An interventional study of Dynamic Rotational Locking and Static Locking in Pertrochanteric Fracture, sponsored by Fraser Orthopaedic Research Society. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Fraser Orthopaedic Research Society · Not applicable, Interventional, and Treatment
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.
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.
Fraser Orthopaedic Research Society is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn.
Procedure: Dynamic Rotational Locking
Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw.
Procedure: Static 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.
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.
Radiographic Assessment
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.
Time frame: 12 months post treatment
Fracture Reduction Quality
Assessed through x-rays of the entire proximal femur
Time frame: Intra-operatively
Femoral Offset
Measured in a method described by O. Paul et al
Time frame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Tip-Apex distance
Measured as described by Baumgaertner et al
Time frame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Complications
SAEs/AEs
Time frame: intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Plan to share: No — Participant data will be kept confidential. Study findings and de-identified study data will be available to other researchers in the form of a published paper.
Started May 2021 (actual). Primary completion is estimated for Jun 2026, 61 months after the start.
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