Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A

  • STATUS
    Recruiting
  • End date
    May 30, 2023
  • participants needed
    218
  • sponsor
    Fraser Orthopaedic Research Society
Updated on 30 May 2021

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.

Description

Hip fractures are common injuries in the elderly population that result in significant morbidity and mortality and a significant burden on health care systems. Hip fractures can be treated with arthroplasty or with internal fixation, depending on the fracture pattern. Cephalomedullary nailing (CMN) has become one of the established treatments for intertrochanteric hip fractures with a wide variety of implant designs from many different companies. The TFN-ADVANCED Proximal femoral nailing system (TFN-A) is a novel implant for treating intertrochanteric and subtrochanteric proximal femur fractures with a paucity of published literature on the performance of this implant.

A method to decrease the amount of fracture compression is to use the set screw to lock the helical screw "statically" so it does not slide to the same degree as if the helical screw is placed in the "dynamic" or sliding position. To the knowledge of the investigators, the role of statically locking the helical screw to prevent fracture collapse has not been studied. Statically locking CMN to treat hip fractures has become standard of care at the Royal Columbian Hospital with all the investigating surgeons having adopted this practice in an attempt to prevent significant fracture collapse and neck shortening. Anecdotally, the investigators have not seen significant rates of cephalic helical screw cut-out over the past five years, and believe the investigators' helical screw cut-out rates are lower than what is reported in the literature. The investigators have been using the Gamma Nail (Stryker) to statically lock the helical screw as the previous TFN lacked the ability for static locking. However, with the advent of the TFN-A, the investigators have adopted this implant as their long cephalomedullary nail of choice for fixation of pertrochanteric femur fractures.

Details
Condition Pertrochanteric Fracture
Treatment Dynamic Rotational Locking, Static Locking
Clinical Study IdentifierNCT04851509
SponsorFraser Orthopaedic Research Society
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

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)
Able and willing to answer patient-reported outcome questionnaires and attend standard-of-care clinical visits

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
Dementia
Unable to complete patient-reported outcome measures
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)
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