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1.
J Spine Surg ; 9(1): 54-64, 2023 Mar 30.
Article in English | MEDLINE | ID: mdl-37038421

ABSTRACT

Background: To date, there are no studies comparing perioperative outcomes of cervical radiculopathy patients managed by anterior cervical discectomy with fusion (ACDF), cervical disc arthroplasty (CDA), or posterior cervical foraminotomy (PCF). To assess if there were differences in perioperative outcomes between cervical radiculopathy patients who can be appropriately treated with ACDF, CDA, or PCF. Methods: Patients diagnosed with cervical radiculopathy who underwent a single-level ACDF, CDA, or PCF between 2012 and 2019 were retrospectively identified from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database using current procedural terminology (CPT) codes. Patients were subsequently stratified into those who underwent ACDF, CDA, or PCF, and propensity score-matched to adjust for differences in patient demographics/characteristics. Differences were assessed in terms of operative time, healthcare utilization metrics (reoperations, readmissions, lengths-of-stay), as well as medical and surgical complications. Results: A total of 18,614 cervical radiculopathy patients undergoing surgery were identified (ACDF: n=15,862; CDA: n=1,731; PCF: n=1,021). After 1:1 propensity score matching (n=535 each), there were no differences in characteristics in patients undergoing ACDF, CDA, or PCF (P>0.05). PCF patients had statistically higher rates of reoperation (2.1%) than ACDF (0.4%), CDA (0.6%) patients (P=0.010). PCF patients also experienced higher rates of superficial infection (P=0.001), and deep infection (P=0.007), relative to ACDF and CDA patients. There were no other significant differences in medical/surgical complications between the ACDF, CDA, or PCF patients. Conclusions: Cervical radiculopathy patients undergoing PCF are associated with higher rates of perioperative infection and overall reoperation than ACDF or CDA. Further research is required to elucidate the mechanism behind this association.

2.
Global Spine J ; : 21925682231162556, 2023 Mar 08.
Article in English | MEDLINE | ID: mdl-36884351

ABSTRACT

STUDY DESIGN: Retrospective comparative study. OBJECTIVES: This study compares supine vs bending flexibility radiographs and evaluates their ability to predict residual postoperative lumbar curvature after selective thoracic fusion for Lenke 1 and 2 curves across different lumbar modifiers (A, B, and C) in adolescent idiopathic scoliosis (AIS). METHODS: This was a retrospective review of AIS Lenke 1 and 2 patients who underwent posterior fusion. All patients had preoperative flexibility radiographs including side-bending and supine posteroanterior (PA) films, in addition to pre- and post-operative standing PA and lateral radiographs. We used SurgiMap 2.0 software for all radiographic measurements. Pearson correlations and linear regression models were developed in SAS. RESULTS: A total of 86 patients were included mean age 14.9 years and follow-up 72.3 months. Preoperative supine lumbar Cobb angle and preoperative side-bending Cobb angles had similar, positive correlations with postoperative lumbar Cobb angle, r = .55 (P < .001) and r = .54 (P < .001), respectively. Three regression models were built to predict postoperative lumbar Cobb angles from preoperative information: Model S (R2 = .39) uses preoperative supine lumbar curve; Model B (R2 = .44) uses preoperative side-bending lumbar curve; Model SB (R2 = .49) uses both preoperative supine and side-bending lumbar curves. Model S and B performed just as well as Model SB. CONCLUSION: Either supine or side-bending radiographs alone may be used to estimate mean residual postoperative lumbar curvature after selective posterior thoracic fusion, but little is to be gained by taking both supine and side-bending radiographs.

