Assessing the Efficacy of Certificate of Need Laws Through Total Joint Arthroplasty.

ABSTRACT: Lawmakers suggest Certificate of Need (CON) laws' main goals are increasing access to healthcare, increasing quality of healthcare, and decreasing healthcare costs. This retrospective database study aims to evaluate the effectiveness of CON through analysis of total knee, hip, and shoulder arthroplasty (TKA, THA, and TSA, respectively). A review was performed using the Humana Insurance PearlDiver national database from 2007 to 2015. Access to care was approximated by the rates of total joint arthroplasty (TJA) in patients diagnosed with arthritis to the corresponding joint. The quality of care was assessed using complication rates after TJA. The total cost of TJA was approximated from average reimbursement to the healthcare facility per procedure. Patients in states without CON programs received TKA, THA, and TSA more frequently (p < .0001, p = .250, p = .019). No significant difference was found in studied complication rates between CON and non-CON states. Similarly, there was no trend found when comparing the cost of each procedure in CON versus non-CON states. These findings are consistent with other recent studies detailing the impact of CON regulation on THA and TKA. The apparent nonsuperiority of CON states in achieving their purported goals may call into question the effectiveness of additional bureaucracy and regulation, suggesting a need for further examination.

Medical Malpractice Litigation Following Primary Total Joint Arthroplasty: A Comprehensive, Nationwide Analysis of the Past Decade.

BACKGROUND: The purpose of this study is to (1) characterize the most common reasons of medical malpractice litigation against adult reconstruction surgeons and (2) report on the outcomes of these lawsuits. METHODS: The Westlaw legal research database was queried for cases between 2008 and 2018 related to total hip and knee arthroplasty (THA and TKA) in the United States. Causes of the lawsuit, patient characteristics, demographics, state/outcome of verdict or settlement, and indemnity payments were noted. RESULTS: A total of 148 records (81 females [55%], 67 males [45%]; 83 TKAs [56%], 65 THAs [44%]) were included in the final analysis. For all patients, infection was the leading cause for malpractice litigation (22%) followed by nerve injury (20%). For TKA, infection was the most common cause of lawsuit (33%). In THA cases, nerve injury was the most common reason for lawsuit (38%), followed by leg-length discrepancy (26%). Procedural errors were alleged in 72% of cases, while diagnostic and post-surgical errors were cited in 55% and 32% of cases. A defense verdict occurred in 74% of cases, plaintiff verdict in 21%, and parties settled in 5%. CONCLUSION: Infection and nerve injury were the most common reasons for litigation in TKA and THA, respectively. The most likely outcome of these lawsuits was a jury verdict in favor of the surgeon. Regardless, surgeons should be cognizant of the potential for lawsuit due to these complications and should ensure they inform patients of these potential complications of TJA preoperatively.

Infection Following Total Joint Arthroplasty Is the Main Cause of Litigation: Data From One Metropolitan Area.

BACKGROUND: A prior survey of members of the American Association of Hip and Knee Surgeons revealed that 78% of responding surgeons were named as a defendant in at least 1 lawsuit, and 69% of these lawsuits were dismissed or settled out of court. The most common sources of litigation were nerve injury, limb-length discrepancy, and infection. This study examined common reasons for lawsuits after total joint arthroplasty (TJA) in a single metropolitan area. METHODS: A retrospective review of lawsuits filed between 2009 and 2015 in a 5-county metropolitan area was performed, including 30 hospitals and 113 TJA surgeons. Complaints underwent a manual review to determine the number of lawsuits and the specific allegations filed against each surgeon. RESULTS: Thirty-one (27.4%) surgeons were named as a defendant in at least 1 lawsuit. Eighty-three total lawsuits were filed during the period, 50 of which were dismissed or settled outside of court. Top reasons for lawsuits were, in descending order, infection, nerve injury, chronic pain, vascular injury, periprosthetic fracture, retention of foreign body, dislocation, limb-length discrepancy, venous thromboembolism, loosening, compartment syndrome, and other medical complaints. CONCLUSION: Infection appears to be the basis of most lawsuits after TJA. Surgeons should be aware of the potential for a lawsuit for complications and should strive to better communicate with patients regarding preoperative informed consent and disclosure after adverse events. Surgeons should minimize performing surgery in patients at high risk of complications, such as patients with a higher likelihood of developing postoperative infection or patients on chronic pain medications.

