Health TrialsbyHealthPanel

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

ConditionPertrochanteric Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFraser Orthopaedic Research Society

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dynamic Rotational Locking

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Dynamic rotational lockingActive comparator 1 intervention
Group B: Static lockingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic Assessment

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.

Time frame
12 months post treatment

Secondary outcomes

1

Fracture Reduction Quality

Assessed through x-rays of the entire proximal femur

Time frame
Intra-operatively
2

Femoral Offset

Measured in a method described by O. Paul et al

Time frame
1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
3

Tip-Apex distance

Measured as described by Baumgaertner et al

Time frame
1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
4

Complications

SAEs/AEs

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fraser Orthopaedic Research Society

Lead sponsor

DePuy Synthes

Collaborator

Source ClinicalTrials.gov
Apply now