Bioinductive patch as an augmentation for rotator cuff repair, a systematic review and meta-analysis.

BACKGROUND: Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction. For those who fail initial conservative treatment, operative intervention can be pursued. A significant and common complication after rotator cuff repair (RCR) is retearing or nonhealing. Numerous augmentations to traditional suture RCR have been studied. Of these, the Smith + Nephew Regeneten bioinductive collagen patch has had promising initial results; however, analytic data for its use are lacking, and there is no meta-analysis comparing the available data to historical RCR outcomes. METHODS: A PRISMA-guided literature search was conducted using Ovid MEDLINE, PubMED, Cochrane, and ClinicalTrials.gov. Thirteen studies met inclusion and exclusion criteria. Only clinical trials on full and partial-thickness tears were included. American Shoulder and Elbow Surgeon score, Constant-Murley Score, the visual analog scale for pain, the minimal clinically important difference (MCID), tendon thickness, and complication rates were primary outcomes of interest. A meta-analysis was performed to determine the overall complication and retear rate from the included studies. RESULTS: American Shoulder and Elbow Surgeon score, Constant-Murley Score, and visual analog scale for pain improved significantly in all studies that reported them, and most patients achieved MCID. Patient-reported outcome measure improvements were similar to historical improvements in standard RCR, and a similar proportion of patients achieved MCID after standard repair. Tendon thickness improved significantly and to a similar degree as standard RCR. Overall retear rate after full thickness RCR augmented with the bioinductive patch was 8.3%. For partial thickness RCR, total retear rate was of 1.1% across all patients. The overall complication rate with the bioinductive patch was 15.5% across all full-thickness RCR studies and 16.2% in partial thickness RCR. We found overall retear rate to be lower after augmentation with the bioinductive patch compared to traditional repair; however, the overall complication rate was similar for full-thickness tears and higher for partial-thickness tears. Lastly, adverse reactions to the bioinductive patch were noted at 0.2%. CONCLUSIONS: The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement in patient-reported outcome measures and significant increases in tendon thickness. Retear rate has been a concern after RCR for decades, and the bioinductive patch may help mitigate this risk. There is lack of case-control studies comparing the bioinductive patch to traditional suture RCR. Such data are needed to better determine the role of the bioinductive patch in the treatment of full and partial-thickness rotator cuff repairs.

Decision-making in the treatment of radial head fractures: Delphi methodology.

BACKGROUND: The treatment of partially displaced radial head fractures is determined not only by the type of fracture but also by patient characteristics such as age, occupation, hand dominance, mechanism of injury, and concomitant injuries and comorbidities. The goal of this study was to employ the Delphi method to achieve consensus on the management of patients with radial head fractures, utilizing the experience of the ASES Elbow Fracture-Dislocation Multicenter Study Group and Mayo Elbow Club surgeons. METHODS: The initial survey was sent to participants, which included consent to participate in the study and questions about their experience, knowledge, and interest in participating in the Delphi method. We used both open-ended and category-based questions. The second questionnaire generated 76 variables, and individual questions with mean Likert ratings of <2.0 or >4.0 were deemed significant and merged to form multifactorial clinical scenarios relating to both nonoperative and operative management, respectively. RESULTS: Of the surgeons who responded to the questionnaire, 64% were from the United States, while the remainder were from overseas practices. Years in practice on average were 12.4 years (range, 1-40). Seven of the 76 factors met the criteria of a mean Likert score of <2.0 or >4.0. These factors were as follows: age, block to the range of motion (ROM) after aspiration/injection, crepitation with ROM, tenderness over the distal radioulnar joint and/or interosseous membrane (dorsal forearm), gap and/or displacement >2 mm on imaging, complete loss of contact of the head with the rest of the radius on imaging, and fracture head involvement 30% on imaging. Twenty-two (46%) of the 96 clinical scenarios gained >90% consensus in favor of surgical treatment, whereas 8 (17%) reached >90% consensus in favor of nonoperative treatment. CONCLUSION: Obtaining expert consensus on the treatment of radial head fractures remains challenging. Certain factors such as gap/displacement ≥2 mm without complete loss of contact, ≥30% head involvement with a block to an ROM regardless of tenderness over distal radioulnar joint or interosseous membrane (dorsal forearm), or crepitation when the patient was <80 years of age led to a recommendation of operative treatment in 100% of the surveyed surgeons. Patients older than 80 years with no block to ROM after aspiration/injection, no crepitation with ROM, and no tenderness on distal radioulnar joint/interosseous membrane (dorsal forearm) were recommended for nonoperative treatment regardless of the size of the radial head involvement on imaging.

