Safety and Early Results for Off-Label Use of Intranasal Calcitonin for Treatment of Nondisplaced Acromial and Scapular Spine Stress Fractures After Reverse Total Shoulder Arthroplasty.

Immobilization for acromial and scapular spine stress AU4fractures (AF/SSF) after reverse total shoulder arthroplasty (RSA) is associated with patient dissatisfaction. Our study reports the effects and safety of intranasal calcitonin alongside sling immobilization on pain and function in the treatment of AF/SSF after RSA. The treatment was regimented calcitonin (salmon) 200 unit/actuation nasal spray (1 spray/day) for 6 weeks with sling immobilization for 4 weeks. Each patient was monitored through blood work. Visual analog scale, American Shoulder and Elbow Surgeons score, and active range of motion were collected preoperatively, postoperatively, at presentation of AF/SSF, and after completion of calcitonin treatment. Two hundred eighty-two RSAs were performed by two board-certified orthopaedic surgeons, of which 18 patients sustained AF/SSF (6.4%). Ten patients met inclusion criteria (nine AFs and one SSF). After calcitonin treatment, patients demonstrated an average improvement of visual analog scale of 5.8 points, active range of motion of 46_, and American Shoulder and Elbow Surgeons score of 43.6 points at average 7.53 months after RSA. No medical complications were reported at 6-month follow-up after calcitonin treatment. The use of intranasal calcitonin was not associated withadverse events including no aberrations/signs of cancer at 6-month follow-up after administration. Calcitonin with sling immobilization markedly improved clinical and functional outcomes of patients with nondisplaced AF/SSF and may be considered by orthopaedic surgeons for symptom management.

Functional somatic syndromes are associated with inferior outcomes and increased complications after hip and knee arthroplasty: a systematic review.

BACKGROUND: Functional somatic syndromes (FSSs), defined as chronic physical symptoms with no identifiable organic cause, may impact results after hip and knee arthroplasty. The purpose of this study was to perform a systematic review assessing the relationship between FSSs and clinical outcomes after primary total hip arthroplasty (THA), total knee arthroplasty (TKA), and unicompartmental knee arthroplasty (UKA). METHODS: The PubMed and Web of Science databases were queried from January 1955 through December 2021 for studies investigating the impact of at least one FSS (fibromyalgia, irritable bowel syndrome (IBS), chronic headaches, and chronic low back pain) on outcomes after primary THA/TKA/UKA. Outcomes of interest included patient-reported outcome measures (PROMs), postoperative opioid use, complications, revisions, and costs of care. RESULTS: There were twenty-eight studies, including 768,909 patients, of which 378,384 had an FSS. Five studies reported preoperative PROMs prior to THA/TKA, all of which showed worse PROMs among patients with at least 1 FSS diagnosis. Thirteen studies reported postoperative PROMs after THA/TKA, all of which demonstrated worse PROMs among patients with at least 1 FSS diagnosis. Patients with FSS diagnoses were more likely to continue using opioids at 3, 6, and 12 months following TKA, THA, and UKA. Medical and surgical complications, as well as revision rates, were higher among patients with FSSs. CONCLUSION: Patients with FSSs have inferior PROMs and are at increased risk for prolonged postoperative opioid use, medical and surgical complications, and revision after hip and knee arthroplasty. Improved understanding of the factors influencing the success of hip and knee arthroplasty is critical. Future studies should address the biopsychosocial determinants of health that can impact outcomes after total joint arthroplasty.

Editorial Commentary: The Social Determinants of Health are Insufficiently Reported in the Orthopaedic Literature.

Socially and economically disadvantaged patients have delays in access to appropriate care, present more severely and to low-volume surgeons and facilities, and achieve lower clinical outcomes than socially advantaged patents. In the United States, 15% live in poverty based upon family income, and evaluation of social determinants of health (SDOH), such as race, ethnicity, employment status, insurance status, education level, and socioeconomic status, is important in helping identify patients at risk. Orthopaedic providers and researchers should collect and report SDOH as routine demographic data. Without an adequate understanding of the historical, institutional, and environmental factors that contribute to an individual's access to health care and subsequent health outcomes, orthopaedic surgeons are effectively neglecting patients' life-course perspective and their biopsychosocial model. Furthermore, we need to understand the value rendered to high-risk patients.

Higher complication rates following primary total shoulder arthroplasty in patients presenting from areas of higher social deprivation.

Aims: The aim of this study was to characterize the influence of social deprivation on the rate of complications, readmissions, and revisions following primary total shoulder arthroplasty (TSA), using the Social Deprivation Index (SDI). The SDI is a composite measurement, in percentages, of seven demographic characteristics: living in poverty, with < 12 years of education, single-parent households, living in rented or overcrowded housing, households without a car, and unemployed adults aged < 65 years. Methods: Patients aged ≥ 40 years, who underwent primary TSA between 2011 and 2017, were identified using International Classification of Diseases (ICD)-9 Clinical Modification and ICD-10 procedure codes for TSA in the New York Statewide Planning and Research Cooperative System database. Readmission, reoperation, and other complications were analyzed using multivariable Cox proportional hazards regression controlling for SDI, age, ethnicity, insurance status, and Charlson Comorbidity Index. Results: A total of 17,698 patients with a mean age of 69 years (SD 9.6), of whom 57.7% were female, underwent TSA during this time and 4,020 (22.7%) had at least one complication. A total of 8,113 patients (45.8%) had at least one comorbidity, and the median SDI in those who developed complications 12 months postoperatively was significantly greater than in those without a complication (33 vs 38; p < 0.001). Patients from areas with higher deprivation had increased one-, three-, and 12-month rates of readmission, dislocation, humeral fracture, urinary tract infection, deep vein thrombosis, and wound complications, as well as a higher three-month rate of pulmonary embolism (all p < 0.05). Conclusion: Beyond medical complications, we found that patients with increased social deprivation had higher rates of humeral fracture and dislocation following primary TSA. The large sample size of this study, and the outcomes that were measured, add to the literature greatly in comparison with other large database studies involving TSA. These findings allow orthopaedic surgeons practising in under-served or low-volume areas to identify patients who may be at greater risk of developing complications.

Retinal arterial Aß40 deposition is linked with tight junction loss and cerebral amyloid angiopathy in MCI and AD patients.

INTRODUCTION: Vascular amyloid beta (Aß) protein deposits were detected in retinas of mild cognitively impaired (MCI) and Alzheimer's disease (AD) patients. We tested the hypothesis that the retinal vascular tight junctions (TJs) were compromised and linked to disease status. METHODS: TJ components and Aß expression in capillaries and larger blood vessels were determined in post mortem retinas from 34 MCI or AD patients and 27 cognitively normal controls and correlated with neuropathology. RESULTS: Severe decreases in retinal vascular zonula occludens-1 (ZO-1) and claudin-5 correlating with abundant arteriolar Aß40 deposition were identified in MCI and AD patients. Retinal claudin-5 deficiency was closely associated with cerebral amyloid angiopathy, whereas ZO-1 defects correlated with cerebral pathology and cognitive deficits. DISCUSSION: We uncovered deficiencies in blood-retinal barrier markers for potential retinal imaging targets of AD screening and monitoring. Intense retinal arteriolar Aß40 deposition suggests a common pathogenic mechanism of failed Aß clearance via intramural periarterial drainage.

Scaffold- and graft-based biological augmentation of rotator cuff repair: an updated systematic review and meta-analysis of preclinical and clinical studies for 2010-2022.

BACKGROUND: Despite advancements in the surgical techniques of rotator cuff repair (RCR), there remains a high retear rate. Biological augmentation of repairs with overlaying grafts and scaffolds may enhance healing and strengthen the repair construct. This study aimed to investigate the efficacy and safety of scaffold-based (nonstructural) and overlay graft-based (structural) biological augmentation in RCR (excluding superior capsule reconstruction and bridging techniques) in both preclinical and clinical studies. METHODS: This systematic review was performed in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, as well as guidelines outlined by The Cochrane Collaboration. A search of the PubMed, Embase, and Cochrane Library databases from 2010 until 2022 was conducted to identify studies reporting the clinical, functional, and/or patient-reported outcomes of ≥1 biological augmentation method in either animal models or humans. The methodologic quality of included primary studies was appraised using the Checklist to Evaluate a Report of a Non-pharmacological Trial (CLEAR-NPT) for randomized controlled trials and using the Methodological Index for Non-randomized Studies (MINORS) for nonrandomized studies. RESULTS: A total of 62 studies (Level I-IV evidence) were included, comprising 47 studies reporting outcomes in animal models and 15 clinical studies. Of the 47 animal-model studies, 41 (87.2%) demonstrated biomechanical and histologic enhancement with improved RCR load to failure, stiffness, and strength. Of the 15 clinical studies, 10 (66.7%) illustrated improvement in postoperative clinical, functional, and patient-reported outcomes (eg, retear rate, radiographic thickness and footprint, and patient functional scores). No study reported a significant detriment to repair with augmentation, and all studies endorsed low complication rates. A meta-analysis of pooled retear rates demonstrated significantly lower odds of retear after treatment with biological augmentation of RCR compared with treatment with non-augmented RCR (odds ratio, 0.28; P < .00001), with low heterogeneity (I2 = 0.11). CONCLUSIONS: Graft and scaffold augmentations have shown favorable results in both preclinical and clinical studies. Of the investigated clinical grafts and scaffolds, acellular human dermal allograft and bovine collagen demonstrate the most promising preliminary evidence in the graft and scaffold categories, respectively. With a low risk of bias, meta-analysis revealed that biological augmentation significantly lowered the odds of retear. Although further investigation is warranted, these findings suggest graft and scaffold biological augmentation of RCR to be safe.

