Patient Hardware Research Articles

Assessing the efficacy of manual reduction and novel traction techniques for distal radius fractures: A randomized controlled trial.

One of the leading reasons that patients, particularly older persons, are brought to the orthopedic emergency room is a fracture at the end of the radius. In this study, a new traction method for distal radius fractures was compared with manual reduction. The census method was used in this clinical trial to study 45 patients (46 hands) who were referred to Hamedan Besat Hospital in 2021. Patients were randomly assigned to two groups. The manual reduction (pressure and traction by an assistant and a doctor) method was implemented in Group A, and the new traction procedure (pressure and traction by hardware or a device) was performed in Group B. The radiographic results of reduction in both groups were investigated and compared immediately and in the first and 6 weeks after surgery. The following results were observed in the new and manual groups in the sixth week after surgery: average volar tilt: 4.19 ± 3.79 and 4.08 ± 3.88 (p = 0.926), radial angulation: 2.18 ± 1.27 and 2.21 ± 1.35 (p = 0.934), radial shortening: 10.52 ± 0.65 and 10.56 ± 0.68 (p = 0.828), radial inclination: 22.52 ± 2.46 and 22.71 ± 2.01 (p = 0.787), dorsal angulation: -5.89 ± 0.33 and 5.22 ± -1.91 (p = 1.00), ulnar variance: 1.66 ± 0.90 and 1.67 ± 0.81 (p = 0.958), and average pain score: 2.40 ± 0.68 and 2.47 ± 0.73 (p = 0.737). The new reduction procedure with hardware in patients with distal radius fractures showed the same effect as the traditional method based on pressure and traction by the assistant and doctor in terms of radiographic changes and pain score of the fracture site.

Abstract 17614: “Watchful Waiting” - Successful Medical Management of an Infected Watchman Device

Description of Case: A 68-year-old male with a past medical history of alcoholic cirrhosis, ischemic cardiomyopathy, atrial fibrillation, ventricular tachycardia, and sick sinus syndrome presented with exertional dyspnea and lower extremity edema consistent with acutely decompensated systolic heart failure. He had multiple implantable cardiac devices including a watchman device. He was subsequently found to have methicillin-sensitive staphylococcus aureus (MSSA) bacteremia and developed sepsis. A transesophageal echocardiogram (TEE) was done to evaluate for infective endocarditis and a 1 cm mobile echodensity attached to the anterior aspect of the watchman device was found. Given active bacteremia, the echocardiographic appearance was felt to be most likely consistent with a vegetation. Due to significant medical and cardiac comorbidities, device extraction was deemed very high risk and deferred in favor of antibiotic therapy by a multi-disciplinary team. The patient was treated with intravenous cefazolin and oral rifampin. Clinical defervescence and clearance of bacteremia were achieved. A follow-up TEE in 6 weeks showed complete resolution of the watchman device vegetation. Discussion: Cardiac implantable devices provide significant morbidity and mortality benefits to patients but incur the potential risk of infection. Watchman device infection, though rare, has been reported. The current guidelines recommend the removal of all hardware in patients with established device infection. However, percutaneous, or surgical extraction of the watchman device bears significant risk and may not be feasible in all patients. Our case demonstrates the potential role of antimicrobial therapy alone with close surveillance in treating high-risk patients with watchman device infection.

Miniplate Versus Reconstruction Bar Fixation for Oncologic Mandibular Reconstruction with Free Fibula Flaps.

