There is an increasing epidemic of trauma in the develop world, and musculoskeletal unwholesomeness takes a substantial and disproportionate human and economic price [ 1, 5 ]. One of the most lay waste to and coarse traumatic injuries in the develop world is the long bone fracture. Until recently, the best option available for many long bone fractures in this set was a hearty period of immobilization and grip, because there was circumscribed access to the orthopedic surgical resources considered common in the grow global [ 4 ]. SIGN Fracture Care International ( besides known as the Surgical Implant Generation Network, or SIGN ), a nonprofit organization, has developed and donated an intramedullary and interlock prosthesis known as the SIGN nail. This collar is designed for use in the femur and the tibia without the motivation for fluoroscopic imagination and allows for low-cost intramedullary fixation in resource-limited settings [ 14 ]. Implants and relate materials are donated to affiliated hospital sites where SIGN-trained surgeons can treat farseeing bone fractures with SIGN intramedullary prostheses without concern for device-related costs [ 14 ]. prepare is didactic and practical and is done through either a site visit by a volunteer visiting a SIGN surgeon educator or through a surgeon visiting a SIGN educator regionally or at the SIGN headquarters in Richland, Washington. SIGN presently has greater than 250 sites in more than 50 countries where SIGN nails have become a pillar of treatment used by local surgeons [ 14 ]. The SIGN nails have been approved by the FDA and have shown adept clinical results in small clinical series [ 7, 12, 13 ]. The SIGN standard pinpoint was designed and began function in 1999 and is a solid stainless steel smash with a 9° proximal crouch and 1.5° distal fold, offered in 8 millimeter to 12 millimeter diameters and 280 millimeter to 420 mm length [ 14 ]. It is a utilitarian design and is used in the femur, tibia, and humerus in antegrade and regress approaches. Using a particularly designed proximal jig and extended aiming arm, the nail down is designed to be interlocked proximally and distally without fluoroscopic imaging [ 7, 14 ]. The nail is designed and manufactured in-house by SIGN in Richland, Washington, and the standard breeze through has now been joined by several other implants including the fin complete ( which uses distal flanges in stead of distal interlock screws ), a pediatric collar, and hip nails. A sum of 537 femur fractures were divided and analyzed by the four authors. Five hundred patients were assigned primitively and because several patients had bilateral femur fractures, extra fractures were added to the study group. An extra 25 femur fractures were analyzed by all four authors for the purpose of assessing interobserver dependability. Of the 537 sum femur fractures assessed, 36 ( 7 % ) either were mislabeled as femur fractures or did not have any available postoperative radiogram. There were eight femur fractures in which the radiogram were of such poor quality that measurement of postoperative alignment was impossible, leading to a entire of 42 ( 8 % ) without imaging. consequently, approximately 92 % of the femur fractures had adequate imaging for assessment. The study population had a mean historic period of 33 years ( range, 13–90 years ), and was 77 % male and 33 % female. Treatment groups of the fractures were 71 % ( 356/501 ) acuate fractures, 14 % ( 68/501 ) subacute, 13 % ( 67/501 ) nonunions, and 2 % ( 10/501 ) deformities or malunions. fracture locations in the diaphysis were 89 % ( 448/501 ) center, 5 % ( 26/501 ) proximal, and 5 % ( 27/501 ) distal ( Table ). The fractures were classified according to the AO/OTA classification [ 8 ] and the most park course of fracture in the group was the simple cross character, with more than 1/3 of all fractures in the study sample ( Table ). All patients were skeletally mature and undergo operation for treatment of a diaphyseal femoral fracture. Because of the clinical set ( s ), not all patients were treated for acute fractures. We besides examined the effect of different discussion groups on clinical outcomes. Patients were grouped into four treatment groups based on clinical context to address our second research question ( clock time to surgery variable ) : ( 1 ) acute : patients who received acute fracture caution with the SIGN nail within 4 weeks of injury ; ( 2 ) subacute : delay treatment–patients who received their sign nail more than 4 weeks from the time of injury but less than 6 months and did not have a nonunion or another attempt at authoritative treatment using a unlike surgical technique ; ( 3 ) nonunion : treatment for a nonunion with date of wound more than 6 months from the SIGN nail ; and ( 4 ) deformity : surgical treatment for well-established malunion or chronic deformity correction. The study sample size of 500 was divided by the four authors who each acted as independent raters, each planning for judgment of 125 mugwump femur fractures. To ensure calibration and reproducibility, interobserver dependability was assessed. previous study of multirater alliance measurements in the femur showed an intraclass correlation coefficient ( ICC ) of 0.90 [ 10 ]. Based on these results we eschewed intraoberver analysis and performed sample size psychoanalysis for the interobserver dependability using the ICC of 0.90 and our sum of four individual and mugwump raters to find that 25 cases reviewed by all four raters would allow an appropriate calculation of interobserver dependability. A entire of 25 unique and random femur fractures