Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A

Pertrochanteric Fracture Clinical Trial

— TFN-A  

Official title:

Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04851509
• Other study ID #: FHREB#: 2021-015
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Fraser Orthopaedic Research Society
• Contact: Kyrsten Butterfield, BSc
• Phone: 604-553-3247
• Email: kyrsten.butterfield[@]fraserhealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: January 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Pertrochanteric Fracture

Intervention

Procedure:
• Dynamic 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.
• Static 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.

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital/Fraser Health Authority	New Westminster	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Fraser Orthopaedic Research Society	DePuy Synthes

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Bishop JA, Palanca AA, Bellino MJ, Lowenberg DW. Assessment of compromised fracture healing. J Am Acad Orthop Surg. 2012 May;20(5):273-82. doi: 10.5435/JAAOS-20-05-273. — View Citation

Gausden EB, Sin D, Levack AE, Wessel LE, Moloney G, Lane JM, Lorich DG. Gait Analysis After Intertrochanteric Hip Fracture: Does Shortening Result in Gait Impairment? J Orthop Trauma. 2018 Nov;32(11):554-558. doi: 10.1097/BOT.0000000000001283. — View Citation

Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C; IOF Working Group on Epidemiology and Quality of Life. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int. 2012 Sep;23(9):2239-56. doi: 10.1007/s00198-012-1964-3. Epub 2012 Mar 15. — View Citation

Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, Girard J, Mertl P, Marchetti E, Stindel E. Femoral offset: anatomical concept, definition, assessment, implications for preoperative templating and hip arthroplasty. Orthop Traumatol Surg Res. 2009 May;95(3):210-9. doi: 10.1016/j.otsr.2009.03.010. Epub 2009 May 6. — View Citation

Paul O, Barker JU, Lane JM, Helfet DL, Lorich DG. Functional and radiographic outcomes of intertrochanteric hip fractures treated with calcar reduction, compression, and trochanteric entry nailing. J Orthop Trauma. 2012 Mar;26(3):148-54. doi: 10.1097/BOT.0b013e31821e3f8c. — View Citation

Stapert JW, Geesing CL, Jacobs PB, de Wit RJ, Vierhout PA. First experience and complications with the long Gamma nail. J Trauma. 1993 Mar;34(3):394-400. doi: 10.1097/00005373-199303000-00015. — View Citation

Yoo JH, Kim TY, Chang JD, Kwak YH, Kwon YS. Factors influencing functional outcomes in united intertrochanteric hip fractures: a negative effect of lag screw sliding. Orthopedics. 2014 Dec;37(12):e1101-7. doi: 10.3928/01477447-20141124-58. — View Citation

Zickel RE. A new fixation device for subtrochanteric fractures of the femur: a preliminary report. Clin Orthop Relat Res. 1967 Sep-Oct;54:115-23. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months post treatment
Secondary	Fracture Reduction Quality	Assessed through x-rays of the entire proximal femur	Intra-operatively
Secondary	Femoral Offset	Measured in a method described by O. Paul et al	1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Secondary	Tip-Apex distance	Measured as described by Baumgaertner et al	1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Secondary	Complications	SAEs/AEs	intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months