Fibula free flaps (FFF) are the gold standard tissue for the reconstruction of segmental mandibular defects. A comparison of miniplate (MP) and reconstruction bar (RB)-based fixation of FFFs has been previously described in a systematic review; however, long-term, single-center studies comparing the two plating methods are lacking. The authors aim to examine the complication profile between MPs and RBs at a single tertiary cancer center. We hypothesized that increased components and a lack of rigid fixation inherent to MPs would lead to higher rates of hardware exposure/failure. A retrospective review was performed from a prospectively maintained database at Memorial Sloan Kettering Cancer Center. All patients who underwent FFF-based reconstruction of mandibular defects between 2015 and 2021 were included. Data on patient demographics, medical risk factors, operative indications, and chemoradiation were collected. The primary outcomes of interest were perioperative flap-related complications, long-term union rates, osteoradionecrosis (ORN), return to the operating room (OR), and hardware exposure/failure. Recipient site complications were further stratified into two groups: early (<90 days) and late (>90 days). In total, 96 patients met the inclusion criteria (RB = 63, MP = 33). Patients in both groups were similar with respect to age, presence of comorbidities, smoking history, and operative characteristics. The mean follow-up period was 17.24 months. In total, 60.6 and 54.0% of patients in the MP and RB cohorts received adjuvant radiation, respectively. There were no differences in rates of hardware failure overall; however, in patients with an initial complication after 90 days, MPs had significantly higher rates of hardware exposure (3 vs. 0, p = 0.046). MPs were found to have a higher risk of exposed hardware in patients with a late initial recipient site complication. It is possible that improved fixation with highly adaptive RBs designed by computer-aided design/manufacturing technology explains these results. Future studies are needed to assess the effects of rigid mandibular fixation on patient-reported outcome measures in this unique population.

Atypical pathogens associated with cardiac implantable electronic device infections.

BackgroundCardiovascular implantable electronic device (CIED) infections are associated with significant morbidity and mortality making the identification of the causative organism critical. The vast majority of CIED infections are caused by Staphylococcal species. CIED infections associated with atypical pathogens are rare and have not been systematically investigated. The objective of this study is to characterize the clinical course, management and outcome in patients with CIED infection secondary to atypical pathogens.MethodsMedical records of all patients who underwent CIED system extraction at the University of Chicago Medical Center between January 2010 and November 2020 were retrospectively reviewed to identify patients with CIED infection. Demographic, clinical, infection‐related and outcome data were collected. CIED infections were divided into typical and atypical groups based on the pathogens isolated.ResultsAmong 356 CIED extraction procedures, 130 (37%) were performed for CIED infection. Atypical pathogens were found in 5.4% (n = 7) and included Pantoea species (n = 2), Kocuria species (n = 1), Cutibacterium acnes (n = 1), Corynebacterium tuberculostearicum (n = 1), Corynebacterium striatum (n = 1), Stenotrophomonas maltophilia (n = 1), and Pseudozyma ahidis (n = 1). All patients with atypical CIED infections were successfully treated with total system removal and tailored antibiotic therapy. There were no infection‐related deaths.ConclusionsCIED infections with atypical pathogens were rare and associated with good outcome if diagnosed early and treated with total system removal and tailored antimicrobial therapy. Atypical pathogens cultured from blood, tissue or hardware in patients with CIED infection should be considered pathogens and not contaminants.

Elective removal vs. retaining of hardware after osteosynthesis in asymptomatic patients\u2014a scoping review

BackgroundOsteosynthesis is the internal fixation of fractures or osteotomy by mechanical devices (also called hardware). After bone healing, there are two options: one is to remove the hardware, the other is to leave it in place. The removal of the hardware in patients without medical indication (elective) is controversially discussed. We performed a scoping review to identify evidence on the elective removal of hardware in asymptomatic patients compared to retaining of the hardware to check feasibility of performing a health technology assessment. In addition, we wanted to find out which type of evidence is available.MethodsA systematic literature search was performed in PubMed, Embase, EconLit, and CINAHL (November 2019). We included studies comparing asymptomatic patients with an internal fixation in the lower or upper extremities whose internal fixation was electively (without medical indication) removed or retained. We did not restrict inclusion to any effectiveness/safety outcome and considered any comparative study design as eligible. Study selection and data extraction was performed by two reviewers.ResultsWe identified 13476 titles/abstracts. Of these, we obtained 115 full-text publications which were assessed in detail against the inclusion criteria. We included 13 studies (1 RCT, 4 cohort studies, 8 before-after studies) and identified two ongoing RCTs. Nine assessed the removal of the internal fixation in the lower extremities (six of these syndesmotic screws in ankle fractures only) and two in the upper extremities. One study analysed the effectiveness of hardware removal in children in all types of extremity fractures. Outcomes reported included various scales measuring functionality, pain and clinical assessments (e.g. range of motion) and health-related quality of life.ConclusionsWe identified 13 studies that evaluated the effectiveness/safety of hardware removal in the extremities. The follow up times were short, the patient groups small and the ways of measurement differed. In general, clinical heterogeneity was high. Evidence on selected topics, e.g. syndesmotic screw removal is available nevertheless not sufficient to allow a meaningful assessment of effectiveness.

