Osteoarthritis Clinical Trial
Official title:
A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon
Verified date | June 2017 |
Source | DePuy International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the performance and compare the wear characteristics of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be evaluated at regular intervals using clinical and x-ray assessments.
Status | Completed |
Enrollment | 122 |
Est. completion date | September 1, 2013 |
Est. primary completion date | September 1, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: i) Male or female subjects, aged between 45 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 with non-inflammatory arthritis of the hip who require a primary hip arthroplasty and are considered by the Clinical Investigator to be suitable for a cemented femoral component and an uncemented acetabular component. v) Subjects who have a Charnley C classification vi) Subjects who have undergone a contralateral hip replacement within past 6 months vii) Subjects with a poorly functioning contralateral hip replacement or one which has been identified as requiring revision viii) The first hip replacement scheduled for subjects identified as requiring primary bi-lateral hip replacements which will not be conducted simultaneously (i.e. on the same day). 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) 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 month. |
Country | Name | City | State |
---|---|---|---|
New Zealand | University Otago, Wellington Medical School of Medicine | Wellington |
Lead Sponsor | Collaborator |
---|---|
DePuy International |
New Zealand,
Calvert GT, Devane PA, Fielden J, Adams K, Horne JG. A double-blind, prospective, randomized controlled trial comparing highly cross-linked and conventional polyethylene in primary total hip arthroplasty. J Arthroplasty. 2009 Jun;24(4):505-10. doi: 10.101 — View Citation
Mutimer J, Devane PA, Adams K, Horne JG. Highly crosslinked polyethylene reduces wear in total hip arthroplasty at 5 years. Clin Orthop Relat Res. 2010 Dec;468(12):3228-33. doi: 10.1007/s11999-010-1379-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the linear and volumetric wear at the three-year time point. | 10yrs post surgery | ||
Secondary | Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively | 10yrs post surgery | ||
Secondary | Radiographic analysis | 10yrs post surgery | ||
Secondary | Oxford Hip Score | 10yrs post surgery | ||
Secondary | SF-12 for Mental and Physical well-being | 10yrs post surgery |
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