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

NCT06521671 | Recruiting

• 1 other identifier: 2401073
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

femoral neck fracture; radiostereometric analysis; hip fracture; internal fixation

Outcome Measures

Primary Outcomes (1)

• Static fracture migration

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

  12 weeks

Secondary Outcomes (8)

• Static fracture migration

  6 weeks

• New mobility score

  Baseline, 6 weeks, 12 weeks

• Modified Harris Hip Score

  Baseline, 6 weeks, 12 weeks

• EQ-5D-5L

  Baseline, 6 weeks, 12 weeks

• Pain VRS

  Baseline, 6 weeks, 12 weeks

Study Arms (3)

Dynaloc

EXPERIMENTAL

Randomisation

Device: Dynaloc implant

Cannulated cancellous screws

ACTIVE COMPARATOR

Randomisation

Device: Cannulated cancellous screws

Sliding hip screw

ACTIVE COMPARATOR

Prospective cohort

Device: Sliding hip screw

Interventions

Dynaloc implant DEVICE

Internal fixation with Dynaloc implant

Dynaloc

Cannulated cancellous screws DEVICE

Internal fixation with two or three cannulated cancellous screws

Cannulated cancellous screws

Sliding hip screw DEVICE

Internal fixation with a sliding hip screw

Sliding hip screw

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• Region of Southern Denmark: collaborator
• Swemac Innovation AB: collaborator
• Gødstrup Hospital: collaborator

Study Sites (4)

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

Related Publications (1)

• Hansen MM, Petersen ET, Gundtoft PH, Jensen J, Stilling M, Ding M, Viberg B. 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. Trials. 2026 Feb 7;27(1):202. doi: 10.1186/s13063-026-09497-7.

  PMID: 41652608 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Michaela Manalili Hansen, MD

CONTACT

+4560808836; michaela.manalili.hansen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomisation groups will be kept blinded during statical analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: June 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)