The impact of prior authorization review on orthopaedic subspecialty care: a prospective multicenter analysis.

BACKGROUND: Prior authorization review (PAR), in the United States, is a process that was initially intended to focus on hospital admissions and costly high-acuity care. Over time, payors have broadened the scope of PAR to include imaging studies, prescriptions, and routine treatment. The potential detrimental effect of PAR on health care has recently been brought into the limelight, but its impact on orthopedic subspecialty care remains unclear. This study investigated the denial rate, the duration of care delay, and the administrative burden of PAR on orthopedic subspecialty care. METHODS: A prospective, multicenter study was performed analyzing the PAR process. Orthopedic shoulder and/or sports subspecialty practices from 6 states monitored payor-mandated PAR during the course of providing routine patient care. The insurance carrier (traditional Medicare, managed Medicare, Medicaid, commercial, worker's compensation, or government payor [ie, Tricare, Veterans Affairs]), location of service, rate of approval or denial, time to approval or denial, and administrative time required to complete process were all recorded and evaluated. RESULTS: Of 1065 total PAR requests, we found a 1.5% (16/1065) overall denial rate for advanced imaging or surgery when recommended by an orthopedic subspecialist. Commercial and Medicaid insurance resulted in a small but statistically significantly higher rate of denial compared to traditional Medicare, managed Medicare, worker's compensation, or governmental insurance (P < .001). The average administrative time spent on a single PAR was 19.5 minutes, and patients waited an average of 2.2 days to receive initial approval. Managed Medicare, commercial insurance, worker's compensation, and Medicaid required approximately 3-4 times more administrative time to process a PAR than to traditional Medicare or other governmental insurance (P < .001). After controlling for the payor, we identified a significant difference in approval or denial based on geographic location (P < .001). An appeal resulted in a relatively low rate of subsequent denial (20%). However, approximately a third of all appeals remained in limbo for 30 days or more after the initial request. CONCLUSIONS: This is the largest prospective analysis to date of the impact of PAR on orthopedic subspecialty care in the United States. Nearly all PAR requests are eventually approved when recommended by orthopedic subspecialists, despite requiring significant resource use and delaying care. Current PAR practices constitute an unnecessary process that increases administrative burden and negatively impacts access to orthopedic subspecialty care. As health care shifts to value-based care, PAR should be called into question, as it does not seem to add value but potentially negatively impacts cost and timeliness of care.

Risk of Recall for Total Joint Arthroplasty Devices Over 10 Years.

BACKGROUND: Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are approved without supporting clinical data through the Food and Drug Administration's 510(k) pathway. The risk of recall of orthopaedic arthroplasty devices approved through the 510(k) pathway has not been previously studied. METHODS: The FDA 510(k) database was queried for orthopaedic devices approved between January 01, 2008 and December 31, 2018 and subsequently codified to hip and knee arthroplasty devices using product codes. The database included 904 arthroplasty devices during the study period, with hip and knee making up 53.7% (485) and 46.3% (419) of devices, respectively. Information regarding numbers, dates, and reasons for recall were recorded. Cumulative incidence function was conducted to compare the risk of recall between hip and knee arthroplasty. RESULTS: In total, 94 (19.4%) hip and 85 (20.3%) knee devices were recalled. The hazard of recall by 10 years for hip and knee arthroplasty devices was approximately 24%, with no statistical differences between each region. The most common causes of recall were process control and device design, accounting for 29.6% and 26.3% of recalls, respectively, with no significant difference between study groups. CONCLUSION: The risk of recall for arthroplasty devices is more than that previously understood. Improved postmarket surveillance strategies along with increased physician participation in detecting and reporting device safety issues are necessary to strengthen patient safety.

Posteromedial rotatory incongruity of the elbow: a computational kinematics study.

BACKGROUND: Our objective was to analyze the effect of different anteromedial coronoid fracture patterns with different combinations of ligamentous repairs. We hypothesized that smaller fractures would be sufficiently treated with ligamentous repair alone but that larger fragments would require a combination of ligament and bony repair versus reconstruction. METHODS: Two multibody models were created from cadaveric specimens in the ADAMS program. Four different conditions were simulated: (1) no fracture, (2) O'Driscoll anteromedial subtype I (2.5-mm) fracture, (3) subtype II 2.5-mm fracture, and (4) subtype II 5-mm fracture. In each of these conditions, 3 ligament repairs were studied: lateral ulnar collateral ligament (LUCL), posterior bundle of the medial collateral ligament (pMCL), and both LUCL and pMCL. For each condition, kinematics and articular contact areas were calculated. RESULTS: LUCL repair alone increases whereas pMCL repair decreases internal rotation of the ulna relative to all tested posteromedial rotatory instability conditions; their rotational effects are summative when both ligaments are repaired. With a subtype I fracture and both pMCL and LUCL injuries, repairing the LUCL alone corrects angulation whereas rotational stability is satisfactory through the arc from 0° to 90°. In a subtype II 2.5-mm fracture, isolated repair of the LUCL or pMCL is not capable of restoring rotation or angulation. For a subtype II 5-mm fracture, no combination of ligamentous repairs could restore rotation or angulation. CONCLUSIONS: This study suggests that LUCL repair alone is sufficient to restore kinematics for small subtype I fractures for an arc avoiding deep flexion; whereas nearly normal kinematics throughout the arc of motion can be achieved if the pMCL is also repaired. Larger anteromedial coronoid fractures should ideally have fragments fixed in addition to ligament repairs.

The annular ligament-revisited.

BACKGROUND: Studies investigating the annular ligament have presented confusing information about its anatomy and nomenclature. Cadaver elbow dissections were used to clarify the anatomy and terminology of the annular ligament. METHODS: Nineteen elbows were dissected (7 fresh frozen and 12 embalmed). Target structures were identified, photographed, and measured by independent observers. RESULTS: There are 3 layers to the lateral elbow ligaments: the superficial lateral ulnar collateral and radial collateral ligament; a deeper layer of the superior oblique band (SOB) and inferior oblique band (IOB) of the annular ligament; and the deepest capsular layer. The annular ligament measured 9.5 ± 1.4 mm anteriorly. The SOB (15/19) was 3.9 ± 1.0 mm wide by 10.5 ± 3.8 mm long. The IOB (13/19) was 3.6 ± 1.1 mm wide by 11.4 ± 4.2 mm long. The IOB inserts onto the anterior proximal ulna rather than the supinator crest. The anterior oblique band (8/19) was 3.8 ± 1.7 mm wide. CONCLUSION: The SOB and IOB were present in the majority of specimens. The previously described accessory lateral collateral ligament is a localized thickening on the lateral ligament complex arising from the supinator insertion independent of the IOB that attaches to the annular ligament inferiorly and distally and attaches onto the proximal anterior ulna at the bicipital fossa floor, medial to the supinator crest.

Long-term outcome of custom triflange outrigger ulnar component in revision total elbow arthroplasty.

