Actively Recruiting
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
Led by Fraser Orthopaedic Research Society · Updated on 2025-02-28
218
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
Sponsors
F
Fraser Orthopaedic Research Society
Lead Sponsor
D
DePuy Synthes
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.
CONDITIONS
Official Title
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- AO/OTA 31-A fractures suitable for cephalomedullary nail treatment as judged by the surgeon
- Both open and closed fractures
- Able to walk before the injury, with or without walking aids
- The opposite hip must be native (no previous fracture or implant)
- Willing and able to provide consent or have a substitute decision maker provide consent
You will not qualify if you...
- Previous fracture or hip arthroplasty in the opposite hip
- Fracture not suitable for cephalomedullary nail treatment
- Patient unable to walk
- Fracture older than 14 days from injury to surgery
- Bilateral pertrochanteric hip fractures
- Non-union fractures
- Pathologic fractures
- Periprosthetic fractures
- Patients with spinal injuries
- Incarcerated individuals
- Pregnant patients
- Limited life expectancy due to serious medical conditions or contraindications to surgery
- Patients unlikely to maintain follow-up due to unstable living situation or lack of support
AI-Screening
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Trial Site Locations
Total: 1 location
1
Royal Columbian Hospital/Fraser Health Authority
New Westminster, British Columbia, Canada, V3L 3W7
Actively Recruiting
Research Team
K
Kyrsten Butterfield, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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