Effect of age on outcomes after allogeneic disc tissue supplementation in patients with chronic discogenic low back pain in the VAST trial.

Aim: To explore the effects of viable allogeneic disc tissue supplementation in younger patients with discogenic chronic low back pain (CLBP). Patients & methods: VAST was a randomized placebo-controlled trial of disc allograft supplementation in 218 patients with discogenic CLBP. We conducted a post hoc analysis of change from baseline to 12 months in Oswestry Disability Index (ODI) and visual analog scale for pain intensity scores stratified by patient age. Results: Patients aged <42 years receiving allograft experienced greater improvement in ODI (p = 0.042) and a higher ODI response rate (≥10-, ≥15- and ≥20-point reductions in ODI) than those receiving saline (p = 0.001, p = 0.002 and p = 0.021, respectively). Conclusion: Young patients with discogenic CLBP may have significant functional improvement following nonsurgical disc allograft supplementation.

The VAST trial evaluated a new treatment for patients with chronic back pain resulting from one or two degenerated spinal discs. The treatment consists of a single injection of disc tissue supplement. A total of 218 adults participated in the study; most received the active treatment, while a smaller number (39 patients) received an injection of saline. In this paper we explain what happened over the 12 months after the injections. Patients who were younger (<42 years old) experienced more functional benefits (i.e., ability to perform daily tasks) after active treatment compared with those who received the saline injection, as measured by disability score. In contrast, older patients (≥42 years old) experienced functional benefits with both active and saline treatments, with no differences between the groups. There were more side effects in both age groups in those who received the active treatment compared with those who received saline, but almost all of the side effects were temporary and not serious. Clinical Trial Registration number: NCT03709901 (ClinicalTrials.gov).

The Unintended Impact of the Removal of Total Knee Arthroplasty From the Center for Medicare and Medicaid Services Inpatient-Only List.

BACKGROUND: Total knee arthroplasty (TKA) was removed from the Centers for Medicare and Medicaid Services (CMS) Inpatient-Only (IPO) list starting January 1, 2018. Many hospitals responded by instructing surgeons to schedule all TKAs as outpatient procedures, and some local Medicare Advantage contractors began to expect outpatient status for all or most TKA cases. This activity and ensuing confusion has caused considerable unintended disruption for surgeons, hospitals, and patients. The purpose of this study was to gauge the impact on providers and patients. METHODS: Active members of the American Association of Hip and Knee Surgeons were sent a 9-question survey asking if the surgeon's hospital was treating all patients undergoing TKA as outpatients and if Medicare Advantage administrators and commercial payers were treating all or most the same. Questions also inquired about the impact on surgeon practices and their patients. RESULTS: Seven hundred thirty members (26%) responded; of which, 59.5% reported that their hospitals have instructed them that all Medicare TKAs should be scheduled as outpatient procedures; 40.5% have been asked to use proscribed documentation to justify that change; 30.4% reported that their patients have incurred added personal cost secondary to their surgical procedure being billed as an outpatient procedure; and 76.1% report that this issue has become an administrative burden. CONCLUSION: The CMS clearly stated its expectation in the 2018 Outpatient Prospective Payment System Final Rule that the great majority of Medicare fee-for-service TKA patients would continue to be treated as inpatients. Nonetheless, many hospitals have decided to schedule all TKA cases as outpatients due to the 2-midnight rule despite a moratorium on recovery audits. It is the position of the American Association of Hip and Knee Surgeons that the CMS needs to provide more specific expectations concerning the needed language justifying admission or exempt TKA from the 2-midnight rule to mitigate the unintended confusion demonstrated by hospitals and some payers that has resulted from the removal of TKA from the Inpatient-Only list.

Can Total Knee Arthroplasty Be Performed Safely as an Outpatient in the Medicare Population?

BACKGROUND: The Centers for Medicare and Medicaid Services has solicited public comments for the 2017 Proposed Rule to consider removing total knee arthroplasty (TKA) from the Inpatient Only List. The purpose of this study is to compare the complication rates between outpatient (same-day discharge), short-stay (discharge within 1 day), and inpatient TKA and to identify the ideal candidates for a short-stay or outpatient procedure. METHODS: We queried the American College of Surgeons-National Surgical Quality Improvement Program database for patients over age 65 years who underwent TKA from 2014 to 2015. Demographics, comorbidities, 30-day complications, and readmission rates were compared between patients after outpatient, short-stay, and inpatient procedures. A multivariate regression analysis was then performed to identify at-risk patients who should not be candidates for outpatient or short-stay TKA. RESULTS: Of the 49,136 Medicare-aged TKA patients, 365 (0.7%) were outpatient, 3033 (6%) were short-stay and 45,738 (93%) were inpatient. Short-stay patients had a lower complication rate than both the outpatient and inpatient groups (2% vs. 8% vs. 8%, P < .001). Independent risk factors (all P < .05) for experiencing a complication or requiring an inpatient stay include female gender (odds ratio [OR] 1.655), general anesthesia (OR 1.282), diabetes mellitus (OR 1.171), chronic obstructive pulmonary disease (OR 1.579, P < .001), hypertension (OR 1.144), kidney disease (OR 1.425), American Society of Anesthesiologists Score 4 (OR 1.748), body mass index >35 kg/m2 (OR 1.265), and age >75 years (OR 1.429). CONCLUSION: TKA can be performed safely as an outpatient in a subset of healthy Medicare patients with a complication rate similar to an inpatient stay. A 23-hour stay, however, may be the "sweet spot" that minimizes complications in this population.

