Study name (abbreviation, registration number, registration date) | Primary objective | Number | Sites |
---|---|---|---|
Assessment of severe extremity wound bioburden at the time of definitive wound closure or coverage: correlation with subsequent post-closure deep wound infection (Bioburden, NCT01496014, 12/21/2011) [14]. | To assess the extremity wound bioburden at the time of definitive wound closure or coverage and its correlation with subsequent deep wound infection | 608 | 34 |
Improving recovery after orthopaedic trauma: cognitive-behavioral therapy based physical therapy (CBPT, NCT03335657, 11/8/2017) [15]. | To test the efficacy of a phone-based cognitive-behavioral-based physical therapy (CBPT) program for managing pain in service members and civilians at risk for poor outcomes following lower-extremity trauma | 636 | 9 |
A prospective randomized trial to assess fixation strategies for severe open tibia fractures: modern ring external fixator versus internal fixation (FIXIT, NCT01494519, 12/19/2011) [16]. | To compare the outcomes associated with modern ring external fixators versus standard internal fixation techniques in treating severe open tibia shaft or metaphyseal fractures with or without a bone defect of any size | 258 | 37 |
A multicenter prospective observational study of nerve repair and reconstruction associated with major extremity trauma (NERVE, NCT02718768, 3/24/2016) [17]. | To capture the detailed information about the treatment and long-term outcomes of peripheral nerve injury (PNI) resulting from upper extremity trauma | 250 | 17 |
Outcomes after severe distal tibia, ankle, and/or foot trauma: comparison of limb salvage versus transtibial amputation (OUTLET, NCT01606501, 5/25/2012) [18]. | To compare the outcomes following limb salvage vs. amputation of a severe distal tibia, ankle, and/or foot trauma | 651 | 27 |
Supplemental perioperative oxygen to reduce surgical site infection after high-energy fracture surgery (OXYGEN, NCT01798810, 2/26/2013) [19]. | To assess the efficacy of supplemental perioperative oxygen in the prevention of surgical site infections | 1173 | 29 |
Improving pain management and long-term outcomes following high-energy orthopaedic trauma (PAIN, NCT01789216, 2/12/2013) [20]. | To compare the outcomes among patients randomized to three groups receiving standard pain management and either (1) oral and intravenous placebo, (2) NSAIDS (oral meloxicam and intravenous ketorolac) and oral placebo, or (3) oral pregabalin and intravenous placebo | 450 | 25 |
A prospective randomized trial to assess oral versus intravenous antibiotics for treatment of postoperative wound infection after extremity fractures (POvIV, NCT01714596, 10/26/2012) [21]. | To assess the efficacy of oral antibiotic therapy vs. intravenous antibiotics in the treatment of acute infection after fixation of fractures or fusion of joints | 371 | 28 |
PhBMP-2 versus autograft for critical size tibial defects: a multicenter randomized trial (pTOG, NCT00853489, 3/2/2009) [22]. | To compare rhBMP-2 vs. autograft for critical size tibial defects | 33 | 17 |
Transtibial amputation outcomes study (TAOS, NCT01821976, 4/1/2013) [23]. | To compare the outcomes for patients undergoing a transtibial amputation and receiving an end-bearing tibia-fibula synostosis vs. standard posterior flap procedure | 381 | 28 |
Streamlining trauma research evaluation with advanced measurement (STREAM, NCT02079714, 3/6/2014) [24]. | To evaluate the reliability, validity, and responsiveness of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Outcomes Tools | 1054 | 52 |
Local antibiotic therapy to reduce infection after operative treatment of fractures at high risk of infection: a multicenter randomized controlled trial (VANCO, NCT02227446, 8/28/2014) [25]. | To compare the efficacy of using local vancomycin powder in the prevention of surgical site infections | 1000 | 35 |