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 prospectivelycollected 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 prospectivelycollected 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
I
II
IIIA
IIIB
IIIC
total
Number of fractures
18
57
17
5
1
98
Deep infections
2
6
4
4
1
17
Nail removal required
1
3
4
4
1
14
Deep infection rate
11.1%
10.5% 23.5% 80% 100% 17.4%
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)
95% Confidence Interval
(5.7, 17.1)
(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
I
II
IIIA
IIIB
IIIC
total
Number of fractures
10
16
4
0
1
31
Deep infections
0
0
0
0
0
0
Nail removal required
0
0
0
0
0
0
Deep infection rate
0%
0%
0%
0%
0%
0%
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)
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;88:281289.
• 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!!!