Customizable pre-printed consent forms: a solution in light of the Montgomery ruling.

INTRODUCTION: This article presents an audit cycle supported quality improvement project addressing best practice in the consent process for lower limb arthroplasty which takes into account the new standard in surgical consent and the importance of material risks. METHODS: 50 consecutive total hip and total knee replacement consent forms over a 3-month period were reviewed for legibility and completeness. Following the introduction of a new, pre-printed but customizable consent form the review process was repeated. RESULTS: The introduction of a customizable, pre-printed consent form that can be adjusted to reflect the individualized material risks of each patient increased legibility, reduced inappropriate human error variation and abolished the use of abbreviations and medical jargon. CONCLUSIONS: When used as part of an extended consent process, the authors feel that the use of pre-printed but customizable consent forms improves legibility, completeness and consistency and also provides the ability to highlight those complications that are of particular importance for that patient to satisfy the new accepted standard in surgical consent.

Reported Litigation Associated With Primary Hip and Knee Arthroplasty.

BACKGROUND: Greater than 75% of arthroplasty surgeons report having been the subject of a malpractice lawsuit. Despite this, few studies have analyzed the causes of litigation following total joint arthroplasty in the United States. METHODS: This study is a retrospective analysis of malpractice lawsuits following total hip and knee arthroplasty using VerdictSearch, a database encompassing legal cases compiled from February 1988 to May 2015. Complications leading to litigation were categorized and assessed for patient, surgeon, and lawsuit factors. All monetary awards were reflected for inflation. RESULTS: A total of 213 lawsuits were analyzed (119 total hip and 94 total knee arthroplasty cases). Overall, 15.0% of cases ended in settlement and 29.6% ended in a verdict in favor of the plaintiff (physician loss). The average payment for cases lost in court ($1,929,822 ± $3,679,572) was significantly larger than cases that ended in settlement ($555,347 ± $822,098) (P = .006). The most common complication following hip arthroplasty was "nerve injury" (29 cases, settlement rate: 10.3%, physician loss rate: 53.9%, and average payment: $1,089,825). The most common complication following knee arthroplasty was "pain or weakness" (17 cases, settlement rate: 5.9%, physician loss rate: 6.3%, and average payment: $451,867). Technical complications were the most likely complications to result in a physician loss (P = .019). CONCLUSION: While complications like "pain and weakness" are less likely to result in favorable litigation for patients, the presence of an objective technical complication or nerve injury was associated with an increased risk of a physician loss and a higher payment.

Lawsuits After Primary and Revision Total Hip Arthroplasties: A Malpractice Claims Analysis.

BACKGROUND: As the prevalence of total hip arthroplasty (THA) expands, so too will complications and patient dissatisfaction. The goal of this study was to identify the common etiologies of malpractice suits and costs of claims after primary and revision THAs. METHODS: Analysis of 115 malpractice claims filed for alleged neglectful primary and revision THA surgeries by orthopedic surgeons insured by a large New York state malpractice carrier between 1983 and 2011. RESULTS: The incidence of malpractice claims filed for negligent THA procedures is only 0.15% per year in our population. In primary cases, nerve injury ("foot drop") was the most frequent allegation with 27 claims. Negligent surgery causing dislocation was alleged in 18 and leg length discrepancy in 14. Medical complications were also reported, including 3 thromboembolic events and 6 deaths. In revision cases, dislocation and infection were the most common source of suits. The average indemnity payment was $386,153 and the largest single settlement was $4.1 million for an arterial injury resulting in amputation after a primary hip replacement. The average litigation cost to the insurer was $61,833. CONCLUSION: Nerve injury, dislocation, and leg length discrepancy are the most common reason for malpractice after primary THA. Orthopedic surgeons should continue to focus on minimizing the occurrence of these complications while adequately incorporating details about the risks and limitations of surgery into their preoperative education.

