Minimally Displaced Femoral Neck Fracture Pilot Study

NCT05947058 | Active Not Recruiting

• 1 other identifier: HP-00100917
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 12

Brief 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.

Conditions

Femoral Neck Fractures

Keywords

Minimally Displaced Femoral Neck Fractures; Arthroplasty; Internal Fixation

Outcome Measures

Primary Outcomes (4)

• Feasibility of Participant Enrollment

  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.

  12 months

• Feasibility of Treatment Allocation

  Feasibility of the treatment allocation will be assessed using the following metrics: * Adherence to arthroplasty treatment allocation * Adherence to internal fixation treatment allocation

  12 months

• Refine Data Collection Methods

  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

  12 months

• Assess Protocol Compliance

  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)

  12 months

Study Arms (2)

Arthroplasty

EXPERIMENTAL

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.

Procedure: Arthroplasty

Internal Fixation

ACTIVE COMPARATOR

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.

Procedure: Internal Fixation

Interventions

Arthroplasty PROCEDURE

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

Arthroplasty

Internal Fixation PROCEDURE

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

Internal Fixation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• McMaster University: collaborator
• Orthopaedic Trauma Association: collaborator
• University of Southern California: collaborator
• University of California, Irvine: collaborator

Study Sites (12)

University of Southern California

Los Angeles, California, 90007, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland Capital Region Health

Largo, Maryland, 20774, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z2, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Arthroplasty; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Fracture Fixation; Therapeutics

Study Officials

• Gerard Slobogean, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Sheila Sprague, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Joseph Patterson, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 17, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (8); CA (3); ES (1)