Staying out of trouble: FDA regulation of orthobiologics and the shoulder surgeon.

BACKGROUND: Food and Drug Administration (FDA) regulation of orthobiologics can be challenging to interpret for the nonregulatory scientist. However, understanding how regulations apply to clinical use of these orthobiologic products is critical, as there are both ethical and legal ramifications to using orthobiologics in conflict with regulations. Recent FDA guidances have attempted to clarify these issues, although questions still remain regarding nuances in regulatory applications. METHODS: FDA guidances, industry blogs, and relevant publications were searched for citations regarding recent orthobiologics and regulations. These sources were compiled into a current assessment of FDA regulations regarding the use of orthobiologics in the shoulder. RESULTS: Key to understanding these regulations is the FDA differentiation of human cellular and tissue-based products into 361 and 351 category products. Although some controversy still exists, the FDA has attempted to clarify these issues with several recent guidances. Of equal importance, the FDA has ended enforcement discretion for many biologic products in June of 2021, creating a previously tolerated class of orthobiologics that now requires an Investigational New Drug application and subsequent Biologic License Application to legally market these orthobiologics. The same surgical procedure exception was further clarified in 2017 to exempt facilities from regulatory controls when specific guidelines are met. CONCLUSIONS: This article attempts to clarify the current thinking on FDA regulations and will allow the shoulder and elbow surgeon to stay within the current bounds of ethical and legal use of these products.

Does Use of GLP-1 Agonists Increase Postoperative Complications in Patients Undergoing Shoulder Arthroplasty?

BACKGROUND: Amidst the rising prevalence of type 2 diabetes mellitus (T2DM) and obesity among individuals undergoing total shoulder arthroplasty (TSA), the impact of glucagon-like-peptide-1 (GLP-1) therapy on surgical outcomes merits thorough investigation. Though it is known that GLP-1 therapy poses an interesting challenge for anesthesia during the perioperative period, little is known regarding the effects of these medications on surgical outcomes. This study aimed to evaluate the influence of GLP-1 on postoperative outcomes and length of stay (LOS) in T2DM patients undergoing TSA. METHODS: A retrospective cohort analysis was performed using a national database to identify primary TSA patients aged 18 and above with T2DM prescribed GLP-1 therapy at the time of surgery. Exclusion criteria included revision surgery, TSA for fracture, type 1 diabetes, steroid-induced diabetes, and contraindications for GLP-1 therapy. A control group of T2DM TSA patients not on GLP-1 therapy was used, and a 1:4 propensity-score match was performed. Incidence rates and odds ratios (OR) via multivariable logistic regression were calculated. The primary outcomes were 90-day major medical complications and LOS. Secondary outcomes included 2-year joint-related complications. RESULTS: In the 90-day follow-up cohort, 64,567 patients met inclusion criteria, with 8,481 (13.1%) on GLP-1 therapy. No significant increase in 90-day major complications, including DVT, cardiac arrest, myocardial infarction, cerebrovascular accident, pneumonia, pulmonary embolism, urinary tract infection, surgical site infection, hypoglycemic event, sepsis, or readmission, was found between GLP-1 and non-GLP-1 cohorts after multivariable logistic regression. In the 2-year follow-up cohort, 47,814 patients were included, with 5,969 (12.5%) on GLP-1 therapy. Similarly, 2-year joint-related complications, including all-cause revision, prosthetic joint infection, periprosthetic fracture, and aseptic revision, showed no significant differences between the GLP-1 and non-GLP-1 cohorts. No significant difference was observed in LOS in the 90-day cohort. CONCLUSION: This study provides a comprehensive analysis of GLP-1 therapy's impact on TSA outcomes, revealing no significant change in postoperative complications or LOS. The lack of increased postoperative risk underscores the potential of GLP-1 therapy in managing T2DM without adverse effects on TSA recovery. These insights contribute to understanding postoperative management in orthopedic surgery, indicating that we did not note any increased risk with GLP-1 use perioperatively in TSA patients, unlike in other populations like the TKA patients. Future research should focus on prospective analyses to further elucidate the role of GLP-1 therapy in surgical outcomes, aiming to enhance patient care and optimize postoperative strategies for T2DM patients undergoing TSA.

Reverse shoulder arthroplasty for patients with cuff tear arthropathy: do clinical outcomes differ by inlay vs. onlay design?

