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Clinical Trials/NCT00208429
NCT00208429WithdrawnPhase 4

Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

DePuy International0 sitesStarted: July 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Sponsor
Primary Endpoint
Kaplan-Meier survivorship calculated at the five-year time-point.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination 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.

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, aged between 18 and 70 years inclusive.
  • •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 are willing to return to the hospital for all the required post-operative follow-ups.
  • •iv) Subjects undergoing primary total hip replacement who are suitable for a cementless acetabular component and a metal on polyethylene bearing.

Exclusion Criteria

  • •i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  • •ii) Subjects undergoing revision hip replacement.
  • •iii) Subjects undergoing simultaneous bilateral hip operation.
  • •iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
  • •v) Women who are pregnant.
  • •vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • •vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
  • •viii) Subjects who are currently involved in any injury litigation claims.

Outcomes

Primary Outcomes

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

Time Frame: 5 yrs post surgery

Secondary Outcomes

  • Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score(6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)
  • Kaplan-Meier survivorship(Annually up to 15 yrs post-surgery)
  • Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score(Annually up to 15 yrs post-surgery)

Investigators

Sponsor
DePuy International
Sponsor Class
Industry
Responsible Party
Sponsor

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