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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
The Chitranjan S. Ranawat Award: Manipulation Under Anesthesia to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
Abdel, Matthew P; Salmons, Harold I; Larson, Dirk R; Austin, Matthew S; Barnes, C Lowry; Bolognesi, Michael P; Della Valle, Craig J; Dennis, Douglas A; Garvin, Kevin L; Geller, Jeffrey A; Incavo, Stephen J; Lombardi, Adolph V; Peters, Christopher L; Schwarzkopf, Ran; Sculco, Peter K; Springer, Bryan D; Pagnano, Mark W; Berry, Daniel J
BACKGROUND:Manipulation under anesthesia (MUA) occurs in 4% of patients after total knee arthroplasty (TKA). Anti-inflammatory medications may target arthrofibrosis pathogenesis, but the data are limited. This multicenter randomized clinical trial investigated the effect of adjuvant anti-inflammatory medications with MUA and physical therapy on range of motion (ROM) and outcomes. METHODS:There were 124 patients (124 TKAs) who developed stiffness after primary TKA for osteoarthritis enrolled across 15 institutions. All received MUA when ROM was < 90° at 4 to 12 weeks postoperatively. Randomization proceeded via a permuted block design. Controls received MUA and physical therapy, while the treatment group also received one dose of pre-MUA intravenous dexamethasone (8 mg) and 14 days of oral celecoxib (200 mg). The ROM and clinical outcomes were assessed at 6 weeks and 1 year. This trial was registered with ClinicalTrials.gov. RESULTS:The ROM significantly improved a mean of 46° from a pre-MUA ROM of 72 to 118° immediately after MUA (P < .001). The ROM was similar between the treatment and control groups at 6 weeks following MUA (101 versus 99°, respectively; P = .35) and at one year following MUA (108 versus 108°, respectively; P = .98). Clinical outcomes were similar at both end points. CONCLUSIONS:In this multicenter randomized clinical trial, the addition of intravenous dexamethasone and a short course of oral celecoxib after MUA did not improve ROM or outcomes. However, MUA provided a mean ROM improvement of 46° immediately, 28° at 6 weeks, and 37° at 1 year. Further investigation in regards to dosing, duration, and route of administration of anti-inflammatory medications remains warranted. LEVEL OF EVIDENCE/METHODS:Level 1, RCT.
PMCID:11283995
PMID: 38417555
ISSN: 1532-8406
CID: 5691512
Outpatient vs. inpatient designation in total hip arthroplasty: can we predict who will require hospitalization?
Connolly, Patrick; Thomas, Jeremiah; Bieganowski, Thomas; Schwarzkopf, Ran; Lajam, Claudette M; Davidovitch, Roy I; Rozell, Joshua C
INTRODUCTION/BACKGROUND:Following removal of total hip arthroplasty (THA) from the inpatient only (IPO) list by the Center for Medicare Services (CMS), arthroplasty surgeons face increased pressure to perform procedures on an outpatient (OP) basis. The purposes of the present study were to compare patients booked for THA as OP who required conversion to IP status postoperatively, to patients who were booked as, and remained OP, and to identify factors predictive of conversion from OP to IP status. METHODS:We retrospectively reviewed all patients who underwent a primary THA at our institution between January 1, 2020 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 were used to determine factors predictive of status conversion. RESULTS:Of 1,937 patients, 372 (19.2%) designated as OP preoperatively required conversion to IP status postoperatively. These patients had significantly higher facility discharge rates (P < 0.001) and 90-day readmission rates (P = 0.024). Patients aged 65 and older (P < 0.001), females (P < 0.001), patients with Black/African American race (P = 0.027), with a recovery room arrival time after 12 pm (P < 0.001), with a BMI > 30 kg/m2 (P = 0.001), and with a Charlson Comorbidity Index (CCI) ≥ 4 (P = 0.013) were Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation more likely to require conversion to IP designation. Marital status and time of procedure were also significant factors, as patients who were married (P < 0.001) and who were the first case of the day (P < 0.001) were less likely to be converted to IP. CONCLUSION/CONCLUSIONS:Several factors were identified which could help determine appropriate hospital designation status at the time of surgical booking to ultimately avoid insurance claim denials. These included BMI, certain demographic factors, CCI ≥ 4, and patients 65 or older. LEVEL III EVIDENCE/METHODS:Retrospective Cohort Study.
