Status:

RECRUITING

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

Lead Sponsor:

Fraser Orthopaedic Research Society

Collaborating Sponsors:

DePuy Synthes

Conditions:

Pertrochanteric Fracture

Eligibility:

All Genders

18+ years

Phase:

NA

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 asse...

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 arthro...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

May 17 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2027

Estimated Enrollment :

218 Patients enrolled

Trial Details

Trial ID

NCT04851509

Start Date

May 17 2021

End Date

January 1 2027

Last Update

February 28 2025

Active Locations (1)

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1

Royal Columbian Hospital/Fraser Health Authority

New Westminster, British Columbia, Canada, V3L 3W7