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Does Melatonin Improve Sleep Following Primary Total Hip 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 hip arthroplasty (THA) is common and may decrease patient satisfaction and early recovery. Standardized postoperative recommendations for sleep disturbance have not been established. We aimed to assess whether melatonin use improves sleep quality and quantity in the acute period following THA. METHODS:Patients undergoing primary, elective THA between July 2021 and March 2024 were prospectively enrolled and randomized to receive either five mg of melatonin or a placebo nightly for 14 days postoperatively. Participants recorded nightly pain scores on the visual analog scale (VAS), the number of hours slept, and the number of nighttime awakenings in a sleep diary. Sleep disturbance was assessed preoperatively and on postoperative day (POD) 14 using the patient-reported outcome measurement information system sleep disturbance (PROMIS-SD) form. Epworth Sleepiness Scores (ESS) were collected to assess sleep quality and were the primary outcome of this study. Of the 139 patients who completed the study protocol, there were 64 patients in the placebo group and 75 patients in the melatonin group. RESULTS:Both groups demonstrated comparable postoperative ESS (melatonin: 6.0 ± 4.0; placebo: 6.8 ± 4.5, P = 0.35). Melatonin patients experienced significantly more hours slept on POD2 (6.5 ± 1.7; 5.7 ± 2.4, P = 0.017) and averaged over POD one to three (6.1 ± 1.6; 5.7 ± 2.0, P = 0.14), although this was not statistically significant. Fewer nighttime awakenings in the melatonin group were observed on POD two (2.7 ± 1.5; 3.1 ± 2.0, P = 0.28), although this was not statistically significant. The melatonin group demonstrated significantly lower postoperative PROMIS-SD scores (52.5 ± 9.3; 56.3 ± 9.2, P = 0.040). CONCLUSION/CONCLUSIONS:Melatonin may not improve overall postoperative sleep quality following THA as measured by the ESS. Melatonin may promote sleep duration in the POD one to three period, although potential benefits wane after POD three. Melatonin is safe and can be considered for THA patients experiencing early postoperative sleep disturbance.
PMID: 40383169
ISSN: 1532-8406
CID: 5852672

Serum Metal Ion Levels in Modular Dual Mobility Liners after Total Hip Arthroplasty: A Comparison by Years and Implant Manufacturers

Parikh, Nihir; Lam, Alan D; Waren, Daniel; Hobbs, John; Pipa, David; Schwarzkopf, Ran; Krueger, Chad
INTRODUCTION/BACKGROUND:Modular dual mobility (DM) liners are commonly used in total hip arthroplasty (THA) to decrease the risk of instability. However, there are concerns about accelerated wear, corrosion, and metal ion release in modular DM constructs. This study aimed to investigate serum metal ion levels over time after THA and evaluate any differences between implant manufacturers. METHODS:This retrospective study enrolled 165 patients who underwent THA with a modular DM liner. Serum cobalt (Co), chromium (Cr), and zirconium (Zr) levels were assessed via a one-time blood draw. Patients were grouped into time cohorts of one to two, two to five, five to eight, and eight plus years based on years since DM placement. The primary outcome was serum Co, Cr, and Zr levels. Reference values of < 1.5 mcg/L for Co and < 1.2 mcg/L for Cr were considered within normal limits. RESULTS:Median Co and Cr levels were 0.3 (range, 0.2 to seven) and 0.3 (range, zero to 3.1) mcg/L, respectively. There were 13 patients (7.9%) who had abnormally elevated metal ion levels; 10 received Implant A (13%), two received Implant B (4%), and one received Implant C (3%). The Zr levels were undetectable in all patients. Median Co levels (0.4 mcg/L) were higher within two years of DM implantation and had a greater range of values than other time periods (P < 0.001). Successive time periods displayed a decreased range of Co values over time. CONCLUSION/CONCLUSIONS:There was a greater range of Co levels within two years of implantation, which reduced in variability over successive time periods. Although this could suggest an initial "settling-in" period of DM constructs, sequential blood draws from individual patients over time are needed to confirm such trends. Longitudinal tracking of metal ion levels over time in modular DM implants is recommended.
PMID: 40349877
ISSN: 1532-8406
CID: 5843862

Comparison of Short-Term Outcomes and Survivorship of Three Modular Dual Mobility Implants in Primary Total Hip Surgery

Kennedy, Mitchell; Terner, Braden; Gwam, Chukwuweike; Schwarzkopf, Ran
PMCID:12524843
PMID: 41096057
ISSN: 2077-0383
CID: 5954952

Risk of Early Manipulation in Cemented Versus Cementless Total Knee Arthroplasty: An Analysis of the American Joint Replacement Registry

Schaffler, Benjamin C; Zaniletti, Isabella; Arshi, Armin; De, Mita; Schwarzkopf, Ran; Rozell, Joshua C
BACKGROUND:Cementless total knee arthroplasty (TKA) has recently regained popularity, yet data has raised concerns about rates of arthrofibrosis following these procedures. The purpose of this study was to utilize the American Joint Replacement Registry to compare rates of early manipulation under anesthesia (MUA) in cementless and cemented primary TKAs that use technology or manual instrumentation. METHODS:We queried the American Joint Replacement Registry for all patients ages 18 to 95 years who underwent cemented or cementless primary TKA over a 7-year period. Patients were stratified based on whether technology (robotics or computer-assisted navigation) was used during the primary surgery. Groups were then compared for rates of MUA within 90-day of the index surgery using multivariable logistic regression models. A total of 340,841 cases were included in the study, 78,397 (23%) of which used technology and 262,444 (77%) which did not. Within the technology cohort, there were 51,500 (65%) robotic and 26,897 (35%) navigated cases. There were 65% of technology-assisted TKAs and 92% of manual TKAs cemented. RESULTS:In the technology group, multivariable analysis demonstrated significantly higher odds of MUA in cemented TKAs compared to cementless (odds ratio [OR] 1.95, 95% confidence interval [CI] [1.06 to 3.59]; P = 0.031). Robotic cases had significantly higher odds of MUA with cemented compared to cementless implants (OR 2.38, 95% CI [1.27 to 4.46]; P = 0.007), while there was no difference in MUA related to cementation in the navigated cases (OR 3.53, 95% CI [0.48 to 25.95]; P = 0.22). In the manual group, there were no significant differences in MUA rates related to cementation use (OR 1.14, 95% CI [0.8 to 1.64]; P = 0.46). CONCLUSIONS:Cementless TKA did not increase odds of MUA. In further analyzing cement use into technology and manual cohorts, robotic-assisted cemented TKAs had higher rates of early MUA than cementless. Identification of risk factors leading to early arthrofibrosis may be patient dependent and further study is required to elucidate any surgical considerations.
PMID: 40209822
ISSN: 1532-8406
CID: 5871882

Patient Characteristics Associated with Loss to Follow-Up after Total Joint Arthroplasty

