Clinical outcomes of patients with isolated femoral shaft fractures treated with S.I.G.N interlock nails versus Cannulated Interlock Intramedullary nails

Panti, Juan Paulo; Geronilla, Mario; Arada, Ernesto Carlo B.

doi:10.1016/j.jor.2013.09.003

Cited by 11 publications

(12 citation statements)

References 9 publications

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“…(2,(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) Despite their use of heterogeneous outcome measurements, these SIGN nail results have been found to be comparable to those from other studies that evaluated more traditional cannulated interlocking intramedullary nails. (2,12) There are several limitations of the current study. The SIGN database we used has the potential for lack of input standardization and quality control, given that data is entered by surgeons around the world.…”

Section: Discussionmentioning

confidence: 86%

“…(2,(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) Complications found by prior studies have included delayed union in 4-34% of patients, and infection in 1-11%, implant failure in 3-4%. (2,(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) Despite their use of heterogeneous outcome measurements, these SIGN nail results have been found to be comparable to those from other studies that evaluated more traditional cannulated interlocking intramedullary nails. (2,12) There are several limitations of the current study.…”

Section: Discussionmentioning

confidence: 99%

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Surgical Implant Generation Network Implant Follow-up: Assessment of Squat and Smile and Fracture Healing

Alves

Lerner

Silva

et al. 2020

Journal of Orthopaedic Trauma

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Objectives: The aims of this study were to evaluate the reliability, sensitivity, and specificity of the Squat and Smile (S&S) test, a clinical photographic follow-up, in determination of fracture healing and to assess the extent of continued fracture healing beyond one-year post-operation. Design: Retrospective review of the SIGN database. Setting: The S&S test is utilized in low-resource settings where the SIGN intramedullary nail is used due to unavailability of intraoperative fluoroscopy. Patients/Participants: 150 patients undergoing fracture fixation utilizing SIGN intramedullary nails with data available at least one year (9-16 months) post-surgery. Intervention: None Main Outcome Measurements: We extracted clinical data and calculated scores for the S&S photographs and radiographs at the one-year (9-16 months post-operative) follow-up and last follow-up available beyond that. We analyzed the sensitivity of S&S scoring, using radiograph assessment as the gold standard for fracture union. Results: Of the 126 patients analyzed, 21% were found to have incomplete healing at one year, whereas 17% of the 64 patients with further follow-up past one year had incomplete healing. We found that both S&S and radiographic fracture healing scores had good inter-rater reliability (k=0.73-0.78 for S&S and 0.94 for radiographs). The S&S test had poor sensitivity (0.11) and specificity (0.85) in determining fracture healing at the one-year follow-up. Conclusions: The S&S scoring method was reliable but neither sensitive nor specific for determining fracture healing at one year. Fractures deemed incompletely healed by radiographic evaluation at one year following SIGN implant may still have the potential to heal over time.

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Surgical Implant Generation Network Implant Follow-up: Assessment of Squat and Smile and Fracture Healing

Alves

Lerner

Silva

et al. 2020

Journal of Orthopaedic Trauma

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“…[ 8 ] Multiple studies have subsequently shown that the SIGN nail is an effective treatment choice in these circumstances, with union rates above 90% in multiple series. [ 9 , 11 , 12 , 18 – 20 ]…”

Section: Discussionmentioning

confidence: 99%

Clinical and radiographic outcomes following retrograde SIGN fin nailing for femoral shaft fractures

