Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208442
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2005-09-13
Brief Title:
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon and Enduron Polyethylene Cup Liners in Primary Total Hip Replacement
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
Official Title:
A Prospective Randomised Controlled Single Centre Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces Enduron vs Marathon
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The original protocol intended to perform clinical assessment using the Harris Hip Score Merle DAubigne score and UCLA Activity Level Rating at 6 months 1 year 2 years 3 years 4 years 5 years and 10 years post-operative Merle DAubigne score evaluation was removed per Amendment 2
However protocol-specified data collected included only the linear and volumetric wear and incidence and pattern of radiological signs at 10 years post surgery Data collected outside of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10 years post surgery and revision for any reason
However protocol-specified data collected included only the linear and volumetric wear and incidence and pattern of radiological signs at 10 years post surgery Data collected outside of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10 years post surgery and revision for any reason
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None