Types of Fixation of Vancouver B1 Periprosthetic Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Femur Fractures
• Intervention / Treatment: Procedure: Cable Plating and Strut Allograft with Cerclage Wiring; Procedure: Isolated Locked Compression Plate

• Study Type: Interventional
• Enrollment (Anticipated): 89
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emil Schemitsch, MD, FRCS(C); Phone Number: 416-864-6003; Email: schemitsche@smh.ca
• Study Contact Backup: Name: Michael McKee, MD, FRCS(C); Phone Number: 416-864-5880; Email: mckeem@smh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1R1
      • Recruiting
      • St. Michael's Hospital
      • Principal Investigator: Emil Schemitsch, MD, FRCS(C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cable plating with strut; The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.	Procedure: Cable Plating and Strut Allograft with Cerclage Wiring; The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.
Active Comparator: isolated plating; A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.	Procedure: Isolated Locked Compression Plate; A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TUG test score at 6 weeks post-op	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.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Emil Schemitsch, MD, FRCS(C), Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: periprosthetic; femur fractures; Vancouver B1
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 13052011