BACKGROUND: Patients missing the distal humeral condyles are prone to premature bushing wear after total elbow arthroplasty. A midterm study has demonstrated that a custom triflange outrigger ulnar component was successful in preventing this. The aim of this study was to determine whether these results remained stable over time. MATERIALS AND METHODS: The outcomes of 6 patients who underwent revision of a loose ulnar component using a custom triflange outrigger component were reviewed in this retrospective case study. The average patient age at the time of revision was 51. The average number of prior operations was 2 (range, 1-3). The mean follow-up was 15 years (range, 10-18 years). RESULTS: At final follow-up, the mean range of extension-flexion was 35° to 135°, and pronation-supination was 65° to 63°. The average Mayo Elbow Performance Score improved to 75 of 100. Four implants were still in place with no radiolucencies or osteolysis. Three patients required revision surgery for broken humeral stems. Two required conversion to another total elbow arthroplasty system after 18 and 14 years for humeral component loosening. CONCLUSIONS: These components lasted an average of 4 times longer than the original ulnar components. In our experience, periarticular osteolysis caused by polyethylene wear creates a region of unsupported stem and a stress riser at the junction with the remaining well-supported stem and causes component stem fractures. The concept of an outrigger type of hinge might be useful for active patients requiring an elbow prosthesis in the setting of deficient condyles.

Adverse Effects of Smoking on Musculoskeletal Health.

Smoking remains a prevalent part of present day society, with over 42 million Americans who continue to use cigarettes. Smoking is strongly associated with a variety of conditions that result in increased morbidity and mortality. Research also indicates that smoking has an adverse effect on surgical outcomes. Its effect on the musculoskeletal system is evident and results in postoperative complications such as infection, nonunion, and malunion. These complications also come with a price, as there are severe economic implications of smoking. Patients who smoke may benefit from a period of perioperative cessation to help diminish some of these negative outcomes. It is the physician's duty to educate patients preoperatively about these outcomes and the potential benefit of smoking cessation.

The Economic Impact of Orthopaedics in Missouri.

Orthopaedics contributes a significant benefit to the Missouri economy. Economic modeling and data quantified the direct and indirect impact within Missouri. Multipliers were applied to direct expenditures to calculate the indirect impact attributable to initial spending. Nearly $1.8 billion can be attributed to the output of orthopaedic related services. The related physical therapy industry increases this figure to nearly $2.3 billion. It is clear that orthopaedics benefits Missouri with both medical services and economic growth.

Lipoma arborescens of the knee.

PURPOSE: Lipoma arborescens (LA) is a benign lesion described as replacement of mature fat cells with sub-synovial tissue, which causes the formation of villous projections. Underlying inflammatory conditions might predispose LA. This study demonstrates the treatment, post-operative survey and MRI demonstrations of this rare entity. METHODS: Five patients (6 knees) diagnosed and treated with arthroscopic (5/6) and open (1/6) synovectomy were reviewed retrospectively. An additional mini-transquadricipital incision is used for excision of the extensive suprapatellar lesions. The patients had post-operative follow-ups at first and sixth months and then yearly. Radiographs and MRI of the affected knees were taken at the final follow-up. RESULTS: The median follow-up was 59 (4-105) months. Major symptom was painless swelling of the joint. The presenting age was under 18 years in four patients. Recurrent lesions were detected in MRI scan of three patients with JRA, ARF and Tbc. Two out of three were located adjacent to the posterior capsule. The median of the Kujala questionnaire scores was 88 (74-95), and the median of the Knee Society Clinical Rating System scores was 95 (80-100) at the final follow-up. CONCLUSIONS: Lipoma arborescens should be considered in the differential diagnosis of paediatric patients who have painless swelling of the knee joint. The lesion is totally curable. However, underlying persistent disease might aggravate the inflammatory process and might cause recurrent lesions. Although resecting the lesion adjacent to the posterior capsule of the knee joint is technically demanding, arthroscopic treatment is an effective procedure and transquadricipital approach may help resection of the extensive lesions in suprapatellar pouch. LEVEL OF EVIDENCE: Case series, Level IV.