Результаты контролируемого клинического испытания аппаратной интраоперационной реинфузии крови, собранной из брюшной полости в условиях медленного и быстрого режимов

Conducting parallel clinical and experimental control on the basis of controlled clinical trials was necessitated by, on the whole, a more thorough assessment of the effectiveness of intraoperative blood reinfusion hardware with the establishment of the possibility of ‘transfer’ of experimental data on modeling cavity blood loss to a clinical platform. Objective: a comparative description of the results of the following studies performed in the context of controlled clinical trials: 1) experimental control — a study of blood collected from the pleural and abdominal cavities before and after intraoperative blood reinfusion hardware under simulation conditions in animal injuries of the abdomen and chest with the formation, respectively, of hemothorax and hemoperitoneum; 2) clinical control — a study of blood collected from the abdominal and thoracic cavities before and after intraoperative blood reinfusion hardware in patients with injuries and injuries of the chest and abdomen with the corresponding formation of hemothorax and hemoperitoneum.

Fate of Hardware in Spinal Infections.

Background: Removal of hardware with irrigation and debridement in patients with surgical site infections (SSIs) is performed commonly. However, the removal of hardware from patients with SSIs after spinal procedures is controversial. Moreover, primary spinal infections such as spondylodiscitis may require instrumentation along with surgical debridement. The purpose of this article was to evaluate critically and summarize the available evidence related to retention of hardware in patients with deep SSIs, and the use of instrumentation in surgical treatment of primary spinal infections. Methods: A literature search utilizing PubMed database was performed. Studies reporting the management of deep SSIs after instrumented spinal procedures, and of primary spinal infections using instrumentation published in peer-reviewed journals were included. Identified publications were evaluated for relevance, and data were extracted from the studies deemed relevant. Results: Because SSIs occur typically during the early post-operative period before stable bony fusion has been achieved, the removal of instrumentation may be associated with instability of the spinal column, pseudarthrosis, progressive deformity, pain, loss of function, and deterioration in the activities of daily living (ADL). Hence, early SSIs after spinal instrumentation are usually treated without removal of hardware. Moreover, primary spinal infections such as spondylodiscitis may require surgical debridement and instrumentation in cases with associated instability. Conclusions: Retaining or using instrumentation in patients with SSIs after spinal procedures or in patients with primary spinal infections, respectively, are commonly practiced in the field of spine surgery. Further evidence is required for the development of definitive algorithms to guide spine surgeons in decision making regarding the fate of instrumentation in the treatment of spinal infections.