Lessons Learned From Bundled Payment Programs.

To encourage the shift to value-based health care, the Center for Medicare & Medicaid Innovation created bundled payment programs in which episodes of care are paid for in a bundled fashion. Hip arthroplasty and knee arthroplasty were believed to be good procedures to pilot in bundled payment programs because these procedures had an easily defined episode of care and accounted for a considerable amount of the Medicare budget. Cost savings for hip and knee arthroplasty in bundled payment programs can be divided into cost savings achieved in the operating room, in the hospital, and in the postacute care period. Orthopaedic surgeons should be aware of the clinical results of hip and knee arthroplasty in bundled payment programs in various practice settings, including large healthcare systems, large academic centers, and private practices. Cost savings have been achieved in all phases of hip and knee arthroplasty in bundled payment programs. Almost all successful practice settings have developed an infrastructure to organize, administer, and manage patients through the different phases of patient care in bundled payment programs. Patient-reported outcomes and quality measures are being developed to determine the quality of the services provided in bundled payment programs.

Should Medicare Remove Total Knee Arthroplasty From Its Inpatient Only List? A Total Knee Arthroplasty Is Not a Partial Knee Arthroplasty.

BACKGROUND: The Centers for Medicare and Medicaid Services have solicited comments to consider removing total knee arthroplasty (TKA) from the Inpatient Only list, as it has done for unicompartmental knee arthroplasty (UKA). The purpose of this study is to determine whether Medicare-aged patients undergoing TKA had comparable outcomes to those undergoing UKA. METHODS: We queried the American College of Surgeons-National Surgical Quality Improvement Program database for all patients aged 65 years or older who underwent elective TKA or UKA from 2014 and 2015. Demographic variables, comorbidities, length of stay (LOS), 30-day complication, and readmission rates were compared between UKA and TKA patients. A multivariate regression analysis was then performed to identify independent risk factors for complications and hospital LOS greater than 1 day. RESULTS: Of the 50,487 patients in the study, there were 49,136 (97%) TKA patients and 1351 UKA patients (3%). Medicare-aged TKA patients had a longer mean LOS (2.97 vs 1.57 days, P < .001), had a higher complication rate (9% vs 3%, P < .001), and were more likely to be discharged to a rehabilitation facility (31% vs 9%, P < .001) than Medicare-aged UKA patients. When controlling for other variables, TKA patients were more likely to experience a complication (odds ratio, 2.562; P < .001) and require LOS >1 day (odds ratio, 14.679; P < .001) than UKA patients. CONCLUSION: TKA procedure in the Medicare population is an independent risk factor for increased complications and LOS compared to UKA. Policymakers should use caution extrapolating UKA data to TKA patients and recognize the inherent disparities between the 2 procedures.

Alternative Reimbursement Models: Bundled Payment and Beyond: AOA Critical Issues.

The Bundled Payments for Care Improvement (BPCI) initiative was begun in January 2013 by the U.S. Centers for Medicare & Medicaid Services (CMS) through its Innovation Center authority, which was created by the U.S. Patient Protection and Affordable Care Act (PPACA). The BPCI program seeks to improve health-care delivery and to ultimately reduce costs by allowing providers to enter into prenegotiated payment arrangements that include financial and performance accountability for a clinical episode in which a risk-and-reward calculus must be determined. BPCI is a contemporary 3-year experiment designed to test the applicability of episode-based payment models as a viable strategy to transform the CMS payment methodology while improving health outcomes. A summary of the 4 models being evaluated in the BPCI initiative is presented in addition to the awardee types and the number of awardees in each model. Data from one of the BPCI-designated pilot sites demonstrate that strategies do exist for successful implementation of an alternative payment model by keeping patients first while simultaneously improving coordination, alignment of care, and quality and reducing cost. Providers will need to embrace change and their areas of opportunity to gain a competitive advantage. Health-care providers, including orthopaedic surgeons, health-care professionals at post-acute care institutions, and product suppliers, all have a role in determining the strategies for success. Open dialogue between CMS and awardees should be encouraged to arrive at a solution that provides opportunity for gainsharing, as this program continues to gain traction and to evolve.

