Types of Fixation of Vancouver B1 Periprosthetic Fractures

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Femur Fractures	Procedure: Isolated Locked Compression Plate; Procedure: Cable Plating and Strut Allograft with Cerclage Wiring	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	89 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial
Study Start Date :	February 2013
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	June 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. TUG test score at 6 weeks post-op [ Time Frame: 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 :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Emil Schemitsch, MD, FRCS(C)	416-864-6003	schemitsche@smh.ca
Contact: Michael McKee, MD, FRCS(C)	416-864-5880	mckeem@smh.ca

Locations

Canada, Ontario
St. michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5C 1R1
Contact: Milena Vicente, RN, CCRP 416-864-6060 ext 2608 vicentem@smh.ca
Principal Investigator: Emil Schemitsch, MD, FRCS(C)
Sub-Investigator: Aaron Nauth, MD, FRCSC

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators

Principal Investigator:	Emil Schemitsch, MD, FRCS(C)	St. Michael's Hospital, Toronto
Principal Investigator:	Aaron Nauth, MD, FRCSC	St. Michael's Hospital, Toronto

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01354535 History of Changes
Other Study ID Numbers:	13052011
First Posted:	May 17, 2011
Last Update Posted:	November 17, 2017
Last Verified:	November 2017

Keywords provided by St. Michael's Hospital, Toronto:

periprosthetic; femur fractures; Vancouver B1

Additional relevant MeSH terms:

Fractures, Bone; Femoral Fractures; Periprosthetic Fractures; Wounds and Injuries; Leg Injuries