Ruff, Garrett; Sarfraz, Anzar; Lawrence, Kyle W; Arshi, Armin; Rozell, Joshua C; Schwarzkopf, Ran
INTRODUCTION/BACKGROUND:Maintaining follow-up after total joint arthroplasty (TJA) is critical to monitor patient outcomes and complications. However, patient factors associated with follow-up compliance have not been described previously. This study aimed to characterize demographic and perioperative characteristics associated with TJA follow-up compliance. METHODS:This was a retrospective review of all primary, elective total hip and knee arthroplasty (THA and TKA) procedures at an urban, tertiary care center from 2011 to 2022. Patient follow-ups were categorized as early (0 to 90 days), mid-term (91 days to two years), and late-term (greater than two years). Patient characteristics, including age, sex, race, smoking status, spoken language, body mass index, income class, insurance type, distance from hospital, 90-day readmission, American Society of Anesthesia Status, and Charlson Comorbidity Index (CCI), were compared at each period, and logistic regression identified predictors of follow-up. RESULTS:In total, 2,836 TKA and 3,056 THA procedures were analyzed, with overall follow-up rates of 78.9 and 76.8%, respectively. Among all TJA patients, those who did not have follow-up were more likely to be younger, men, White, active smokers, live further from the hospital, and have lower CCIs. Uniquely, for TKA patients, higher income status predicted lower overall and early follow-up rates, while English-speaking predicted lower early and higher late follow-up rates in this subgroup. Differences between groups based on follow-up status decreased as follow-up time increased. Regression analyses showed loss to follow-up increased with increased distance from the hospital and current smoking. Uniquely, for THA, men predicted loss-to-follow-up. CONCLUSION/CONCLUSIONS:Younger age, men, White race, higher income, current smoking, and increased distance from the hospital are associated with increased early, but not late, loss to follow-up after TJA. Future studies should assess the influence of other factors, including home support and telemedicine use, on follow-up rates.
PMID: 40334949
ISSN: 1532-8406
CID: 5839292

Impact of Spacer Constraint on Outcomes in Two-Stage Exchange Revision Total Knee Arthroplasty

Sarfraz, Anzar; Aziz, Hadi H; Kurapatti, Mark; Roof, Mackenzie A; Rozell, Joshua C; Schwarzkopf, Ran; Aggarwal, Vinay
INTRODUCTION/BACKGROUND:A two-stage revision has long been the gold standard for chronic periprosthetic joint infections (PJI), with real-component articulating spacers becoming overwhelmingly popular. While several studies have evaluated the success of these spacers in revision total knee arthroplasty (rTKA), to our knowledge, this is the first to specifically compare outcomes of spacers stratified by the level of liner constraint. METHODS:This retrospective analysis reviewed 135 patients who were indicated for two-stage rTKA due to PJI between 2011 and 2023 at a single specialty urban academic institution. Patients were categorized into three groups based on the polyethylene liner constraint used during the first stage: cruciate retaining (CR), posterior stabilized (PS), and varus-valgus constrained (VVC). Of these 135 patients, 60 (44%) were categorized in the CR group, 47 (35%) were in the PS group, and 28 (21%) were in the VVC group. These groups were compared after each stage for peri- and postoperative outcomes such as operative time, length of stay (LOS), discharge disposition, knee range of motion (ROM), as well as incidence of re-revision and reinfection. RESULTS:The mean postoperative LOS was not different among cohorts for both stages. Operative time was significantly longer in the VVC group after the second stage (P = 0.007), while there was no difference after the first stage (P = 0.085). There were no differences in ROM after both stages. The mean ROM after the first stage was 92° in the CR group, 90° in the PS group, and 85° in the VVC group (P = 0.46). After the second stage, ROM was 101° in both the CR and VVC groups and 107° in the PS group (P = 0.28). There were no differences in the risk of re-revision due to re-infection across the groups after the first or second stage procedures. The re-infection incidence after the first stage was 14% in the VVC group, compared to 5% in the CR group and 4% in the PS group (P = 0.14). After the second stage, the reinfection risk was 21% in the VVC group, 8% in the CR group, and 13% in the PS group (P = 0.21). CONCLUSION/CONCLUSIONS:No significant differences were observed in the risk of complications such as re-infection, re-revisions, and postoperative ROM, suggesting that the choice of liner constraint in two-stage revision can be left up to surgeon's discretion.
PMID: 40349865
ISSN: 1532-8406
CID: 5843842

The James A. Rand Young Investigator's Award: What is the Safest and Most Effective Dose of Intravenous Dexamethasone in Total Knee Arthroplasty? A Multicenter Randomized Controlled Trial