were anonymized and read by all four study authors to allow for calculation of interobserver dependability. A multiple linear regression mannequin and odds ratio ( OR ) calculations were used to assess the correlation between radiographic malalignment and the patient, fracture, and proficiency variables. Chi-square and Student ’ s t-test analyses besides were performed. patient case data were accessed through the password-protected and anonymous SIGN on-line surgical database. significant unevenness existed for trope choice owing to quality of the radiogram and/or the upload image, which normally was a digital photograph taken of the radiogram. postoperative radiogram were assessed and the succeed information analyzed and recorded : sufficiency of radiogram ( i, the ability to assess the radiogram and make aforethought measurements ) ; placement of diaphyseal femur fracture ( proximal versus middle versus distal third ) ; fracture classification ( AO/OTA classification ) [ 8 ] ; degree of comminution ( Winquist and Hansen classification ) [ 16 ] ; antegrade versus retrograde nail down ; and alliance of the femur or fracture in the wreath and sagittal planes. Adequate reduction was defined as angles of 5° or less in the wreath and sagittal planes. Measurements were made using an on-screen protractor ( Screen Protractor ; Iconico Inc, New York, NY, USA ) on the AP and lateral radiogram ( Fig. ). The on-screen protractor has extendible protractor arms and varying degrees of translucence, such that the protractor origin can be placed over the fault web site and the arms extended longitudinally along the axes of the femur proximal and distal to the fracture, and this therefore allows it to be used through an overlie technique on any digital radiographic double on screen. The discipline by Ricci et aluminum. [ 11 ], which examined postoperative malalignment after intramedullary pinpoint of 374 femur fractures at a trauma focus on in the United States, served as a guidebook in the development of the study method. In determining sample size, we assumed a prevalence of malalignment of at least 8 %, and that in a worst-case scenario 25 % of radiogram would be unsuitable for analysis. With these conditions, the selected sample size of 500 gave probabilities between 0.89 and 1.00 of obtaining a CI half-width between 3 % and 4 %. Using a random number generator, 500 femur fractures of the available 32,362 closed diaphyseal femur fractures from the SIGN operation database were sampled.
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inclusion criteria included diaphyseal femur fractures ( AO/Orthopaedic Trauma Association [ OTA ] classification 32 ) [ 8 ] and patients treated with the standard SIGN nail. exclusion criteria included open fractures and patients who did not have postoperative radiogram or whose radiographs were not adequate for assessment. A total of 32,362 patients in the database at the clock time of the discipline met the inclusion body criteria and exception criteria of exposed fractures. The exclusion standard of appropriate visualize had to be applied after sampling because of the unevenness in upload image in the database. A retrospective analysis of close up diaphyseal femur fractures was performed using the SIGN database. This on-line database was started in 2003 and is a prospectively populate clinical care database with anonymized data of about all patients treated with the SIGN nail down. It includes patient demographics, specifications of the implant used, and preoperative and postoperative radiogram. The database presently has entries for greater than 75,000 patients [ 14 ]. It is one of the largest fracture or injury treatment databases focusing on low- and middle-income countries, and its completeness and clinical relevance have served as a model for other external injury databases [ 2 ]. SIGN surgeons are required to upload preoperative and postoperative radiogram for their hospital to receive unblock surrogate SIGN implants. For the purposes of this cogitation, all anonymous data were accessed remotely from computers based at our institutions and using a guarantee login. Research ethics board approval was obtained at our institutions and there were no risks to patients in the study because all data were retrospective and already anonymous. Factors associated with malalignment included fracture placement in either the proximal or distal diaphysis, degree of comminution, and time from injury to surgery greater than 4 weeks. Fracture types that had greater than average findings of postoperative malalignment included elementary oblique fractures with fracture angulation greater than 30° ( 32-A2 ) and metameric fractures ( 32-C2 ). implicit in fracture stability, based on fracture site comminution per the Winquist and Hansen classification ( Classes 0–1 stable versus 2–4 unstable ) [ 16 ] showed an OR of 2.3 ( 95 % CI, 1.2–4.3 ) for malalignment in mentally ill fractures ( p < 0.01 ) ( board ). fault location in the proximal or distal diaphysis was powerfully correlated with risk of malalignment, with an 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 ( phosphorus < 0.001 ) ( table ). There was no dispute in the rates of malalignment between antegrade versus retrograde nail down insertion ( phosphorus < 0.01 ). time from injury to surgery greater than 4 weeks besides was powerfully correlated to risk of malalignment ( phosphorus < 0.001 ) ( board ). Patients receiving discussion sharply ( < 4 weeks from the date of injury ) had a risk of malalignment of 7 %, whereas those treated subacutely ( > 4 weeks ) had a rate of 12 % .
