- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208455
A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Bad Abbach, Germany
- Asklepios Klinikum
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Rome, Italy
- Ospedale San Pietro
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Valencia, Spain
- Arnau de Vilanova
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Bristol, United Kingdom
- North Bristol NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: DePuy Proxima™ Hip
A short, anatomic, cementless femoral component for use in total hip arthroplasty
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A short, anatomic, cementless femoral component for use in total hip arthroplasty
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Kaplan-Meier survivorship calculated at the five-year time-point
Time Frame: 5 yrs
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5 yrs
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Annual Kaplan-Meier survivorship calculations
Time Frame: Annually
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Annually
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Radiographic analysis
Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
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6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
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Harris Hip Score
Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7 yrs, 10yrs and 15 yrs post-surgery
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6mths, 1yr, 2yrs, 5yrs, 7 yrs, 10yrs and 15 yrs post-surgery
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Oxford Hip score
Time Frame: 6mths, and annually post-surgery
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6mths, and annually post-surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Fractures, Bone
- Wounds and Injuries
- Leg Injuries
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Hip Injuries
- Musculoskeletal Abnormalities
- Joint Dislocations
- Femoral Fractures
- Arthritis
- Necrosis
- Hip Dislocation
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
Other Study ID Numbers
- CT03/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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