BACKGROUND: The influence of position of the humeral tray (inlay or onlay) on clinical outcomes in reverse shoulder arthroplasty (RSA) is a topic of debate. The purpose of this study was to compare clinical and radiographic outcomes of patients with cuff tear arthropathy treated with RSA systems with inlay or onlay humeral tray design, similar neck-shaft angles, and lateralized glenospheres. METHODS: This was a retrospective study of prospectively obtained data from 1 tertiary care center. We identified all patients who underwent primary RSA between 2009 and 2017 (N = 511). We included 102 patients with diagnosed cuff tear arthropathy treated with RSA prostheses with a lateralized glenosphere and 135° neck-shaft angle (with either an inlay or onlay humeral tray design) who had a minimum of 2 years of follow-up (mean, 44 months; range, 24-125 months). Sixty-three patients (62%) had an inlay humeral tray (inlay group) and 39 (38%) had an onlay tray (onlay group). All patients underwent preoperative and postoperative evaluations, including measures of patient-reported outcomes (PROs), shoulder range of motion (ROM) testing, and radiographic imaging. Clinical relevance of changes in PROs and ROM was evaluated using published values for minimal clinically important differences. RESULTS: The 2 groups did not differ by demographic characteristics except for a higher proportion of women in the inlay group (75%) than in the onlay group (56%) (P = .04). Preoperative PROs and ROM were not significantly different between groups. At final follow-up, PROs and ROM were not different between groups in terms of statistical significance or clinical relevance. We found no significant differences in the rate of baseplate loosening (inlay, 3.2% vs. onlay, 5.1%, P = .63), revision surgery (inlay, 0% vs. onlay 5.1%, P = .07), acromial stress fracture (inlay, 3.2% vs. onlay, 5.1%, P = .63), prosthesis dislocation (inlay, 0% vs. onlay, 2.6%, P = .20), or scapular notching (inlay, 21% vs. onlay, 7.7%, P = .08). CONCLUSION: At 2-year minimum follow-up, the position of the humeral tray in RSA prostheses (either inlay or onlay) for cuff tear arthropathy was not associated with PROs, shoulder ROM, or rates of complications, including baseplate loosening, acromial stress fracture, and scapular notching.

Reverse total shoulder arthroplasty within 6 weeks of proximal humerus fracture is associated with the lowest risk of revision.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) has become an increasingly popular treatment strategy in the management of complex proximal humeral fractures (PHFs). However, no definitive consensus has been reached regarding the optimal surgical timing of RTSA following PHF, particularly considering nonoperative management is often a viable option. Therefore, the aim of this study was (1) to identify optimal timing intervals that maximize the likelihood of revision following RTSA and (2) to determine differences in revision etiologies using the identified timing intervals. METHODS: A retrospective cohort analysis of patients undergoing PHF-indicated RTSA from 2010 to 2021 was conducted using a national administrative claims database. Stratum-specific likelihood ratio (SSLR) analysis was conducted to determine data-driven timing strata between PHF and RTSA that maximized the likelihood of revision surgery within 2 years of RTSA. To control for confounders, multivariable regression analysis was conducted to confirm the identified data-driven strata's association with 2-year revision rates as well as compare the likelihood of various indications for revision including mechanical loosening, dislocation, periprosthetic joint infection (PJI), and periprosthetic fracture (PPF). RESULTS: In total, 11,707 patients undergoing TSA following PHF were included in this study. SSLR analysis identified 2 timing categories: 0-6 weeks and 7-52 weeks from the time of PHF to TSA surgery. Relative to the 0-6-week cohort, the 7-52-week cohort was more likely to undergo revision surgery within 2 years (OR 1.93, P < .001). Moreover, the 7-52-week cohort had significantly higher odds of revision indicated for dislocation (OR 2.24, P < .001), mechanical loosening (OR 1.71, P < .001), PJI (OR 1.74, P < .001), and PPF (OR 1.96, P < .001). CONCLUSIONS: Using SSLR, we were successful in identifying 2 data-driven timing strata between PHF and RTSA that maximized the likelihood of 2-year revision surgery. As it can be difficult to determine whether RTSA or nonoperative management is initially more appropriate, considering the results of this study, an early trial of 4-6 weeks of nonoperative management may be appropriate without altering the risks associated with RTSA.