PMID: 39172260
ISSN: 1434-3916
CID: 5680892
The Impact of Culture Negativity on the Outcomes of Revision Total Knee Arthroplasty for Chronic PJI
Ronan, Emily M; Ruff, Garrett; Ashkenazi, Itay; Raymond, Hayley; Cardillo, Casey; Villa, Jordan C; Schwarzkopf, Ran; Aggarwal, Vinay K
Culture-positive (CP) and culture-negative (CN) periprosthetic joint infections (PJI) remain a crucial area of research; however, current studies comparing these infections rely on unstandardized outcome reporting tools. Our study aimed to compare the outcomes of two-stage revision of CP and CN PJI using the standardized Musculoskeletal Infection Society (MSIS) outcome reporting tool. We retrospectively reviewed 138 patients who were diagnosed with PJI and indicated for two-stage revision total knee arthroplasty (rTKA). The majority of patients in both CP and CN cohorts achieved infection control without the need for reoperation (54.1% and 62.5%, respectively). There was a significant difference in the overall distribution of MSIS outcomes (p = 0.043), with a significantly greater rate of CN patients falling into Tier 1 (infection control without the use of suppressive antibiotics) (52.5% versus 29.6%, p = 0.011). There was also a significant difference in the distribution of septic versus aseptic reoperations after 2nd stage (p = 0.013), with more CP reoperations being septic and more CN reoperations being aseptic. The duration from first to second stage was significantly shorter in the CN cohort (p = 0.002). While overall infection control was similar between cohorts, these data suggest that the outcomes of two-stage rTKA are favorable in cases of CN PJI.
PMCID:11278513
PMID: 39065152
ISSN: 2076-2607
CID: 5723832
Nanoparticle ultrasonication outperforms conventional irrigation solutions in eradicating Staphylococcus aureus biofilm from titanium surfaces: an in vitro study
Schaffler, Benjamin C; Longwell, Mark; Byers, Barbara; Kreft, Rachel; Ramot, Roi; Ramot, Yair; Schwarzkopf, Ran
PURPOSE/OBJECTIVE:Bacterial biofilms create a challenge in the treatment of prosthetic joint infection (PJI), and failure to eradicate biofilms is often implicated in the high rates of recurrence. In this study, we aimed to compare the effectiveness of a novel nanoparticle ultrasonication technology on Staphylococcus aureus biofilm eradication compared to commonly used orthopedic irrigation solutions. METHODS:Twenty-four sterile, titanium alloy discs were inoculated with a standardized concentration of methicillin-resistant S. aureus and cultured for seven days to allow for biofilm formation. Discs were then treated with either ultrasonicated nanoparticle therapy or irrigation with chlorhexidine gluconate, povidone-iodine or normal saline. The remaining bacteria on each surface was subsequently plated for colony-forming units of S. aureus. Bacterial eradication was reported as a decrease in CFUs relative to the control group. Mann-Whitney U tests were used to compare between groups. RESULTS:Treatment with ultrasonicated nanoparticles resulted in a significant mean decrease in CFUs of 99.3% compared to controls (p < 0.0001). Irrigation with povidone-iodine also resulted in a significant 77.5% reduction in CFUs compared to controls (p < 0.0001). Comparisons between ultrasonicated nanoparticles and povidone-iodine demonstrated a significantly higher reduction in bacterial CFUs in the nanoparticle group (p < 0.0001). CONCLUSION/CONCLUSIONS:Ultrasonicated nanoparticle were superior to commonly used bactericidal irrigation solutions in the eradication of S. aureus from a titanium surface. Future clinical studies are warranted to evaluate this ultrsonication technology in the treatment of PJI.
PMID: 38761198
ISSN: 1432-1068
CID: 5731122
The Financial Feasibility of Bilateral Total Knee Arthroplasty: A Matched Cohort Analyses of Revenue and Contribution Margin Between Simultaneous and Staged Procedures
Ashkenazi, Itay; Rajahraman, Vinaya; Lawrence, Kyle W; Lajam, Claudette M; Bosco, Joseph A; Schwarzkopf, Ran
BACKGROUND:Financial analyses of simultaneous bilateral total knee arthroplasty versus staged bilateral total knee arthroplasty (simBTKA and staBTKA, respectively) have shown improved cost-effectiveness of simBTKA, though revenue and contribution margin (CM) for these procedures have not been investigated. Our analyses compared surgical outcomes, revenues, and CMs between simBTKA and staBTKA. METHODS:We retrospectively reviewed all patients who underwent simBTKA (both procedures done on the same day) and staBTKA (procedures done on a different day within one year) between 2012 and 2021. Patients were 1:1 propensity matched based on baseline characteristics. Surgical outcomes, as well as revenue, cost, and CM of the inpatient episode were compared between groups. Of the 2,357 patients evaluated (n = 595 simBTKA, n = 1,762 staBTKA), 410 were included in final matched analyses (205 per group). RESULTS:Total (P < .001) and direct (P < .001) costs were significantly lower for simBTKA procedures compared to overall costs of both staBTKA procedures. Significantly lower revenue for simBTKA procedures (P < .001), resulted in comparable CM between groups (P = .477). Postoperative complications including 90-day readmission (P = 1.000), 90-day revision (P = 1.000) and all-cause revision at latest follow-up (P = .083) were similar between groups. CONCLUSIONS:In our propensity-matched cohort, lower costs for simBTKA compared to staBTKA were matched by lower revenues, with a resulting similar CM between procedures. Given that postoperative complication rates were similar, both procedures had comparable cost-effectiveness. Future research is needed to identify patients for whom simBTKA may represent a better surgical intervention compared to staBTKA with respect to clinical and patient reported outcomes.