Incidence of primary anatomic and reverse total shoulder arthroplasty in patients less than 50 years of age and high early revision risk.

BACKGROUND: Compared with the overall incidence of shoulder arthroplasty (SA), the relative risk and burden of revision may vary among patients specifically 40-50 years of age and less than 40 years of age. Our aim was to investigate the incidence of primary anatomic total SA and reverse SA, rate of revision within 1 year, and determine the associated economic burden in patients younger than 50 years. METHODS: A total of 509 patients less than 50 years old who underwent SA were included, using a national private insurance database. Costs were based on the grossed covered payment. Multivariate analyses were performed to identify risk factors associated with revisions within 1 year of the index procedure. RESULTS: SA incidence in patients less than 50 years old increased from 2.21 to 2.5 per 100,000 patients from 2017 to 2018. The overall revision rate was 3.9% with a mean time to revision of 96.3 days. Diabetes was a significant risk factor for revision (P = .043). Surgeries performed in patients less than 40 years old cost more than those performed in patients aged 40-50 years for both primary ($41,943 ± $23,842 vs. $39,477 ± $20,874) and revision cases ($40,370 ± $21,385 vs. $31,669 ± $10,430). CONCLUSIONS: This study demonstrates that the incidence of SA in patients less than 50 years old is higher than previously reported in the literature and most commonly reported for primary osteoarthritis. Given the high incidence of SA and subsequent high early revision rate in this subset population, our data portend a large associated socioeconomic burden. Policymakers and surgeons should use these data for implementing training programs focused on joint sparing techniques.

Evidence for Utilization of Injectable Biologic Augmentation in Primary Rotator Cuff Repair: A Systematic Review of Data From 2010 to 2022.

Background: Biologic healing after rotator cuff repair remains a significant challenge. Injectable biologic augmentation may improve tissue quality at the suture-tendon interface. Purpose: To investigate the effect of injectable biologic supplementation in rotator cuff repair and to assess the quality and adherence to evolving reporting standards. Study Design: Systematic review; Level of evidence, 3. Methods: A systematic review was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Included were 40 studies: 29 preclinical (in vivo animal models) and 11 clinical. Each clinical study was assessed for quality, risk of bias, and adherence to relevant MIBO (Minimum Information for Studies Evaluating Biologics in Orthopaedics) guidelines. The outcomes of interest were reported load to failure, load to gap, gap size, and stiffness in the preclinical studies, and healing rate and any patient-reported outcome measures in the clinical studies. Results: Injectables reported included growth factors (eg, transforming growth factor-beta 3, erythropoietin), bone marrow-derived mesenchymal stem cells and adipose-derived mesenchymal stem cells (ADSCs), and other agents such as platelet-rich plasma (PRP) and hyaluronic acid. The most common findings for preclinical injectables were increased load to failure (16/29 studies; 55.2%) and improved collagen histological quality (11/29 studies; 37.9%). All 11 clinical studies (10 PRP, 1 ADSC) indicated no adverse events, with similar or improved patient-reported outcomes compared with repairs in the control groups. In 1 study utilizing an innovative delivery technique, a concentrated PRP globule with fibrin matrix was shuttled over a suture to maintain concentrated PRP at the repair site and demonstrated a significant decrease in retears (P = .03) at a 31-month follow-up. A matched-cohort study investigating augmentation with ADSCs demonstrated a significantly lower retear rate in the ADSC-augmented group than the control group at a 28-month follow-up (P < .001). On average, the clinical studies adhered to 66% of relevant MIBO reporting guidelines and had a low risk of bias. Conclusion: Approximately 83% of preclinical studies found a positive biomechanical or histological effect, with no studies showing an overall negative effect. Clinically, utilization of innovative delivery techniques may reduce the risk of arthroscopic washout of PRP and improve retear rates. ADSCs were shown to reduce retear rates at a 28-month follow-up.

