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

NCT06521671 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-27

No results posted yet for this 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.

Conditions

  • Femoral Neck Fractures
  • Internal Fixation; Complications
  • Hip Fractures

Interventions

DEVICE

Dynaloc implant

Internal fixation with Dynaloc implant

DEVICE

Cannulated cancellous screws

Internal fixation with two or three cannulated cancellous screws

DEVICE

Sliding hip screw

Internal fixation with a sliding hip screw

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • Swemac Innovation AB

    collaborator UNKNOWN

  • Gødstrup Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521671 on ClinicalTrials.gov