NCT06521671 Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA
| NCT ID | NCT06521671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Femoral Neck Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-06-16 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2025-06-16 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06521671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Femoral Neck Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06521671 currently recruiting?
Yes, NCT06521671 is actively recruiting participants. Contact the research team at michaela.manalili.hansen@rsyd.dk for enrollment information.
Where is the NCT06521671 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Gødstrup, Denmark, Hvidovre, Denmark, Odense, Denmark.
Who is sponsoring the NCT06521671 clinical trial?
NCT06521671 is sponsored by Odense University Hospital. The trial plans to enroll 75 participants.