Types of Fixation of Vancouver B1 Periprosthetic Fractures - Full Text View

Purpose

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	Intervention
Femur Fractures	Procedure: Isolated Locked Compression Plate Procedure: Cable Plating and Strut Allograft with Cerclage Wiring


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Leg Injuries and Disorders

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

TUG test score at 6 weeks post-op [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
We will measure rates of re-operationin each of the treatment groups on study specific case report forms.


Estimated Enrollment:	89
Study Start Date:	February 2013
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354535

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


Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01354535 History of Changes
Other Study ID Numbers:	13052011
Study First Received:	May 13, 2011
Last Updated:	April 18, 2016
Health Authority:	Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 29, 2016