Periprosthetic Distal Femur Fracture

Not Applicable

• Conditions: Distal Femur Fractures; Periprosthetic Fractures

• Registration Number: NCT01973712
• Lead Sponsor: Unity Health Toronto

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Study Start: 2014-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG) test	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 Outcome Measures

Name	Time	Method
Rates of re-operation	12 months

Trial Locations

Locations (1)

St. Michael's Hospital, Department of Orthopaedic Surgery; 🇨🇦 Toronto, Ontario, Canada