Status:
COMPLETED
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint ...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged between 18 and 75 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 requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
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) Women who are pregnant.
- iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect 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 with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00872066
Start Date
March 1 2006
End Date
July 1 2016
Last Update
March 3 2017
Active Locations (1)
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1
Orthopaedic-traumatology Clinic University Hospital Martin
Martin, Slovakia