3.
J Neurosurg Spine ; : 1-9, 2023 Feb 24.
Article in English | MEDLINE | ID: mdl-36840734

ABSTRACT

OBJECTIVE: The US-based Spinal Laminectomy versus Instrumented Pedicle Screw (SLIP) trial reported improvement in disability following laminectomy with fusion versus laminectomy alone for patients with lumbar spondylolisthesis. Despite using similar methods, a concurrent Swedish trial investigating the same question did not reach the same conclusion. The authors performed a simulation-based analysis to elucidate potential causes of these divergent results. METHODS: The mean and standard deviation of the preoperative and 2-year postoperative Oswestry Disability Index (ODI) scores for each study group (laminectomy with fusion and laminectomy alone) were collected from the spondylolisthesis stratum of the Swedish trial and used to create a MATLAB simulator using linear transformations to predict postoperative ODI distributions. Applying this simulator to both varied and published preoperative ODI distributions from the SLIP trial, the authors simulated the results of the US-based trial using treatment effects from the Swedish study and compared simulated US results to those published in the SLIP trial. RESULTS: Simulated US results showed that as preoperative disability increased, the difference in postoperative ODI scores grew between treatment groups and increasingly favored laminectomy alone (p < 0.0001). In 100 simulations of a similarly sized US trial, the average mean change in ODI scores postoperatively was significantly higher than was published for laminectomy alone in the SLIP trial (-21.3 vs -17.9), whereas it was significantly lower than published for fusion (-16.9 vs -26.3). CONCLUSIONS: The expected benefit of surgical treatments for spondylolisthesis varied according to preoperative disability. Adapting Swedish-estimated treatment effects to the US context mildly overapproximated the improvement in postoperative disability scores for laminectomy, but more severely underapproximated the improvement reported for laminectomy and fusion in the SLIP trial. The observed heterogeneity between these studies is influenced more by patient response to fusion than response to laminectomy. This analysis paves the way for future studies on the impact of preoperative treatment group heterogeneity, differences in surgical methods, and empirical design on reported clinical benefits. Although bayesian reanalysis of published randomized controlled trial data is susceptible to biases that typically limit post hoc analyses, the authors' method offers a simple and cost-effective approach to improve the understanding of published clinical trial results and their implications for future studies.

4.
J Spine Surg ; 9(4): 390-397, 2023 Dec 25.
Article in English | MEDLINE | ID: mdl-38196728

ABSTRACT

Background: Given differences in residency training background, there has been increasing interest in characterizing differential outcomes between orthopaedic surgeons (OS) and neurosurgeons (NS) with regards to outcomes after cervical disc arthroplasty (CDA). This study aimed to assess if there were differences in perioperative outcomes of CDA between OS and NS. Methods: Patients who underwent a single-level CDA between 2012 and 2019 were identified from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database using current procedural terminology codes. The patients were subsequently stratified into those who underwent CDA with OS versus NS, and propensity score-matched to adjust for differences in patient characteristics. Differences were assessed in medical and surgical complications, as well as operative time and healthcare utilization parameters [reoperations, readmissions, and lengths-of-stay (LOS)]. Results: A total of 2,148 patients were identified (NS: n=1,395; OS: n=753). After 1:1 propensity score matching (n=741 each), there were no differences in characteristics between patients who underwent CDA by OS versus NS (P>0.05). There were no significant differences in any of the medical or surgical complications between the two groups (P>0.05 for each). There was a significant difference in the operative time between NS and OS (103.7±36.18 vs. 98.75±36.69 minutes; P=0.009). There were no significant differences in readmissions, reoperations, or LOS between the two groups (P>0.05 for each). Conclusions: There were no differences in medical or surgical complications, as well as in reoperations, readmissions, and LOS in patients who underwent a single-level CDA between OS and NS. There was a statistically significant shorter operative time of four minutes for OS as compared to NS, which is unlikely to have clinical relevance.

