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Types of Fixation of Vancouver B1 Periprosthetic Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01354535
Recruitment Status : Recruiting
First Posted : May 17, 2011
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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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 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 2023
Estimated Study Completion Date : June 2023

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Arms and Interventions
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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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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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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354535


Contacts
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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
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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
Unity Health Toronto
Investigators
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Principal Investigator: Emil Schemitsch, MD, FRCS(C) Unity Health Toronto
Principal Investigator: Aaron Nauth, MD, FRCSC Unity Health Toronto
More Information
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT01354535    
Other Study ID Numbers: 13052011
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Keywords provided by Unity Health Toronto:
periprosthetic
femur fractures
Vancouver B1
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries