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Trauma

LEADERSHIP

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Dr. Sheila Sprague

Petrisor

​Dr. ​Brad Petrisor

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Dr. Mohit Bhandari

Trauma is the leading cause of death in the first four decades of life surpassed only by cancer and atherosclerosis as the major cause of death in all age groups. For every person killed as a result of an injury, threefold more survive and are left permanently disabled. CEO is committed to I will addressing important gaps in fracture care by identifying modifiable surgical risk factors and evaluating simple and cost-effective therapies to improve global fracture care.

CURRENT STUDIES

PREPARE (PREP-IT Program)

PREPARE is a cluster randomized crossover trial of at least 7,820 patients with open and closed fractures comparing the effectiveness of two antiseptic skin preparation solutions, iodine-povacrylex (0.7% free iodine) in alcohol versus 2% chlorhexidine gluconate.  The primary outcome is surgical site infection and secondary outcomes are unplanned fracture-related reoperation and health-related quality of life.

Principal Investigators: Dr. Gerard Slobogean, Dr. Sheila Sprague, and Dr. Mohit Bhandari 

Aqueous-PREP (PREP-IT Program)

Aqueous-PREP is a cluster randomized crossover trial of at least 1,540 patients with open fractures comparing the effectiveness of two aqueous antiseptic skin preparation solutions, 10% povidone-iodine (1% free iodine) and 4% chlorhexidine gluconate. The primary outcome is surgical site infection and secondary outcome is unplanned fracture-related reoperation.

Principal Investigators: Dr. Gerard Slobogean, Dr. Sheila Sprague, and Dr. Mohit Bhandari 

Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty vs. Hemi-Arthroplasty (HEALTH)

HEALTH is a 1500-patient multi-centre randomized controlled trial comparing total hip arthroplasty with hemi-arthroplasty in patients with femoral neck fractures. The primary outcome is revision surgery rates at 24 months post initial surgery and the secondary outcome is quality of life up to 24 months post initial hip surgery.

Principal Investigators: Dr. Mohit Bhandari 

​FAITH-2

FAITH-2 is a 2x2 factorial randomized controlled trial, comparing two surgical implants (sliding hip screws versus cancellous screws) AND nutritional supplementation (vitamin D3 4,000 international units per day for six months versus placebo) on patient important complications and quality of life in 898 non-geriatric (ages 18 to 60 years) femoral neck fracture patients.

Principal Investigators: Dr. Mohit Bhandari and Dr. Gerard Slobogean

​VITA-SHOCK

Vita-Shock is a single-center phase II exploratory clinical trial seeking to improve patient outcomes in tibia and femur fractures by addressing the nutritional optimization of bone health. Using a randomized placebo-controlled design, the trial compares three different doses of vitamin D3 and a control (placebo) to assess their effect on fracture healing at three months in 96 patients ages 18-50. Each participant is randomized to one of four treatment groups: 1) 150,000 IU loading dose vitamin D3 plus daily dose placebo; 2) loading dose placebo plus 4,000 IU vitamin D3 per day; 3) loading dose placebo plus 600 IU vitamin D3 per day; or 4) loading dose placebo plus daily dose placebo. The daily treatment commences within one week of injury and is taken for three months. The loading doses are given within one week of injury and at six-weeks post-injury. Participants are followed for 12 months. 

Principal Investigators: Dr. Sheila Sprague, Dr. Mohit Bhandari and Dr. Gerard Slobogean

COPE

COPE​ is a randomized controlled trial evaluating cognitive behavioral therapy (CBT) and its effect on persistent post-surgical pain in patients with extremity fractures. 1000 patients will be randomly assigned to either usual care or CBT with the participants choosing between six, one-hour therapy sessions OR online module with asynchronous feedback. 

Principal Investigators:  Dr. Jason Busse and Dr. Sheila Sprague 

 

Completed Multi-Centre Trials

SPRINT

SPRINT Investigators. Study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskeletal Disorders. 2008;9:91.

Trust

TRUST Investigators writing group, Busse JW, Bhandari M4, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P 3rd, Leung KS, Heels-Ansdell D, Makosso-Kallyth S, Della Rocca GJ, Jones CB, Guyatt GH. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016 Oct 25;355:i5351.

Flow

FLOW Investigators, Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. New England Journal of Medicine. 2015;373(27):2629-41.

​FAITH

Bhandari M, Devereaux PJ, Guyatt G, Thabane L, Walter S, Heetveld MJ, Jeray KJ, Liew S, Schemitsch EH, Tornetta III P, Della Rocca GJ, Buckley RE, McCormack R, Oliver TM, Segers MJM, Rangan A, Richardson M, Sprague S, Scott T, Agel J, Garibaldi A, Zhou Q, Heels-Ansdell D, Viveiros H, Zielinski SM, Van Lieshout EMM, Johal H, Hanusch BC, Swiontkowski M; FAITH Investigators. A Trial of Fracture Fixation in the Operative Management of Hip Fractures. Lancet. 2017;389(10078):1519-1527.

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