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:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Kaplan-Meier survivorship calculated at the five-year time-point.
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
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