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 II Open Fracture

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 Gustilo & Anderson Type Number of fractures Deep infections Nail removal required Deep infection rate I II IIIA IIIB IIIC total 18 2 57 6 17 4 5 4 1 1 98 17 1 3 4 4 1 14 11.1% 10.5% 23.5% 80% 100% 17.4%

Results – Part 1

98 Open Tibia Fractures Deep Infection Avg. hours to IV antibiotics (range) 12.2 (1-48) 95% Confidence Interval (6.4, 18.2) Avg. hours to debridement (range) 95% Confidence Interval 11.4 (1-48) (5.7, 17.1) No Deep Infection 19.8 (1-312) (11.3, 28.4) 11.5 (2-72) (9.0, 14.0)

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 Gustilo & Anderson Type Number of fractures Deep infections Nail removal required Deep infection rate I 10 0 0 0% II 16 0 0 0% IIIA IIIB IIIC total 4 0 0 0% 0 0 1 0 0 0% 0 0% 31 0 0 0%

Results – Part 2

31 Open Femur Fractures Avg. hours to IV antibiotics (range) Avg. days of antibiotic treatment (range) Avg. hours to debridement (range) Avg. days to wound closure (range) All patients 42.3 (2-288) 4.8 (1-14) 16.7 (2-96) 2.5 (1-18)

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

Asante Sana!!!