Hannon, Charles P; DeBenedetti, Anne; Barrack, Robert L; Kwon, Young-Min; Lonner, Jess H; Huddleston, James I; Nelson, Charles L; Schwarzkopf, Ran; Sierra, Rafael J; Vail, Thomas P; Hansen, Erik; Lee, Gwo-Chin; Geller, Jeffrey A; Della Valle, Craig J
INTRODUCTION/BACKGROUND:The purpose of this multicenter, double-blinded, prospective, randomized controlled trial was to determine the safest and most effective dose of intravenous (IV) dexamethasone administered during primary total knee arthroplasty (TKA). METHODS:There were 404 patients undergoing inpatient primary TKA randomized across 11 centers to receive four mg (n = 138), eight mg (n = 137), or 16 mg (n = 129) of IV dexamethasone intraoperatively. All sites utilized the same perioperative multimodal protocol. Opioid consumption measured in morphine milligram equivalents (MME), pain scores, nausea scores, vomiting episodes, and sleep duration was collected for seven days postoperatively. Glucose levels were measured on postoperative day (POD) one. The mean age was 68 years, the mean body mass index was 33, and 62% were women. Independent sample t-tests were used for continuous data, and Chi-square and Fisher's exact tests were used for discrete data. Demographic characteristics were comparable between groups, suggesting successful randomization. RESULTS:Patients who received 16 mg IV dexamethasone consumed less MME on POD one (38 versus 37 versus 27 MME; P = 0.047) and had fewer vomiting episodes (P = 0.02). Patients who received 16 mg also had lower pain scores at rest at 24 hours, 48 hours, and one week. There were no differences in cumulative opioid consumption within the first 48 hours (P = 0.24), one week (P = 0.43), or pain with activity at any time point. The POD one glucose was highest in patients who received 16 mg (P < 0.001). There were no differences in length of stay, hours slept, or 90-day complication rates between groups. CONCLUSION/CONCLUSIONS:High-dose (16 mg) IV dexamethasone in TKA reduces opioid consumption, pain, and vomiting on the first day after surgery. Outcomes, including opioid consumption, sleep, and nausea, are comparable beyond 24 hours for all doses.
PMID: 40339943
ISSN: 1532-8406
CID: 5839442

The Three-Month Wound Complication and Infection Rates after Vancomycin Powder and Dilute Povidone-Iodine Lavage for Infection Prophylaxis in High-Risk Total Joint Arthroplasty: A Multicenter Randomized Controlled Trial

Saba, Braden V; Higuera-Rueda, Carlos A; Dundon, John; Cooper, H John; Dennis, Douglas A; Long, William J; Chen, Antonia F; Schwarzkopf, Ran; ,
BACKGROUND:Periprosthetic joint infection (PJI) is a high-cost and extremely morbid complication following total joint arthroplasty (TJA); thus, developing a better understanding of perioperative infection prevention strategies is prudent. Literature is mixed regarding the efficacy of vancomycin powder and dilute povidone-iodine lavage, and limited on the combination thereof. To our knowledge, no prospective orthopaedic clinical trials to date have evaluated the efficacy of local vancomycin powder, dilute povidone-iodine lavage, or a combination vancomycin-povidone-iodine-protocol (VPIP) against normal saline irrigation. METHODS:In a large, prospective, multi-center, randomized-controlled study, four distinct infection prevention strategies were implemented in high-risk TJA patients. Local vancomycin powder, dilute povidone-iodine solution, combined VPIP, and saline control were used. Primary outcomes included PJI, wound complications, revisions, emergency department (ED) visits, readmissions, and serious adverse events within three months of index surgery. Chi-square tests were used to compare incidence rates. The criteria used for the diagnosis of PJI were the International Consensus Meeting (ICM) guidelines. RESULTS:There were 821 total hip arthroplasty (THA) and 1,080 total knee arthroplasty (TKA) patients randomized into well-balanced study groups. In the THA and TKA cohorts, respectively, there were no statistically significant differences in rates of persistent wound drainage or dehiscence (P = 0.98, P = 0.95), cellulitis or abscess (P = 0.81, P = 0.51), 3-month infection rates (P = 0.14, P = 0.13), type of septic revisions performed (P = 0.51, P = 0.80), aseptic revision rates (P = 0.07, P = 0.90), ED visits (P = 0.61, P = 0.46), or readmissions (P = 0.78, P = 0.87) between the four treatment groups. CONCLUSIONS:There were no statistically significant differences in PJI or other surgical outcomes following THA or TKA among the study groups. Therefore, the use of such prophylactic measures, including povidone-iodine and vancomycin powder in high-risk patients, can be left up to the surgeon or hospital discretion.
PMID: 40349869
ISSN: 1532-8406
CID: 5843852

