Early Migration of Internal Fixation Implants for Femoral Neck Fractures in Young Adults

Not Applicable

Not yet recruiting

• Conditions: Hip Fractures; Femoral Neck Fractures; Internal Fixation; Complications
• Interventions: Device: Dynaloc implant; Device: Cannulated cancellous screws

• Registration Number: NCT06521671
• Lead Sponsor: Odense University Hospital

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 using AutoRSA (Radiostereometric analysis).

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 superior to internal fixation with cancellous screws in young adults under 65 years of age?

Researchers will assess postoperative complications and functional outcomes as well as implant migration using AutoRSA.

The participants will be treated with either Dynaloc or cannulated cancellous screws and followed up at 6 weeks, 12 weeks, 6 months and 12 months.

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). The hypothesis is that internal fixation with the novel implant consisting of three angle stable screws locked together by a plate is superior to internal fixation with CCS using fracture migration as the primary outcome.

Both Dynaloc and CCS are CE-marked medical devices used as intended by the manufacturer.

Trial design The study is designed as a single blinded randomised controlled trial (RCT) with Radiostereometric Analysis (RSA).

Interventions Patients will be randomised to internal fixation with CCS or a novel implant designed to minimise fracture migration (Dynaloc, Swemac). The standard internal fixation can include either two or three CCS. The operation procedures will be according to the manufacturer's surgical technique/instructions for use.

Sample size calculation Primary and secondary outcomes include shortening of the femoral neck at 6 weeks, 12 weeks and 1 year. A clinical relevance can be expected at \>5mm shortening of the femoral neck. Femoral neck shortening in the group randomised to internal fixation with CCS is expected to be 5.3mm (SD 4.5mm) at 6 weeks.

Using power 0.9, significance level 0.05, and expecting femoral neck shortening of maximum 1mm for the angle stable screws (Dynaloc) compared with 5.3mm (SD 4.5mm) using 2-3 cancellous screws a total sample size of N=50 can be calculated, N=25/group.

We expect approx. 10% loss to follow up and will therefore include a total of 54 patients.

Randomization/allocation If informed consent is provided, eligible patients can be enrolled in the study.

Patients will be entered into an electronic database and randomised to either CCS or Dynaloc using blocks of n=4 and n=6 and will be stratified based on the Garden classification (Garden 1-2 or 3-4) to account for fracture displacement and stratified based on hospital of admission. The patients will be stratified according to the Garden classification as studies show significantly higher failure rates in Garden type 3 and 4. The operating surgeon will contact a central coordinator, who performs the randomisation, prior to the surgery. Therefore, the surgeon knows which implant to use before entering the operating theatre.

Blinding The implant and outcome will be blinded to patients involved in the trial. A standard phrase for the surgery will be used.

Data Collection Project staff will collect data, CT scans and radiostereometric x-rays and will analyse using AutoRSA. Screening will be performed by the admitting doctor. Baseline data will be collected during admission and will be entered directly into REDcap by project personnel. Questionnaires will be sent directly to the patients using REDcap, and the answers will be automatically uploaded into REDcap. At follow ups, project personnel will see the patients in the outpatient clinic, and enter data directly into REDcap.

Statistical methods Data will be analysed using computerised statistical software. The data distribution will be assessed and data presented accordingly. Continuous data will be analysed using Linear Mixed Model statistics and categorical data will be compared using the χ2 test or the Fisher exact test.

A p-value of \<0.05 will be considered statistically significant. The postoperative complication rates will be defined as the sum of the individual rates of complications and reoperations. Mortality will be analysed using Cox-regression.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Study Start: 2024-09
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Femoral neck fracture (DS720)
• Age 18-64 years
• Ability to speak and read Danish
• Willingness to participate

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dynaloc	Dynaloc implant	-
Cannulated cancellous screws	Cannulated cancellous screws	-

Primary Outcome Measures

Name	Time	Method
Static fracture migration	12 weeks	Static non-weight bearing fracture migration in a supine set-up

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	Baseline, 6 weeks, 12 weeks	Health related Quality of Life
New mobility score	Baseline, 6 weeks, 12 weeks	Assessment of gait. 0-9 points
Modified Harris Hip Score	Baseline, 6 weeks, 12 weeks	Measure of hip dysfunction. \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Pain VRS	Baseline, 6 weeks, 12 weeks	Pain verbal rating scale 0-10
Reoperation	0-12 weeks	Any secondary operation
Complication	0-12 weeks	Any complication (non-union, avascular necrosis of the femoral head, fixation failure)
Static fracture migration	6 weeks	Static non-weight bearing fracture migration in a supine set-up
Mortality	0-12 weeks	Death