Treatment With the SIGN Nail in Closed Diaphyseal Femur Fractures Results in Acceptable Radiographic Alignment

Abstract

Background The burden of orthopaedic trauma in the developing world is substantial and disproportionate. SIGN Fracture Care International is a nonprofit organization that has developed and made available to surgeons in resourcelimited settings an intramedullary interlocking nail for use in the treatment of femoral and tibial fractures. Instrumentation also is donated with the nail. A prospectively populated database collects information on all procedures performed using this nail. Given the challenging settings and numerous surgeons with varied experience, it is important to document adequate alignment and union using the device. Questions/purposes The primary aim of this research was to assess the adequacy of operative reduction of closed diaphyseal femur fractures using the SIGN interlocking intramedullary nail based on radiographic images available in the SIGN database. The secondary aims were to assess correlations between postoperative alignment and several associated variables, including fracture location in the diaphysis, degree of fracture site comminution, and time to surgery. The tertiary aim was to assess the functionality of the SIGN database for radiographic analyses. Methods A review of the prospectively populated SIGN database was performed for patients with a diaphyseal femur fracture treated with the SIGN nail, which at the time of the study totaled 32,362 patients. After study size calculations, a random number generator was used to select 500 femur fractures for analysis. Exclusion criteria included open fractures and those without radiographs during the early postoperative period. The following information was recorded: location of the fracture in the diaphysis; fracture classification (AO/Orthopaedic Trauma Association [OTA] classification); degree of comminution (Winquist and Hansen classification); time from injury to surgery; and patient demographics. Measurements of alignment were obtained from the AP and lateral radiographs with malalignment defined as deformity in either the sagittal or coronal plane greater than 5°. Measurements were made manually by the four study authors using onscreen protractor software and interobserver reliability was assessed. Results The frequency of malalignment greater than 5°o bserved on postoperative radiographs was 51 of 501 (10%; 95% CI, 6.5-11.5), and malalignment greater than Clinical Orthopaedics and Related Research ®A Publication of The Association of Bone and Joint Surgeons® 10°occurred in eight of 501 (1.6%) of the femurs treated with this nail. Fracture location in the proximal or distal diaphysis was strongly correlated with risk of malalignment, with an odds ratio (OR) of 3.7 (95% CI, 1.5-9.3) for distal versus middle diaphyseal fractures and an OR of 4.7 (95% CI, 1.9-11.5) for proximal versus middle fractures (p \ 0.001). Time from injury to surgery greater than 4 weeks also was strongly correlated with risk of malalignment (p \ 0.001). Inherent fracture stability, based on fracture site comminution as per the Winquist and Hansen clas...

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

“…(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.…”

Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision under WALANT: A Prospective Series of 34 Patients from a Low-Resource Tertiary Setting

“…The former was successfully treated with 2-week regimen of 500 mg oral cefuroxime (CEFUREX ® ; Cathay Drug Co. Inc., Makati City, PH) twice daily and the latter, with six weeks of physical therapy. It has been recognized that traditional clinical research using standard follow-up is extraordinarily difficult in the developing world, where resources are limited [ 22 ]. It is financially challenging for our patients to pursue regular follow-up after surgery, and similar to the experiences of Young et al [ 23 ], patients most commonly seek follow-up for the removal of wound sutures or due to development of a complication and less for surveillance.…”

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

“…[ 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°.…”

“…The SOSD is a robust registry that serves as a model for trauma system data tracking globally. In their large review of the SOSD, Carsen et al [ 23 ] found that >90% of patients treated for femur fractures with the standard SIGN nail had orthogonal imaging adequate for evaluation of post-operative alignment. [ 23 ] Our study found the registry to be similarly adequate but somewhat less comprehensive, with only 80% of the 56 selected cases containing orthogonal views for analysis.…”

“…In their large review of the SOSD, Carsen et al [ 23 ] found that >90% of patients treated for femur fractures with the standard SIGN nail had orthogonal imaging adequate for evaluation of post-operative alignment. [ 23 ] Our study found the registry to be similarly adequate but somewhat less comprehensive, with only 80% of the 56 selected cases containing orthogonal views for analysis. Given the relatively small number of Fin nail cases available for analysis, however, we included all cases with at least one adequate postoperative radiographic view available.…”