Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405470
Status:
COMPLETED
Last Update Posted:
2010-08-12
First Post:
2006-11-28
Brief Title:
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
Sponsor:
Dalhousie University
Organization:
Dalhousie University
Study Overview
Official Title:
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
Status:
COMPLETED
Status Verified Date:
2010-08
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 determine whether this particular knee replacement is better than those already on the market By participation it will further refine the design of future total knee replacements and perhaps increase longevity
Detailed Description:
Joint arthroplasty is an effective surgical intervention however prosthetic survivorship is finite New or modified prosthetic components are routinely introduced partly in an effort to improve survivorship When new technologies emerge for total knee replacement it is not always evident that they are an improvement over existing options This determination requires long-term follow-up studies Conventional studies require a large number of patients and approximately 10 years of follow-up By using RSA to measure micromotion of prostheses over time problems can be elucidated with a much smaller sample over a shorter time period RSA involves using tantalum markers 05-10 mm beads inserted in the bone and prosthesis during surgery to measure motion in subsequent bi-planar x-rays of the joint The relatively new Medial Pivot Knee ADVANCE Knee theoretically reproduces the natural kinematics of the knee but it is unclear what effect this design may have on the forces applied to the tibial component-bone interface The amount of micromotion of the tibial component is directly related to the amount of force exerted on it and inversely related to its fixation In this study we propose to compare in vivo micromotion at the tibial component-bone interface with the ADVANCE Medial-Pivot Knee experimental group versus a more conventional prosthesis control the ADVANCE Traditional Knee Patients n60 age 45-80 years old with primary osteoarthritis of the knee and mono-articular disease will be randomized to receive either the ADVANCE Traditional or ADVANCE Medial-Pivot Knee using Simplex cement Eight tantalum markers will be placed in both the tibia and femur proximal to the prosthesis and in the polyethylene tray of the tibial component Pre-operatively and at 6 12 and 24 months all patients will complete general health SF-12 and joint specific questionnaires Oxford -12 Item Knee Score have their body mass index calculated and have the range of motion alignment extensor function and ligamentous competency of their index knee recorded On the first weight-bearing day after surgery bi-planar standing x-rays will be taken and used as a reference point for tibial component position At 6 12 and 24 months post-operatively patients will undergo more bi-planar standing x-rays incorporating provocative loading tests Micromotion will be analyzed through serial comparison of digital x-rays by blinded study personnel using RSA software Parametric statistics unpaired Students t-test will be used to compare the 2 groups
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