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Minimally Displaced Femoral Neck Fracture Pilot Study

Femoral Neck Fractures

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    60 and up

Participation Criteria

Inclusion Criteria:

* Patients 60 years of age or older.
* Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
* Minimally displaced fracture that could be, in the judgment of the attending surgeon, optimally managed with either arthroplasty or in situ internal fixation without 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 internal fixation are available to perform surgery. Note: Surgeons do not need to be experts in all techniques.

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 internal fixation.
* Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
* 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 the patient.
* 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 Location

Hamilton Health Sciences
Hamilton Health Sciences
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Thomas Wood, MD

University of British Columbia
University of British Columbia
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Aresh Sepehri, MD

[email protected]
Study Sponsored By
University of Maryland, Baltimore
Participants Required
More Information
Study ID: NCT05947058