Types of Fixation of Vancouver B1 Periprosthetic Fractures
Not Applicable
- Conditions
- Femur Fractures
- Interventions
- Procedure: Isolated Locked Compression PlateProcedure: Cable Plating and Strut Allograft with Cerclage Wiring
- Registration Number
- NCT01354535
- Lead Sponsor
- Unity Health Toronto
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 89
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description isolated plating 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. Cable plating with strut 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.
- Primary Outcome Measures
Name Time Method TUG test score at 6 weeks post-op 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.
- Secondary Outcome Measures
Name Time Method Re-operation rates 1 year We will measure rates of re-operationin each of the treatment groups on study specific case report forms.
Trial Locations
- Locations (1)
St. michael's Hospital
🇨🇦Toronto, Ontario, Canada