Wilson

Moen²,

Shaw

et al. 2020

OTA International: The Open Access Journal of Orthopaedic Trauma

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Purpose: The Surgical Implant Generation Network (SIGN) intramedullary nail was designed for use in resource limited settings which often lack fluoroscopy, specialized fracture tables, and power reaming. A newer design iteration, the SIGN Fin nail, was developed to further simplify retrograde femoral nailing by making proximal interlocking screw placement unnecessary. Instead, the leading end of the Fin nail achieves stability through an interference fit within the proximal femoral canal. While the performance of the traditional SIGN nail has been reported previously, no large series has examined long-term clinical and radiographic outcomes of femoral shaft fractures treated with the SIGN Fin nail. Methods: The SIGN online surgical database was used to identify all adult femoral shaft fractures treated with the SIGN Fin nail since its introduction. All patients with minimum 6 month clinical and radiographic follow-up were included in the analysis. Available demographic, injury, and surgical characteristics were recorded. Fracture alignment was evaluated on final follow-up radiographs using a previously validated on-screen protractor tool. Coronal and sagittal plane alignment measurements were recorded as deviation from anatomic alignment (DFAA), with units in degrees. Fracture healing was assessed on final follow-up radiographs, with union defined as any bridging callus and/or cortical remodeling across one cortex on orthogonal views. Clinical outcomes available in the database included knee range of motion (ROM) greater than 90° and weight-bearing status at final follow-up. Clinical and radiographic outcomes were then compared between patients with united and nonunited fractures. Results: The database query identified 249 femoral shaft fractures stabilized with the Fin nail in 242 patients who had minimum 6 month clinical and radiographic follow-up. Final follow-up radiographs were performed at an average of 48 weeks postoperatively. Average coronal and sagittal plane alignment measured on final follow-up radiographs were 2.18° and 2.58°, respectively. The rate of malalignment (DFAA > 10° in either plane) at final follow-up was 6%. Two hundred twenty-nine fractures (92%) were united at final follow-up. Overall, 209 (84%) of patients achieved full weight bearing and 214 (86%) achieved knee ROM >90° at final follow-up. Compared to patients with united fractures, those with nonunion were less likely to achieve full weight bearing (20% vs 90%, P < .001) and knee ROM >90° (30% vs 91%, P < .001). There was no significant difference in mean DFAA between united and nonunited fractures in the coronal (2.1° vs 3.8°, P = .298) or sagittal (2.5° vs 3.5°, P = .528) planes. Conclusion: The SIGN Fin nail achieves satisfactory radiographic alignment and clinical outcomes at minimum 6 month follow-up...

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“…[ 11 ] Multiple studies have subsequently shown that the SIGN nail is an effective treatment choice in these circumstances. [ 12 , 14 , 15 , 20 – 22 ] Carsen et al [ 23 ] recently analyzed the postoperative radiographs of 500 cases in which the standard SIGN nail was used to treat fractures of the femoral shaft. The authors found that 10% of cases demonstrated fracture malalignment greater than 5°.…”

Section: Discussionmentioning

confidence: 99%

Satisfactory postoperative alignment following retrograde SIGN Fin nailing for femoral shaft fractures

Wilson

Shaw

Malaba

et al. 2019

OTA International: The Open Access Journal of Orthopaedic Trauma

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Purpose: In developing countries, long bone fractures following trauma are a significant contributor to morbidity, and operating room resources are often limited in these settings. The Surgical Implant Generation Network (SIGN) Fin nail may reduce the challenges of retrograde intramedullary nailing of femoral fractures without fluoroscopy. In contrast to the traditional SIGN nail placed in a retrograde fashion, the Fin nail does not require proximal interlocking screws. Instead, the nail achieves stability through an interference fit within the proximal femoral canal. The purpose of this study is to compare postoperative alignment in femoral shaft fractures treated with either a retrograde SIGN Fin nail or a standard retrograde SIGN nail. Method: Using the SIGN online surgical database, we identified all femoral shaft fractures treated with a retrograde SIGN Fin nail at 2 African hospitals. Two examiners independently classified fracture patterns using the Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) classification system. Using an on-screen protractor tool, postoperative coronal and sagittal plane alignment were measured and recorded as deviation from anatomic alignment (DFAA), with units in degrees. Available patient demographics and surgical details were also recorded. Fin nail cases were matched in a 1:1 ratio to retrograde standard SIGN nail cases based on AO/OTA fracture type. Results: Twenty-eight retrograde Fin nail cases were identified, and 28 matched retrograde SIGN nail cases were selected. The Fin nail and retrograde SIGN nail groups were well matched in terms of demographics, AO/OTA fracture type, and surgical characteristics. There was no significant difference in postoperative coronal or sagittal plane alignment between the groups. There were no cases in either group of average postoperative malalignment >5° in any plane. Conclusion: The SIGN Fin nail appears to achieve satisfactory radiographic alignment without the need for proximal interlocking screws, making it an attractive implant for retrograde femoral shaft fracture fixation in resource-limited settings. Further research is required to validate these findings and determine long-term Fin nail clinical outcomes.

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Clinical outcomes of patients with isolated femoral shaft fractures treated with S.I.G.N interlock nails versus Cannulated Interlock Intramedullary nails

Cited by 11 publications

References 9 publications

Surgical Implant Generation Network Implant Follow-up: Assessment of Squat and Smile and Fracture Healing

Surgical Implant Generation Network Implant Follow-up: Assessment of Squat and Smile and Fracture Healing

Clinical and radiographic outcomes following retrograde SIGN fin nailing for femoral shaft fractures

Satisfactory postoperative alignment following retrograde SIGN Fin nailing for femoral shaft fractures

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