Hip Arthroplasty Malpractice Claims in the Netherlands: Closed Claim Study 2000-2012.

BACKGROUND: A total hip arthroplasty (THA) is a successful and reliable operation with few complications. These complications however, do form a potential source for compensation claims. In the Netherlands, there are no studies available concerning filed claims after THA. The aim of this study was to determine the incidence of claims related to THAs in the Netherlands and the reasons to claim, which claims lead to compensation, the costs involved for the insurer, and the demographics of the claimants. METHODS: In this observational study, we analyzed all closed claims from 2000 to 2012 from the national largest insurer of medical liability and compared it to data from our national implant registry in the Netherlands. With the intention to contribute to prevention, we have identified the demographics of the claimant, the reasons for filing claims, and the outcome of claims. RESULTS: Overall, 516 claims were expressed in 280 closed claim files after THA. Claims were most often related to sciatic nerve injury (19.6%). Most claimants were women (71.6%) with an average age of 63.1 years. The median cost per compensated claim is €5.921. CONCLUSION: The claimant is more likely to be female and to be younger than the average patient receiving a THA. The incidence of a claim after a THA is 0.14%-0.30%. Nerve damage is the most common reason to file for compensation. The distribution in reasons to claim does not resemble the complication rate in literature after a THA. The outcome of this study can be used to improve patient care, safety, and costs.

The 72-Hour Medicare Mandate After Total Joint Arthroplasty: Is This Medically Necessary?

INTRODUCTION: Currently, Medicare total joint arthroplasty patients are required to stay postoperatively 3 days in the hospital before discharge to a skilled nursing facility (SNF). We evaluated Medicare's mandated 3-night hospital stay rule to find out how many total joint arthroplastic patients are safe for discharge to SNFs on postoperative day 2 (POD2). METHODS: This is a retrospective case series analyzing Medicare primary total hip or total knee arthroplastic patients at a single hospital over 1 year. Patients meeting 15 separate criteria by POD2 were considered safe for discharge home rather than to a SNF. RESULTS: Of 259 patients, 47.88% met discharge criteria to SNF POD2. 31.66% did not meet 1, 13.13% did not meet 2, and 6.95% did not meet ≥3 criteria on POD2. Common criteria delaying discharge were blood pressure abnormalities, increasing or elevated white blood cell count, cardiac abnormalities, and fever. Thirty-day readmission rate for patients in the group safe for discharge POD2 was 1.75%. CONCLUSION: Of the total, 47.88% of patients required to stay by the Medicare 3-night stay rule were safe for discharge to SNF on POD2 without an increase in readmission rate at 30 days when compared to our institutional mean.

Litigation after hip and knee replacement in the National Health Service.

The results of hip and knee replacement surgery are generally regarded as positive for patients. Nonetheless, they are both major operations and have recognised complications. We present a review of relevant claims made to the National Health Service Litigation Authority. Between 1995 and 2010 there were 1004 claims to a value of £41.5 million following hip replacement surgery and 523 claims to a value of £21 million for knee replacement. The most common complaint after hip surgery was related to residual neurological deficit, whereas after knee replacement it was related to infection. Vascular complications resulted in the highest costs per case in each group.Although there has been a large increase in the number of operations performed, there has not been a corresponding relative increase in litigation. The reasons for litigation have remained largely unchanged over time after hip replacement. In the case of knee replacement, although there has been a reduction in claims for infection, there has been an increase in claims for technical errors. There has also been a rise in claims for non-specified dissatisfaction. This information is of value to surgeons and can be used to minimise the potential mismatch between patient expectation, informed consent and outcome.

Can patient injury claims be utilised as a quality indicator?

