Early Fracture Migration After Internal Fixation of Femoral Neck Fractures in Young Adults

Launched by ODENSE UNIVERSITY HOSPITAL · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of implant called Dynaloc, which is used to help fix femoral neck fractures in young adults. Femoral neck fractures are breaks in the upper part of the thigh bone near the hip, and they are common in younger people. The study will compare the effectiveness of this new implant to the standard treatment, which uses a set of screws called cannulated cancellous screws. Researchers want to find out if the new implant can help keep the fracture stable just as well as the traditional screws, and they will monitor any complications and how well patients recover over the course of a year.

To participate in this trial, you need to be between 18 and 64 years old and have a specific type of femoral neck fracture. You should also be able to speak and read Danish and be willing to follow post-surgery care instructions. If you have certain medical conditions or other types of fractures, you may not be eligible. Participants will be treated with either the new implant or the standard screws and will have follow-up appointments at 6 weeks, 12 weeks, 6 months, and 12 months to track their progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Femoral neck fracture (DS720)
• • Age 18-64 years
• • Ability to speak and read Danish
• • Willingness to participate
• Exclusion Criteria:
• • Pathological, basicervical or transcervical fracture
• • Clinical Frailty Scale ≥5, indicating mild to severe frailty prior to the fracture
• • Cognitive impairment that hinders informed consent
• • Previous fracture in the ipsilateral femur
• • Patients who are unwilling or incapable of following post-operative care instructions.
• * Comorbidities making the participant ineligible for internal fixation such as:
• • Material sensitivity, documented or suspected
• • Active or suspected latent infection, sepsis or marked local inflammation in or around the surgical area
• • Compromised vascularity, inadequate skin or neurovascular status
• • Compromised bone stock that cannot provide adequate support and/or fixation of the device due to disease, infection or prior implantation
• • Other physical, mental, medical or surgical conditions that would preclude the potential benefit of surgery.