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

Launched by FRASER ORTHOPAEDIC RESEARCH SOCIETY · Apr 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how different types of surgical techniques affect the healing of pertrochanteric femur fractures, which are breaks in the thigh bone near the hip. Specifically, the researchers want to compare two ways of locking the surgical nails used in treatment: statically locked nails, which stay in one position, and dynamically locked nails, which allow for some movement. The trial will involve eligible patients receiving one type of treatment for two months, then switching to the other type for another two months, and continuing to alternate like this until the study is complete.

To be eligible for this trial, patients need to be over 18 years old and have a specific type of fracture that can be treated with a special nail system. They should have been able to walk before their injury, and their other hip should not have any fractures or implants. Patients who are non-ambulatory, have certain medical conditions, or are pregnant may not be included. Those who participate can expect careful monitoring and support throughout the study to help understand how well each treatment works in promoting healing and preventing complications.

Gender

ALL

Eligibility 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).