OBJECTIVES: To examine the association between patient injury claims and well-known quality indicators and to assess whether claims can be utilised in performance measurement. METHODS: Data were derived from administrative registers and comprised hip and knee replacement patients (n=34181) in Finland from 1998 to 2003. Hospital-level correlations were calculated between claims and quality indicators (5-year revision rate, 1-year deep infection rate, and 14-day readmission rate), while logistic regression analysis was used to analyze patient-level data for an association between claims and quality indicators. RESULTS: Correlations between claims and revisions as well as claims and infections were statistically significant, with correlation coefficients ranging from 0.21 to 0.62. In the regression analysis, both the revision and the infection indicator had a positive and statistically significant association with filing a claim (OR 1.002; 95% CI 1.001-1.003 and 1.001; 1.00005-1.001, respectively) and obtaining compensation (1.003; 1.001-1.005 and 1.001; 1.0003-1.002, respectively). CONCLUSIONS: A claims indicator has the potential to be applied as a quality indicator. It should be complemented, however, with other indicators or actions to improve its acceptability by health professionals and to mitigate its possible undesirable effects.

Consent process for elective total hip and knee arthroplasty.

PURPOSE: To assess the consent process for elective primary total hip replacement (THR) and total knee replacement (TKR) in our hospital. METHODS: Consent processes of 47 THR and 53 TKR patients performed by 11 surgeons were reviewed. Complications that were documented were recorded, as was the grade of surgeon (consultant or specialist trainee) performing consent, and the location at which this took place. Comparisons were made between rates of documented, clinically significant complications discussed during consent, and those listed in the British Orthopaedic Association (BOA), in the literature, and other joint registries. RESULTS: The consent processes of 37, 57, and 6 patients were conducted by consultants, specialist trainees, and both, respectively. 13% and 21% of THR patients had 'revision' and 'heterotropic ossification', respectively, documented as complications, neither of which were listed on the BOA consent form. Similarly 4% and 11% of TKR patients had 'revision' and 'dissatisfaction', respectively, documented as complications, neither of which were listed on the BOA consent form. In 23% of THR and 32% of TKR patients, none of the BOA-listed complications was documented. In 13% of THR and 15% of TKR patients, no complications were documented. In 13% of THR and 17% of TKR patients, only nonspecific descriptions of complications (e.g. morbidity, mortality and medical complications) were used in their consent forms. CONCLUSION: Documentation of complications for THR and TKR patients was often incomplete and variable. The use of structured, procedure-specific consent forms is recommended.

Trends in joint arthroplasty litigation over five years: the British experience.

INTRODUCTION: Increasing numbers of joint arthroplasty are performed in Britain. While associated complications are well documented, it is not known which of those initiate malpractice claims. METHOD: A five-year period was assessed for trends to highlight areas for further improvement in patient information and surgical management. RESULTS: The National Health Service paid out almost £14 million for 598 claims. Forty per cent of this was for legal costs. The number of claims increased over time while the rate of successful claims decreased. CONCLUSIONS: A failure to consent adequately and to adhere to policies and standard practice can result in a successful malpractice claim. Protecting patients intraoperatively and maintaining high technical expertise while implementing policies and obtaining informed consent decreases the litigation burden.

[Factors of successful integrated care settings for total knee and hip arthroplasty: findings of a qualitative process analysis]. / Erfolgsfaktoren integrierter Versorgungsprozesse in der Endoprothetik: Ergebnisse einer qualitativen Prozessanalyse.

