Minimally Displaced Femoral Neck Fracture Pilot Study

Description

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.

Conditions

Femoral Neck Fractures

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Study Overview

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Study Details

Study overview

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.

Multicenter Randomized Controlled Trial Comparing Hip Arthroplasty to Internal Fixation for Minimally Displaced Femoral Neck Fractures: a Pilot Study

Minimally Displaced Femoral Neck Fracture Pilot Study

Condition
Femoral Neck Fractures
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90007

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Gainesville

University of Florida, Gainesville, Florida, United States, 32611

Baltimore

University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, Maryland, United States, 21201

Largo

University of Maryland Capital Region Health, Largo, Maryland, United States, 20774

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Falls Church

Inova Fairfax Medical Campus, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Maryland, Baltimore,

Gerard Slobogean, MD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Sheila Sprague, PhD, PRINCIPAL_INVESTIGATOR, McMaster University

Joseph Patterson, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

2025-12