Types of Fixation of Vancouver B1 Periprosthetic Fractures
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ClinicalTrials.gov Identifier: NCT01354535 |
Recruitment Status :
Recruiting
First Posted : May 17, 2011
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Femur Fractures | Procedure: Isolated Locked Compression Plate Procedure: Cable Plating and Strut Allograft with Cerclage Wiring | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | June 2023 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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. |
- TUG test score at 6 weeks post-op [ Time Frame: 6 weeks ]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.
- Re-operation rates [ Time Frame: 1 year ]We will measure rates of re-operationin each of the treatment groups on study specific case report forms.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354535
Contact: Emil Schemitsch, MD, FRCS(C) | 416-864-6003 | schemitsche@smh.ca | |
Contact: Michael McKee, MD, FRCS(C) | 416-864-5880 | mckeem@smh.ca |
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 |
Principal Investigator: | Emil Schemitsch, MD, FRCS(C) | Unity Health Toronto | |
Principal Investigator: | Aaron Nauth, MD, FRCSC | Unity Health Toronto |
Responsible Party: | Unity Health Toronto |
ClinicalTrials.gov Identifier: | NCT01354535 |
Other Study ID Numbers: |
13052011 |
First Posted: | May 17, 2011 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
periprosthetic femur fractures Vancouver B1 |
Fractures, Bone Femoral Fractures Wounds and Injuries Leg Injuries |