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Sponsored by: |
DePuy International |
---|---|
Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208403 |
A randomised controlled trial to compare the performance of SmartSet HV & Palacos R bone cement by assessing the clinical and radiographic performance (including RSA stability data) of Charnley total hip replacements
Condition | Intervention | Phase |
---|---|---|
Primary Osteoarthritis |
Device: Smartset HV Bone Cement Device: Palacos R |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised, Prospective, RSA, PMS Study Comparing SmartSet HV & Palacos R in Primary Total Hip Arthroplasty |
Estimated Enrollment: | 36 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
SmartSet HV
|
Device: Smartset HV Bone Cement
A high viscosity bone cement for use in total hip replacement
|
2: Active Comparator
Palacos R
|
Device: Palacos R
A high viscosity bone cement for use in total hip replacement
|
Ages Eligible for Study: | 60 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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.
Responsible Party: | DePuy International Ltd ( Michael Borroff ) |
Study ID Numbers: | CT02/08 |
Study First Received: | September 13, 2005 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00208403 |
Health Authority: | Norway: Directorate for Health and Social Affairs |
Hip Cement |
Polymethyl Methacrylate Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |