Dynamic Rotational Locking: Performed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver.
Static Locking: Performed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the screw within the nail.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients \>18 years of age
* AO/OTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail
* Open and closed fractures
* Ambulatory prior to injury (with or without walking aides)
* Native (non-fractured, no implant) contralateral hip
* Willing and able to sign consent (substitute decision maker)
Exclusion Criteria:
* Contralateral hip fracture or hip arthroplasty
* Fracture not amenable to treatment with a cephalomedullary nail
* Non-ambulatory patient
* Fractures \>14 days (time of injury to OR)
* Bilateral pertrochanteric hip fractures
* Non-unions
* Pathologic fractures
* Periprosthetic fractures
* Patients with spinal injury
* Incarceration
* Pregnancy
* Limited life expectancy due to significant medical co-morbidities or medical contra-indications to surgery
* Likely problems, in the judgement 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).
Primary outcome measure(s)
Radiographic Assessment — 12 months post treatment The primary objective of this study will be to investigate how statically locking the TFN-A influences shortening or collapse of pertrochanteric fractures by measuring radiographic shortening or collapse of pertrochanteric fractures treated with the TFN-A implant.
Trial sites (1)
Facility
City
Region
Status
Royal Columbian Hospital/Fraser Health Authority
New Westminster
British Columbia
Recruiting
More Fraser Orthopaedic Research Society trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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