Infection following mini-open rotator cuff repair: a single surgeon experience.

BACKGROUND: Surgical technique has been shown to influence risk of surgical site infection following rotator cuff repair (RCR). Few studies have reported the rate of infection associated with mini-open RCR. The goal of this study was to report the postoperative infection rate and risk factors for infection among patients undergoing RCR performed by a single surgeon using a modified mini-open technique. Our hypothesis was that the rate of infection after mini-open RCR would be lower than previously reported for this surgical approach. METHODS: We retrospectively reviewed an institutional shoulder surgery database to identify patients who underwent mini-open RCR performed by one surgeon at an academic tertiary care institution between 2003 and 2020. Patient records were reviewed to determine which individuals returned within 3 months postoperatively with a superficial or deep surgical site infection requiring operative management. Patient demographics, preoperative clinical characteristics, intraoperative variables, microbiological findings, infection management, and clinical course after infection were recorded. Backward elimination multivariate regression was used to assess for significant risk factors for infection. RESULTS: Of the 925 patients identified, 823 (89%) had at least 3 months of follow-up and were included for further analysis. A majority of the patients undergoing RCR were men (57%). The mean age was 58.4 ± 9.9 years, and the mean body mass index was 29.3 ± 5.9 kg/m2. Fourteen cases (1.7%) of postoperative surgical site infection were identified in 13 patients. Ten infections (1.2%) were superficial and 4 (0.49%) were deep. The most commonly identified organisms were Staphylococcus aureus and Cutibacterium acnes. Male sex (odds ratio [OR] 4.3, 95% CI 1.2-15.3) and diabetes mellitus (OR 3.9, 95% CI 1.2-12.6) were found to be associated with greater risk of infection. The RCR construct was found to be intact in all 10 patients with superficial infections and 2 of the 4 patients with deep infections. All infections were successfully treated with 1 round of surgical débridement and wound irrigation, and with 6 or fewer weeks of intravenous antibiotic therapy. All patients with postoperative infections recovered with no sequelae at a median final follow-up of 63.5 months (range, 3-215 months). CONCLUSIONS: This single-surgeon series of a large patient cohort undergoing mini-open RCR over an 18-year period demonstrated a low overall infection rate of 1.7%. Only 4 infections were deep, which suggests that deep infection after mini-open RCR is uncommon and approximates infection rates seen with arthroscopic techniques.

Epidemiology of Pediatric Dog Walking-Related Injuries Among Children Presenting to US Emergency Departments, 2001 to 2020.

BACKGROUND: Dog walking is associated with a significant injury burden among adults, but the risk of injury associated with dog walking among children is poorly understood. This study describes the epidemiology of children treated at US emergency departments for injuries related to leash-dependent dog walking. METHODS: The National Electronic Injury Surveillance System (NEISS) database was retrospectively analyzed to identify children (5 to 18 years of age) presenting to US emergency departments between 2001 and 2020 with dog walking-related injuries. Primary outcomes included annual estimates of injury incidence, injury characteristics, and risk factors for fracture or traumatic brain injury (TBI). Weighted estimates, odds ratios (ORs), and 95% confidence intervals (CIs) were generated using NEISS sample weights. RESULTS: An estimated 35,611 children presented to US emergency departments with injuries related to dog walking. The mean age of patients was 11 years, and most patients were girls (63%). Over half (55%) of injuries were orthopaedic, and patients commonly injured their upper extremity (57%) and were hurt while falling when pulled or tripped by the leash (55%). The most frequent injuries were wrist strain/sprain (5.6%), finger strain/sprain (5.4%), and ankle strain/sprain (5.3%). On multivariable analysis, injured children aged 5 to 11 years were more likely to have sustained a TBI (OR: 3.2, 95% CI: 1.1-9.7) or fracture (OR: 1.6; 95% CI: 1.1-2.3). Boys were more likely than girls to have experienced a fracture (OR: 2.0, 95% CI: 1.3-2.5). CONCLUSIONS: Dog walking-related injuries in children are primarily orthopaedic and involve the upper extremity. Younger children and boys are at greater risk for serious dog walking-related injuries. LEVEL OF EVIDENCE: Level III.

Lateralized glenosphere reverse shoulder arthroplasty: inlay and onlay designs have similar clinical outcomes in patients with glenohumeral osteoarthritis.

BACKGROUND: Whether or how the position of the humeral tray (inlay or onlay) in reverse shoulder arthroplasty (RSA) affects outcomes is unclear. Our goal was to compare the clinical and radiographic results of RSA systems with inlay vs. onlay designs but with similar neck shaft angles (NSAs) and lateralized glenospheres. METHODS: We screened the institutional database at our tertiary academic center for patients who underwent primary RSA (with a lateralized glenosphere and a 135° NSA) from 2009 through 2017. The indication for surgery was glenohumeral osteoarthritis with glenoid bone loss (Walch classification A2, B2, B3, or C) and an intact rotator cuff. All patients were followed for a minimum of 2 years (mean, 47 months; range, 24-123 months). The humeral tray design was inlay for 79 patients and onlay for 71. All patients underwent preoperative and postoperative evaluations, including physical examination, radiography, and patient-reported outcome measures (visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Western Ontario Osteoarthritis of the Shoulder index). RESULTS: Compared with preoperative values, both groups achieved minimal clinically important differences in range of motion and patient-reported outcomes at the final follow-up. We found no significant differences between groups in any of these measures at the final follow-up. Rates of revision (inlay, 3.8% vs. onlay, 1.4%), scapular notching (inlay, 5.1% vs. onlay, 7.0%), acromial stress fracture (inlay, 0% vs. onlay, 2.8%), and tuberosity resorption (inlay, 25% vs. onlay, 27%) were not significantly different between groups (all, P > .05). CONCLUSION: For patients with glenohumeral osteoarthritis with glenoid bone loss and an intact rotator cuff who underwent RSA using a lateralized glenosphere prosthesis with a 135° NSA, there were no significant differences between the inlay and onlay groups for range of motion, patient-reported outcomes, or complication rates. These findings are limited to this off-label indication for RSA.

Descriptive Epidemiology of Injuries in Professional Speedball Athletes.

CONTEXT: Speedball is an increasingly popular racquet sport played in more than 25 countries. Our objective was to describe injury incidence and patterns among Egyptian national-level speedball athletes. DESIGN: Descriptive epidemiological. METHODS: We conducted a survey of athletes who were registered with the Egyptian Speedball Federation during the 2018-2019 professional season. The survey inquired about injury types and athlete exposures (AEs). The response rate was 63% (100/160 athletes). Respondent ages ranged from 18 to 41 years. We analyzed demographic characteristics; number, location, and mechanism of injuries; treatment; and speedball participation time lost because of injury. RESULTS: Of 100 respondents, 65 reported having sustained at least one injury during the season for a total of 90 injuries and a rate of 4.7 injuries per 1000 AEs (95% confidence interval, 3.7 to 5.7). More injuries occurred during practice (77%) than during competition (23%). Thirty percent of respondents reported having missed a competition because of injury. The most frequent anatomic locations of injury were the shoulder (50%; 2.4/1000 AEs), elbow (14%; 0.68/1000 AEs), and low back (9%; 0.4/1000 AEs). The most frequently cited causes of injury were increased intensity of training (40%) and lack of warming up (18%). Seventy-seven percent of injured respondents underwent treatment by a health care professional, and 9% of these respondents underwent surgery. CONCLUSION: The shoulder was the most common anatomic location for injuries in speedball athletes. Our results suggest that attention should be directed toward sport-specific injury prevention and intervention strategies because speedball is a fast-growing sport in several countries.

Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears Is Associated With Improved Shoulder Function and High Patient Satisfaction.

PURPOSE: To investigate associations between clinical and demographic parameters and Constant-Murley (CM) scores after subacromial balloon placement for massive, irreparable rotator cuff tears and to evaluate implant survival, shoulder function, and patient satisfaction. METHODS: We prospectively analyzed patients with rotator cuff tears deemed irreparable on preoperative magnetic resonance imaging for whom nonoperative therapy was unsuccessful and who underwent balloon placement from 2014 to 2017 with minimum 1-year follow-up. Shoulder function was assessed using the CM score and the 12-Item Short Form Health Survey. RESULTS: The study included 51 patients (22 women and 29 men) with a mean age at surgery of 63 years (range, 50-78 years). The mean follow-up period was 36 months (range, 24-56 months). The postoperative acromiohumeral interval and total preoperative CM score predicted the postoperative CM score at final follow-up. The implant survival rates were 92% at 6 and 12 months, 90% at 2 years, and 87% at 3 and 4 years. Five patients underwent reverse total shoulder arthroplasty, and 1 underwent latissimus dorsi tendon transfer. Postoperatively, mean CM scores (± standard deviation) improved for range of motion (from 11 ± 5.4 to 34 ± 6.8) and strength (from 13 ± 5.4 to 28 ± 12) (P < .01 for both). The total CM score improved from 27 ± 7.4 preoperatively to 77 ± 15 postoperatively (P < .01). The physical and mental component summary scores on the 12-Item Short Form Health Survey improved from 27 ± 5.0 to 51 ± 6.5 (P = .02) and from 44 ± 15 to 56 ± 8.0, respectively (P < .01). Thirty-eight patients reported excellent satisfaction, 8 were satisfied, and 5 were dissatisfied. Of the patients, 50 (98%) exceeded the minimal clinically important difference (≥10.4) and patient acceptable symptom state (≥44). CONCLUSIONS: At mean 3-year follow-up, subacromial balloon spacer placement for massive, irreparable rotator cuff tears was associated with a significant improvement in shoulder function, limited need for revision surgery, and high patient satisfaction. A greater postoperative acromiohumeral interval and lower preoperative CM score predicted a lower postoperative CM score at final follow-up. LEVEL OF EVIDENCE: Level IV, retrospective cohort study and treatment study.

Acute compartment syndrome caused by hematoma after shoulder surgery: a case series.

BACKGROUND: The development of acute compartment syndrome (ACS) of the upper extremity after an elective surgical shoulder procedure is rare but can have devastating results. We describe a series of patients who developed ACS of the upper extremity caused by hematoma formation and subsequent upper extremity swelling after undergoing elective surgical shoulder procedures. METHODS: We retrospectively reviewed the database of our tertiary care institution between 2004 and 2019 to find patients who developed ACS after elective shoulder surgery. We found 4 such patients and reviewed their medical records and extracted data on their history, clinical examination, predisposing factors, treatment, and clinical and radiographic outcomes. RESULTS: Of the 4 patients treated, 2 had undergone reverse total shoulder arthroplasty, 1 had undergone open biceps tenodesis, and 1 had undergone closed manipulation for adhesive capsulitis. Two patients developed symptoms of ACS within 24 hours of the index procedure. Both were treated with immediate decompression of the hematoma, and both experienced complete pain relief and full recovery of function at 1-year follow-up. Two patients were on anticoagulation therapy. Of these, 1 patient developed ACS symptoms 14 days after a revision reverse total shoulder arthroplasty and was treated successfully with compartment release. Despite treatment, the other patient developed extensive necrosis of muscles and nerves in the upper extremity and severe neurologic deficits in hand and forearm function. CONCLUSION: ACS of the upper extremity caused by hematoma formation can lead to catastrophic outcomes if diagnosis and treatment are not immediate. Providers should be aware of ACS and the need for prompt diagnosis and treatment.

Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States.

BACKGROUND: The purpose of this study was to determine the incidence of primary reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA) in the United States and examine changes in age- and sex-based procedure rates. A secondary goal was to determine the incidence of hemiarthroplasty. METHODS: Using nationally representative data along with US Census data, we identified >508,000 cases of primary RTSA, anatomic TSA, and shoulder hemiarthroplasty from 2012 to 2017. Trends in the incidence of each procedure were analyzed, and sex- and age-adjusted procedure rates were calculated. RESULTS: From 2012 to 2017, the population-adjusted incidence of primary RTSA increased from 7.3 cases per 100,000 persons (22,835 procedures) to 19.3 cases per 100,000 (62,705 procedures); anatomic TSA increased from 9.5 cases per 100,000 (29,685 procedures) to 12.5 cases per 100,000 (40,665 procedures); and hemiarthroplasty decreased from 3.7 cases per 100,000 (11,695 procedures) to 1.5 cases per 100,000 (4930 procedures). These trends were observed among male and female patients, as well as all age groups. The greatest increase in incidence was seen in male patients as well as patients aged 50-64 years undergoing RTSA. CONCLUSION: The incidence of primary RTSA and incidence of anatomic TSA have increased substantially in the United States from 2012 to 2017 whereas the incidence of hemiarthroplasty has decreased.

