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CompletedNCT03493893Updated Feb 28, 2019

10 Year Review of the Experience of the PFNA ,TFNA the Affixus Nail

An observational study in Fractured Neck of Femur, sponsored by Princess Alexandra Hospital, Brisbane, Australia. Completed. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by Princess Alexandra Hospital, Brisbane, Australia · Observational

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Study type
Observational
Enrollment
800
Ages
18 Years to 110 Years
Sex
All
01

Study summary

The aim of this study was to investigate the clinical effects of design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

Read the detailed description

Intertrochanteric hip fractures are one of the more common orthopaedic presentations, with an approximate incidence in Australia of 230 cases per 100,000 population. The importance of this pathology is well documented being the major fracture-related health care cost and cause of mortality in all sexes over 50 years of age.

Contemporary fixation of the proximal femur is performed utilising a number of implants adopting different concepts and techniques. Cephalomedullary/Intermedullary femoral nails (IM nails) over the last 15 years have gained popularity. IM nails are implanted via a small incision and intermedullary insertion through the greater trochanter, secured by passing a screw or blade through the femoral neck into the femoral head. This nailing technique offers the theoretical benefits of a smaller incision with less tissue dissection and hence reduced blood loss, infection and operating time. As well as a proposed biomechanical advantage due to a shorter lever arm, sharing the load and minimising proximal collapse.

Biomechanical studies of IM nails in the use of extracapsular fractures of the femoral neck have found benefit over existing sliding/compression hip screws (CHS). Advantages have been observed in combined bending and compression performance to failure. As well as postoperative rigidity in unstable subtrochanteric fractures, and load bearing capability. Significantly greater fatigue strength and fatigue life have additionally been shown in cyclic loading assessment and reduced incidence of cut out has been observed, showing benefit over the use of CHS.

Early trials however found a higher rate of operative complications involving IM fixation, including fractures at the tip of the nail or related to distal locking. Following this several studies have compared the clinical outcomes of CHS vs IM nails with varying findings questioning the overall patient benefit, especially in stable fracture patterns. From a review of the past literature the common trend is a longer operative time and higher associated blood loss with CHS, but fewer intraoperative surgical related complications and less fluoroscopic time with the use of nails. IM nail use has shown to offer better post-operative ambulatory function and reduced limb shortening but it appears due to the early complications of this technique numerous variations in implant design have emerged.

Purpose In recent years further development has occurred in nail design in an attempt to reduce the incidence of fixation failure. The aim of this study was to investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

02

Conditions studied

  • Fractured Neck of Femur
03

In context

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

This study's enrollment of 800 is above the median of 137 across 60 observational studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Princess Alexandra Hospital, Brisbane, Australia is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

. fractured neck of femur

Exclusion criteria

Exclusion Criteria:

. NOT fractured neck of femur

05

Study design

Enrollment
800 participants (actual)
Patient registry
No

Groups and cohorts

  • Affixus

    To compare Affixus to PFNA and TFNA

    Device: Intermedullary nail

  • PFNA

    To compare PFNA to Affixus and TFNA

    Device: Intermedullary nail

  • TFNA

    To compare TFNA toPFNA and Affixus

    Device: Intermedullary nail

Interventions

  • DeviceIntermedullary nail

    investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

    Also known as: Affixus, PFNA, TFNA

06

What researchers measure

Primary outcomes

  1. Reoperation

    Taken back to the operating room for reoperation

    Time frame: 12 months

Secondary outcomes

  1. Failure

    Unable to weight bear

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2006 to primary completion in Sep 2016, 120 months.

Of 20 observational studies under Femoral Neck Fractures, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 120. This study's 120 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2017
First posted
Apr 11, 2018
StartActual
Sep 2006
Primary completionActual
Sep 2016
CompletionActual
Sep 2016
Last update
Feb 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03493893
Lead sponsor
Princess Alexandra Hospital, Brisbane, Australia
Responsible party
Genni Lynch (Research coordinator, Princess Alexandra Hospital, Brisbane, Australia) — Principal investigator
First posted
Apr 11, 2018
Start date
Sep 2006
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Feb 28, 2019

Study contacts

Cameron Cooke
principal investigator · Princess Alexandra Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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