1. 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

2. Disclosures
Nothing to disclose for either author

3. 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

4. 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

5. Type II Open Fracture

6. Type IIIB Open Fracture
Provisional External Fixation With Large Skin/Soft Tissue Defect

7. Type IIIB Open Fracture
Soleus Flap to Cover Fracture Site

8. Type IIIB Open Fracture
Split Thickness Skin Graft (STSG) After Soleus Flap

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. Methods Primary outcome measures: Secondary outcome measures:
Deep infection at follow-up
Need for additional surgery
Secondary outcome measures:
Rates of union
Rates of mal-union
Knee flexion > 90°

16. 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)

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

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

19. 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)

20. Gustilo & Anderson Type
Results – Part 2
31 Open Femur Fractures
Gustilo & Anderson Type I II
IIIA
IIIB
IIIC
total
Number of fractures 10 16 4 1 31
Deep infections
Nail removal required
Deep infection rate 0%

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

22. Results – Follow-up 98 Open Tibia fractures: 31 Open Femur 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)

23. 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:
among patients who followed up: 100%
One case of varus deformity >10° => osteotomy

24. 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)

25. 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

26. 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%

27. 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

28. 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

29. 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

30. 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

31. 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:
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:
Melvin JS et al. Open Tibial Shaft Fractures: I. Evaluation and Initial Wound Management. J Am Acad Orthop Surg 2010;18:
Melvin JS et al. Open Tibial Shaft Fractures: II. Definitive Management and Limb Salvage. J Am Acad Orthop Surg 2010;18:
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:

32. Asante Sana!!!