Comparing implants to keep femoral neck fractures steady in adults under 65
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
We will test whether a new angle-stable implant (Dynaloc) keeps femoral neck fractures steadier than cancellous screws or a sliding hip screw in adults aged 18–64.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 4 sites (Aarhus and 3 other locations) |
| Trial ID | NCT06521671 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–64 with an acute femoral neck fracture who are eligible for internal fixation, able to read and speak Danish, and able to give informed consent are ideal candidates.
Not a fit: Patients older than 64, those with pathological, basicervical or transcervical fractures, significant frailty (Clinical Frailty Scale ≥5), major comorbidities preventing fixation, or cognitive impairment are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the Dynaloc implant could reduce fracture displacement and lower the risk of fixation failure and reoperation for younger patients with femoral neck fractures.
How similar studies have performed: RSA has been used successfully in prior studies to detect small differences in implant stability, and while cancellous screws and sliding hip screws are well-studied, randomized data specifically comparing Dynaloc to cannulated cancellous screws are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus and 3 other locations
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Regional Hospital Gødstrup — Gødstrup, Denmark (Recruiting)
- Hvidovre Hospital — Hvidovre, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Michaela Manalili Hansen, MD
- Email: michaela.manalili.hansen@rsyd.dk
- Phone: +4560808836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.