Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
NCT ID: NCT04851509
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
218 participants
INTERVENTIONAL
2021-05-17
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures
NCT04441723
Randomized Comparison of 2 Fixation Techniques for Unstable Intertrochanteric Hip Fractures
NCT00597779
Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)
NCT02305121
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
NCT02074969
DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
NCT00546429
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 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.
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
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DePuy Synthes
INDUSTRY
Fraser Orthopaedic Research Society
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bertrand Perey, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital/Fraser Health Authority
David Cinats, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Surgeon, Fraser Health Authority
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Columbian Hospital/Fraser Health Authority
New Westminster, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FHREB#: 2021-015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.