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Fractured Neck of FemurNCT03493893

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

An observational study of Fractured Neck of Femur, run by Princess Alexandra Hospital, Brisbane, Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Fractured Neck of Femur
What is being tested?
Intermedullary nail
Type of treatment
Medical device
How many people
800 participants
Where
No sites listed yet
Study dates
Sep 2006to Sep 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . fractured neck of femur

Who cannot join

  • . NOT fractured neck of femur

About this study

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.

Being tested
Intermedullary nail
Medical subject headings
Femoral Neck Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermedullary nailDevice

    Also called Affixus, PFNA, TFNA

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

Study groups in NCT03493893
Study groupRoleWhat they receive
AffixusTo compare Affixus to PFNA and TFNA
Receives: Device: Intermedullary nail
PFNATo compare PFNA to Affixus and TFNA
Receives: Device: Intermedullary nail
TFNATo compare TFNA toPFNA and Affixus
Receives: Device: Intermedullary nail

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reoperation

    Taken back to the operating room for reoperation

    Measured: 12 months

Secondary outcomes (1)
  1. Failure

    Unable to weight bear

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study startSep 2006
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493893
Sponsor's protocol ID
123456
Status last verified
Feb 2019
First submitted
10 Apr 2017
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fractured Neck of Femur, run by Princess Alexandra Hospital, Brisbane, Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reoperation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.

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