Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA
Evaluation of Femoral Neck Fracture Migration After Internal Fixation With an Angle Stable Implant Compared With Gold Standard Cannulated Cancellous Screws in Young Adults: Study Protocol for a Clinical RCT Using Radiostereometric Analysis
Odense University Hospital
75 participants
Jun 16, 2025
INTERVENTIONAL
Conditions
Summary
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 or sliding hip screw and followed up at 6 weeks, 12 weeks, 6 months and 12 months. Recruitment will continue until 75 participants, 25 in each group, have completed the 12-week follow-up for the primary outcome.
Eligibility
Inclusion Criteria4
- Femoral neck fracture (DS720)
- Age 18-64 years
- Ability to speak and read Danish
- Willingness to participate
Exclusion Criteria11
- 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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Interventions
Internal fixation with Dynaloc implant
Internal fixation with two or three cannulated cancellous screws
Internal fixation with a sliding hip screw
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06521671