Clinical trial NCT02507505: Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
Official title: A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-07-24
Enrollment: 1848
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.

Detailed description: Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide.

Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery.

No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia, making the anesthetic care episode a major opportunity to impact outcomes.

Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice.

REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice.

Approximately 2,424 subjects will be enrolled (i.e. informed consent for participation will be obtained) in order to yield approximately 1,600 randomized patients. This estimate is based on an assumption that one in three patients (33%) who undergo consent prior to surgery will not be randomized on the day of surgery due to active clinical issues, timing of medication dosing, clinical assessments by treating physicians or the site Clinical Director or their designate, or patient withdrawal of consent.

Eligibility criteria: Inclusion Criteria:

* Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture
* Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure
* Ability to walk 10 feet or across a room without human assistance before fracture

Exclusion Criteria:

* Planned concurrent surgery not amenable to spinal anesthesia
* Absolute contraindications to spinal anesthesia
* Periprosthetic fracture

Primary outcomes:
measure: Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance
timeFrame: Approximately 60 days after Randomization
Secondary outcomes:
measure: Overall Health and Disability
timeFrame: Approximately 60, 180, and 365 days after randomization
measure: Ability to Return to Home
timeFrame: Approximately 60, 180, and 365 days after randomization
measure: Chronic Pain
timeFrame: Approximately 60, 180, and 365 days after randomization
measure: Cognitive Function
timeFrame: Baseline and approximately 60, 180, and 365 days after randomization
measure: All-cause Mortality
timeFrame: Approximately 60, 180, and 365 days after randomization
measure: Need for Assistive Devices for Walking
timeFrame: Approximately 60, 180, and 365 days after randomization
measure: Acute Postoperative Pain
timeFrame: Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first
measure: Satisfaction With Care
timeFrame: Postoperative day 3 or day of discharge, whichever occurs first
measure: Postoperative Delirium
timeFrame: Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first
measure: Inpatient Mortality
timeFrame: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first
measure: Major Inpatient Morbidity
timeFrame: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Gainesville
country: United States
facility: University of Florida Gainesville
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Winter Park
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinics
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers-Robert Wood Johnson University Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Mineola
country: United States
facility: NYU-Winthrop Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Springfield
country: United States
facility: Sacred Heart at RiverBend
state: Oregon
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospitals
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: University Medical Center Brackenridge and Seton Medical Center Williamson
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Fairfax
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: New Westminster
country: Canada
facility: Simon Fraser Orthopaedic Fund - Royal Columbian Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Pennsylvania
name: Mark D Neuman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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