Back to resultsTypes of Fixation of Vancouver B1 Periprosthetic Fractures
Primary Purpose
Femur Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Isolated Locked Compression Plate
Cable Plating and Strut Allograft with Cerclage Wiring
Sponsored by
About this trial
This is an interventional treatment trial for Femur Fractures focused on measuring periprosthetic, femur fractures, Vancouver B1
Eligibility 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)
Sites / Locations
- St. michael's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cable plating with strut
isolated plating
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Re-operation rates
We will measure rates of re-operationin each of the treatment groups on study specific case report forms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01354535
Brief Title
Types of Fixation of Vancouver B1 Periprosthetic Fractures
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fractures
Keywords
periprosthetic, femur fractures, Vancouver B1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cable plating with strut
Arm Type
Active Comparator
Arm Description
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.
Arm Title
isolated plating
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Isolated Locked Compression Plate
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cable Plating and Strut Allograft with Cerclage Wiring
Intervention Description
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.
Primary Outcome Measure Information:
Title
TUG test score at 6 weeks post-op
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Re-operation rates
Description
We will measure rates of re-operationin each of the treatment groups on study specific case report forms.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Schemitsch, MD, FRCS(C)
Phone
416-864-6003
Email
schemitsche@smh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael McKee, MD, FRCS(C)
Phone
416-864-5880
Email
mckeem@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch, MD, FRCS(C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Vicente, RN, CCRP
Phone
416-864-6060
Ext
2608
Email
vicentem@smh.ca
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch, MD, FRCS(C)
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD, FRCSC
12. IPD Sharing Statement
Learn more about this trial
Types of Fixation of Vancouver B1 Periprosthetic Fractures
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