Clinical Trial: Types of Fixation of Vancouver B1 Periprosthetic Fractures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial

Brief Summary: The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.

Detailed Summary:
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: TUG test score at 6 weeks post-op [ Time Frame: 6 weeks ]

We will administer the TUG test to each patient at 6 weeks to determine if there is a difference in functional status between both groups.


Original Primary Outcome: Rate of re-operation as measured at one year [ Time Frame: 1 year ]

We will measure the number of re-operations in each of the treatment groups on study specific case report forms.


Current Secondary Outcome: Re-operation rates [ Time Frame: 1 year ]

We will measure rates of re-operationin each of the treatment groups on study specific case report forms.


Original Secondary Outcome: Rates of union [ Time Frame: 1 year ]

We will measure time to union in each of the treatment groups on study specific case report forms.


Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: May 13, 2011
Date Started: February 2013
Date Completion: June 2018
Last Updated: October 24, 2016
Last Verified: October 2016