Clinical Trial: Periprosthetic Distal Femur Fracture

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

Official Title: Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing

Brief Summary:

A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.

Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.

The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.


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

Current Primary Outcome: Timed Up and Go (TUG) test [ Time Frame: 3 months ]

The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again


Original Primary Outcome: Radiographic malunion, defined as greater than five degrees deviation from the anatomic axis in any plane [ Time Frame: 12 months ]

Current Secondary Outcome: Rates of re-operation [ Time Frame: 12 months ]

Original Secondary Outcome: Rates of nonunion and implant failure [ Time Frame: 12 months ]

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: October 25, 2013
Date Started: May 2014
Date Completion: January 2022
Last Updated: May 17, 2017
Last Verified: May 2017