Patients With Functional Somatic Syndromes-Fibromyalgia, Irritable Bowel Syndrome, Chronic Headaches, and Chronic Low Back Pain-Have Lower Outcomes and Higher Opioid Usage and Cost After Shoulder and Elbow Surgery.

PURPOSE: To perform a systematic review assessing the relationship between functional somatic syndromes (FSSs) and patient-reported outcome measures (PROMs), postoperative opioid consumption, and hospitalization costs after shoulder and elbow surgery. METHODS: A systematic review of the PubMed and Web of Science databases was conducted according to Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines to identify all studies evaluating the effect of having at least 1 FSS (fibromyalgia, irritable bowel syndrome, chronic headaches, chronic low back pain) on outcomes after shoulder and elbow surgeries. Outcomes of interest included postoperative analgesic use, PROMs, and hospitalization costs. RESULTS: The review identified a total of 320 studies, of which 8 studies met the inclusion criteria. The total number of participants in our 8 included studies was 57,389. Three studies (n = 620) reported PROMs. These studies demonstrated that the presence of at least 1 FSS is predictive of significantly greater pain scores and lower quality of recovery, Disability Arm Shoulder and Hand, American Shoulder and Elbow Surgeons Shoulder Score, and Single Assessment Numeric Evaluation scores postoperatively. Although scores were inferior in among patients with FSS, 2 of the 3 studies showed improvement in PROMs in this group of patients. Seven studies (n = 56,909) reported postoperative opioid use. Of these, 5 reported that a diagnosis of at least 1 FSS was a strong risk factor for long-term opioid use after surgery. One study (n = 480) found that time-driven activity-based costs were significantly greater in patients with FSSs. CONCLUSIONS: Patients with functional somatic syndromes have less-favorable PROMs postoperatively, consume more opioids postoperatively, and have greater health care costs after elective shoulder and elbow procedures. Although PROMs among patients with FSSs are inferior compared with those without FSSs, PROMs still improved compared with baseline. LEVEL OF EVIDENCE: Level III, systematic review of Level II-III studies.

Comparison of Overall Complication Rates in VCR-Based vs Non-VCR-Based Corrective Techniques in Severe Rigid Kyphoscoliosis Patients: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: Compilation of complication outcomes data from the surgical management of severe rigid kyphoscoliosis patients using VCR-based vs non-VCR-based corrective maneuvers is lacking. This meta-analysis aimed to compare complication outcomes between those classified osteotomy approaches. METHODS: Thorough literature review and meta-analysis were conducted between January 2000 and September 2021. The selection criteria were studies: i) reporting major curve Cobb angle of ≥80° and flexibility of <25% or 30%; ii) comparing VCR or ≥ Type V Schwab osteotomy defined as VCR-based vs [non-VCR-based] techniques, (any osteotomy or technique other than VCR); iii) published in English with ≥10 patients; iv) reporting complication rates; and v) having minimum of 2-year follow-up. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Significance level was set at (P < .05). RESULTS: Of the 174 patients included, 52.30% (n = 91) and 47.70% (n = 83) were VCR-based and non-VCR-based, respectively. The incidence of dural tears/nerve injuries/significant intraoperative-neuromonitoring changes was significantly higher; [OR = 6.78, CI= (1.75 to 26.17), I2 = 0%, (P = .006)] in the VCR-based group than the non-VCR-based group. The 'overall surgical and medical' complication rate was significantly higher in the VCR-based group, [OR = 1.94, CI= (1.02 to 3.67), I2 = 31%, (P = .04)]. CONCLUSION: Both VCR-based and non-VCR-based surgical techniques for management of severe rigid scoliosis and kyphoscoliosis patients pose comparable overall surgical complication rates, while a significantly higher perioperative neurological complication incidence was associated with VCR-based technique compared to the non-VCR-based techniques. The VCR-based technique was associated with 6.78 times higher incidence of neurological complications compared to non-VCR-based techniques.

Social determinants of health influence clinical outcomes of patients undergoing rotator cuff repair: a systematic review.

