Recruiting

TFN-Advanced Nailing

Sponsor:

Fraser Orthopaedic Research Society

Code:

NCT04851509

Conditions

Pertrochanteric Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dynamic Rotational Locking

Static Locking

Study Details

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.

Conditions

Pertrochanteric Fracture

Study ID

NCT04851509

Start date

May 17, 2021

Status verified date

Feb, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dynamic rotational locking

Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn.

experimental: Static locking

Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw.

Interventions

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.

Primary outcome measure

  • Radiographic Assessment [ Time Frame: 12 months post treatment ]

Central Contacts and Locations

Central contacts

Kyrsten Butterfield, BSc

604-553-3247kyrsten.butterfield@fraserhealth.ca

Locations

Royal Columbian Hospital/Fraser Health Authority

Recruiting

New Westminster, British Columbia, Canada, V3L 3W7

Contacts

Kyrsten Butterfield, BSc

604-553-3247kyrsten.butterfield@fraserhealth.ca

More Information

Sponsor

Fraser Orthopaedic Research Society

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fraser Orthopaedic Research Society on 2025-02-28.