Recruiting

Observational StudyTypes of Fixation of Vancouver B1 Periprosthetic Fractures

Sponsor:

Unity Health Toronto

Code:

NCT01354535

Conditions

Femur Fractures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Isolated Locked Compression Plate

Cable Plating and Strut Allograft with Cerclage Wiring

Study Details

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.

Conditions

Femur Fractures

Study ID

NCT01354535

Start date

Feb, 2013

Status verified date

Jun, 2021

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

89 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Isolated Locked Compression Plate

Cable Plating and Strut Allograft with Cerclage Wiring

Primary outcome measure

TUG test score at 6 weeks post-op [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Emil Schemitsch, MD, FRCS(C)

416-864-6003 schemitsche@smh.ca

Michael McKee, MD, FRCS(C)

416-864-5880 mckeem@smh.ca

Locations

St. michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5C 1R1

Contacts

Milena Vicente, RN, CCRP

416-864-6060 vicentem@smh.ca

Principal Investigator:

Emil Schemitsch, MD, FRCS(C)

More Information

Sponsor

Unity Health Toronto

Last update posted

Jun 18, 2021

Last verified

Jun, 2021

Keywords

periprosthetic
femur fractures
Vancouver B1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-06-18.