5.
Clin Spine Surg ; 35(10): 422-430, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36447347

ABSTRACT

INTRODUCTION: Degenerative cervical myelopathy (DCM) is defined as dysfunction of the spinal cord as a result of compression from degenerative changes to surrounding joints, intervertebral disks, or ligaments. Symptoms can include upper extremity numbness and diminished dexterity, difficulty with fine manipulation of objects, gait imbalance, and incoordination, and compromised bowel and bladder function. Accurate diagnosis and evaluation of the degree of impairment due to degenerative cervical myelopathy remain a challenging clinical endeavor requiring a thorough and accurate history, physical examination, and assessment of imaging findings. METHODS: A narrative review is presented summarizing the current landscape of imaging modalities utilized in DCM diagnostics and the future direction of research for spinal cord imaging. RESULTS AND DISCUSSION: Current imaging modalities, particularly magnetic resonance imaging and, to a lesser extent, radiographs/CT, offer important information to aid in decision making but are not ideal as stand-alone tools. Newer imaging modalities currently being studied in the literature include diffusion tensor imaging, MR spectroscopy, functional magnetic resonance imaging, perfusion imaging, and positron emission tomography. These newer imaging modalities attempt to more accurately evaluate the physical structure, intrinsic connectivity, biochemical and metabolic function, and perfusion of the spinal cord in DCM. Although there are still substantial limitations to implementation, future clinical practice will likely be revolutionized by these new imaging modalities to diagnose, localize, surgically plan and manage, and follow patients with DCM.


Subject(s)
Diffusion Tensor Imaging , Spinal Cord Diseases , Humans , Spinal Cord Diseases/diagnostic imaging , Spinal Cord Diseases/surgery , Neck , Ligaments
6.
Article in English | MEDLINE | ID: mdl-35503776

ABSTRACT

INTRODUCTION: Traumatic proximal tibiofibular joint dislocations occur infrequently and are typically the result of high-energy trauma. These injuries can be a marker of limb injury severity because patients often sustain vascular injury and are at high risk of amputation. The purpose of this study was to present a systematic review of traumatic proximal tibiofibular joint dislocations and compare rates of associated injuries with a retrospective series of patients at a level 1 trauma center. The secondary objective was to report rates and clinical predictors of limb amputation. METHODS: A systematic review was conducted, identifying three studies meeting eligibility criteria. A retrospective chart review was conducted identifying 17 skeletally mature patients with proximal tibiofibular dislocation treated from January 2010 to February 2021. A chart review extracted patient demographics, fracture patterns, open fracture, preoprative and postoperative peroneal nerve injury, vascular injury, and amputation. Binary logistic regression analysis was used to identify clinical predictors of outcomes. RESULTS: Sixteen of 17 proximal tibiofibular injuries (94.1%) were associated with fracture, most commonly tibial shaft (n = 11, 68.75%). Twelve of 17 fractures (76.5%) were open. Five vascular injuries (29.4%) occurred requiring surgical intervention. Seven (41.2%) preoperative peroneal nerve deficits were noted; six had persistent deficits postoperatively or underwent amputation (average follow-up 31.3 ± 32.6 months). Two patients in the sample without preoperative peroneal nerve deficits were noted to exhibit them after fixation. Eight patients (47%) underwent an amputation, 7 (87.5%) of whom had an open fracture and 4 (50%) of whom had documented vascular injury. DISCUSSION: Traumatic proximal tibiofibular fractures indicate severe injury to the lower extremity with high risk for nerve injury and possible amputation. Patients who present with vascular injury and open fracture in association with proximal tibiofibular joint disruption may be at elevated risk of amputation.


Subject(s)
Fractures, Open , Joint Dislocations , Knee Dislocation , Vascular System Injuries , Humans , Joint Dislocations/epidemiology , Joint Dislocations/surgery , Knee Dislocation/epidemiology , Knee Dislocation/surgery , Retrospective Studies , Trauma Centers , Vascular System Injuries/epidemiology , Vascular System Injuries/surgery
7.
J Am Acad Orthop Surg ; 30(4): 168-176, 2022 Feb 15.
Article in English | MEDLINE | ID: mdl-35040808

