Types of Fixation of Vancouver B1 Periprosthetic Fractures

Not Applicable

• Conditions: Femur Fractures

• Registration Number: NCT01354535
• Lead Sponsor: Unity Health Toronto

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Study Start: 2013-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Age: over 18, no upper limit
• Vancouver type B1 periprosthetic fracture
• Fracture is amenable to either treatment group
• Prosthesis is well fixed
• Provision of informed consent

Exclusion Criteria

• Presence of an active infection around the fracture (soft tissue or bone)
• Loose prosthesis
• Trauma patients with an ISS > 16 or associated major injuries of the lower extremities
• Known substance abuse
• Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TUG test score at 6 weeks post-op	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.

Secondary Outcome Measures

Name	Time	Method
Re-operation rates	1 year	We will measure rates of re-operationin each of the treatment groups on study specific case report forms.

Trial Locations

Locations (1)

St. michael's Hospital; 🇨🇦 Toronto, Ontario, Canada