Types of Fixation of Vancouver B1 Periprosthetic Fractures

Unity Health Toronto

Status: Unknown

Conditions: Femur Fractures

Treatments: Procedure: Isolated Locked Compression Plate; Procedure: Cable Plating and Strut Allograft with Cerclage Wiring

Study type: Interventional

Funder types: Other

Identifiers

NCT01354535

13052011

Details and patient eligibility

About

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.

Enrollment: 89 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Cable plating with strut

Active Comparator group

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.

Treatment:

Procedure: Cable Plating and Strut Allograft with Cerclage Wiring

isolated plating

Active Comparator group

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.

Treatment:

Procedure: Isolated Locked Compression Plate