ABSTRACT

INTRODUCTION: The purpose of this study was to investigate the cost-effectiveness of robotic-assisted total knee arthroplasty (TKA) versus conventional manual TKA in patients with knee osteoarthritis. METHODS: A Markov model simulated the lifetime outcomes of TKA of patients at average age 60 years. Costs of robotic-assisted TKA included a preoperative CT scan and the costs for acquisition and use of robotic equipment (average $706,250). We used three institutional case volumes to generate average per-case robotic costs: low volume (10 cases, $71,025 per case), mid volume (100 cases, $7,463 per case), and high volume (200 cases, $3,931 per case). Systematic reviews were used to determine early (≤1 year) and late (> 1 year) revision rates after robotic-assisted TKA (0.3 and 0.6%, respectively) and conventional TKA (0.78% and 1.5%, respectively). Outcomes were total costs and health outcomes measured in quality-adjusted life-years (QALYs). Costs and QALYs were organized into incremental cost-effectiveness ratios (ICERs). A procedure was considered cost-effective if its ICER fell below willingness-to-pay (WTP) thresholds of $50,000 and $100,000/QALY. Sensitivity analyses evaluated the effect of data uncertainty. RESULTS: Robotic-assisted TKA produced 13.55 QALYs versus 13.29 QALYs for conventional TKA. Total costs per case for robotic-assisted TKA were $92,823 (low volume), $29,261 (mid volume), and $25,730 (high volume) compared with $25,113 for conventional. The ICERs for robotic-assisted TKAs were $256,055/QALY (low volume), $15,685/QALY (mid volume), and $2,331/QALY (high volume). ICERs for mid- and high-volume institutions were below WTP. Average number needed to treat was >42 and >24 robotic-assisted TKAs for cost-effectiveness at the $50,000 and $100,000/QALY WTP. Robotic-assisted TKAs remained cost-effective when annual revision rates <1.6% and quality of life values were >0.85. CONCLUSION: With lower annualized revision rates and higher postoperative quality of life, robotic-assisted TKAs potentially offer improved health outcomes, especially when annual institutional case volume >24 cases per year. Continued prospective investigation will be crucial to demonstrate the value of this new technology.


Subject(s)
Arthroplasty, Replacement, Knee , Osteoarthritis, Knee , Robotic Surgical Procedures , Cost-Benefit Analysis , Humans , Middle Aged , Osteoarthritis, Knee/surgery , Prospective Studies , Quality of Life , Quality-Adjusted Life Years
8.
J Surg Educ ; 79(1): 112-121, 2022.
Article in English | MEDLINE | ID: mdl-34301519

ABSTRACT

INTRODUCTION: The Orthopaedic Interview Spreadsheet (OIS) is an annual, open-source Google sheet used by prospective orthopaedic surgery applicants to share applicant statistics, interview data, and program information. The purpose of the current study was to determine whether self-reported applicant statistics within the OIS were representative of the official orthopaedic applicant pool, as reported by the National Resident Matching Program (NRMP). METHODS: A total of 243 self-reported applicants from the 2017-2018 (n=136) and 2019-20 (n=107) orthopaedic surgery residency application cycles who used the OIS were identified. USMLE: Step1 scores, Step2 scores, total research items reported on the Electronic Residency Application Service® (ERAS), and Alpha Omega Alpha (AOA) status were compared to NRMP weighted means from the 2018 and 2020 Charting Outcomes in the Match reports using one-sampled t-tests and one-sample binomial tests. RESULTS: According to the 2017-2018 OIS data, the self-reported Step 1 score (n=126) (M:251.3 ±10.5, p<0.001), Step 2 score (n=113) (M:259.4 ±8.5, p<0.001), and total research items (n=129) (M:8.9 ±8.6, p=0.019) were all statistically different from their respective NRMP weighted means. The NRMP cohort of applicants with AOA membership (36.4%) was significantly different than the OIS cohort (53.7%), (p<0.001). Similarly, for 2019-2020, the OIS Step 1 score (n=105) (M: 248.8 ±0.7, p=0.016) and Step 2 score (n=93) (M:257.4 ±9.4, p<0.001) were statistically different from their respective NRMP weighted means. OIS total research items (n=102) (M: 15.0 ±15.2, p=0.656) was not statistically different from its NRMP weighted mean. The NRMP cohort of applicants with AOA membership (36.4%) was significantly different than the OIS cohort (53.7%), (p=0.040). CONCLUSION: Prospective applicants should be cautious about using this document to solely gauge their competitiveness during the application process. The real value of the OIS is its non-quantifiable message board functions that provide peer-to-peer mentorship and the collaborative, uncensored community it fosters.


