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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
Connecticut
Yale University
RECRUITING
New Haven
Florida
University of Florida
RECRUITING
Gainesville
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
University of Maryland, R Adams Cowley Shock Trauma Center
RECRUITING
Baltimore
University of Maryland Capital Region Health
RECRUITING
Largo
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Virginia
Inova Fairfax Medical Campus
RECRUITING
Falls Church
Other Locations
Canada
Hamilton Health Sciences
RECRUITING
Hamilton
London Health Sciences Centre
RECRUITING
London
University of British Columbia
RECRUITING
Vancouver
Spain
Vall d'Hebron University Hospital
ENROLLING_BY_INVITATION
Barcelona
Contact Information
Primary
Heather Phipps, MPS
hphipps@som.umaryland.edu
410-706-2492
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern California, Orthopaedic Trauma Association, McMaster University
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov