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Does Melatonin Improve Sleep Following Primary Total Knee Arthroplasty? A Randomized, Double-Blind, Placebo-Controlled Trial

Haider, Muhammad A; Lawrence, Kyle W; Christensen, Thomas; Schwarzkopf, Ran; Macaulay, William; Rozell, Joshua C
BACKGROUND:Sleep impairment following total knee arthroplasty (TKA) is common and may decrease patient satisfaction and recovery. Standardized postoperative recommendations for sleep disturbances have not been established. We aimed to assess whether melatonin use could promote healthy sleep and reduce sleep disturbance in the acute period following TKA. METHODS:Patients undergoing primary, elective TKA between July 19, 2021 and January 4, 2024 were prospectively enrolled and randomized to receive either 5 mg of melatonin nightly or placebo for 14 days postoperatively. Participants recorded their nightly pain on the visual analog scale, the number of hours slept, and the number of nighttime awakenings in a sleep diary starting the night of surgery (postoperative day [POD] 0). Sleep disturbance was assessed preoperatively and on POD 14 using the patient-reported outcome measurement information system sleep disturbance form. Epworth Sleepiness Scores were collected on POD 14 to assess sleep quality. RESULTS:Of the 138 patients enrolled, 128 patients successfully completed the study protocol, with 64 patients in each group. Melatonin patients trended towards more hours of sleep on POD 2 (placebo: 5.0 ± 2.4, melatonin: 5.8 ± 2.0, P = 0.084), POD 3 (placebo: 5.6 ± 2.2, melatonin: 6.3 ± 2.0, P = 0.075), and averaged over POD 1 to 3 (placebo: 4.9 ± 2.0, melatonin: 5.6 ± 1.8, P = 0.073), though no differences were observed on POD 4 or after. Fewer nighttime awakenings in the melatonin group were observed on POD 1 (placebo: 4.4 ± 3.9, melatonin: 3.6 ± 2.4, P = 0.197), although this was not statistically significant. Preoperative and postoperative Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS-SD) score increases were comparable for both groups (placebo: 4.0 ± 8.4, melatonin: 4.6 ± 8.2, P = 0.894). The melatonin (65.4%) and placebo (65%) groups demonstrated similar rates of increased sleep disturbance. CONCLUSION/CONCLUSIONS:Melatonin may promote longer sleep in the immediate postoperative period after TKA, though these benefits wane after POD 3. Disturbances in sleep should be expected for most patients, though melatonin may have an attenuating effect. Melatonin is safe and can be considered for TKA patients experiencing early sleep disturbances postoperatively.
PMID: 38401621
ISSN: 1532-8406
CID: 5634702

Genicular Artery Embolization: A Review of Essential Anatomic Considerations

Liu, Shu; Swilling, David; Morris, Elizabeth; Macaulay, William; Golzarian, Jafar; Hickey, Ryan; Taslakian, Bedros
Genicular artery embolization is increasingly recognized as a safe and effective treatment option for symptomatic knee osteoarthritis and recurrent hemarthrosis following total knee arthroplasty. Genicular arteries are an essential vascular supply for the knee joint and demonstrate considerable variability. Familiarity with the anatomy and common variations is critical for pre-procedural planning, accurate target selection, and minimizing adverse events in trans-arterial embolization procedures. This review aims to provide a detailed discussion of the genicular artery anatomy that is relevant to interventional radiologists performing genicular artery embolization.
PMID: 38128722
ISSN: 1535-7732
CID: 5612112

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers

Taslakian, Bedros; Swilling, David; Attur, Mukundan; Alaia, Erin F; Kijowski, Richard; Samuels, Jonathan; Macaulay, William; Ramos, Danibel; Liu, Shu; Morris, Elizabeth M; Hickey, Ryan
PURPOSE/OBJECTIVE:To characterize the safety, efficacy, and potential role of genicular artery embolization (GAE) as a disease-modifying treatment for symptomatic knee osteoarthritis (OA). MATERIALS AND METHODS/METHODS:This is an interim analysis of a prospective, single-arm clinical trial of patients with symptomatic knee OA who failed conservative therapy for greater than 3 months. Sixteen patients who underwent GAE using 250-μm microspheres and had at least 1 month of follow-up were included. Six patients completed the 12-month follow-up, and 10 patients remain enrolled. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was evaluated at baseline and at 1, 3, and 12 months. Serum and plasma samples were collected for biomarker analysis. The primary end point was the percentage of patients who achieved the minimal clinically important difference (MCID) for WOMAC pain score at 12 months. Baseline and follow-up outcomes were analyzed using the Wilcoxon matched-pairs signed-rank test. RESULTS:Technical success of the procedure was 100%, with no major adverse events. The MCID was achieved in 5 of the 6 (83%) patients at 12 months. The mean WOMAC pain score decreased from 8.6 ± 2.7 at baseline to 4.9 ± 2.7 (P = .001), 4.4 ± 2.8 (P < .001), and 4.7 ± 2.7 (P = .094) at 1, 3, and 12 months, respectively. There was a statistically significant decrease in nerve growth factor (NGF) levels at 12 months. The remaining 8 biomarkers showed no significant change at 12 months. CONCLUSIONS:GAE is a safe and efficacious treatment for symptomatic knee OA. Decreased NGF levels after GAE may contribute to pain reduction and slowing of cartilage degeneration.
PMID: 37640104
ISSN: 1535-7732
CID: 5611392

Patient Designation Prior to Total Knee Arthroplasty: How Can Preoperative Variables Impact Postoperative Status? [Case Report]

Thomas, Jeremiah; Bieganowski, Thomas; Carmody, Mary; Macaulay, William; Schwarzkopf, Ran; Rozell, Joshua C
BACKGROUND:Removal of total knee arthroplasty (TKA) from the inpatient only list has led to a greater focus on outpatient (OP) procedures. However, the impact of OP-centered models in at-risk patients is unclear. Therefore, the current analysis investigated the effect of conversion from OP to inpatient (IP) status on postoperative outcomes and determined which factors put patients at risk for status change postoperatively. METHODS:We retrospectively reviewed all patients who underwent a primary TKA at our institution between January 2, 2018, and April 26, 2022. All patients included were originally scheduled for OP surgery and were separated based on conversion to IP status postoperatively. Multiple regression analyses were used to determine the significance of all perioperative variables. Modeling via binary logistic regressions was used to determine factors predictive of status conversion. RESULTS:Of the 2,313 patients originally designated for OP TKA, 627 (27.1%) required a stay of 2 midnights or longer. Patients in the IP group had significantly higher facility discharge rates (P < .001) compared to the OP group. Factors predictive of conversion included age of 65 years and older (P < .001), women (P < .001), arriving at the postanesthesia care unit after 12 pm (P < .001), body mass index greater than 30 (P = .004), and Charlson Comorbidity Index of 4 and higher (P = .004). Being the first case of the day (P < .001) and being married (P < .001) were both protective against conversion. CONCLUSION:Certain intrinsic patient factors may predispose a patient to an IP stay, and an understanding of predisposing factors which could lead to IP conversion may improve perioperative planning moving forward.
PMID: 37590392
ISSN: 1532-8406
CID: 5597912

Selective Use of Dual-Mobility Did Not Significantly Reduce 90-Day Readmissions or Reoperations after Total Hip Arthroplasty

Simcox, Trevor; Singh, Vivek; Ayres, Ethan; Macaulay, William; Schwarzkopf, Ran; Aggarwal, Vinay K; Hepinstall, Matthew S
INTRODUCTION/BACKGROUND:Selective use of dual mobility (DM) implants in total hip arthroplasty (THA) patients at high dislocation risk has been proposed. However, evidence-based utilization thresholds have not been defined. We explored whether surgeon-specific rates of DM utilization correlate with rates of readmission and reoperation for dislocation. METHODS:We retrospectively reviewed 14,818 primary THA procedures performed at a single institution between 2011 and 2021, including 14,310 FB and 508 DM implant constructs. Outcomes including 90-day readmissions and reoperations were compared between patients who had fixed-bearing (FB) and DM implants. Cases were then stratified into three groups based on the attending surgeon's rate of DM utilization (≤1, 1 to 10, or >10%) and outcomes were compared. RESULTS:There were no differences in 90-day outcomes between FB and DM implant groups. Surgeon frequency of DM utilization ranged from 0 to 43%. There were 48 surgeons (73%) who used DM in ≤ 1% of cases, 11 (17%) in 1 to 10% of cases, and 7 (10%) in >10% of cases. The 90-day rates of readmission (7.3 vs 7.6 vs 7.2%, P=0.7) and reoperation (3.4 vs 3.9 vs 3.8%, P=0.3), as well as readmission for instability (0.5 vs 0.6 vs 0.8%, P=0.2) and reoperation for instability (0.5 vs 0.5 vs 0.8%, P=0.6), did not statistically differ between cohorts. CONCLUSION/CONCLUSIONS:Selective DM utilization did not reduce 90-day readmissions or reoperations following primary THA. Other dislocation-mitigation strategies (i.e., surgical approach, computer navigation, robotic assistance, and large diameter fixed-bearings) may have masked any benefits of selective DM use.
PMID: 37068565
ISSN: 1532-8406
CID: 5466022

Pain-management protocol aimed at reducing opioids following total knee arthroplasty does not negatively impact patient satisfaction

Manjunath, Amit K; Bloom, David A; Fried, Jordan W; Bieganowski, Thomas; Slover, James D; Macaulay, William B; Schwarzkopf, Ran
BACKGROUND:Prior research has demonstrated that the prescription of opioid medications may be associated with the desire to treat pain in order to achieve favorable patient satisfaction. The purpose of the current study was to investigate the effect of decreased opioid prescribing following total knee arthroplasty (TKA) on survey-administered patient satisfaction scores. METHOD/METHODS:This study is a retrospective review of prospectively collected survey data for patients who underwent primary elective TKA for the treatment of osteoarthritis (OA) between September 2014 and June 2019. All patients included had completed Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPS) survey information. Patients were stratified into two cohorts based on whether their surgery took place prior to or subsequent to the implementation of an institutional-wide opioid-sparing regimen. RESULTS:Of the 613 patients included, 488 (80%) were in the pre-protocol cohort and 125 (20%) in the post-protocol cohort. Rate of opioid refills (33.6% to 11.2%; p < 0.001) as well as length of stay (LOS, 2.40 ± 1.05 to 2.13 ± 1.13 days; p = 0.014) decreased significantly after protocol change while rate of current smokers increased significantly (4.1% to 10.4%; p = 0.011). No significant difference was observed in "top box" percentages for satisfaction with pain control (Pre: 70.5% vs Post: 72.8%; p = 0.775). CONCLUSIONS:Protocols calling for reduced prescription of opioids following TKA resulted in significantly lower rates of opioid refills, and were associated with significantly shorter LOS, while causing no statistically significant deleterious changes in patient satisfaction, as measured by HCAPS survey. LOE: III. CLINICAL RELEVANCE/CONCLUSIONS:This study suggests that HCAPS scores are not negatively impacted by a reduction in postoperative opioid analgesics.
PMID: 37385111
ISSN: 1873-5800
CID: 5540472

Genicular artery embolization for treatment of knee osteoarthritis pain: Systematic review and meta-analysis

Taslakian, Bedros; Miller, Larry E.; Mabud, Tarub S.; Macaulay, William; Samuels, Jonathan; Attur, Mukundan; Alaia, Erin F.; Kijowski, Richard; Hickey, Ryan; Sista, Akhilesh K.
Objective: Genicular artery embolization (GAE) is a novel, minimally invasive procedure for treatment of knee osteoarthritis (OA). This meta-analysis investigated the safety and effectiveness of this procedure. Design: Outcomes of this systematic review with meta-analysis were technical success, knee pain visual analog scale (VAS; 0"“100 scale), WOMAC Total Score (0"“100 scale), retreatment rate, and adverse events. Continuous outcomes were calculated as the weighted mean difference (WMD) versus baseline. Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) rates were estimated in Monte Carlo simulations. Rates of total knee replacement and repeat GAE were calculated using life-table methods. Results: In 10 groups (9 studies; 270 patients; 339 knees), GAE technical success was 99.7%. Over 12 months, the WMD ranged from −34 to −39 at each follow-up for VAS score and −28 to −34 for WOMAC Total score (all p "‹< "‹0.001). At 12 months, 78% met the MCID for VAS score; 92% met the MCID for WOMAC Total score, and 78% met the SCB for WOMAC Total score. Higher baseline knee pain severity was associated with greater improvements in knee pain. Over 2 years, 5.2% of patients underwent total knee replacement and 8.3% received repeat GAE. Adverse events were minor, with transient skin discoloration as the most common (11.6%). Conclusions: Limited evidence suggests that GAE is a safe procedure that confers improvement in knee OA symptoms at established MCID thresholds. Patients with greater knee pain severity may be more responsive to GAE.
ISSN: 2665-9131
CID: 5549022

Opioid Use During Hospitalization Following Total Knee Arthroplasty: Trends in Consumption From 2016 to 2021