Subject(s)
Internship and Residency , Orthopedic Procedures , Orthopedics , Humans , Orthopedics/education , Prospective Studies , Self Report , United States
9.
Spine J ; 21(10): 1718-1728, 2021 10.
Article in English | MEDLINE | ID: mdl-33971323

ABSTRACT

BACKGROUND: Prolonged operative time of single-level ACDF has been associated with adverse postoperative outcomes. The current literature does not contain a comprehensive quantitative description of these associations PURPOSE: This study characterized the associations between single-level anterior cervical discectomy and fusion(ACDF) operative time and (1)30-day postoperative healthcare utilization, and (2)the incidence of local wound complications, need for transfusion and mechanical ventilation. DESIGN/SETTING: Retrospective database analysis PATIENT SAMPLE: The American College of Surgeons National Surgical Quality Improvement Program(ACS-NSQIP) database was queried for single-level ACDF cases(2012-2018) using current procedural terminology codes. A total of 24,593 cases were included. OUTCOME MEASURES: Primary outcomes included healthcare utilization(lengths of stay[LOS], discharge dispositions, 30-day readmissions, and reoperations) per operative time category. The secondary outcome was the incidence of wound complications, blood transfusion and need for ventilation per operative time category. METHODS: Multivariate regression determined operative time categories associated with increased risk while adjusting for patient demographics and comorbidities. Predictive spline regression models visualized the associations. RESULTS: Compared to the reference operative time of 81-100-minutes, the 101-120-minute category was associated with higher odds of LOS >2 days(OR:1.36,95%CI(1.18-1.568);p<.001) and non-home discharge(OR:1.341,95%CI(1.081-1.664);p=.008). Three-times greater odds of LOS >2 days(OR:3.367,95%CI(2.719-4.169); p<.001) and twice the odds of non-home discharge(OR:2.174,95%CI(1.563-3.022);p<.001) were detected at 181-200-minutes. The highest operative time category(≥221 minutes) was associated with the highest odds of LOS>2 days(OR:4.838,95%CI(4.032-5.804);p<.001), non-home discharge(OR:2.687,95%CI(2.045-3.531);p<.001) and reoperation(OR:1.794,95%CI(1.094-2.943);p=.021). Patients within the 201-220 and the ≥221-minute categories exhibited a significant association with greater odds of transfusion(OR:8.57,95%CI(2.321-31.639);p<.001, and OR:11.699, 95%CI(4.179-32.749);p=.001, respectively). Spline regression demonstrated that the odds of LOS >2 days, non-home discharge disposition, reoperation and bleeding requiring transfusion events began to rise, starting at 94, 91.6, 91.6, and 93.3 minutes of operative time, respectively. CONCLUSION: This study demonstrated that prolonged operative time is associated with increased odds of healthcare utilization and transfusion after single-level ACDF. Operative times greater than 91 minutes may carry higher odds of postoperative complications.


Subject(s)
Patient Discharge , Spinal Fusion , Blood Transfusion , Cervical Vertebrae/surgery , Diskectomy/adverse effects , Humans , Length of Stay , Operative Time , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Spinal Fusion/adverse effects
12.
J Bone Joint Surg Am ; 102(18): e104, 2020 Sep 16.
Article in English | MEDLINE | ID: mdl-32453118

