Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adu… (NCT06521671) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA
Denmark75 participantsStarted 2025-06-16
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.