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NCT Number: NCT04851509

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital/Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

Location status: Recruiting

Location contact

Kyrsten Butterfield, BSc

CONTACT

[email protected]

604-553-3247

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dynamic Rotational Locking

Procedure

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

Procedure

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.

Primary outcomes

  1. Radiographic Assessment

    Time frame: 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.

Secondary outcomes

  1. Fracture Reduction Quality

    Time frame: Intra-operatively

    Assessed through x-rays of the entire proximal femur

  2. Femoral Offset

    Time frame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

    Measured in a method described by O. Paul et al

  3. Tip-Apex distance

    Time frame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

    Measured as described by Baumgaertner et al

  4. Complications

    Time frame: intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

    SAEs/AEs

Study contacts

Contact information is provided by the study sponsor or research team.

Kyrsten Butterfield, BSc

CONTACT

[email protected]

604-553-3247

Sponsors and collaborators

Lead sponsor

Fraser Orthopaedic Research Society

Network

Collaborators

  • DePuy Synthes

Registry information

Official study title

Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial

Acronym: TFN-A

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Apr 20, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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