Summary

for people ages 50 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

Official Title

A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Details

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.

Keywords

Hip Fractures Fractures, Bone Anesthetics Regional Anesthesia General Anesthesia

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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

You CAN'T join if...

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

Locations

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Sacred Heart at RiverBend accepting new patients
    Springfield Oregon 97477 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
Links
Sign up for this study
ID
NCT02507505
Study Type
Interventional
Last Updated