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Management of Open Tibia and Femur Fractures with the SIGN Intramedullary Nail System. Paul Whiting M.D. and Daniel Galat M.D. SIGN Conference – September 20, 2012. Disclosures. Nothing to disclose for either author. Background.
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Management of Open Tibia and Femur Fractures with the SIGN Intramedullary Nail System Paul Whiting M.D. and Daniel Galat M.D. SIGN Conference – September 20, 2012
Disclosures • Nothing to disclose for either author
Background • Open fractures of the tibial or femoral shaft present challenges to the treating surgeon: • High energy mechanisms of injury • Incidence of associated injuries • Represent severe injuries to bone and soft tissue • Involve contamination at the fracture site
Background • Open fractures of the tibial or femoral shaft often require: • Multiple debridements • Staged soft tissue management procedures prior to final closure/coverage • Provisional external fixation prior to definitive fracture fixation
Type IIIB Open Fracture Provisional External Fixation With Large Skin/Soft Tissue Defect
Type IIIB Open Fracture Soleus Flap to Cover Fracture Site
Type IIIB Open Fracture Split Thickness Skin Graft (STSG) After Soleus Flap
Background • Intramedullary Nail Fixation: • Safe and effective for open tibia & femur fractures (Giannoudis et al. JBJS Br 2006) • Surgical Implant Generation Network (SIGN) nailing system: • facilitates intramedullary fixation of tibia & femur fractures in developing countries, which may lack: • Real-time imaging • Power reaming • Specialized fracture tables
Purpose • Part 1: To evaluate the outcomes of patients with open tibia fractures stabilized with the Surgical Implant Generation Network (SIGN) intramedullary nail in a developing country
Purpose • Part 2: To evaluate the outcomes of patients with open femur fractures stabilized with the Surgical Implant Generation Network (SIGN) intramedullary nail in a developing country
Methods • Retrospective analysis of prospectively- collected data from the SIGN online database • Inclusion criteria: • All open fractures of the tibia or femur treated with a SIGN intramedullary nail at Tenwek Mission Hospital, (Bomet, Kenya) • November 2008 through January 2012
Methods • Retrospective analysis of prospectively- collected data from the SIGN online database • Exclusion criteria: • cases of subacute open fractures (> 14 days) • cases of nailing for non-union, deformity correction, or other complications of open fracture management
Methods • Reviewed clinical and radiographic data from time of injury, fixation, and follow-up visits • Time from injury to intravenous antibiotics • Time from injury to initial surgical debridement • Time from injury to skin closure • Time from injury to IM nail fixation
Methods • Primary outcome measures: • Deep infection at follow-up • Need for additional surgery • Secondary outcome measures: • Rates of union • Rates of mal-union • Knee flexion > 90°
Results – Part 1 • 98 Open tibia fractures • Average age 36.9 years (Range 16-90) • 69 male (70%), 29 female (30%) • Average interval from injury to SIGN nail: • 2.9 days (Range 0-13)
Results – Part 1 98 Open Tibia Fractures
Results – Part 1 98 Open Tibia Fractures
Results – Part 2 • 31 Open femur fractures • Average age 29.6 years (Range 17-60) • 28 male (90%), 3 female (10%) • Average interval from injury to SIGN nail: • 3.8 days (Range 0-13)
Results – Part 2 31 Open Femur Fractures
Results – Part 2 31 Open Femur Fractures
Results – Follow-up • 98 Open Tibia fractures: • 48% overall follow-up rate • Average length of follow-up: 19.2 weeks (1-64) • 31 Open Femur fractures: • 52% overall follow-up rate • Average length of follow-up: 14.2 weeks (3-43)
Results – Secondary Outcomes • 98 Open Tibia fractures: • Rates of union: • among patients who followed up: 67% • True rate: likely 86% or better • One case of procurvatum >10° => observation • 31 Open Femur fractures: • Rates of union: • among patients who followed up: 100% • One case of varus deformity >10° => osteotomy
Conclusions – Tibia Fractures • Open tibia fractures can be managed effectively with the SIGN nail • Overall deep infection rate: 17% • Fractures with adequate soft tissue coverage (Types I, II, & IIIA): 13% • Fractures requiring flap coverage or with vascular injury (Types IIIB & IIIC): 83% • Overall union rate: 67% • True rate may be 86% (or higher)
Conclusions – Tibia Fractures • Deep infection vs. no deep infection: • No statistically significant differences in time to: • Intravenous antibiotics • Initial debridement • However, importance of these factors has been demonstrated previously • Patzakis and Wilkins (CORR 1989) • Significantly increased rate of infection in open tibia fxs if antibiotic ppx given >3 hours after injury compared with <3 hours after (7.4% vs. 4.7%, respectively) • Crowley DJ, Kanakaris NK, Giannoudis PV (Injury 2007) • Importance of timing to debridement in open tibia fxs
Conclusions – Femur Fractures • Open femur fractures can be managed effectively with the SIGN nail • Overall deep infection rate: 0% despite significant delays from injury to… • Intravenous antibiotic administration • Initial surgical debridement • Overall non-union rate: 0%
Discussion • Challenges in international fracture research: • Poor follow-up rates • Outliers: create wide distributions of data and large standard deviations, making it difficult to draw significant conclusions • Constraints inherent to online data collection
Discussion • Assumption: all patients with infections would have followed up at our hospital given the extreme scarcity of nearby orthopaedic providers. • Given fee-for-service model in Kenya, patients without complications have a disincentive to return for scheduled follow-up visits • Clinic visit fees • X-ray charges
Future Directions • Prospective, randomized trial of open tibia fractures managed with: SIGN nail vs. external fixation (as definitive treatment): • Radiographic outcomes: • Rates of union • Rates of mal-union • Clinical outcomes: • Wound healing (& number of previous debridements) • Infection • Subsequent surgery
Future Directions • Prospective, randomized trial of open tibia fractures managed with: SIGN nail vs. external fixation (as definitive treatment): • Functional outcomes • Knee ROM • Pain • Validated outcome measures • Incentivize routine f/u even in favorable outcomes • Record patient contact information to facilitate functional outcomes assessment post-operatively
References • Crowley DJ, Kanakaris NK, Giannoudis PV: Debridement and wound closure of open fractures: The impact of the time factor on infection rates. Injury 2007;38:879-889. • Giannoudis PV, Papakostidis C, Roberts C: A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br 2006;88:281-289. • Melvin JS et al. Open Tibial Shaft Fractures: I. Evaluation and Initial Wound Management. J Am Acad Orthop Surg 2010;18: 10-19. • Melvin JS et al. Open Tibial Shaft Fractures: II. Definitive Management and Limb Salvage. J Am Acad Orthop Surg 2010;18: 108-117 • Patzakis MJ, Wilkins J: Factors influencing infection rate in open fracture wounds. Clin Orthop Relat Res 1989;243:36-40. • Zalavras CG and Patkazis MJ; Open Fractures: Evaluation and Management. J Am Acad Orthop Surg 2003;11:212-219