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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
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 →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.
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.
. fractured neck of femur
Exclusion Criteria:
. NOT fractured neck of femur
To compare Affixus to PFNA and TFNA
Device: Intermedullary nail
To compare PFNA to Affixus and TFNA
Device: Intermedullary nail
To compare TFNA toPFNA and Affixus
Device: Intermedullary 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
Reoperation
Taken back to the operating room for reoperation
Time frame: 12 months
Failure
Unable to weight bear
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Princess Alexandra Hospital, Brisbane, Australia