Worsening racial disparities in patients undergoing anatomic and reverse total shoulder arthroplasty in the United States.

BACKGROUND: The most comprehensive health care policy changes aimed at reducing racial disparities were implemented in 2011 and continue today. It is unknown if these initiatives have led to a decrease in racial differences among patients undergoing total shoulder arthroplasty. The purpose of this study is to examine racial differences in procedural rates, complications, and mortality in patients undergoing total shoulder arthroplasty. METHODS: National rates of utilization of primary anatomic (TSA) and reverse total shoulder arthroplasty (RTSA) were analyzed from 2012 to 2017. Population-adjusted and gender-adjusted procedural rates were trended over time and standardized based on insurance status. Multivariable logistic regression was used to determine racial differences in complications and mortality. RESULTS: In 2012, the incidence of TSA and RTSA among white patients was 18.7/100,000 compared to 5.1/100,000 among black patients (difference: 13.6/100,000) and increased to 36.9/100,000 in white patients and 10.8/100,000 in black patients in 2017 (difference: 26.1/100,000). This equated to an increase in the race disparity by 12.5/100,000 over the study period. Blacks underwent lower rates of TSA and RTSA than whites regardless of insurance status. Black patients had a longer length of hospital stay and a higher rate of discharge to facility. Black patients had increased odds of complications, including acute myocardial infarction (odds ratio [OR] 1.43), pulmonary embolism (OR 1.97), acute renal failure (OR 1.40), sepsis (OR 1.68), and surgical site infection (OR 2.19). Black patients had increased odds of mortality compared with white patients (OR 2.88). CONCLUSION: Racial disparities in patients undergoing TSA and RTSA are worsening over time. Black patients undergo TSA and RTSA at lower rates than white patients regardless of insurance status and have increased odds of complications and mortality. Improved initiatives are needed to reduce these racial disparities and further research is warranted to understand their root causes.

Examination of the Shoulder for Beginners and Experts: An Update.

Compared with other joints in the body, examination of the shoulder continues to be a challenge for practitioners, whether they be trainers, physical therapists, primary care physicians, or orthopedic surgeons. There are many reasons for this challenge, the primary being the highly complex architecture of bony and soft-tissue anatomy which allows for the greatest range of motion of any joint of the body. As a result, the clinical examination as Ralph Hertel, MD, has commented "perhaps it is just not easy." His comment reflects that one cannot just expect to understand how to interpret the examination unless the observer has some knowledge of how the shoulder complex works, how to perform the basics of the examination, how to interpret radiographs, and how to integrate these variables into a diagnosis. This chapter will attempt to delineate the principles which make the shoulder examination more attainable, plus highlight the areas where a combination of factors is necessary to arrive at a diagnosis.

Minimal clinically important differences after subpectoral biceps tenodesis: definition and retrospective assessment of predictive factors.

BACKGROUND: Minimal clinically important differences (MCIDs) at 1 year after subpectoral biceps tenodesis are unknown for the American Shoulder and Elbow Surgeons (ASES) scale, Subjective Shoulder Value (SSV), and visual analog scale (VAS) for pain. Our objectives were to determine MCIDs for these measures at 1 year after biceps tenodesis and to identify preoperative factors that predict attainment of MCIDs. METHODS: We included 52 patients who underwent arthroscopic débridement, decompression, and mini-open biceps tenodesis from 2016-2018. We analyzed age, sex, body mass index value, arm dominance, diagnosis, range of shoulder motion, and preoperative and 1-year postoperative ASES, SSV, and VAS scores. MCIDs were calculated using a distribution-based method of one-half the standard deviation. Preoperative thresholds predictive of MCIDs were calculated with univariate logistic regression. Multiple logistic regression was used to determine factors that predict MCIDs. Significance was set at a 2-tailed P value of <.05. RESULTS: MCIDs for the ASES, SSV, and VAS were 13, 12, and 1.6 points, respectively. Preoperative ASES score <59 predicted MCID on the ASES (P = .03); VAS score >3 predicted MCID on the VAS (P < .01); external shoulder rotation >40° predicted MCID on the SSV (P = .02); and age >41 years predicted MCID on the VAS (P = .02). CONCLUSION: At 1 year after débridement, decompression, and biceps tenodesis, MCIDs were 13, 12, and 1.6 points for the ASES, SSV, and VAS, respectively. Patients most likely to attain MCIDs were those aged >41 years, those with the most preoperative pain, and those with the poorest preoperative shoulder function.

