Recruiting

Arthroplasty vs. Internal Fixation

Sponsor:

University of Southern California

Code:

NCT07244211

Conditions

Femoral Neck Fractures

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Hip arthroplasty

Internal fixation

Study Details

Brief summary:

This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomized, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old. We hypothesize that arthroplasty will reduce death, preserve ambulation, increase days alive and out of hospital, and improve health status compared to internal fixation within 4 months and 12 months from randomization.

Conditions

Femoral Neck Fractures

Study ID

NCT07244211

Start date

Jan 23, 2026

Status verified date

Jun, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture
  • The patient has a health condition affecting physical mobility.
  • Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging.
  • Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction.
  • Low energy injury mechanism.
  • Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery.

Exclusion Criteria:

  • The patient is not clinically suitable for either compared treatment.
  • Expected injury survival of less than 12 months.
  • Terminal illness with expected survival of less than 12 months.
  • Incarceration.
  • Unable to obtain informed consent due to language barriers.
  • Unable to obtain informed consent because the legally authorized representative was unavailable.
  • Problems, in the judgment of the study personnel, with maintaining follow-up with the patient.
  • Currently enrolled in a study or intervention domain that does not permit co-enrollment.
  • Prior enrollment in the specific platform trial intervention domain.
  • Patient or legally authorized representative did not provide informed consent (declined participation).
  • Eligible patient or legally authorized representative was not approached within the screening window (missed participant).
  • Other reasons to exclude the patient, as approved by the data coordinating center.
  • Associated lower extremity injury that prevents post-operative weight-bearing.
  • 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.
  • Injury did not occur within 21 days of screening.
  • Patient is too ill, in the judgment of the attending surgeon, for internal fixation.
  • Patient is too ill, in the judgment of the attending surgeon, for arthroplasty.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hip arthroplasty

active comparator: Internal fixation

Interventions

Hip arthroplasty

Participants will undergo surgical treatment using standard hip arthroplasty techniques for femoral minimally displaced femoral neck fracture. 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. The type of hip prosthesis (hemiarthroplasty or total hip arthroplasty), bearing (single or dual mobility), or the method of arthroplasty fixation (cemented or uncemented) will be at the discretion of the treating surgeon.

Internal fixation

Participants will undergo surgical treatment using standard fixation techniques for minimally displaced femoral neck fractures. The treating surgeon may 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. Internal fixation constructs combining cancellous screws and fixed-angle devices will be permitted.

Primary outcome measure

  • Composite outcome of death, ambulation status, and days alive and out of hospital. [ Time Frame: 120 days after randomization ]

Central Contacts and Locations

Central contacts

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92660

Contacts

Principal Investigator:

Gerard Slobogean, MD

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Joshua L Gary, MD

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Joshua L Gary, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Carol Lin, MD

carol.lin@cshs.org

Principal Investigator:

Carol Lin, MD

Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Dillon O'Neill, MD

doneill5@iuhealth.org

Principal Investigator:

Dillon O'Neill, MD

University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Mark Gage, MD

University of Maryland Capital Region Health

Recruiting

Largo, Maryland, United States, 20774

Contacts

Principal Investigator:

Todd Jaeblon, MD

University of Mississippi

Recruiting

University, Mississippi, United States, 38677

Contacts

Patrick Bergin, MD

pbergin@umc.edu

Principal Investigator:

Patrick Bergin, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

Contacts

Michael Beltran, MD

beltrame@ucmail.uc.edu

Principal Investigator:

Michael Beltran, MD

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Brandon Hull, MD

Brandon-Hull@ou.edu

Principal Investigator:

Brandon Hull, MD

Prisma Health-Upstate

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Principal Investigator:

Kyle Jeray, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

Lauren Tatman, MD

lauren.m.tatman@vumc.org

Principal Investigator:

Lauren Tatman, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Lucas Marchand, MD

lucas.marchand@hsc.utah.edu

Principal Investigator:

Lucas Marchand, MD

Inova Health Care Services

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Grag Gaski, MD

greg.gaski@inova.org

Principal Investigator:

Greg Gaski, MD

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53706

Contacts

Chris Domes, MD

domes@ortho.wisc.edu

Principal Investigator:

Chris Domes, MD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z4

Contacts

Principal Investigator:

Aresh Sephri, MD

Fraser Health Authority

Recruiting

Vancouver, British Columbia, Canada

Contacts

Principal Investigator:

Darius Viskontas, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9,

Contacts

Emil Schemitsch, MD

emil.schemitsch@lhsc.on.ca

Principal Investigator:

Emil Schemitsch, MD

More Information

Sponsor

University of Southern California

Last update posted

Aug 25, 2026

Last verified

Jun, 2026

Keywords

  • Minimally displaced femoral neck fractures
  • arthroplasty
  • hip fractures
  • femoral fractures
  • orthopaedic procedures
  • older adults
  • patient-centered outcomes
  • adaptive trial
  • internal fixation
  • pragmatic trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-08-25.