Status:
NOT_YET_RECRUITING
Early Fracture Migration After Internal Fixation of Femoral Neck Fractures in Young Adults
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Aarhus University Hospital
Region of Southern Denmark
Conditions:
Femoral Neck Fractures
Internal Fixation; Complications
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of the clinical trial is to assess a novel implant (Dynaloc, Swemac) for internal fixation of femoral neck fractures and compare it to standard treatment with cannulated cancellous screws usi...
Detailed Description
Objective The overall purpose is to assess a novel implant (Dynaloc, Swemac) for internal fixation of femoral neck fractures and compare it to treatment with cannulated cancellous screws (CCS) using f...
Eligibility Criteria
Inclusion
- Femoral neck fracture (DS720)
- Age 18-64 years
- Ability to speak and read Danish
- Willingness to participate
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06521671
Start Date
April 1 2025
End Date
December 1 2028
Last Update
February 24 2025
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