Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A (NCT04851509) | Clinical Trial Compass
RecruitingNot Applicable
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
Canada218 participantsStarted 2021-05-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.