Status:
TERMINATED
A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Post-traumatic Arthritis
Eligibility:
All Genders
60-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palaco...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.
- 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 with non-inflammatory arthritis of the hip.
- v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.
- vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.
Exclusion
- i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other 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 undergoing corticosteroid treatment.
- vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00208403
Start Date
October 1 2002
End Date
October 1 2005
Last Update
March 28 2017
Active Locations (1)
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1
University Hospital of Trondheim
Trondheim, Sor-Trondelag, Norway