ACTIVE_NOT_RECRUITING

Minimally Displaced Femoral Neck Fracture Pilot Study

Conditions

Femoral Neck Fractures Minimally Displaced Femoral Neck Fractures Arthroplasty Internal Fixation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-01

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05947058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Gerard Slobogean, MD

PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Sheila Sprague, PhD

PRINCIPAL_INVESTIGATOR

McMaster University

Joseph Patterson, MD

PRINCIPAL_INVESTIGATOR

University of Southern California

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90007

United States

Yale University

New Haven, Connecticut, 06520

United States

University of Florida

Gainesville, Florida, 32611

United States

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201

United States

University of Maryland Capital Region Health

Largo, Maryland, 20774

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Gerard Slobogean, MD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore
Sheila Sprague, PhD, PRINCIPAL_INVESTIGATOR, McMaster University
Joseph Patterson, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Minimally Displaced Femoral Neck Fractures
Arthroplasty
Internal Fixation

Additional Relevant MeSH Terms

Femoral Neck Fractures