Nonstandard glenoid components for bone deficiencies in shoulder arthroplasty.

BACKGROUND: Glenoid bone deficiencies may be addressed by specialized components. The purpose of this study is to evaluate the clinical and radiographic outcomes of 3 different types of nonstandard glenoid components. MATERIALS AND METHODS: Thirty-eight patients with a mean age of 65 years (range, 34-84 years) underwent a primary or revision anatomic shoulder arthroplasty with one of 3 nonstandard glenoid components: a polyethylene component with an angled keel for posterior glenoid wear without posterior subluxation; a polyethylene component with 2 mm of extra thickness for central glenoid erosion; or a posteriorly augmented metal-backed glenoid component for posterior glenoid wear and posterior subluxation. Average clinical follow-up was 7.3 years (range, 2-19 years) or until revision surgery. RESULTS: At the most recent follow-up, 24 patients had no, mild, or occasionally moderate pain. Mean elevation improved from 91° to 126°, and mean external rotation improved from 24° to 53°. Thirteen patients had moderate or severe subluxation preoperatively, and 11 had subluxation at follow-up. On radiographic evaluation, 3 glenoid components had loosened and 3 were at risk for loosening at an average 5.5 years of follow-up. Seven patients had revision surgery: 4 for instability, 1 for osteolysis, 1 for component loosening with osteolysis, and 1 for a periprosthetic fracture. Three additional patients had removal of glenoid components, 2 for infection and 1 for loosening. Ten-year survival rate free of revision or removal of the angled keel component was 73% (95% CI: 75.3-70.7); of the extra thick (+2 mm) component, 69% (95% CI: 65-73); and of the posteriorly augmented metal-backed glenoid component, 31% (95% CI: 35.6-26.4). CONCLUSIONS: The effectiveness of nonstandard glenoid components in addressing glenoid bone deficiencies is compromised by an increased rate of component loosening and by only partial success in eliminating subluxation.

Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements.

Importance: High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association between device modifications and risk to patient safety has not previously been analyzed. Objective: To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall. Design, Setting, and Participants: In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices from January 1, 2008, through December 31, 2021, giving a minimum 2-year follow-up after initial approval. Data were analyzed from July 6 to August 6, 2022. Retrospective, time-to-event analysis investigated the association between the number and type of supplements and risk of recall. Exposures: Supplements submitted by manufacturers for FDA approval to modify devices. Main Outcomes and Measures: A mixed-effects Cox proportional hazards regression model with frailty terms was used, modeling device recall as an outcome variable during the observation period. A second model was performed for class 1 (high-risk) recall. Explanatory variables are the number of supplements, number of panel track supplements, and cardiovascular devices. Multivariable analysis was performed to identify independent risk factors for recall with hazard ratios (HRs) as the main end point. Results: A total of 373 original PMA devices with 10 776 associated supplements were included in the analysis. A median 2.5 (IQR, 1.2-5.0) supplements per device were approved annually. Cardiovascular devices contributed 138 supplements (37.0%), followed by microbiology with 45 (12.1%). No other specialty contributed more than 10%. Multivariable analysis demonstrated that each increase of 1 supplement per year was associated with increased risk of recall (HR, 1.28 [95% CI, 1.15-1.44]; P < .001). For class 1 recall, increased number of supplements (HR, 1.32 [95% CI, 1.06-1.64]; P = .01) and cardiovascular vsnoncardiovascular classification of devices (HR, 3.51 [95% CI, 1.15-10.72]; P = .03) were significantly associated with an increased risk of recall. Conclusions and Relevance: The findings of this cohort study suggest that PMA supplements are associated with an approximately 30% increased risk of any recall and class 1 recall. The FDA processes for approving modifications to high-risk medical devices should be reevaluated to optimize patient safety and public health.