PMID: 38242509
ISSN: 1532-8406
CID: 5668452
Total hip arthroplasty outcomes in Ehlers-Danlos patients: data from the Statewide Planning and Research Cooperative System
Shichman, Ittai; Rajahraman, Vinaya; Anil, Utkarsh; Lin, Charles C; Rozell, Joshua C; Schwarzkopf, Ran
INTRODUCTION/UNASSIGNED:Ehlers-Danlos syndromes (EDS) are genetic connective tissue disorders affecting multiple organ systems that frequently result in connective tissue hyperlaxity and early osteoarthritis. Short- and long-term outcomes after primary total hip arthroplasty (THA) in this patient population remain poorly characterised. The primary purpose of this study is to compare postoperative outcomes and survivorship after primary THA in patients with and without EDS. METHODS/UNASSIGNED:The New York Statewide Planning and Research Cooperative System (SPARCS) database was queried for all patients undergoing primary elective THA between September 2009 and December 2020. Patients with EDS were identified using ICD9 and ICD10 diagnosis codes. Given the relatively low incidence of EDS in this patient population, the cohort was propensity-matched 1:10 to patients without diagnosis of EDS based on demographics characteristics and medical comorbidities as measured by the Elixhauser Comorbidity Index. RESULTS/UNASSIGNED: 0.063). CONCLUSIONS/UNASSIGNED:EDS patients undergoing primary THA have increased rate of all cause revision and demonstrate decreased revision free survival compared to non-EDS THA patients.
PMID: 38619151
ISSN: 1724-6067
CID: 5732882
Corrigendum to 'Hospital Revenue, Cost, and Contribution Margin in Inpatient Versus Outpatient Primary Total Joint Arthroplasty' [The Journal of Arthroplasty 38 (2023) 203-208]
Christensen, Thomas H; Bieganowski, Thomas; Malarchuk, Alex W; Davidovitch, Roy I; Bosco, Joseph A; Schwarzkopf, Ran; Macaulay, William B; Slover, James D; Lajam, Claudette M
PMID: 38644059
ISSN: 1532-8406
CID: 5705402
Revision rate following unipolar versus bipolar hemiarthroplasty
Kugelman, David; Robin, Joseph X; Schaffler, Benjamin C; Davidovitch, Roy; Egol, Kenneth; Schwarzkopf, Ran
INTRODUCTION/UNASSIGNED:There has been much debate on use of bipolar or unipolar femoral heads in hemiarthroplasty for the treatment of femoral neck fractures. The outcome of these implants should be studied in the America Joint Replacement Registry (AJRR). METHODS/UNASSIGNED:All primary femoral neck fractures treated with hemiarthroplasty between January 2012 and June 2020 were searched in the AJRR. All cause-revision of unipolar and bipolar hemiarthroplasty and reasons for revision were assessed for these patients until June of 2023. RESULTS/UNASSIGNED: 0.0192) had a significant increase in revision risk. CONCLUSIONS/UNASSIGNED:We suggest that surgeons should consider using bipolar prosthesis when performing hemiarthroplasty for femoral neck fracture in patients expected to live >2 years post injury.
PMID: 38481377
ISSN: 1724-6067
CID: 5692202
Mini-Navigation Utilization in THA Results in Shorter Length of Stay, Increased Home Discharge, and Higher Physical Therapy Mobilization Scores Compared to THA Without Navigation
Wang, Charles; Mahure, Siddharth A; Kirschner, Noah; Feng, James E; Schwarzkopf, Ran; Long, William J
BACKGROUND:As volume of total hip arthroplasty (THA) continues to increase, the utilization and availability of in-traoperative advanced technologies to arthroplasty surgeons continues to rise as well. Our primary goal was to determine whether the use of a mini navigation technology extended operative times and secondarily if it affected postoperative outcomes following elective THA. METHODS:A single-institution total joint arthroplasty da-tabase was utilized to identify adult patients who underwent elective THA from 2017 to 2019. Baseline demographic data along with surgical operative time, length of stay (LOS) and discharge disposition were collected. The Activity Measure for Post-Acute Care (AM-PAC) was used to determine physi-cal therapy progress. RESULTS:A total of 1,162 THAs were performed of which 69.1% (803) used navigation while 30.9% (359) did not. Baseline demographics including age, sex, body mass index (BMI), insurance, and smoking status were not statistically different between groups. The operative time was shorter in the navigation group compared to THA without navigation (115.1 vs. 118.9 min, p < 0.0001). Mean LOS was signifi-cantly shorter in the navigation THA group as compared to THA without navigation (2.1 vs. 2.6 days, p < 0.0001). Postoperative AM-PAC scores were higher in the navigation group on postoperative day 1 as compared to patients with-out navigation (18.87 vs. 17.52, p < 0.0001). Additionally, a greater percentage of patients were discharged directly home after THA with navigation as compared to THA without navigation (89.54% vs. 83.57%, p < 0.0001). CONCLUSION/CONCLUSIONS:Our study demonstrates that hip navigation technology in the setting of THA is associated with reduced operative times and higher AM-PAC mobilization scores. Hip mini navigation technology shortens operative times while improving early patient outcome scores in association with shorter LOS and greater home-based discharge.
PMID: 38739661
ISSN: 2328-5273
CID: 5658592