Minimally Displaced Femoral Neck Fracture Pilot Study

Last updated: April 7, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Internal Fixation

Arthroplasty

Clinical Study ID

NCT05947058
HP-00100917
  • Ages > 60
  • All Genders

Study Summary

The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, hip arthroplasty or internal fixation. Participants will be followed for 1 year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 60 years of age or older.

  • Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposteriorand lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).

  • Minimally displaced fracture that could be, in the judgment of the attendingsurgeon, optimally managed with either arthroplasty or in situ internal fixationwithout reduction.

  • Low energy injury mechanism defined as a fall from standing height.

  • Informed consent obtained from patient or proxy.

  • Surgeons with expertise in total hip arthroplasty, hemiarthroplasty, and internalfixation are available to perform surgery. Note: Surgeons do not need to be expertsin all techniques.

Exclusion

Exclusion Criteria:

  • Unable to ambulate 10 feet pre-injury with any assistance.

  • Associated lower extremity injury that prevents post-operative weightbearing.

  • Retained hardware around the hip that precludes either study treatment.

  • Infection around the hip (soft tissue or bone).

  • Pathologic fracture with a lytic lesion in the femoral neck that precludes internalfixation.

  • Patient is too ill, in the judgement of the attending surgeon, for internalfixation.

  • Patient is too ill, in the judgement of the attending surgeon, for arthroplasty.

  • Unable to obtain informed consent due to language barriers.

  • Problems, in the judgment of study personnel, with maintaining follow-up with thepatient.

  • Currently enrolled in a study that does not permit co-enrollment.

  • Prior enrollment in the trial.

  • Other reason to exclude the patient, as approved by the Methods Centre.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Internal Fixation
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Nearly half of all elderly hip fractures are femoral neck fractures (FNFs) and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this significant practice change remains lacking.

The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for individuals that experience a minimally displaced FNF. Treating minimally displaced FNFs with arthroplasty, instead of internal fixation, would be a paradigm shift in clinical care. This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary. If feasibility is successfully demonstrated, the pilot activities will be considered a vanguard phase for the definitive clinical trial.

Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture treated with surgery will be eligible to participate in the study. Patients will be randomized to receive either hip arthroplasty or internal fixation. Patients will be followed for 1 year, with visits occurring at 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, days at home, and health status will be collected.

The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.

Connect with a study center

  • University of British Columbia

    Vancouver, British Columbia V6T 1Z2
    Canada

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Vall d'Hebron University Hospital

    Barcelona, 08035
    Spain

    Site Not Available

  • University of Southern California

    Los Angeles, California 90007
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32611
    United States

    Active - Recruiting

  • University of Maryland, R Adams Cowley Shock Trauma Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland Capital Region Health

    Largo, Maryland 20774
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

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