Pertrochanteric Fracture
Conditions
Brief summary
The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.
Detailed description
Hip fractures are common injuries in the elderly population that result in significant morbidity and mortality and a significant burden on health care systems. Hip fractures can be treated with arthroplasty or with internal fixation, depending on the fracture pattern. Cephalomedullary nailing (CMN) has become one of the established treatments for intertrochanteric hip fractures with a wide variety of implant designs from many different companies. The TFN-ADVANCED™ Proximal femoral nailing system (TFN-A) is a novel implant for treating intertrochanteric and subtrochanteric proximal femur fractures with a paucity of published literature on the performance of this implant. A method to decrease the amount of fracture compression is to use the set screw to lock the screw statically so it does not slide to the same degree as if the screw is placed in the dynamic or sliding position. To the knowledge of the investigators, the role of statically locking the screw to prevent fracture collapse has not been studied. Statically locking CMN to treat hip fractures has become standard of care at the Royal Columbian Hospital with all the investigating surgeons having adopted this practice in an attempt to prevent significant fracture collapse and neck shortening. Anecdotally, the investigators have not seen significant rates of cephalic screw cut-out over the past five years, and believe the investigators' screw cut-out rates are lower than what is reported in the literature. The investigators have been using the Gamma Nail (Stryker) to statically lock the screw as the previous TFN lacked the ability for static locking. However, with the advent of the TFN-A, the investigators have adopted this implant as their long cephalomedullary nail of choice for fixation of pertrochanteric femur fractures.
Interventions
PROCEDUREDynamic Rotational Locking
Performed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver.
PROCEDUREStatic Locking
Performed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the screw within the nail.
Sponsors
DePuy Synthes
Fraser Orthopaedic Research Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Surgeons cannot be blinded to the treatment allocation of the surgical intervention due to having to perform the static or dynamic rotational lock. Participants will be blinded to the form of locking they receive. Research personnel completing the outcome measures will be blinded. Data analyst(s) and the radiographic reviewer(s) will be blinded to the treatment arm.
Intervention model description
Randomized trial design utilizing alternating treatment allocation to assign patients to treatment arms, treatment allocations will last for two months at a time.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years of age * AO/OTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail * Open and closed fractures * Ambulatory prior to injury (with or without walking aides) * Native (non-fractured, no implant) contralateral hip * Willing and able to sign consent (substitute decision maker)
Exclusion criteria
* Contralateral hip fracture or hip arthroplasty * Fracture not amenable to treatment with a cephalomedullary nail * Non-ambulatory patient * Fractures \>14 days (time of injury to OR) * Bilateral pertrochanteric hip fractures * Non-unions * Pathologic fractures * Periprosthetic fractures * Patients with spinal injury * Incarceration * Pregnancy * Limited life expectancy due to significant medical co-morbidities or medical contra-indications to surgery * Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Assessment | 12 months post treatment | The primary objective of this study will be to investigate how statically locking the TFN-A influences shortening or collapse of pertrochanteric fractures by measuring radiographic shortening or collapse of pertrochanteric fractures treated with the TFN-A implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fracture Reduction Quality | Intra-operatively | Assessed through x-rays of the entire proximal femur |
| Femoral Offset | 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months | Measured in a method described by O. Paul et al |
| Tip-Apex distance | 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months | Measured as described by Baumgaertner et al |
| Complications | intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months | SAEs/AEs |
Countries
Canada
Contacts
Primary ContactKyrsten Butterfield, BSc
Outcome results
None listed