Clinical trial NCT04851509: Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
Official title: Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pertrochanteric Fracture
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
Collaborators: name: DePuy Synthes
First posted: 2021-04-20
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial design utilizing alternating treatment allocation to assign patients to treatment arms, treatment allocations will last for two months at a time.
Primary purpose: TREATMENT

Brief 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.

Detailed 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 screw "statically" so it does not slide to the same degree as if the screw is placed in the "dynamic" or sliding position. To the knowledge of the investigators, the role of statically locking the 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 screw cut-out over the past five years, and believe the investigators' 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 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.

Eligibility criteria: 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 outcomes:
measure: Radiographic Assessment
timeFrame: 12 months post treatment
Secondary outcomes:
measure: Fracture Reduction Quality
timeFrame: Intra-operatively
measure: Femoral Offset
timeFrame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
measure: Tip-Apex distance
timeFrame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
measure: Complications
timeFrame: intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital/Fraser Health Authority
state: British Columbia
Study officials:
affiliation: Royal Columbian Hospital/Fraser Health Authority
name: Bertrand Perey, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Surgeon, Fraser Health Authority
name: David Cinats, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gausden EB, Sin D, Levack AE, Wessel LE, Moloney G, Lane JM, Lorich DG. Gait Analysis After Intertrochanteric Hip Fracture: Does Shortening Result in Gait Impairment? J Orthop Trauma. 2018 Nov;32(11):554-558. doi: 10.1097/BOT.0000000000001283.
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