Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design

Study Overview
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Brief Summary
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This is a prospective case series of elderly adult patients sustaining pertrochanteric fractures who will be treated by a proximal femoral nail with a non-helical (straight) blade. This study seeks to observe and evaluate the outcomes, advantages and complication rates in using the HERACLES PFN with a non-helical (T-shaped parallel) blade.

Detailed Description
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The trochanteric area is defined by AO as the area bordered by the tip of the greater trochanter, extracapsular portion of the femoral neck extending to a line parallel to the inferior most border of the lesser trochanter. Pertrochanteric fracture is a fracture is of the trochanteric area which is usually reducible. Unstable pertrochanteric fracture is defined as AO-31A2 or AO-31A3. Instability arises from the degree of comminution, the presence, and comminution of the posteromedial fragment and lastly, lateral wall involvement The ideal implant for fixation of this kind of fractures is still under debate, but intramedullary implants are preferred than extramedullary implants in these unstable fractures. On the other hand, unique fracture configurations predispose to instability such as reverse obliquity fractures and fractures extending to the subtrochanteric area. Proximal femoral locking plate as used in unstable pertrochanteric fracture has a high complication rate. In one study in 2014, there is up to 41.4% failure rate due to the proud plate, screw malposition, too rigid construct when used as a bridge plate. Intramedullary implants specifically cephalomedullary nails has been the mainstay of treatment in unstable pertrochanteric fractures primarily because of the short moment arm and load-sharing properties. It employs relative stability and can be applied in a minimally invasive manner. In 1997, the AO/ASIF group developed the proximal femoral nail. The proximal femoral nail has two proximal screws that traverse the neck to the femoral head. The inferior screw is the load-bearing screw, and the superior screw is the anti-rotation screw. Good to excellent results were observed using this implant compared to previous implant designs, but complications still exist. These complications are related to the position of the two screws. There is difficulty attaining the ideal placement of proximal locking screws. As a result, the early medial cutout of one screw and lateral migration of the second screw occurs which is the so-called Z-effect. To address these disadvantages, the AO/ASIF group in 2004 developed a new implant design wherein the two proximal locking screws are replaced by a single helical blade. This improvement in design maximizes bone purchase and bone contact in cancellous bone hereby improving cutout rates. Even with the new PFNA implant is not exempted from complications. Zhou and Chang in 2012 identified 12 cases of helical blade protrusion in 6 papers. Biomechanically, the helical blade migrates axially through the porotic bone in the geriatric population. The new design of the blade includes a T-shaped anchor for stable fixation in osteoporotic bone. The nail also features a flat lateral design with a smooth radius transition from proximal to distal portion of the nail compared to the bulky profile of conventional nail resulting in easier insertion. Locking mechanism inherent to the nail and blade limits gliding and rotation of the blade. One of the advantages of the system is the use of a radiolucent arm with targeting options for an anti-rotation pin and determination of the superior most aspect of the femoral head for reference. This case-series introduces a modification in implant design of the PFNA and aims to observe outcomes, advantages, and complications related to its use.

Official Title
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Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design

Conditions
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Pertrochanteric Fracture, Intertrochanteric Fractures, Pertrochanteric Fracture of Femur, Closed, Pertrochanteric Fracture of Femur, Open

Intervention / Treatment
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* Device: Proximal femoral nail with straight parallel blade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sustained stable pertrochanteric fracture (AO31A.1) Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.) Exclusion Criteria: Patients who are bedridden Patients with a neurologic/psychiatric disorder (previous or present) Patients with severe dementia/Alzheimer's disease Patient with a history of hip dislocation (whether reduced or unreduced) Patient who underwent previous operation on the hip Patient with amputation of one or both legs Patient with segmental fractures involving the ipsilateral femoral shaft/metaphysis Patient with pathologic fractures, e.g. secondary to metastatic bone disease/ metabolic bone disease Patient presenting with an infection Patient who sustained multiple injuries from other body systems

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PFN straight parallel blade<br>All patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade. | Device: Proximal femoral nail with straight parallel blade<br>* Petrochanteric fixation with Heracles proximal femoral nail<br>* Other names: Heracles proximal femoral nail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Clinical Union | Weeks until Union Clinical Union - fracture site becomes stable and pain-free | 2 months to 4 months | 
| Time to full weightbearing | weeks until full weight bearing without pain | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality and Maintenance of Reduction | Acceptable reduction was defined as: Range of neck angle between 5° varus and 20° valgus. <20 deg angulation on lateral No fragment greater than 4 mm displaced Reduction is defined as good (3/3), adequate (2/3) and poor (0-1/3) | up to 2 years | 
| Tip-Apex Distance | expressed in millimetres, is the sum of the distance from the tip of the blade to the apex of the femoral head on both AP and lateral radiographic views | up to 2 years | 
| Blood Loss | Blood loss during the procedure in milliliters | Taken immediately postop | 
| Fluoroscopy time | Total time of exposure during the procedure starting from identification of starting point to insertion of distal locking screw | Intraoperative measurement | 
| Mobility scale | Mobility scoring modified for use in patients who sustained a hip fracture (Bowers and Parker 2016). 1 is best and 10 is worst. Never uses any walking aid, no restriction in walking distance Never uses any walking aid, can walk less than one kilometer Occasionally uses a walking aid Normally uses one walking stick or needs to hold on to furniture Normally uses two sticks or crutches Mobilizes with a frame alone, without the need for assistance Mobilizes with a frame and the assistance of one other person Mobilizes with a frame and the assistance of two people Bed-to-chair, or wheelchair-bound Bedbound most or all of the day. | up to 2 years | 
| Social dependence scale | Modified to apply for hip fractures; includes determination of independence to ADLs and advanced ADLs (Bowers and Parker 2016) 1 is best and 8 is worst Completely independent Minimal assistance Moderate assistance Regular assistance Dependent Severely dependent Fully dependent Patient temporarily resident in hospital | up to 2 years | 
| Pain scale | Pain scale adapted for hip fractures (Bowers and Parker 2016) 1 is best and 8 is worst 0. Unable to answer No pain at all in the hip Occasional and slight pain Some pain when starting to walk, no rest pain. None or minimal pain at rest, some pain with activities Regular pain with activities which limits walking distance. Frequent rest pain and pain at night. Pain on walking. Constant pain presents around the hip. Constant and severe pain in the hip requires regular strong analgesia such as opiates. | Postop up to 2 years | 
| Radiographic Union Score for the Hip | is a validated outcome instrument designed to improve intra and interobserver reliability when describing the radiographic healing of proximal femur fractures Based on grading of the anterior cortex, posterior cortex, lateral cortex and medial cortex bridging - No cortical bridging - Some cortical bridging - Complete Cortical Bridging In addition, disappearance of the fracture line in the anterior cortex, posterior cortex, medial cortex, lateral cortex - Fully visible fracture line - Some evidence of the fracture line - No evidence of fracture line Add all component scores to get the total score | up to 2 years | 
| Radiation load | Amount of radiation during the procedure as measured by a Dosimeter | Intraoperative measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertrochanteric fracture, Intertrochanteric fracture, subtrochanteric extension, Proximal femoral nail, Proximal locking screw, Distal locking screw