ABSTRACT

BACKGROUND: Use of platelet-rich-plasma (PRP) injections for treating knee osteoarthritis has increased over the past decade. We used cost-effectiveness analysis to evaluate the value of PRP in delaying the need for total knee arthroplasty (TKA). METHODS: We developed a Markov model to analyze the baseline case: a 55-year-old patient with Kellgren-Lawrence grade-II or III knee osteoarthritis undergoing a series of 3 PRP injections with a 1-year delay to TKA versus a TKA from the outset. Both health-care payer and societal perspectives were included. Transition probabilities were derived from systematic review of 72 studies, quality-of-life (QOL) values from the Tufts University Cost-Effectiveness Analysis Registry, and individual costs from Medicare reimbursement schedules. Primary outcome measures were total costs and quality-adjusted life years (QALYs), organized into incremental cost-effectiveness ratios (ICERs) and evaluated against willingness-to-pay thresholds of $50,000 and $100,000. One and 2-way sensitivity analyses were performed as well as a probabilistic analysis varying PRP-injection cost, TKA delay intervals, and TKA outcomes over 10,000 different simulations. RESULTS: From a health-care payer perspective, PRP resulted in 14.55 QALYs compared with 14.63 for TKA from the outset, with total health-care costs of $26,619 and $26,235, respectively. TKA from the outset produced a higher number of QALYs at a lower cost, so it dominated. From a societal perspective, PRP cost $49,090 versus $49,424 for TKA from the outset. The ICER for TKA from the outset was $4,175 per QALY, below the $50,000 willingness-to-pay threshold. Assuming the $728 published cost of a PRP injection, no delay time that was <10 years produced a cost-effective course. When the QOL value was increased from the published value of 0.788 to >0.89, PRP therapy was cost-effective with even a 1-year delay to TKA. CONCLUSIONS: When considering direct and unpaid indirect costs, PRP injections are not cost-effective. The primary factor preventing PRP from being cost-effective is not the price per injection but rather a lack of established clinical efficacy in relieving pain and improving function and in delaying TKA. PRP may have value for higher-risk patients with high perioperative complication rates, higher TKA revision rates, or poorer postoperative outcomes. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.


Subject(s)
Cost-Benefit Analysis , Osteoarthritis, Knee/economics , Osteoarthritis, Knee/therapy , Platelet-Rich Plasma , Arthroplasty, Replacement, Knee , Humans , Markov Chains , Middle Aged , Time Factors
13.
Spine J ; 20(3): 329-336, 2020 03.
Article in English | MEDLINE | ID: mdl-31654809

ABSTRACT

BACKGROUND CONTEXT: With the increasing emphasis on value-based healthcare in Centers for Medicare and Medicaid Services reimbursement structures, bundled payment models have been adopted for many orthopedic procedures. Immense variability of patients across hospitals and providers makes these models potentially less viable in spine surgery. Machine-learning models have been shown reliable at predicting patient-specific outcomes following lumbar spine surgery and could, therefore, be applied to developing stratified bundled payment schemes. PURPOSE: (1) Can a Naïve Bayes machine-learning model accurately predict inpatient payments, length of stay (LOS), and discharge disposition, following dorsal and lumbar fusion? (2) Can such a model then be used to develop a risk-stratified payment scheme? STUDY DESIGN: A Naïve Bayes machine-learning model was constructed using an administrative database. PATIENT SAMPLE: Patients undergoing dorsal and lumbar fusion for nondeformity indications from 2009 through 2016 were included. Preoperative inputs included age group, gender, ethnicity, race, type of admission, All Patients Refined (APR) risk of mortality, APR severity of illness, and Clinical Classifications Software diagnosis code. OUTCOME MEASURES: Predicted resource utilization outcomes included LOS, discharge disposition, and total inpatient payments. Model validation was addressed via reliability, model output quality, and decision speed, based on application of training and validation sets. Risk-stratified payment models were developed according to APR risk of mortality and severity of illness. RESULTS: A Naïve Bayes machine-learning algorithm with adaptive boosting demonstrated high reliability and area under the receiver-operating characteristics curve of 0.880, 0.941, and 0.906 for cost, LOS, and discharge disposition, respectively. Patients with increased risk of mortality or severity of illness incurred costs resulting in greater inpatient payments in a patient-specific tiered bundled payment, reflecting increased risk on institutions caring for these patients. We found that a large range in expected payments due to individuals' preoperative comorbidities indicating an individualized risk-based model is warranted. CONCLUSIONS: A Naïve Bayes machine-learning model was shown to have good-to-excellent reliability and responsiveness for cost, LOS, and discharge disposition. Based on APR risk of mortality and APR severity of illness, there was a significant difference in episode costs from lowest to highest risk strata. After using normalized model error to develop a risk-adjusted proposed payment plan, it was found that institutions incur significantly more financial risk in flat bundled payment models for patients with higher rates of comorbidities.