Biomechanical comparison of lesser tuberosity osteotomy versus subscapularis tenotomy in total shoulder arthroplasty.

BACKGROUND: Total shoulder arthroplasty is traditionally performed through an anterior deltopectoral exposure with subscapularis tenotomy. Postoperative subscapularis dysfunction is common and adversely affects clinical outcomes. Consequently, surgeon interest in lesser tuberosity osteotomy has grown in an effort to improve subscapularis repair strength. This study investigated the biomechanical strength of subscapularis tenotomy vs lesser tuberosity osteotomy in the setting of total shoulder arthroplasty. MATERIALS AND METHODS: Uncemented humeral prostheses were placed in 20 paired upper extremities from 10 cadavers. For each respective cadaver, 1 limb underwent lesser tuberosity osteotomy and the contralateral limb underwent subscapularis tenotomy. The cadaveric specimens then underwent cyclic displacement and maximum load to failure testing. RESULTS: The subscapularis tenotomy specimens exhibited significantly less cyclic displacement (0.8 mm) than the osteotomy group (1.8 mm), with a 95% confidence interval (CI) for the difference of 0.5 to 1.5 mm (P = 0.002). The maximum load to failure was 439 ± 96 N for tenotomy and 447 ± 89 N for osteotomy (95% CI for the difference of -58 to 75), which was not significant (P = .78). CONCLUSION: Lesser tuberosity osteotomy was not significantly stronger than subscapularis tenotomy in maximum load to failure testing, with minimal clinical significance set at 100 N. Subscapularis tenotomy repair showed statistically significant less cyclic displacement than lesser tuberosity osteotomy. Further research is needed to clarify how the biomechanical results immediately after subscapularis tenotomy and lesser tuberosity osteotomy correlate with clinical outcomes.

The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.

Orthopaedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopaedic devices cleared or approved by the FDA for marketing in the United States annually. Advances in technology and biologic therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard the public health. The FDA uses multiple different premarket pathways for devices, biologics, and combination products based on perceived risk of the novel product. More than 97% of orthopaedic devices go through the FDA's 510(k) pathway, which does not require clinical trials. The remaining high-risk devices must receive premarket approval and submit clinical trial data demonstrating safety and effectiveness. Similarly, high-risk biologics must obtain a biologics license application by submitting clinical trial data. Postmarketing surveillance strategies, including extended clinical trials or real-world evidence from registries, are increasingly being relied on by the FDA to expedite approval while also improving its capacity to identify problematic products.

Custom triflange outrigger ulnar component in revision total elbow arthroplasty.

HYPOTHESIS: This study describes the rationale for, and tests the hypothesis that, a custom outrigger triflange ulnar component for revision total elbow arthroplasty would decrease the contact stresses at the bushings and overcome excessive bushing wear in active patients who have bone and ligamentous deficiency. MATERIALS AND METHODS: Five consecutive revisions for failed Coonrad-Morrey total elbow arthroplasties were performed with the custom outrigger triflange ulnar component for patients with accelerated bushing wear, ulnar component loosening, and deficient humeral condyles. The mean age at the time of surgery was 48 years (range, 32-64 years). Follow-up averaged 81 months (range, 65-124 months). The average number of previous operations was 2.4 (range, 2-3). RESULTS: The Mayo Elbow Performance Score improved from 40 (range, 15-65) preoperatively to 91 (range, 80-100) at the latest follow-up. There were two excellent and three good results. There was no radiographic or clinical evidence of bushing wear at 6.8 years of follow-up (range, 5.5-10.3 years). One patient required further revision of the humeral component due to mechanical loosening, which had not been revised at the time of the index surgery. DISCUSSION: A custom outrigger triflange ulnar component is an effective alternative for revising loose Coonrad-Morrey ulnar components in active patients with absent humeral epicondyles and accelerated bushing wear. CONCLUSION: It may be an alternative to revision with standard components until improved surgical designs addressing this problem become commercially available.

