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

NCT04851509 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-02-28

No results posted yet for this study

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • Fraser Orthopaedic Research Society

    lead NETWORK

Principal Investigators

  • Bertrand Perey, MD, FRCSC · Royal Columbian Hospital/Fraser Health Authority

  • David Cinats, MD · Orthopaedic Surgeon, Fraser Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2026-06-30
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851509 on ClinicalTrials.gov