Subject(s)
Spinal Fusion , Aged , Bayes Theorem , Humans , Machine Learning , Medicare , Reproducibility of Results , United States
14.
J Am Heart Assoc ; 8(11): e012756, 2019 06 04.
Article in English | MEDLINE | ID: mdl-31433706

ABSTRACT

Background Regulators increasingly rely on registries for decision making related to high-risk medical devices in the United States. However, the limited uniform standards for registries may create substantial variability in registry implementation and utility to regulators. We surveyed the current landscape of US cardiovascular device registries and chart the extent of inconsistency in goals, administration, enrollment procedures, and approach to data access. Methods and Results A systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines identified studies (1995-2017) referencing cardiovascular device registries with a US-based institution. Registries were then evaluated by reviewing associated articles and websites. Extracted data included device type, primary scientific aim(s), funding, stewardship (eg, administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. The 138 cardiovascular device registries in the cohort covered devices addressing interventional cardiology (65.9%), arrhythmias (15.2%), heart failure (10.1%), and valvular disease (10.1%). While the majority (55.8%) were industry-funded, stewardship was predominantly overseen by academic centers (74.0%). Most registry participation was voluntary (77.5%), but a substantial minority (19.7%) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primarily accessible only to stewards (84.1%), with 13.8% providing pathways for external applications. Conclusions The majority of cardiovascular device registries were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries suggests a role for regulators to further strengthen guidelines to improve quality, consistency, and ethical standards.


Subject(s)
Cardiovascular Diseases/therapy , Consumer Product Safety , Product Surveillance, Postmarketing , Prosthesis Implantation/instrumentation , Registries , Research Design , Access to Information , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/physiopathology , Consumer Product Safety/legislation & jurisprudence , Humans , Informed Consent , Patient Safety , Patient Selection , Prosthesis Design , Prosthesis Implantation/adverse effects , Registries/ethics , Research Design/legislation & jurisprudence , Research Support as Topic , Risk Factors
15.
J Bone Joint Surg Am ; 100(3): e13, 2018 Feb 07.
Article in English | MEDLINE | ID: mdl-29406347

ABSTRACT

BACKGROUND: There is no consensus on the optimal fixation method for patients who require a surgical procedure for distal radial fractures. We used cost-effectiveness analyses to determine which of 3 modalities offers the best value: closed reduction and percutaneous pinning, open reduction and internal fixation, or external fixation. METHODS: We developed a Markov model that projected short-term and long-term health benefits and costs in patients undergoing a surgical procedure for a distal radial fracture. Simulations began at the patient age of 50 years and were run over the patient's lifetime. The analysis was conducted from health-care payer and societal perspectives. We estimated transition probabilities and quality-of-life values from the literature and determined costs from Medicare reimbursement schedules in 2016 U.S. dollars. Suboptimal postoperative outcomes were determined by rates of reduction loss (4% for closed reduction and percutaneous pinning, 1% for open reduction and internal fixation, and 11% for external fixation) and rates of orthopaedic complications. Procedural costs were $7,638 for closed reduction and percutaneous pinning, $10,170 for open reduction and internal fixation, and $9,886 for external fixation. Outputs were total costs and quality-adjusted life-years (QALYs), discounted at 3% per year. We considered willingness-to-pay thresholds of $50,000 and $100,000. We conducted deterministic and probabilistic sensitivity analyses to evaluate the impact of data uncertainty. RESULTS: From the health-care payer perspective, closed reduction and percutaneous pinning dominated (i.e., produced greater QALYs at lower costs than) open reduction and internal fixation and dominated external fixation. From the societal perspective, the incremental cost-effectiveness ratio for closed reduction and percutaneous pinning compared with open reduction and internal fixation was $21,058 per QALY and external fixation was dominated. In probabilistic sensitivity analysis, open reduction and internal fixation was cost-effective roughly 50% of the time compared with roughly 45% for closed reduction and percutaneous pinning. CONCLUSIONS: When considering data uncertainty, there is only a 5% to 10% difference in the frequency of probability combinations that find open reduction and internal fixation to be more cost-effective. The current degree of uncertainty in the data produces difficulty in distinguishing either strategy as being more cost-effective overall and thus it may be left to surgeon and patient shared decision-making. LEVEL OF EVIDENCE: Economic Level III. See Instructions for Authors for a complete description of levels of evidence.


