Comparing implants to keep femoral neck fractures steady in adults under 65

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, single-blinded randomized trial using radiostereometric analysis (RSA) to measure how much femoral neck fractures move after internal fixation. Eligible patients under 65 are randomized to receive either the Dynaloc angle-stable implant or cannulated cancellous screws, while a separate prospective cohort treated with a sliding hip screw is followed with the same protocol. Fracture migration is the primary outcome, and the study also records complications and tracks pain, hip function, and health-related quality of life at 6 weeks, 12 weeks, 6 months, and 12 months. All procedures follow manufacturers' instructions and are performed at participating Danish hospitals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Regional Hospital Gødstrup
  Gødstrup, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Hvidovre Hospital
  Hvidovre, Denmark Not yet recruiting

Study contacts

• Study coordinator: Michaela Manalili Hansen, MD
• Email: michaela.manalili.hansen@rsyd.dk
• Phone: +4560808836

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.