Discharge Disposition After Joint Replacement and the Potential for Cost Savings: Effect of Hospital Policies and Surgeons.

BACKGROUND: Up to 55% of total joint arthroplasty costs come from post-acute care, with large variability dependent on a patient's discharge location. At our institution, we identified a group of surgeons using a preoperative discharge planning protocol emphasizing the merits of home discharge. We hypothesized that using the protocol would increase patients' odds for discharge home. METHODS: Administrative data from 14,315 total hip and knee arthroplasties performed over a 3-year period were retrospectively analyzed to determine predictors of patient discharge location. Bayesian hierarchical logistic regression modeling was used to account for the complex multilevel structure within the data as we considered patient-, surgeon-, and hospital-level predictors. A simplified case-control data structure with logistic regression analysis was also used to better understand the impact of the preoperative discharge planning protocol. RESULTS: A variety of patient- and surgeon-level variables are predictive of patients being discharged home after total joint arthroplasty including a patient's length of stay, age, illness severity, and insurance, as well as surgeon's affiliation. In the case-control data, patients exposed to the rapid recovery protocol had 45% increased odds of being discharged home compared to patients not exposed to the protocol. CONCLUSIONS: Although patient factors are known to play a role in predicting postdischarge destination, this analysis describes additional surgeon- and hospital-level factors that predict discharge location. Exogenous factors based on how surgeons and hospital staff practice and interact with patients may impact the postdischarge decision-making process and provide a cost savings opportunity.

Return to Sports Activity following UKA and TKA.

Unicompartmental medial knee arthritis can be successfully treated with either unicompartmental or total knee arthroplasty (UKA or TKA). Active patients often inquire about the relative likelihood of returning to a sport-related activity after surgery. Some advocates of UKA suggest that UKA can lead to a higher rate of return to sports activity postoperatively, but little information is available comparing the outcomes of UKA versus TKA. We identified 33 patients with UKA and 39 patients with TKA with minimum 2-year follow-up (4 ± 1.2 years) who had similar preoperative clinical and radiographic examinations. Clinical evaluation revealed no difference in the number of patients who returned to sports or their satisfaction, but patients with UKA returned to sports more quickly and exhibited better postoperative knee scores than TKA patients.

Polyethylene Liner Dissociation Is a Complication of the DePuy Pinnacle Cup: A Report of 23 Cases.

BACKGROUND: Polyethylene liner dissociation is a rare but catastrophic event in total hip arthroplasty (THA), and certain implant designs are known to be at greater risk. Although the DePuy Pinnacle (Warsaw, IN, USA) modular acetabular construct has an excellent record of fixation and wear, an unexpectedly high number of liner dissociations has been noted. QUESTIONS/PURPOSES: The purposes of this study were (1) to characterize the clinical parameters observed in a large group of patients who have experienced liner dissociations with the DePuy Pinnacle acetabular component; (2) to describe the radiographic findings in this group of patients; and (3) to calculate a minimum frequency of this complication. METHODS: Since 2001, 23 patients with previously well-functioning THAs presented with sudden atraumatic polyethylene liner dissociation at four separate institutions. These THAs were performed between 2001 and 2013. Eight different arthroplasty specialists had performed the index hip arthroplasties using the DePuy Pinnacle acetabular component with a polyethylene liner. Polyethylene failures were evaluated for liner type and radiographic cup position. For three of the surgeons who contributed cases, institutional registries allowed the calculation of the number of components of this type that they used during the period in question, which provided a conservative estimate of the frequency of this type of failure. RESULTS: All 23 liner failures occurred atraumatically in previously asymptomatic THAs at a mean of 48 months (range, 3-138 months). Patients characteristically reported a new and sudden onset of discomfort with audible, reproducible squeaking. Surgical inspection of dissociated liners demonstrated displacement of polyethylene with shearing of the peripheral locking tabs. Radiographic evaluation demonstrated that 14 cups were well positioned and nine cups were malpositioned outside the so-called safe zone. Conservative estimates of the frequency of this complication from the three surgeons' practices whose institutional registries allowed calculation of the lowest possible frequency were 0.32% (six of 1888), 0.77% (three of 391), and 0.82% (three of 367). CONCLUSIONS: With this report of 23 additional liner dissociations, we suggest that surgeons should be aware of the problem and take extra precautions when using this implant to ensure locking mechanism integrity at the time of surgery. We caution that the frequency of liner dissociation may be higher than previously reported. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Bundled Payment in Total Joint Care: Survey of AAHKS Membership Attitudes and Experience with Alternative Payment Models.

