Minimally Displaced Femoral Neck Fracture Pilot Study

NCT05947058 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Maryland, Baltimore

Phase

Not applicable

Started

2023-11-01

Last updated

2026-02-13

Condition(s) studied

Femoral Neck Fractures

Investigational drug(s) / intervention(s)

ArthroplastyInternal Fixation

Arthroplasty: The type of hip prothesis (hemi or total; cemented or uncemented) will be at the discretion of the treating surgeon.

Internal Fixation: Both fixed angle devices and multiple screws will be permitted for the internal fixation group.

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

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Feasibility of Participant Enrollment — 12 months
Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Proportion of clinical sites initiated and able to screen consecutive patients with minimally displaced FNF * Proportion of patients who are screened for eligibility to participate in the trial * Proportion of patients who meet the eligibility criteria * Proportion of patients who provide informed consent * Proportion of time required to enroll at least four participants per clinical site * Proportion of reasons for exclusion.
Feasibility of Treatment Allocation — 12 months
Feasibility of the treatment allocation will be assessed using the following metrics: * Adherence to arthroplasty treatment allocation * Adherence to internal fixation treatment allocation
Refine Data Collection Methods — 12 months
To refine the data collection methods, the following metrics will be reviewed: * Proportion of participants with missing data * Review of missing data to identify data fields that are not feasible to collect * Data errors to identify ways to improve the flow of the case report forms (CRFs) and data collection
Assess Protocol Compliance — 12 months
The following metrics will be used to assess compliance with the protocol: * Proportion of randomization errors * Proportion of participants who complete each follow-up visit * Proportion of participants who withdraw from the trial (withdrawal of consent) * Proportion of participants who cannot be located (loss to follow-up)

Trial sites (12)

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

More University of Maryland, Baltimore trials in Canada

Symptomatic Carotid Outcomes Registry Active, not recruiting

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy Recruiting

Other trials for the same condition

MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05947058 on ClinicalTrials.gov ↗ ← All trials in Canada