Intertrochanteric Fractures, Pertrochanteric Fracture, Pertrochanteric Fracture of Femur, Closed, Pertrochanteric Fracture of Femur, Open
Conditions
Keywords
Pertrochanteric fracture, Intertrochanteric fracture, subtrochanteric extension, Proximal femoral nail, Proximal locking screw, Distal locking screw
Brief summary
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
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.
Interventions
DEVICEProximal femoral nail with straight parallel blade
Petrochanteric fixation with Heracles proximal femoral nail
Sponsors
Ilocos Training and Regional Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients who sustained stable pertrochanteric fracture (AO31A.1) 2. Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.)
Exclusion criteria
1. Patients who are bedridden 2. Patients with a neurologic/psychiatric disorder (previous or present) 3. Patients with severe dementia/Alzheimer's disease 4. Patient with a history of hip dislocation (whether reduced or unreduced) 5. Patient who underwent previous operation on the hip 6. Patient with amputation of one or both legs 7. Patient with segmental fractures involving the ipsilateral femoral shaft/metaphysis 8. Patient with pathologic fractures, e.g. secondary to metastatic bone disease/ metabolic bone disease 9. Patient presenting with an infection 10. Patient who sustained multiple injuries from other body systems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to full weightbearing | 4-6 months | weeks until full weight bearing without pain |
| Time to Clinical Union | 2 months to 4 months | Weeks until Union Clinical Union - fracture site becomes stable and pain-free |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tip-Apex Distance | up to 2 years | 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 |
| Blood Loss | Taken immediately postop | Blood loss during the procedure in milliliters |
| Fluoroscopy time | Intraoperative measurement | Total time of exposure during the procedure starting from identification of starting point to insertion of distal locking screw |
| Social dependence scale | up to 2 years | 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 1. Completely independent 2. Minimal assistance 3. Moderate assistance 4. Regular assistance 5. Dependent 6. Severely dependent 7. Fully dependent 8. Patient temporarily resident in hospital |
| Pain scale | Postop up to 2 years | Pain scale adapted for hip fractures (Bowers and Parker 2016) 1 is best and 8 is worst 0\. Unable to answer 1. No pain at all in the hip 2. Occasional and slight pain 3. Some pain when starting to walk, no rest pain. 4. None or minimal pain at rest, some pain with activities 5. Regular pain with activities which limits walking distance. 6. Frequent rest pain and pain at night. Pain on walking. 7. Constant pain presents around the hip. 8. Constant and severe pain in the hip requires regular strong analgesia such as opiates. |
| Radiographic Union Score for the Hip | up to 2 years | 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 1. \- No cortical bridging 2. \- Some cortical bridging 3. \- Complete Cortical Bridging In addition, disappearance of the fracture line in the anterior cortex, posterior cortex, medial cortex, lateral cortex 1. \- Fully visible fracture line 2. \- Some evidence of the fracture line 3. \- No evidence of fracture line Add all component scores to get the total score |
| Radiation load | Intraoperative measurement | Amount of radiation during the procedure as measured by a Dosimeter |
| Mobility scale | up to 2 years | Mobility scoring modified for use in patients who sustained a hip fracture (Bowers and Parker 2016). 1 is best and 10 is worst. 1. Never uses any walking aid, no restriction in walking distance 2. Never uses any walking aid, can walk less than one kilometer 3. Occasionally uses a walking aid 4. Normally uses one walking stick or needs to hold on to furniture 5. Normally uses two sticks or crutches 6. Mobilizes with a frame alone, without the need for assistance 7. Mobilizes with a frame and the assistance of one other person 8. Mobilizes with a frame and the assistance of two people 9. Bed-to-chair, or wheelchair-bound 10. Bedbound most or all of the day. |
| Quality and Maintenance of Reduction | up to 2 years | Acceptable reduction was defined as: 1. Range of neck angle between 5° varus and 20° valgus. 2. \<20 deg angulation on lateral 3. No fragment greater than 4 mm displaced Reduction is defined as good (3/3), adequate (2/3) and poor (0-1/3) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | Intraoperative to postoperative up to 2 years | Intraoperative and Postoperative complications. Will describe presence of complications and description of the specific complications. Intraoperative complications involve redisplacement, iatrogenic fracture and comminution, broken implants (drill bit); These include Infection (superficial or deep); Osteomyelitis; Nonunion; Implant failure; Varus collapse and Others Complications will be described in detail to ascertain its causality and recommend how it could have been prevented. |
| Technical difficulties | Intraoperative | Technical difficulties encountered during each component step of the OR These include difficulty in finding the entry point; difficulty inserting the awl; difficulty putting in the guidewire; Wrong entry point; difficulty finding proximal blade insertion and application; difficulty with distal locking screw determination and insertion Any technical difficulty will be described in detail to ascertain the nature and cause of the difficulty (technique dependent vs implant dependent). |
Contacts
Primary ContactLou Mervyn A. Tec, MD
Backup ContactGualberto Basco, MD
Outcome results
None listed