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

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

Type IIIB Open Fracture

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 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;88:281-289.

• 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!!!