BACKGROUND: Social determinants of health (SDOH) are the collection of environmental, institutional, and intrinsic conditions that may bias access to, and utilization of, health care across an individual's lifetime. The effects of SDOH are associated with disparities in patient-reported outcomes after hip and knee arthroplasty, but its impact on rotator cuff repair (RCR) is poorly understood. This study aimed to investigate the influences that SDOH have on accessing appropriate orthopedic treatment, as well as its effects on patient-reported outcomes following RCR. METHODS: This systematic review was performed in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and guidelines outlined by the Cochrane Collaboration. A search of PubMed, the Cochrane Library, and Embase from inception until March 2022 was conducted to identify studies reporting at least 1 SDOH and its effect on access to health care, clinical outcomes, or patient-reported outcomes following RCR. The search term was created with reference to the PROGRESS-Plus framework. Methodological quality of included primary studies was appraised using the Newcastle-Ottawa Scale (NOS) for nonrandomized studies, and the Cochrane Risk of Bias Tool for randomized studies. RESULTS: Thirty-two studies (level I-IV evidence) from 18 journals across 7 countries, published between 1999 and 2022, met inclusion criteria, including 102,372 patients, 669 physical therapy (PT) clinics, and 71 orthopedic surgery practices. Multivariate analysis revealed female gender, labor-intensive occupation and worker's compensation claims, comorbidities, tobacco use, federally subsidized insurance, lower education level, racial or ethnic minority status, low-income place of residence and low-volume surgery regions, unemployment, and preoperative narcotic use contribute to delays in access to health care and/or more severe disease state on presentation. Black race patients were found to have significantly worse postoperative clinical and patient-reported outcomes and experienced more pain following RCR. Furthermore, Black and Hispanic patients were more likely to present to low-volume surgeons and low-volume facilities. A lower education level was shown to be an independent predictor of poor surgical and patient-reported outcomes as well as increased pain and worse patient satisfaction. Patients with federally subsidized insurance demonstrated significantly worse postoperative clinical and patient-reported outcomes CONCLUSIONS: The impediments created by SDOH lead to worse clinical and patient-reported outcomes following RCR including increased risk of postoperative complications, failed repair, higher rates of revision surgery, and decreased ability to return to work. Orthopedic surgeons, policy makers, and insurers should be aware of the aforementioned SDOH as markers for characteristics that may predispose to inferior outcomes following RCR.

Clinical Effectiveness of Interlaminar Epidural Injections of Local Anesthetic with or without Steroids for Managing Chronic Neck Pain: A Systematic Review and Meta-Analysis.

BACKGROUND: Chronic neck pain is reportedly considered the fourth leading cause of disability. Cervical interlaminar epidural injections are among the commonly administered nonsurgical interventions for managing chronic neck pain, secondary to disc herniation and radiculitis, spinal stenosis, or chronic neck pain of discogenic origin. OBJECTIVES: To systematically review the differences in the effectiveness of cervical epidural injections with local anesthetics with or without steroids for the management of chronic neck pain. STUDY DESIGN: Systematic review and meta-analysis. METHODS: A comprehensive search of the literature of randomized controlled trials (RCTs) that compared epidural injections with local anesthetic with or without steroids was performed, including a search of PubMed, EMBASE, and Cochrane databases for all years up to May 2019. Meta-analysis was done for pain relief based on the Numeric Rating Scale, functional status based on the Neck Disability Index, and opioid intake dosage. RESULTS: Four studies met the inclusion criteria. A total of 370 patients were divided into 2 groups: the experimental group received cervical epidural injection with steroid and local anesthetic, and the control group received injection with local anesthetic only. Regrading pain relief, no significant difference was observed between both groups (weighted mean difference [WMD], -0.006; 95% confidence interval (CI), -0.275 to 0.263; P = 0.963; I² = 0.0% at 12 months). There was also no significant difference in the improvement of the functional status (WMD, 0.159; 95% CI, -1.231 to 1.549; P = 0.823; I² = 9.8% at 12 months). Similarly, there was no significant difference in opioid dosage (WMD, -0.093; 95% CI, -5.952 to 5.766; P = 0.975; I² = 0.0% at 12 months). LIMITATIONS: Only a few studies on this premise were found in the literature. There was also a lack of heterogeneity of the included RCT studies. CONCLUSIONS: The addition of steroids to anesthetic injectates was not associated with better pain and functional score outcomes compared with anesthetic injectate alone in patients with chronic neck pain. KEY WORDS: Chronic neck pain, cervical radiculopathy, cervical disc disease, spinal stenosis, facet joint pathology, cervical epidural injections, steroid injections, local anesthetic injections, systematic review, meta-analysis, randomized control trial.