Types of Fixation of Vancouver B1 Periprosthetic Fractures

Femur Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01354535
• Other study ID #: 13052011
• Status: Recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: June 2023

Study information

• Verified date: June 2021
• Source: Unity Health Toronto
• Contact: Emil Schemitsch, MD, FRCS(C)
• Phone: 416-864-6003
• Email: schemitsche[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fractures
• Fractures, Bone

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St. michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	Re-operation rates	We will measure rates of re-operationin each of the treatment groups on study specific case report forms.	1 year