: September 8, 2014
Last verified: July 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annual Kaplan-Meier survivorship calculations [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15 yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip score [ Time Frame: 3mths, 6mths, and annully post-surgery ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: July 2005
Study Completion Date: November 2013
Primary Completion Date: November 2013 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208455     History of Changes
Other Study ID Numbers: CT03/09
Study First Received: September 13, 2005
Last Updated: September 8, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on October 21, 2014