Subject(s)
Computer Simulation , Cost-Benefit Analysis , Fracture Fixation/economics , Fracture Fixation/methods , Radius Fractures/surgery , Aged , Female , Humans , Male , Markov Chains , Medicare/economics , Middle Aged , Quality of Life , Quality-Adjusted Life Years , United States
16.
Spine (Phila Pa 1976) ; 43(3): 179-184, 2018 02 01.
Article in English | MEDLINE | ID: mdl-28632646

ABSTRACT

STUDY DESIGN: Adult patients who received computed tomography (CT) alone or CT-magnetic resonance imaging (MRI) for the evaluation of cervical spine injury. OBJECTIVE: To evaluate the utility of CT-MRI in the diagnosis of cervical spine injury using propensity-matched techniques. SUMMARY OF BACKGROUND DATA: The optimal evaluation (CT alone vs. CT and MRI) for patients with suspected cervical spine injury in the setting of blunt trauma remains controversial. METHODS: The primary outcome was the identification of a cervical spine injury, with decision for surgery and change in management considered secondarily. A propensity score was developed based on the likelihood of receiving evaluation with CT-MRI, and this score was used to balance the cohorts and develop two groups of patients around whom there was a degree of clinical equipoise in terms of the imaging protocol. Logistic regression was used to evaluate for significant differences in injury detection in patients evaluated with CT alone as compared to those receiving CT-MRI. RESULTS: Between 2007 and 2014, 8060 patients were evaluated using CT and 693 with CT-MRI. Following propensity-score matching, each cohort contained 668 patients. There were no significant differences between the two groups in baseline characteristics. The odds of identifying a cervical spine injury were significantly higher in the CT-MRI group, even after adjusting for prior injury recognition on CT (odds ratios 2.6; 95% confidence interval 1.7-4.0; P < 0.001). However, only 53/668 patients (8%) in the CT-MRI group had injuries identified on MRI not previously recognized by CT. Only a minority of these patients (n = 5/668, 1%) necessitated surgical intervention. CONCLUSION: In this propensity-matched cohort, the addition of MRI to CT alone identified missed injuries at a rate of 8%. Only a minority of these were serious enough to warrant surgery. This speaks against the standard addition of MRI to CT-alone protocols in cervical spine evaluation after trauma. LEVEL OF EVIDENCE: 3.


Subject(s)
Cervical Vertebrae/injuries , Magnetic Resonance Imaging , Spinal Injuries/diagnostic imaging , Tomography, X-Ray Computed , Adult , Aged , Female , Humans , Male , Middle Aged , Propensity Score , Retrospective Studies , Spinal Injuries/etiology , Spinal Injuries/surgery , Wounds, Nonpenetrating/complications
18.
J Hand Surg Am ; 40(8): 1692-702, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26143029

ABSTRACT

Injury to the scapholunate interosseous ligament is one of the most common causes of carpal instability and can impart considerable compromise to the patient's hand function. However, the management of scapholunate ligament injuries remains a dynamic concept, especially with regard to the multitude of options and techniques that exist for its surgical treatment. We present a thorough review of scapholunate anatomy and morphology, and the role of the scapholunate articulations in the kinetics and pathomechanics of wrist instability. We also review the current literature on the biomechanical properties of the scapholunate ligament and its subcomponents. A sound understanding of the anatomy and biomechanics of the scapholunate ligament can clarify its instability and may better orient current reconstructive procedures or pioneer better future techniques.


Subject(s)
Carpal Joints , Ligaments, Articular/anatomy & histology , Ligaments, Articular/physiology , Lunate Bone , Scaphoid Bone , Humans , Range of Motion, Articular , Wrist Joint
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