Discussion
The disproportionate human and economic price of dealings injuries in low- and middle-income countries, with the majority of the earth ’ s traumatic unwholesomeness and mortality, was emphasized with the WHO and the United Nations declaring 2011 to 2020 the “ Decade of Action for Road Safety ” [ 17 ]. An inauspicious sarcasm of the growth in musculoskeletal trauma in the evolve populace has been a worsening mismatch with inadequate health resources, and the SIGN organization has brought an innovative overture to their humanist mission of providing modern intramedullary nail engineering to those who need it most. SIGN has had great clinical success frankincense army for the liberation of rwanda, but they besides have had the prevision to develop and manage a database that allows full-bodied pre- and postoperative affected role data in the form of radiogram, allowing for the assessment of radiographic outcomes. The basal purpose of our study was to assess the adequacy of femoral fracture reduction through judgment of postoperative radiographic alignment, with a secondary coil goal of judgment for risk factors for postoperative malalignment. A general restriction of the discipline was the variability and variable quality of the data available owing to the multicenter and multisurgeon nature of the SIGN database and the variability in their radiographic resources and prototype capture. The veracity of certain immanent elements of the database ( internet explorer, data fields entered directly by the surgical team ) is unmanageable to assess, and we therefore sought to use the most objective separate of the database : the radiogram. The most significant clinical weakness of the study was that it was not truly assessing the clinical result of the surgical interposition but merely the immediate radiographic result. We could not account for genuine radiographic or clinical healing, infection, or other surgical complications. In the absence of those data, we thought postoperative radiogram were the best available objective measurement available that would allow comparison of alignment results using the SIGN breeze through with that using more twist engineering in north american trauma centers. Based on our assessment of radiogram in this discipline, we found that there was a small but substantial proportion ( 42 of 537 ; 8 % ) of logged cases that did not include proper extraneous image or had poor quality images uploaded to the database that precluded full assessment. A likely reservoir of bias in our study would be the apprehensible excommunication of fractures without adequate imaging for assessment. An crucial degree to emphasize to SIGN surgeons in the future is the importance of taking and upload representative wreath and sagittal images of postoperative radiogram. One possible restriction or source of bias could be the nature of the measurements of alignment or our multiple raters, although this electric potential limitation is likely not meaning based on the findings by Owen et alabama. [ 10 ] when measuring femoral alliance among respective raters. They reported very potent intra- and interobserver reliabilities in the appraisal of malalignment of diaphyseal femur fractures with an ICC of 0.90 for varus and valgus angulation correlation, even among nonexperts, using a measurement protocol similar to the one used in our study ; they concluded that a 5° measurement exceeded the unevenness in measurement. Our findings reflected similar results, with interobserver dependability showing agreement of 88 % ( 95 % CI, 83 % –93 % ) and a average kappa of 0.81 ( 95 % CI, 0.65–0.87 ). Using the most conservative definition of malalignment in the femur being anything greater than 5°, the SIGN collar showed an overall malalignment rate of 10 %. In comparison, Ricci et alabama. [ 11 ] reported a malalignment pace of approximately 9 % at a north american english injury plaza. When considering that the majority of the SIGN surgeries were performed without the profit of fluoroscopy and in settings that are far from ideal from the perspective of break countries, alliance results so close approximating those of a Level I trauma center are a solid endorsement of the SIGN nail and instrumentation organization. To by rights compare the malalignment rate reported by Ricci et alabama. [ 11 ] with the pace for the SIGN nail, we must compare similar fracture and patient demographic groups. treatment of femur fractures at a north american injury center is about entirely performed during the first 4 weeks postinjury and most will be treated within hours to days. The lapp can not be said for the SIGN cohort, many of whom experience substantial delays to surgery. We found the frequency of malalignment in fractures treated