Clinical trial NCT05947058: Minimally Displaced Femoral Neck Fracture Pilot Study
Official title: Multicenter Randomized Controlled Trial Comparing Hip Arthroplasty to Internal Fixation for Minimally Displaced Femoral Neck Fractures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Minimally Displaced Femoral Neck Fractures
Arthroplasty
Internal Fixation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: McMaster University
name: University of Southern California
First posted: 2023-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Nearly half of all elderly hip fractures are femoral neck fractures (FNFs) and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this significant practice change remains lacking.

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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of Participant Enrollment
timeFrame: 12 months
measure: Feasibility of Treatment Allocation
timeFrame: 12 months
measure: Refine Data Collection Methods
timeFrame: 12 months
measure: Assess Protocol Compliance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Baltimore
country: United States
facility: University of Maryland, R Adams Cowley Shock Trauma Center
state: Maryland
city: Largo
country: United States
facility: University of Maryland Capital Region Health
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
Study officials:
affiliation: University of Maryland, Baltimore
name: Gerard Slobogean, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Sheila Sprague, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Joseph Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References: