About this trial
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
This trial does not accept healthy volunteersQualifiers
Femoral neck fracture (DS720)
Age 18-64 years
Ability to speak and read Danish
Willingness to participate
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Dynaloc implant
DeviceInternal fixation with Dynaloc implant
Cannulated cancellous screws
DeviceInternal fixation with two or three cannulated cancellous screws
Sliding hip screw
DeviceInternal fixation with a sliding hip screw
Treatment groups
Trial outcomes
Primary outcomes
Static fracture migration
Static non-weight bearing fracture migration in a supine set-up
Secondary outcomes
Static fracture migration
Static non-weight bearing fracture migration in a supine set-up
New mobility score
Assessment of gait. 0-9 points
Modified Harris Hip Score
Measure of hip dysfunction. \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
EQ-5D-5L
Health related Quality of Life
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Region of Southern Denmark
Collaborator
Swemac Innovation AB
Collaborator
Gødstrup Hospital
Collaborator