during the beginning 4 weeks postinjury to be 7 %. This was a more adjustment comparison group and indicated that the SIGN collar had excellent immediate postoperative radiographic outcomes that were comparable to those found at a Level I trauma center in the United States, where Ricci et alabama. [ 11 ] reported postoperative malreduction in 9 % of their report group, or 7 % of static fractures and 12 % of mentally ill fractures. One likely factor in the impressively low frequency of malalignment in SIGN surgeries is that although the operation can be performed without fluoroscopic imaging, the majority of the surgeries are performed using some measure of open reduction. Despite the practice of adjunctive open reduction, infection rates in SIGN surgeries are within the acceptable norm and are more charm by fracture characteristics and the use of preoperative antibiotics [ 19, 20 ].
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fracture characteristics noted to have increased frequency of angular malalignment included fractures in the proximal or distal diaphysis, of increase degree of comminution, and those of the subacute treatment group who were treated greater than 4 weeks from their go steady of injury. Ricci et aluminum. [ 11 ] found like results, with proximal and distal fracture location and comminution being risk factors for malalignment. The increase frequency of malalignment in patients treated more than 4 weeks from the date of injury is potentially indicative mood of running issues associated with waiting for treatment. There is limited literature on risks of malalignment in this patient group, but the increase complexity and challenges involved in surgery for delayed union and aseptic nonunion in the femur is well documented [ 3, 15 ]. There are some centers in the develop world where such waits are common and the result of myriad factors. These findings should act as a admonisher and impulse to ensure that centers around the world have entree to intramedullary arrested development for acute treatment of diaphyseal femur fractures. Of the variables found to be independently linked to malalignment, time of operation is the variable that we have the most control over as surgeons and surgical worry advocates. The SIGN nail and SIGN database show big promise and identical encourage results. Although the quality of the data in the database was by and large good and has been shown to be valid for retrospective research and analysis [ 19 ], it could be improved. Our results show that most upload images were adequate, but not all. Most refer is the relatively low pace of clinical follow-up information in the database, although in our analyze, miss of follow-up was not found to be linked to postoperative malalignment. It is important that the data populating the database be equally accurate as potential. Appropriate orthogonal images make appropriate assessment much easier and more accurate. To facilitate postmarket inquiry and evaluation, the improvement of data can and should be stressed. SIGN and its consort surgeons and hospitals continue to innovate in this region a well, working on providing incentives for follow-up documentation. A holocene prospective study highlighted, through meticulous follow-up, the respective barriers to clinical follow-up in many developing regions, but besides that clinicians and the SIGN database were capturing the patients with complications as these patients were more probable to return for follow-up appointments [ 18 ]. Developing trauma databases and registries in low- and middle-income countries is challenging, and although the SIGN surgery database is not a substitution for a proper register, it is a valid and significant help in coordinating trauma care and resources in developing future registries [ 2, 19 ]. The frequency of malalignment in femoral fractures treated with the SIGN intramedullary nail close approximated the incidence reported by Ricci et alabama. [ 11 ] for a north american trauma center. mugwump risk factors for radiographic malalignment included the acuity of surgical treatment, degree of comminution, and localization of the fracture in the diaphysis. The SIGN database was found to be a satisfactory resource for the purpose of retrospective radiographic research. This study provides back for the continued and expanded use of SIGN implants throughout the develop global and highlights an case of an organization that is using invention in technology and care pitch to meet an submerge challenge. Future prospective clinical cogitation with document clinical outcomes would be of capital benefit, and greater clinical and research resources are needed in the develop global as they deal with the growing trouble of musculoskeletal trauma .