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Clinical Trials/NCT01973712
NCT01973712
Unknown
Not Applicable

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

Unity Health Toronto1 site in 1 country94 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periprosthetic Fractures
Sponsor
Unity Health Toronto
Enrollment
94
Locations
1
Primary Endpoint
Timed Up and Go (TUG) test
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
January 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Rates of re-operation(12 months)

Study Sites (1)

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