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Clinical Trials in Denmark / NCT06521671
Recruiting Not applicable

Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA

NCT06521671 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Not applicable
Started
2025-06-16
Last updated
2026-01-27

Condition(s) studied

Femoral Neck FracturesInternal Fixation; ComplicationsHip Fractures

Investigational drug(s) / intervention(s)

Dynaloc implantCannulated cancellous screwsSliding hip screw

Dynaloc implant: Internal fixation with Dynaloc implant

Cannulated cancellous screws: Internal fixation with two or three cannulated cancellous screws

Sliding hip screw: Internal fixation with a sliding hip screw

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
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

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Other trials for the same condition

Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study Recruiting
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures Recruiting
What Laxative Should be Used After Hip Fracture Surgery? Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06521671 on ClinicalTrials.gov ↗ ← All trials in Denmark