Economic implications of decreased elective orthopaedic and musculoskeletal surgery volume during the coronavirus disease 2019 pandemic.

PURPOSE: In order to reduce viral spread, elective surgery was cancelled in most US hospitals for an extended period during the COVID-19 pandemic. The purpose of this study was to estimate national hospital reimbursement and net income losses due to elective orthopaedic surgery cancellation during the COVID-19 pandemic. METHODS: The National Inpatient Sample (NIS) and the Nationwide Ambulatory Surgery Sample (NASS) were used to identify all elective orthopaedic and musculoskeletal (MSK) surgery performed in the inpatient setting and in hospital owned outpatient surgery departments throughout the USA. Total cost, reimbursement, and net income were estimated for all elective orthopaedic surgery and were compared with elective operations from other specialties. RESULTS: Elective MSK surgery accounted for $65.6-$71.1 billion in reimbursement and $15.6-$21.1 billion in net income per year to the US hospital system, equivalent to $5.5-$5.9 billion in reimbursement and $1.3-$1.8 billion in net income per month. When compared with elective surgery from all other specialties, elective MSK surgery accounted for 39% of hospital reimbursement and 35% of hospital net income. Compared with all hospital encounters for all specialties, elective MSK surgery accounted for 13% of reimbursement and 23% of net income. Estimated hospital losses from cancellation of elective MSK surgery during 8 weeks of the COVID-19 pandemic were $10.9-$11.9 billion in reimbursement and $2.6-3.5 billion in net income. CONCLUSION: Cancellation of elective MSK surgery for 8 weeks during the COVID-19 pandemic has substantial economic implications on the US hospital system.

Exposure of the brachial plexus in complex revisions to reverse total shoulder arthroplasty.

BACKGROUND: Excision of extensive scar tissue (EEST) may be required in certain cases of revision reverse total shoulder arthroplasty (RTSA). Neurovascular structures are at a higher risk of iatrogenic direct injury in these cases. We describe a technique to expose and protect the musculocutaneous and axillary nerves in a series of revision RTSA cases that required EEST. METHODS: Between 2004 and 2013, 83 revision RTSA procedures were identified in our database. Of these, 18 cases (22%) who underwent concomitant nerve exploration for EEST preventing glenoid exposure, preventing reduction of the humeral component, or causing instability of the implanted RTSA, were included. All patients were observed for a minimum of two  years or until reoperation. Patient-reported outcome scores (PROMs), range of motion (ROM), and complication rates were analyzed. RESULTS: Patients had significant pain relief and improvement in PROMs post-operatively. Two patients (11%) required another revision surgery because of infection (one patient with glenoid loosening; one patient with stem loosening). Two patients (11%) had instability successfully managed with closed reduction. Two patients (11%) had a clinically evident post-operative nerve injury. Both cases were neurapraxias (1 partial brachial plexopathy and 1 partial isolated axillary nerve injury) and experienced complete neurologic recovery at last follow-up. CONCLUSIONS: Complete permanent nerve injuries resulting from direct surgical trauma during revision RTSA requiring EEST can be avoided using the technique presented here. Despite proper exposition of the nerves, partial temporary neurapraxic injuries may occur. Patients who underwent this procedure experienced significant improvements in shoulder pain and function with complication rates consistent to those previously reported in revision RTSA.

Incidence and risk factors for aseptic baseplate loosening of reverse total shoulder arthroplasty.