The Usefulness of Perforator Flaps for the Definitive Management of Exposed Hardware in Patients with Lower Extremity Fracture

The Usefulness of Perforator Flaps for the Definitive Management of Exposed Hardware in Patients with Lower Extremity Fracture

Increased risk for complications following removal of hardware in patients with liver disease, pilon or pelvic fractures: A regression analysis

PurposeIndications for removing orthopedic hardware on an elective basis varies widely. Although viewed as a relatively benign procedure, there is a lack of data regarding overall complication rates after fracture fixation. The purpose of this study is to determine the overall short-term complication rate for elective removal of orthopedic hardware after fracture fixation and to identify associated risk factors. Materials and methodsAdult patients indicated for elective hardware removal after fracture fixation between July 2012 and July 2016 were screened for inclusion. Inclusion criteria included patients with hardware related pain and/or impaired cosmesis with complete medical and radiographic records and at least 3-month follow-up. Exclusion criteria were those patients indicated for hardware removal for a diagnosis of malunion, non-union, and/or infection. Data collected included patient age, gender, anatomic location of hardware removed, body mass index, ASA score, and comorbidities. Overall complications, as well as complications requiring revision surgery were recorded. Statistical analysis was performed with SPSS 20.0, and included univariate and multivariate regression analysis. Results391 patients (418 procedures) were included for analysis. Overall complication rates were 8.4%, with a 3.6% revision surgery rate. Univariate regression analysis revealed that patients who had liver disease were at significant risk for complication (p=0.001) and revision surgery (p=0.036). Multivariate regression analysis showed that: 1) patients who had liver disease were at significant risk of overall complication (p=0.001) and revision surgery (p=0.039); 2) Removal of hardware following fixation for a pilon had significantly increased risk for complication (p=0.012), but not revision surgery (p=0.43); and 3) Removal of hardware for pelvic fixation had a significantly increased risk for revision surgery (p=0.017). ConclusionsRemoval of hardware following fracture fixation is not a risk-free procedure. Patients with liver disease are at increased risk for complications, including increased risk for needing revision surgery following hardware removal. Patients having hardware removed following fixation for pilon fractures also are at increased risk for complication, although they may not require a return trip to the operating room. Finally, removal of pelvic hardware is associated with a higher return to the operating room.

The Contribution of Common Surgically Implanted Hardware to Functional MR Imaging Artifacts.

Blood oxygenation level-dependent MR imaging is increasingly used clinically to noninvasively assess cerebrovascular reactivity and/or language and motor function. However, many patients have metallic implants, which will induce susceptibility artifacts, rendering the functional information uninformative. Here, we calculate and interpret blood oxygenation level-dependent MR imaging artifact impact arising from surgically implanted hardware. A retrospective analysis of all blood oxygenation level-dependent MRIs (n = 343; B0 = 3T; TE = 35 ms; gradient echo EPI) acquired clinically (year range = 2006-2014) at our hospital was performed. Blood oxygenation level-dependent MRIs were most commonly prescribed for patients with cerebrovascular disease (n = 80) or patients undergoing language or motor localization (n = 263). Artifact volume (cubic centimeters) and its impact on clinical interpretation were determined by a board-certified neuroradiologist. Mean artifact volume associated with intracranial hardware was 4.3 ± 3.2 cm(3) (range = 1.1-9.4 cm(3)). The mean artifact volume from extracranial hardware in patients with cerebrovascular disease was 28.4 ± 14.0 cm(3) (range = 6.1-61.7 cm(3)), and in patients with noncerebrovascular disease undergoing visual or motor functional mapping, it was 39.9 (3)± 27.0 cm(3) (range = 6.9-77.1 cm(3)). The mean artifact volume for ventriculoperitoneal shunts was 95.7 ± 39.3 cm(3) (range = 64.0-139.6 cm(3)). Artifacts had no-to-mild effects on clinical interpretability in all patients with intracranial implants. Extracranial hardware artifacts had no-to-moderate impact on clinical interpretability, with the exception of 1 patient with 12 KLS-Martin maxDrive screws with severe artifacts precluding clinical interpretation. All examined ventriculoperitoneal shunts resulted in moderate-to-severe artifacts, limiting clinical interpretation. Blood oxygenation level-dependent MR imaging yields interpretable functional maps in most patients beyond a small (30-40 cm(3)) artifact surrounding the hardware. Exceptions were ventriculoperitoneal shunts, particularly those with programmable valves and siphon gauges, and large numbers of KLS-Martin maxDrive screws.

