5/8/2014 A PROSPECTIVE OBSERVATIONAL STUDY Disclosures TO EVALUATE THE OUTCOMES OF OPERATIVELY TREATED FEMORAL SHAFT • No conflicts of interest FRACTURES IN SUB-SAHARAN AFRICA: • Research funded by the OTA and OREF PRELIMINARY RESULTS David Shearer, MD, MPH 1 , Edmund Eliezer, MD 2 , Billy Haonga, MD 2 , Saam Morshed, MD, PhD 1 (1)University of California, San Francisco, CA, USA (2) Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania Background SIGN Fracture Care International • Manufactures and donates IM • Injury accounts for nails for in developing countries 11% Global DALYs • Majority from Road • Implants specifically designed Traffic Injury (RTIs) for use without C-arm and • 1.25 million deaths other specialized equipment • 90% in LMICs • Over 110,000 surgeries SIGN • 20-50 million implants worldwide since 1999 disabled • Prevalence of disability from MSK injury 1.64% in Rawanda Are we preventing disability or (Matheson, WJS 2011), 0.64% in Ghana (Mock, CORR 2008) spreading hardware infections? 1
5/8/2014 Study Partnership Study Design • Investigators met at SIGN Flap Course/IGOT Research • Prospective observational study Course • Skeletally mature patients with femoral shaft fractures (OTA • Muhimbili Orthopaedic Institute 32) presenting to Muhimbili Orthopaedic Institute • Tertiary referral hospital in Dar es Salaam, Tanzania • Primary comparison • Femur fractures rarely treated non-operatively • Locked intramedullary nailing • SIGN site • ORIF with DC plate • 20% cases ORIF with plate (surgeon preference) • Outcome: • 1 0 Reoperation • 2 0 Clinical union, radiographic union, return to work, EQ-5D • Hypothesis: There is a difference in the rate of reoperation for adult femoral shaft fractures comparing intramedullary nailing with open reduction internal fixation with a plate Eligibility Criteria Follow up Protocol • Registry Book Screening: All patients with diagnosis of femoral fracture Bottom line: • Radiographic Screening - Preop x-rays - Routine - Radiographic clinical • Proximal femur fracture: Any fracture extension proximal to the screening evaluation lesser trochanter All adult midshaft femur fractures • Distal femur fracture: Fracture involving the distal femur (as defined by the “rule of squares”) managed with operative treatment • Skeletal immaturity: Open physes present Surgery 2-week 3 month 6 month 1-year Present to 6-week • Pathologic fracture Follow up Follow up Follow up Follow up MOI Follow up • Prior surgery • Delayed presentation (>6 weeks) • Clinical Screening - Clinical - Follow up data - Follow up data - Follow up data - Follow up data screening sheet completed sheet completed sheet completed sheet completed • Evidence of pre-existing infection at the time of surgery - Informed - Plain x-rays - Plain x-rays - Plain x-rays - Plain x-rays consent - EQ-5D - EQ-5D - EQ-5D - EQ-5D • Pathologic fracture - Intake data collection • Severe TBI (GCS < 12 on admission) - Postop data collection • Severe burns (>10% TBSA) - Postop x-rays • Unable to adhere to follow up schedule 2
5/8/2014 REDCap: Research Electronic Data The Research Team Capture • Investigators • MOI • Four Surgeons (2 specialists, 2 residents) • UCSF • Two surgeons (1 attending, 1 resident) • Research Coordinators • Two part-time coordinators • Both medical records department • Communication • Site visits q6months • Bi-weekly Skype meetings From July 2012 to July 2013 Using Technology Research Laptop + Modem: $280 USD Mobile Phone for image upload: $200 USD 3
5/8/2014 Temporary Stabilization, no. (%) Age (years), mean (SD) 31.8 (11.2) None 18 (5.5) Skin traction 303 (93.2) Gender External fixation 1 (0.3) Male, no. (%) 262 (85.9) Female, no. (%) 43 (14.1) Skeletal Traction 3 (0.9) Type of Treatment, no. (%) Baseline EQ-5D Index, mean (range) 0.996 (0.52-1) SIGN Nail 306 (94.2) Non-SIGN Nail 12 (3.7) Baseline EQ-5D VAS, mean (range) 99.2 (70-100) Plate 5 (1.5) External fixation 2 (0.6) Time from Injury to Presentation (days), median (5-95th Periop Antibiotics, no. (%) percentile) 2 (1-4) Yes 318 (98.5) No 5 (1.6) Time from Injury to Surgery (days), median (5-95th IM Nail Approach, no. (%) percentile) 7 (1-40) Antegrade 170 (54.1) Any comorbidity, no. (%) 10 (3) Retrograde 144 (45.9) Reaming, no. (%) Mechanism Yes 314 (99.7) Motorvehicle Crash, no. (%) 157 (49.5) No 1 (0.3) Motorcycle Crash, no. (%) 113 (35.7) Reduction, no. (%) Pedestrian vs. Auto, no. (%) 6 (1.9) Open 322 (100) Fall, no. (%) 21 (14.1) Closed 0 (0) Crush, no. (%) 4 (2.7) Open Fracture, no. (%) Gunshot, no. (%) 0 (0) Yes 7 (2.2) No 312 (97.8) Follow up Reoperation • Goal 80% at 1 year • IM nailing: • Eliminating barriers for the patient • 21/319 = 6.6% • Dedicated Research Clinic • Reduce costs � consultation fees, x-rays • Appointment Reminders • Plates • Weekly phone calls and SMS • 2/5 = 40% • Recruiting patients lost to follow up • Minimum 6 months • 228/331 (68.0%) P = 0.042 • Study scheduled to be completed August 2014 4
5/8/2014 Mode of failure Predictors of reoperation • Age > 60 • 4/22 (15.4%) vs 18/305 (5.9%) Did not matter: Plate IM Nail • P = 0.08 Gender • Delayed presentation (> 24hrs) BMI • 9/80 (11.3%) vs 10/202 (4.9%) Nonunion 2 (40) 10 (3.13) Smoking status • p=0.06 • Early surgery after presentation (<1 week) Deep Infection 0 (0) 6 (1.88) Alcohol use • 15/149 (10.1%) vs 5/161 (3.0%) Comorbidities Implant failure 0 (0) 1 (0.31) • P=0.01 Antegrade/Retrograde Nailing • Nail diameter 8mm Malalignment 0 (0) 1 (0.31) Number interlocking screws • 5/29 (17.2%) vs 14/284 (4.9%) Missed Interlocks 0 (0) 1 (0.31) • P = 0.022 • Motorvehicle vs Motorcycle Crash Nail Migration 0 (0) 1 (0.31) • 11/157 (7.0%) vs 1/113 (0.9%) Painful hardware 0 (0) 1 (0.31) • P = 0.01 Total 2(40) 21 (6.6) Summary Thank you! • Open nailing lower reoperation rate compared to • Co-investigators from Tanzania plate fixation in low-resource environment • Edmund Eliezer • Reoperation rates higher than closed nailing • Billy Haonga • Improved pre-hospital care may improve outcomes • Study coordinators • Academic partnership a viable model for • Joshua Nghayoma collaborative research in low-resource environments • Justin Kessy • Much more to do! • Complete follow up • Radiographic review • Secondary outcomes • Economic analysis 5
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