NCT01354535

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

10.3 years

First QC Date

May 13, 2011

Last Update Submit

June 16, 2021

Conditions

Femur Fractures

Keywords

periprostheticfemur fracturesVancouver B1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Re-operation rates

    1 year

Study Arms (2)

Cable plating with strut

ACTIVE COMPARATOR

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

isolated plating

ACTIVE COMPARATOR

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

Interventions

Isolated Locked Compression PlatePROCEDURE

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.

isolated plating
Cable Plating and Strut Allograft with Cerclage WiringPROCEDURE

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.

Cable plating with strut

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. michael's Hospital

Toronto, Ontario, M5C 1R1, Canada

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Emil Schemitsch, MD, FRCS(C)

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Aaron Nauth, MD, FRCSC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emil Schemitsch, MD, FRCS(C)

CONTACT

416-864-6003schemitsche@smh.ca

Michael McKee, MD, FRCS(C)

CONTACT

416-864-5880mckeem@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 17, 2011

Study Start

February 1, 2013

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

CA(1)