Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN)
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About
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.
Full 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.
Enrollment
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,848 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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