Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arthroplasty
A modern porous-coated press-fit or cemented hip arthroplasty prosthesis will be used at the treating surgeon's discretion. Press-fit implants that have no ingrowth or ongrowth surface will not be permitted. We recommend surgeons consider a total hip arthroplasty for younger active, independent participants; conversely, a hemiarthroplasty is recommended for more frail, lower-demand participants. Similarly, cemented arthroplasty for older adult participants is also recommended. The surgical approach and the use of post-operative hip precautions will be determined by the treating surgeon.
Arthroplasty
The type of hip prothesis (hemi or total; cemented or uncemented) will be at the discretion of the treating surgeon.
Internal Fixation
Based on the fracture displacement eligibility criteria, minimal or no reduction is expected during the surgical procedure. However, the treating surgeon will be allowed to perform fracture reduction maneuvers if desired. Fixed angle devices and multiple screws will be permitted. The internal fixation device(s) will be inserted through a small lateral incision. If using multiple cancellous screws, an inverted triangle or similar screw pattern is recommended. Fixed angle devices, such as a sliding hip screw (with or without an anti-rotation screw) or newer multi-screw fixed angle devices will also be permitted. Internal fixation constructs combining cancellous screws and fixed angle devices will be permitted.
Internal Fixation
Both fixed angle devices and multiple screws will be permitted for the internal fixation group.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Orthopaedic Trauma Association
OTHER
McMaster University
OTHER
University of Southern California
OTHER
University of California, Irvine
OTHER
University of Maryland, Baltimore
OTHER
Responsible Party
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Mark Gage
Associate Professor
Principal Investigators
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Gerard Slobogean, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Sheila Sprague, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Joseph Patterson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Heather Phipps
Role: primary
Todd Jaeblon, MD
Role: primary
Ida L Gitahn, MD
Role: primary
Other Identifiers
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HP-00100917
Identifier Type: -
Identifier Source: org_study_id