Perforating the atretic pulmonary valve with CTO hardware: Technical aspects.

To review the success and technical aspects of pulmonary valve (PV) perforation using chronic total occlusion (CTO) hardware in patients with pulmonary atresia and intact ventricular septum (PA-IVS). Interventional therapy is possible in selected patients with PA-IVS. Among the various interventional options available, radiofrequency and laser assisted perforation may be more successful, but require expertise and may be substantially costly. We describe the technique of mechanical catheter PV perforation using currently available coronary hardware meant for coronary CTO in nine cases with PA-IVS. After complete echocardiographic evaluation and informed parental consent was obtained, patients were electively intubated, mechanically ventilated, adequately heparinized and were placed on intravenous prostaglandin infusion. Basic steps involved were-localizing the atretic segment and accomplishing coaxial alignment of catheters using biplane fluoroscopy, crossing the atretic segment with the soft end of perforating guidewire, stabilizing the assembly and performing graded balloon dilatation with the balloon size never exceeding 130% of pulmonary annulus diameter. For crossing the atretic PV, a retrograde approach was used in one patient where the antegrade approach was not possible. The procedure was successful in 8/9 cases (89%). Valve opening was achieved in all eight patients with immediate fall in right ventricular (RV) systolic pressures. One neonate died following surgery after catheter induced RV perforation. All surviving cases were discharged from the hospital in good general condition with no evidence of heart failure and a room air oxygen saturation of >85%. No patient required an additional pulmonary irrigation procedure. With appropriate patient and hardware selection, PV perforation using readily available coronary hardware is feasible in PA-IVS. © 2014 Wiley Periodicals, Inc.

Proximal migration of hardware in patients undergoing midcarpal fusion with headless compression screws.

Background Scaphoid excision and limited intercarpal fusion is a common surgical procedure performed for degenerative disorders of the wrist including scapholunate advanced collapse (SLAC) and scaphoid nonunion advanced collapse (SNAC) wrist deformities. Postoperative screw migration is a rare but devastating complication that can result in severe degenerative changes in the radiocarpal joint. Questions/Purposes The purpose of this study is to report on a series of patients who developed proximal migration of their hardware following limited intercarpal fusions with headless compression screws. Patients and Methods Four patients were identified between 2001 and 2012 who were indicated for and underwent scaphoid excision and midcarpal fusions with headless compression screw fixation and subsequently developed hardware migration with screw protrusion into the radiocarpal joint. Detailed chart review was performed. Results Mean age at surgery was 64 years (57-69 years). All patients had the diagnosis of SLAC wrist. Mean time to detection of failure was 6 months (4-8 months). All patients demonstrated radiographic union prior to failure based on plain films. Radiographs revealed screw backout with erosion of the radial lunate facet in all patients. Calculated carpal height ratios demonstrated a drop from an average 44.2% to 39.5% at the time of hardware migration. All four patients underwent hardware removal. One patient was not indicated for any further surgery, and two patients underwent further revision surgery. All three patients reported complete pain relief. One patient refused a salvage procedure and had subsequent persistent pain. Conclusions This study reports a serious complication of scaphoid excision and midcarpal fusion performed with headless compression screws. We advise surgeons to be aware of this potential complication and consider employing methods to reduce the risk of hardware migration. Additionally, we recommend at least 8 months of clinical and radiographic follow-up postoperatively to enable early intervention if necessary. Level of Evidence Level IV, therapeutic study.

Arthroscopic removal of painful Bristow hardware

Complications of metallic hardware about the shoulder have been well documented in the literature. This case report presents a recreational athlete who presented to our office with a painful shoulder 4 years after a Bristow procedure. Radiographic imaging confirmed contact of the humeral head on the Bristow screw. In these unusual situations, arthroscopic evaluation, as this case suggests, should be considered: The patient's hardware was removed arthroscopically, obviating an open procedure and hospitalization.