BACKGROUND: Aseptic glenoid baseplate loosening (AGBL) is a catastrophic complication after reverse total shoulder arthroplasty (RTSA). Our goals were to determine the incidence of AGBL in patients who underwent RTSA and identify risk factors for AGBL after RTSA. METHODS: We analyzed 202 shoulders that underwent primary or revision RTSA using 1 implant system and evaluated baseplate loosening at a minimum 2-year follow-up. The associations between AGBL and the following variables were investigated: patient age, sex, primary vs. revision RTSA, scapular notching, use of bone graft, and type of baseplate screw fixation. RESULTS: AGBL occurred in 6 shoulders (3.0%). The incidence of AGBL after revision RTSA (10%) was significantly higher than that after primary RTSA (1.2%; P = .014). There were significant associations between AGBL and the use of bone graft and the use of nonlocking screws. Scapular notching, glenosphere center-of-rotation offset, patient age, and sex were not associated with AGBL. Multiple logistic regression analysis showed that the use of all peripheral nonlocking 3.5-mm screws (odds ratio, 10.6; 95% confidence interval, 1.1- 39) and the use of bone graft (odds ratio, 7.5; 95% confidence interval, 1.9-30) were independent risk factors for AGBL. CONCLUSIONS: The rate of baseplate failure after primary RTSA is low (1.2%) but is significantly higher after revision RTSA (10%). Major risk factors for baseplate failure are the use of all 3.5-mm nonlocking screws for peripheral baseplate fixation and the use of a bone graft to address deficiencies in bony support beneath the baseplate.

Complications of antibiotic cement spacers used for shoulder infections.

BACKGROUND: Our aim was to evaluate complications related to commercially available antibiotic cement spacers used in the treatment of shoulder infections. METHODS: We performed a retrospective review of commercially available antibiotic spacers implanted in 53 patients (60 spacers) between April 2009 and October 2017 as part of a 2-stage treatment plan for infection at the site of a shoulder arthroplasty (n = 39), other (non-arthroplasty) shoulder surgery (n = 8), or primary shoulder infection without previous surgery (n = 6). All patients were followed up from spacer placement to second-stage revision to shoulder arthroplasty. Ten patients retained the spacers and were followed up for a minimum of 1 year. RESULTS: No complications were associated with implantation of the spacers. Of the 44 patients (50 spacers) who underwent a second-stage revision after a mean interval of 6 months (range, 2-18 months), 14 patients had 18 complications. Fourteen complications occurred between implantation and removal. The most common complication was bone erosion (6 in the glenoid and 2 in the humeral shaft). Other complications were fractures of the spacer (n = 4), spacer rotation (n = 3), and humeral fracture (n = 3). Two complications required reoperation. There were 4 spacer-related complications among the 10 patients who retained the implant (3 erosions of the humeral shaft and 1 humeral shaft fracture); none required reoperation or removal. CONCLUSIONS: Complications related to antibiotic spacers are common especially between the first and second stage of revision, and awareness of these complications is important for the treating provider.

Can patients manage toileting after reverse total shoulder arthroplasty? A systematic review.

PURPOSE: A major concern for patients undergoing reverse total shoulder arthroplasty (RTSA) is managing toileting after surgery. The goals of this systematic review of RTSA studies were to determine the following: (1) the percentage of patients who can manage toileting, (2) their degree of difficulty with toileting, and (3) the percentage of patients who can manage toileting after bilateral versus unilateral RTSA. METHODS: Medline, EMBASE, Google Scholar, and the Cochrane Central Register of Controlled Trials were searched for studies reporting the ability to manage toileting after RTSA. Six studies with at least 12 months of follow-up were included, yielding 183 patients (105 unilateral RTSA, 78 bilateral RTSA). We pooled patient data and calculated the weighted mean proportion of patients able to manage toileting, those who reported difficulty, and those able to manage toileting after unilateral versus bilateral RTSA. Statistical significance was set at P < 0.05. RESULTS: Most patients (92%; 95% confidence interval, 87-95%) were able to manage toileting after RTSA. Some degree of difficulty with toileting was reported for 20% of all shoulders. Almost all patients with bilateral RTSA were able to manage toileting with at least one arm (weighted mean proportion 97%; 95% confidence interval, 88-99%). There was no significant difference in the proportion of patients able to manage toileting after unilateral versus bilateral RTSA (P = 0.08). Only 3% of all papers published on the clinical results of RTSA by June 2017 reported upon toileting after the procedure. CONCLUSIONS: With the available evidence, most patients were able to manage toileting after RTSA, although one-fifth reported some degree of difficulty. Ability to manage toileting was similar after unilateral versus bilateral RTSA. In the future, this variable should be a standard question after shoulder arthroplasty. LEVEL OF EVIDENCE: IV.