Kyle R Stephens1, Faseeh Shahab, Daniel Galat, Duane Anderson, Paul S Whiting, Douglas W Lundy, Lewis G Zirkle. 1. *Henry Ford Macomb Hospital Clinton Township, MI; †Rehman Medical Institute, Peshawar, Pakistan; ‡Tenwek Hospital, Bomet, Kenya; §Soddo Christian Hospital, Soddo, Ethiopia; ‖Department of Orthopaedics and Traumatology, Lady Reading Hospital, Peshawar, Pakistan; ¶Department of Orthopaedics and Rehabiliation University of Wisconsin, Madison, WI; **Resurgens Orthopaedics, Marietta, GA; and ††SIGN Fracture Care International.
Abstract
OBJECTIVES: To evaluate the effectiveness of the Surgical Implant Generation Network (SIGN) intramedullary (IM) nail in distal tibial metaphyseal fractures. DESIGN: Retrospective Case Series. SETTING: Three Level I trauma centers in 3 different developing countries from 2009 to 2013. PATIENT/PARTICIPANTS: One hundred sixty patients with 162 distal tibial metaphyseal fractures (AO/OTA 43-A). INTERVENTION: SIGN IM nailing was performed using hand reaming and without the use of an image intensifier. MAIN OUTCOME MEASUREMENTS: The primary outcome measures were the rate of union and complications. The secondary outcome measures were the effect of open fractures on outcomes, effectiveness and safety of open reduction of closed fractures, and risk factors for the development of malalignment and possible solutions. RESULTS: The average age of patients was 35.3 years. Seventy-nine percent were male. Sixty percent of the fractures were closed. The mean time to surgery was 4.1 days. Fracture union occurred in 97.3% of fractures with an average time to union of 105 days. Open reduction of closed fractures was performed in 51 fractures. Nonunion occurred in 3 patients (1.8%). Acceptable alignment (<5 degrees deformity) was found in 134 fractures (83%). Infection occurred in 14 patients (8.6%). Revision surgery was required in 10 fractures (6.2%). CONCLUSIONS: In developing settings, distal metaphyseal tibial fractures can be managed successfully with the SIGN IM nail. There is an increased risk for complications (P = 0.001) and infection (P = 0.0004) in open fractures. Open reduction of closed distal tibia fractures is safe and effective. Malalignment can be improved with fibula stabilization but indications remain unclear. For surgeons interested in international mission work, the SIGN IM nail is an effective tool in managing distal tibial fractures. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
OBJECTIVES: To evaluate the effectiveness of the Surgical Implant Generation Network (SIGN) intramedullary (IM) nail in distal tibial metaphyseal fractures. DESIGN: Retrospective Case Series. SETTING: Three Level I trauma centers in 3 different developing countries from 2009 to 2013. PATIENT/PARTICIPANTS: One hundred sixty patients with 162 distal tibial metaphyseal fractures (AO/OTA 43-A). INTERVENTION: SIGN IM nailing was performed using hand reaming and without the use of an image intensifier. MAIN OUTCOME MEASUREMENTS: The primary outcome measures were the rate of union and complications. The secondary outcome measures were the effect of open fractures on outcomes, effectiveness and safety of open reduction of closed fractures, and risk factors for the development of malalignment and possible solutions. RESULTS: The average age of patients was 35.3 years. Seventy-nine percent were male. Sixty percent of the fractures were closed. The mean time to surgery was 4.1 days. Fracture union occurred in 97.3% of fractures with an average time to union of 105 days. Open reduction of closed fractures was performed in 51 fractures. Nonunion occurred in 3 patients (1.8%). Acceptable alignment (<5 degrees deformity) was found in 134 fractures (83%). Infection occurred in 14 patients (8.6%). Revision surgery was required in 10 fractures (6.2%). CONCLUSIONS: In developing settings, distal metaphyseal tibial fractures can be managed successfully with the SIGN IM nail. There is an increased risk for complications (P = 0.001) and infection (P = 0.0004) in open fractures. Open reduction of closed distal tibia fractures is safe and effective. Malalignment can be improved with fibula stabilization but indications remain unclear. For surgeons interested in international mission work, the SIGN IM nail is an effective tool in managing distal tibial fractures. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.