Minimally Displaced Femoral Neck Fracture Pilot Study

Running, not enrolling · Not applicable

Conditions studied: Femoral Neck Fractures

In brief

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.

Key facts

Study ID

NCT05947058

Run by

University of Maryland, Baltimore

People needed

40

Starts

2023-11-01

Expected to finish

2026-12-01

Last updated by the study team

2026-02-13

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• University of Maryland Capital Region Health — Largo, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Inova Fairfax Medical Campus — Falls Church, Virginia, United States
• University of British Columbia — Vancouver, British Columbia, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Vall d'Hebron University Hospital — Barcelona, Spain

Full record on ClinicalTrials.gov

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