Types of Fixation of Vancouver B1 Periprosthetic Fractures

NCT ID: NCT01354535

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Femur Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cable Plating and Strut Allograft with Cerclage Wiring

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Isolated Locked Compression Plate

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emil Schemitsch, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Aaron Nauth, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Emil Schemitsch, MD, FRCS(C)

Role: CONTACT

416-864-6003

Michael McKee, MD, FRCS(C)

Role: CONTACT

416-864-5880

Facility Contacts

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Milena Vicente, RN, CCRP

Role: primary

416-864-6060 ext. 2608

Other Identifiers

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13052011

Identifier Type: -

Identifier Source: org_study_id

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