Regional Versus General Anesthesia for Promoting Independence After Hip Fracture



Status:Recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:50 - Any
Updated:12/15/2018
Start Date:February 2016
End Date:December 2021
Contact:Lakisha Gaskins, MHS
Email:regain@lists.upenn.edu
Phone:(215) 746-6094

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

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.

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.

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
We found this trial at
39
sites
259 1st Street
Mineola, New York 11501
Principal Investigator: Matthew Giuca, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mark Powell, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Kamen Vlassakov, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Daniel Sessler, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Gainesville, Florida 32611
(352) 392-3261
Principal Investigator: Joshua Sapenfield, MD
University of Florida Gainesville UF has a long history of established programs in international education,...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Brian FS Allen, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Austin, Texas 78705
Principal Investigator: Jared Dabiri, MD
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4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Frederick E Sieber, MD
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Burlington, Massachusetts 01805
Principal Investigator: Balram Sharma, MD
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Burlington, Vermont 05405
Principal Investigator: Timothy Dominick, MD
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Burlington, VT
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Kelly Bolkus, DO
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Antoun Nader, MD
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Chicago, IL
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Mohamed-Rida Alsaden, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Edmonton, Alberta T6G 2J2
Principal Investigator: Derek Dillane, MD
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: Aryeh Shander, MD
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Englewood, NJ
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Fairfax, Virginia 22042
Principal Investigator: Robert A Hymes, MD
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Fairfax, VA
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Courtland Lewis, MD
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hershey, Pennsylvania 17033
Principal Investigator: Sanjib D Adhikary, MD
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Hershey, PA
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Iowa City, Iowa 52242
Principal Investigator: Yatish Ranganath, MD
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Iowa City, IA
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Jacksonville, Florida 32209
Principal Investigator: Matthew Warrick, MD
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Jacksonville, FL
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Robert D Sanders, MBBS PhD FRCA
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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New Brunswick, New Jersey 08901
Principal Investigator: Jeffrey Carson, MD
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New Haven, Connecticut 06520
Principal Investigator: Shamsuddin Akhtar, MD
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New York, New York 10016
Principal Investigator: Mitchell Marshall, MD
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New York, New York 10021
Principal Investigator: Tiffany Tedore, MD
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Newark, Delaware 19713
Principal Investigator: Mark Cipolle, MD, PHD
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Philadelphia, Pennsylvania
Principal Investigator: Derek Donnegan, MD
Phone: 215-294-9132
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Philadelphia, Pennsylvania 19107
Principal Investigator: Eric Schwenk, MD
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Alla Apivak, MD
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jacques Chelly, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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PIttsburgh, Pennsylvania 15212
Principal Investigator: Rafik Tadros, MD
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Reading, Pennsylvania 19601
Principal Investigator: Karen Troxell, MD
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Reading, PA
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Principal Investigator: Stephen L Kates, MD
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Richard L Applegate, II, MD
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Wade Weigel, MD
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Springfield, Oregon 97477
Principal Investigator: Barry Perlman, PhD, MD
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Stony Brook, New York 11794
Principal Investigator: Syed Azim, MD
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Principal Investigator: Doug Jaffe, DO
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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Winter Park, Florida 32792
Principal Investigator: Thomas Looke, MD
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