Types of Fixation of Vancouver B1 Periprosthetic Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
nautha@smh.ca, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01354535
First received: May 13, 2011
Last updated: May 12, 2014
Last verified: May 2014
  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:


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 2015
Estimated Primary Completion Date: June 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
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

No publications provided

Responsible Party: nautha@smh.ca, MD, FRCS(C), 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: May 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
periprosthetic
femur fractures
Vancouver B1

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Periprosthetic Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 28, 2014