AIMS: In Germany, introduction of the law on Integrated Health Care (IC) (section sign 140a-d SGB V) opened up the possibility of cross-sectoral health care settings and new forms of remuneration, and improved the conditions for a closer cooperation between health care providers. However, cross-institutional and interdisciplinary work contexts demand new organizational structures in order to assure the coordination of different competences, resources and interests. This study aims at identifying factors of successful integrated care settings for total hip and knee arthroplasty. Using the example of an integrated care setting between an orthopaedic hospital and a rehabilitation clinic it will be examined which factors lead to successful implementation of the services and measures designed. METHOD: A qualitative research design was developed comprising different methods of data assessment (participant observation, guided expert interviews, document analyses) enabling a comprehensive exploration. Overall, data were derived from six consultations with patients, two integrated care information sessions and various documents (17 patient files, information material, patient lists, etc.). RESULTS: First of all, the different phases of development and implementation of integrated care settings were described. In this context, clearly defined aims, structures and appropriate measures seem to be crucial for an ideal long-term cooperation. Furthermore, the staff perspective on the effects of the IC programme on their daily routines proved an essential basis for process reconstruction. The staff members pointed out four main aspects regarding IC settings, i. e., improved image, increased knowledge, intensity of relationship, and less and more work effort. Against this background, factors of successful IC settings could be generated such as the need for central coordination, a regular staff information systems as well as accompanying process monitoring. CONCLUSION: Several key factors of successful integrated care settings in arthroplasty could be generated which provide important clues for shaping future interdisciplinary and cross-sectoral cooperation settings in health care services in general.

Vascular injuries after total joint arthroplasty.

Vascular injuries, although highly feared, can occur after total joint arthroplasty, often resulting in legal suits. This study evaluates the circumstances related to vascular injuries after joint arthroplasty. Using prospectively collected data on 13,517 patients undergoing total joint arthroplasty at our institution, 16 (0.1%) vascular injuries were identified. Eleven injuries occurred after total knee arthroplasty (TKA) and 5 after total hip arthroplasty (THA). Indirect injury was the most common mechanism in TKA. In contrast, direct injury was most prevalent in THA. One patient died of complications related to vascular injury. Of 16 patients, 8 (50%) had launched a legal suit against the operating surgeon. There appears to be no further specific measure that can be taken to absolutely avoid this complication. Patient awareness regarding this real problem may play a role in defraying the high likelihood of legal suits associated with this complication.

Medical malpractice in hip and knee arthroplasty.

A survey of the American Association of Hip and Knee Surgeons was performed to investigate the perceptions and experiences of medical malpractice litigation and related concerns among its active members. Responses showed that 78% of responding surgeons had been named as a defendant in at least 1 lawsuit alleging medical malpractice. Sixty-nine percent of lawsuits in the survey had been dismissed or settled out of court, and median settlement amounts were in the range of $51,000 to $99,000. Nerve injury was the most commonly cited source of litigation, followed by limb length discrepancy, infection, vascular injury, hip dislocation, compartment syndrome, deep vein thrombosis, chronic pain, and periprosthetic fracture. Survey data suggest that there are targets for surgeon education and awareness that could improve the quality of patient communication and the informed consent process.

[Experience in orthopaedic surgery with minimum provider volumes]. / Erfahrungen mit Mindestmengen in der Orthopädie.

The implementation of minimum provider volumes in orthopaedic surgery appears to be logically evident. A general volume outcome relationship could be found for total knee and hip replacement on a high level of evidence, but no definite threshold value could be identified. For other orthopaedic procedures the evaluated data hint at a volume outcome relationship but do not prove one. Preliminary model calculations on the effects of a regulation based on volume outcome considerations concerning medical care in Germany show that, though for total hip and knee replacement quite a large number of hospitals would be excluded from medical care, the number of patients to be reallocated would be small. Since 1 January 2007 a minimum provider volume of 50 total knee replacements per year per hospital has been mandatory in Germany. The further application of a minimum requirement regulation based on volume outcome considerations in the German health care system must be performed very carefully, because significant effects are to be expected.

Medicolegal aspects of hip and knee arthroplasty.

Hip and knee arthroplasties usually are satisfying for the patient and the surgeon; however, these procedures also have considerable risks for generating a medical malpractice lawsuit. Strict adherence to the standard of care and recently implemented patient safety strategies should reduce the surgeon's liability. Expert technical execution of the surgery, timely evidence-based patient treatment, and detailed documentation in the medical record will not only improve the quality of patient care but also will serve as a strong legal defense should the need arise.