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Clinical Trials/NCT00208455
NCT00208455TerminatedPhase 4

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

DePuy International4 sites in 4 countries184 target enrollmentStarted: February 1, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Terminated
Sponsor
Enrollment
184
Locations
4
Primary Endpoint
Kaplan-Meier survivorship calculated at the five-year time-point
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: 5 yrs

Secondary Outcomes

  • Annual Kaplan-Meier survivorship calculations(Annually)
  • Radiographic analysis(6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)
  • Harris Hip Score(6mths, 1yr, 2yrs, 5yrs, 7 yrs, 10yrs and 15 yrs post-surgery)
  • Oxford Hip score(6mths, and annually post-surgery)

Investigators

Sponsor
DePuy International
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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