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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOdense University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dynaloc implant

    Device

    Internal fixation with Dynaloc implant

  • Cannulated cancellous screws

    Device

    Internal fixation with two or three cannulated cancellous screws

  • Sliding hip screw

    Device

    Internal fixation with a sliding hip screw

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: DynalocExperimental treatment 1 intervention
Group B: Cannulated cancellous screwsActive comparator 1 intervention
Group C: Sliding hip screwActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Static fracture migration

Static non-weight bearing fracture migration in a supine set-up

Time frame
12 weeks

Secondary outcomes

1

Static fracture migration

Static non-weight bearing fracture migration in a supine set-up

Time frame
6 weeks
2

New mobility score

Assessment of gait. 0-9 points

Time frame
Baseline, 6 weeks, 12 weeks
3

Modified Harris Hip Score

Measure of hip dysfunction. \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

Time frame
Baseline, 6 weeks, 12 weeks
4

EQ-5D-5L

Health related Quality of Life

Time frame
Baseline, 6 weeks, 12 weeks

Other outcomes

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