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Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA

RecruitingNAAges 18 Years - 65 YearsAllOdense University Hospital
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In plain words

What the trial is, and whether it could suit you

The goal of the clinical trial is to compare different surgical methods for internal fixation of femoral neck fractures in younger adults. The main question it aims to answer is: Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate equal to internal fixation with cancellous screws or a sliding hip screw in younger adults under 65 years of age in terms of fracture migration? The study will examine how stable the fracture remains during healing. This will be measured by assessing how much the fracture moves after surgery using a highly precise imaging method called radiostereometric analysis (RSA). The study will also record complications and evaluate pain, health related quality of life, and hip function over time. The participants will be treated with either a novel angle stable implant (Dynaloc), cannulated cancellous screws

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Dynaloc implant
  • Cannulated cancellous screws
  • Sliding hip screw
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Where

4 sites
Aarhus University Hospital
Aarhus, Denmark
Regional Hospital Gødstrup
Gødstrup, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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