RecruitingNot ApplicableNCT06521671

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

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


Sponsor

Odense University Hospital

Enrollment

75 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cannulated cancellous screws, a medical device called Dynaloc implant, and others for people with femoral neck fractures, hip fractures, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDynaloc implant

Internal fixation with Dynaloc implant

DEVICECannulated cancellous screws

Internal fixation with two or three cannulated cancellous screws

DEVICESliding hip screw

Internal fixation with a sliding hip screw


Locations(4)

Aarhus University Hospital

Aarhus, Denmark

Regional Hospital Gødstrup

Gødstrup, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Odense University Hospital

Odense, Denmark

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NCT06521671


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