Christensen, Thomas H; Gemayel, Anthony C; Bieganowski, Thomas; Lawrence, Kyle W; Rozell, Joshua C; Macaulay, William; Schwarzkopf, Ran
BACKGROUND:In response to physician and patient concerns, many institutions have adopted protocols aimed at reducing postoperative opioid consumption after total knee arthroplasty (TKA). Thus, this study sought to examine how consumption of opioids has changed following TKA in the past 6 years. METHODS:We conducted a retrospective review of all 10,072 patients who received primary TKA at our institution from January 2016 to April 2021. We collected baseline demographic data including patient age, sex, race, body mass index (BMI), American Society of Anesthesiologist (ASA) classification, as well as dosage and type of opioid medication prescribed on each postoperative day while the patient was hospitalized following TKA. This data was converted to milligram morphine equivalents (MME) per day hospitalized to compare rates of opioid use over time. RESULTS:Our analysis found the greatest daily opioid use was in 2016 (43.2 ± 68.6 MME/day) and the least was in 2021 (15.0 ± 29.2 MME/day). Linear regression analyses found a significant linear downward trend in postoperative opioid consumption over time, with a decrease of 5.55 MME per day per year (Adjusted R-squared: 0.982, P < .001). The highest visual analog scale (VAS) score was 4.45 in 2016 and the lowest was 3.79 in 2021 (P < .001). CONCLUSION/CONCLUSIONS:Opioid reducing protocols have been implemented for patients recovering from primary TKA in an effort to decrease reliance on opioids for postoperative pain control. The results of this study demonstrate that such protocols have been successful in reducing overall opioid use during hospitalization following TKA. LEVEL III EVIDENCE/METHODS:Retrospective Cohort.
PMID: 37019314
ISSN: 1532-8406
CID: 5463782

Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2040-2060

Shichman, I; Askew, N; Habibi, A; Nherera, L; Macaulay, W; Seyler, T; Schwarzkopf, R
Background: National projections of future joint arthroplasties are useful in understanding the changing burden of surgery and related outcomes on the health system. The aim of this study is to update the literature by producing Medicare projections for revision total joint arthroplasty procedures from 2040 through 2060.
Method(s): The study uses 2000-2019 data from the CMS Medicare Part-B National Summary and combines procedure counts using CPT codes for revision total joint arthroplasty procedures. In 2019, revision total knee arthroplasty (rTKA) and revision total hip arthroplasty (rTHA) procedures totaled 53,217 and 30,541, respectively, forming a baseline from which we generated point forecasts between 2020 and 2060 and 95% forecast intervals (FI).
Result(s): On average, the model projects an annual growth rate of 1.77% for rTHAs and 4.67% for rTKAs. By 2040, rTHAs were projected to be 43,514 (95% FI = 37,429-50,589) and rTKAs were projected to be 115,147 (95% FI = 105,640-125,510). By 2060, rTHAs was projected to be 61,764 (95% FI = 49,927-76,408) and rTKAs were projected to be 286,740 (95% FI = 253,882-323,852).
Conclusion(s): Based on 2019 total volume counts, the log-linear exponential model forecasts an increase in rTHA procedures of 42% by 2040 and 101% by 2060. Similarly, the estimated increase for rTKA is projected to be 149% by 2040 and 520% by 2060. An accurate projection of future revision procedure demands is important to understand future healthcare utilization and surgeon demand. This finding is only applicable to the Medicare population and demands further analysis for other population groups.
ISSN: 2352-3441
CID: 5514232

Hospital Revenue, Cost, and Contribution Margin in Inpatient vs. Outpatient Primary Total Joint Arthroplasty

Christensen, Thomas H; Bieganowski, Thomas; Malarchuk, Alex W; Davidovitch, Roy I; Bosco, Joseph A; Schwarzkopf, Ran; Macaulay, William; Slover, James; Lajam, Claudette M
INTRODUCTION/BACKGROUND:Removal of primary total knee arthroplasty (TKA) and primary total hip arthroplasty (THA) from the inpatient-only (IPO) list has financial implications for both patients and institutions. The aim of this study was to evaluate and compare financial parameters between patients designated for inpatient versus outpatient total joint arthroplasty (TJA) surgery. METHODS:We reviewed all patients who underwent TKA or THA after these procedures were removed from the IPO list. Patients were stratified into cohorts based on inpatient or outpatient status, procedure type, and insurance type. This included 5,284 patients, of which 4,279 were designated inpatient while 1,005 were designated outpatient. Patient demographic, perioperative, and financial data including per patient revenues, total and direct costs, and contribution margins (CMs) were collected. Data were compared using t-tests and Chi-square tests. RESULTS:Among Medicare patients receiving THA, CM was 89.1% lower for the inpatient cohort when compared to outpatient (p<0.001), though there was no significant difference between cohorts for TKA (p=0.501). Among patients covered by Medicaid or Government-managed plans, CM was 120.8% higher for inpatients receiving THA (p<0.001) when compared to outpatients and 136.3% higher for inpatients receiving TKA (p<0.001). CONCLUSION/CONCLUSIONS:Our analyses showed that recent costs associated with inpatient stay inconsistently match or outpace additional revenue, causing CM to vary drastically depending on insurance and procedure type. For Medicare patients receiving THA, inpatient surgery is financially disincentivized leaving this vulnerable patient population at risk of losing access to care.
PMID: 35987495
ISSN: 1532-8406
CID: 5300472