The goal of alternative payment models (APMs), particularly bundling of payments in total joint arthroplasty (TJA), is to incentivize physicians, hospitals, and payers to deliver quality care at lower cost. To study the effect of APMs on the field of adult reconstruction, we conducted a survey of AAHKS members using an electronic questionnaire format. Of the respondents, 61% are planning to or participate in an APM. 45% of respondents feel that a bundled payment system will be the most effective model to improve quality and to reduce costs. Common concerns were disincentives to operate on high-risk patients (94%) and uncertainty about revenue sharing (79%). While many members feel that APMs may improve value in TJA, surgeons continue to have reservations about implementation.

Economic Impact of Orthopedic Adult Reconstruction Office Practice: The Implications of Hospital Employment Models on Local Economies.

The purpose of this study was to evaluate the economic attributes of private practice adult reconstruction (AR) offices. 458 AAHKS surgeons responded; 65% were in private practice (fee-for-service, non-salaried, non-employed AR surgeons). 54% had considered hospital employment in the past two years. The average group employs 13.4 orthopedic surgeons (3.4 AR), and 105 other employees. The average total budget is $12.5 million per year with $4 million in salaries, and $238,000 in tax revenue generated. Co-management joint ventures are a better model than hospital employment for aligning AR surgeons and hospitals and realizing the cost effectiveness and quality improvement goals of PPACA and AARA while preserving the economic impact of AR private practice.

Perioperative management strategies to improve outcomes and reduce cost during an episode of care.

Total joint arthroplasty is a successful procedure with measurable and clear outcomes that have historically required a complex array of resources to deliver. The resulting expense burden has placed this procedure at the center of many payment reform efforts, including bundled payments. The orthopedic surgeon, through his orders and known preferences, determines the resource consumption during an episode of care. Strategies to better optimize the medical and social determinants of care prior to surgery can pay off in improved outcomes at reduced cost. Physician leadership is critical to altering the culture and achieving the desired results.

Thirty-day readmission following total hip and knee arthroplasty - a preliminary single institution predictive model.

We sought to identify demographic or care process variables associated with increased 30-day readmission within the total hip and knee arthroplasty patient population. Using this information, we generated a model to predict 30-day readmission risk following total hip and knee arthroplasty procedures. Longer index length of stay, discharge disposition to a nursing facility, blood transfusion, general anesthesia, anemia, anticoagulation status prior to index admission, and Charlson Comorbidity Index greater than 2 were identified as independent risk factors for readmission. Care process factors during the hospital stay appear to have a large predictive value for 30-day readmission. Specific comorbidities and patient demographic factors showed less significance. The predictive nomogram constructed for primary total joint readmission had a bootstrap-corrected concordance statistic of 0.76.

A mobile compression device for thrombosis prevention in hip and knee arthroplasty.

BACKGROUND: Venous thromboembolic events, either deep venous thrombosis or pulmonary embolism, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.) with or without aspirin compared with current pharmacological protocols for prophylaxis against venous thromboembolism in patients undergoing elective primary unilateral arthroplasty of a lower-extremity joint. METHODS: A multicenter registry was established to capture the rate of symptomatic venous thromboembolic events following primary knee arthroplasty (1551 patients) or hip arthroplasty (1509 patients) from ten sites. All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism. RESULTS: Of 3060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thrombi, three proximal deep venous thrombi, and five pulmonary emboli). One death occurred, with no autopsy performed. Symptomatic venous thromboembolic rates observed in patients who had an arthroplasty of a lower-extremity joint using the mobile compression device were noninferior (not worse than), at a margin of 1.0%, to the rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran, except in the knee arthroplasty group, in which the mobile compression device fell short of the rate reported for rivaroxaban by 0.06%. CONCLUSIONS: Use of the mobile compression device with or without aspirin for patients undergoing arthroplasty of a lower-extremity joint provides a noninferior risk for the development of venous thromboembolism compared with current pharmacological protocols.

Bundled payments for care improvement initiative: the next evolution of payment formulations: AAHKS Bundled Payment Task Force.

The Patient Protection and Affordable Care Act contains a number of provision for improving the delivery of healthcare in the United States, among the most impactful of which may be the call for modifications in the packaging of and payment for care that is bundled into episodes. The move away from fee for service payment models to payment for coordinated care delivered as comprehensive episodes is heralded as having great potential to enhance quality and reduce cost, thereby increasing the value of the care delivered. This effort builds on the prior experience around delivering care for arthroplasty under the Acute Care Episode Project and offers extensions and opportunities to modify the experience moving forward. Total hip and knee arthroplasties are viewed as ideal treatments to test the effectiveness of this payment model. Providers must learn the nuances of these modified care delivery concepts and evaluate whether their environment is conducive to success in this arena. This fundamental shift in payment for care offers both considerable risk and tremendous opportunity for physicians. Acquiring an understanding of the recent experience and the determinants of future success will best position orthopaedic surgeons to thrive in this new environment. Although this will remain a dynamic exercise for some time, early experience may enhance the chances for long term success, and physicians can rightfully lead the care delivery redesign process.