Total Hip Arthroplasty in Challenging Settings: Acetabular Fractures, Adolescents, Conversions, and Developmental Dysplasia of the Hip

Anil, Utkarsh; Terner, Braden; Karim, Mahmoud Abdel; Ebied, Ayman; Polkowski, Gregory G; Schwarzkopf, Ran
Total hip arthroplasty (THA) is one of the most common and successful procedures for the treatment of end-stage hip arthritis. However, in certain complex scenarios, THA can present important and unique challenges, specifically following acetabular fractures in adolescent patients, following failed fixation of proximal femoral fractures, and in developmental dysplasia of the hip (DDH). As these cases involve distorted anatomy, poor bone quality, retained hardware, and previous surgeries, detailed planning, specialized instrumentation and implants, and novel surgical techniques are required. This narrative review examines the challenges, surgical considerations, outcomes, and complications in complex THA management.
PMID: 40419031
ISSN: 1532-8406
CID: 5855122

Why Do Total Joint Arthroplasties Get Canceled on the Day of Surgery?

Sandoval, Carlos G; Katzman, Jonathan L; Connolly, Patrick; Grossman, Eric L; Arshi, Armin; Schwarzkopf, Ran
BACKGROUND:Same-day cancellations of elective surgeries present challenges to patients, providers, and healthcare institutions. This study aimed to investigate the frequency and predictors of same-day cancellations for elective total joint arthroplasty (TJA). METHODS:A retrospective review was conducted on 13,744 scheduled primary, elective TJAs at an urban academic center from September 2017 to August 2023. Cases that experienced same-day cancellations were grouped based on the reasoning for cancellation into one of two categories - operative concern (e.g., acute health issues, medication non-compliance) or a nonoperative concern (e.g., financial clearance, transportation issues). Patient demographics were compared between the cancellation and surgery cohorts and between the categorical reasons for cancellation. RESULTS:Out of the 38,849 scheduled TJAs, 362 cases (0.9%) were canceled on the day of surgery. Higher patient body mass index (BMI) was the singular patient factor predictive of same-day cancellation across all TJAs. Non-white race, men, and higher Charlson Comorbidity Index (CCI) were additional significant predictors for THA, but not TKA cancellation. Operative concerns accounted for 74.9% of the cancellations, and nonoperative concerns accounted for 25.1%. Increased patient BMI was predictive of TJAs canceled due to operative concerns, whereas younger patient age was predictive of TJAs canceled due to nonoperative concerns. Of all same-day cancellations, 81.8% were ultimately rescheduled, and rescheduled cases occurred at a median of 25 days (range, one to 425) after cancellation. There were no significant differences in rescheduling rates and time to reschedule cases between the reasons for cancellation. CONCLUSION/CONCLUSIONS:Approximately 1% of patients experienced a same-day cancellation of their elective TJA, most of which occurred due to operative concerns. These findings may guide the development of preoperative optimization strategies aimed at reducing the occurrence of same-day cancellations for high-risk patients, thereby maximizing the utilization of operative resources and enhancing care for TJA patients.
PMID: 40122218
ISSN: 1532-8406
CID: 5814572