Status:
TERMINATED
A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
60-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used in the treatment of patients with hip joint disease requiring a total hip replacement. Pati...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged between 60 and 80 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 that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.
Exclusion
- 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 replacements.
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00872573
Start Date
July 1 2006
End Date
October 1 2007
Last Update
June 26 2017
Active Locations (1)
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1
North Bristol NHS Trust
Bristol, United Kingdom