Comparing two methods of locking screws in hip fracture surgery
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial
This study is testing two different ways to secure screws in hip fracture surgery to see which method helps patients heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fraser Orthopaedic Research Society Research network |
| Locations | 1 site (New Westminster, British Columbia) |
| Trial ID | NCT04851509 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of pertrochanteric femur fractures treated with the TFN-Advanced nailing system by comparing two surgical techniques: static locking and dynamic locking of screws. It is a randomized control study where eligible patients will receive one of the two treatments for two months, followed by a switch to the alternate treatment for another two months, continuing this pattern until all participants are enrolled. The primary focus is on assessing the radiographic outcomes related to fracture shortening and collapse. This approach aims to determine the effectiveness of static locking in preventing complications associated with hip fractures.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 18 years old with AO/OTA 31-A pertrochanteric fractures who are ambulatory prior to their injury.
Not a fit: Patients with contralateral hip fractures, non-ambulatory status, or significant medical co-morbidities that contraindicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that reduce complications and enhance recovery for patients with hip fractures.
How similar studies have performed: While the use of cephalomedullary nailing is established, the specific approach of statically locking screws has not been extensively studied, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
New Westminster, British Columbia
- Royal Columbian Hospital/Fraser Health Authority — New Westminster, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Bertrand Perey, MD, FRCSC — Royal Columbian Hospital/Fraser Health Authority
- Study coordinator: Kyrsten Butterfield, BSc
- Email: kyrsten.butterfield@fraserhealth.ca
- Phone: 604-553-3247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.