Actively Recruiting
Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA
Led by Odense University Hospital · Updated on 2026-01-27
75
Participants Needed
4
Research Sites
180 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Femoral neck fracture (DS720)
- Age 18-64 years
- Ability to speak and read Danish
- Willingness to participate
You will not qualify if you...
- Pathological, basicervical or transcervical fracture
- Clinical Frailty Scale ≥5 indicating mild to severe frailty prior to fracture
- Cognitive impairment that prevents informed consent
- Previous fracture in the same femur
- Unwilling or unable to follow post-operative care instructions
- Material sensitivity, documented or suspected
- Active or suspected infection, sepsis, or significant local inflammation near the surgery site
- Poor blood flow, inadequate skin or nerve status around the surgical area
- Weak bone that cannot support or fix the device due to disease, infection, or prior implants
- Other physical, mental, medical, or surgical conditions that prevent benefit from surgery
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Regional Hospital Gødstrup
Gødstrup, Denmark
Actively Recruiting
3
Hvidovre Hospital
Hvidovre, Denmark
Not Yet Recruiting
4
Odense University Hospital
Odense, Denmark
Actively Recruiting
Research Team
M
Michaela Manalili Hansen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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