Vancomycin prophylaxis for revision hip arthroplasty in penicillin and cephalosporin sensitive patients: Is dose adjustment necessary in accordance with blood loss and fluid replacement?

OBJECTIVE: The aims of this study were (1) to investigate the changes in the serum concentration of prophylactically administrated vancomycin in the perioperative period of revision hip arthroplasty in penicillin/cephalosporin-allergic patients, (2) to assess whether the postoperative re-administration of vancomycin is needed, and (3) to determine the relationships of vancomycin serum concentration with blood loss, body weight, and fluid replacement in such patients. METHODS: This study consisted of 29 patients (20 females, 9 males; mean age=63.3 years; age range=45-79 years) with a history of penicillin/cephalosporin allergy undergoing revision hip arthroplasty secondary to aseptic loosening or periprosthetic fractures. Serum vancomycin levels were measured (1) before administration of vancomycin, (2) at the time of skin incision, (3) every 1,5 hours thereafter until the end of the operation, (4) during the skin closure, and (5) after three and 12 hours from the initial dosage. Data regarding body weight, amounts of intraoperative blood loss, fluid and blood replacements and postoperative wound drainage were recorded. RESULTS: The average blood loss, fluid replacement, and drain volume were 1280.3±575.8 (500-2700) mL, 2922.6±768.8 (1700-4600) mL, and 480.2±163.7 (200-850) mL, respectively. The mean levels of serum vancomycin were 46.3±21.8 (14.1-80.7) mg/L at the time of skin incision, 17.9±4.7 (9.4-30.9) and 9.8±2.2 (4.3-13.8) mg/L after 1.5 and 3 hours from the beginning of the surgery and 5.1±1.1 (2.9-6.8)mg/L after 12th hour postoperatively. The measured vancomycin levels were below the effective serum concentrations (< 5 mg/L) for 18 patients at 12 hours the administration of the first dose. A moderate level negative correlation between the blood loss/body weight ratio and vancomycin levels was found (p=0.004, r=-0.493). Predictive ROC curve analysis resulted in determining a blood loss volume higher than 1150 ml and a blood loss/body weight ratio higher than 18,5 is significant to estimate the vancomycin level below the minimum effective serum level at 12th hour postoperatively (AUC=0.793±0.16, p=0.009, AUC=0.753) 26±0.12, p=0.025, respectively). CONCLUSION: Evidence from this study has indicated vancomycin concentration at 12th hour is below the effective level in most patients. Thus, earlier repetitive infusion of vancomycin seems to be necessary in penicillin/cephalosporin-allergic patients undergoing revision hip arthroplasty, especially in those with high blood loss. LEVEL OF EVIDENCE: Level III, Therapeutic Study.

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Importance: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA. Objectives: To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties. Design, Setting, and Participants: This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020. Main Outcomes and Measures: The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed. Results: During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital. Conclusions and Relevance: This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.

Arthroscopy and the dramatic increase in frequency of anterior acromioplasty from 1980 to 2005: an epidemiologic study.

PURPOSE: The purposes of this study was to better understand the utilization of anterior acromioplasty over time, in the absence of rotator cuff repair; to examine the relation to patient characteristics (age, sex) and types of rotator cuff pathology (inflammation or fibrosis, partial-thickness tearing, full-thickness tearing undergoing debridement); and to assess the utilization of arthroscopy in this procedure. METHODS: Using the resources of the Rochester Epidemiology Project, cataloging medical records of residents in Olmsted County, Minnesota, we identified 246 patients who underwent anterior acromioplasty between 1980 and 2005. It has previously been shown that rarely does a resident of Olmsted County undergo an orthopaedic procedure at a facility outside the county. RESULTS: The incidence of anterior acromioplasty increased over time (P < .001), with crude rates of 3.3 per 100,000 persons in 1980 to 1985 and 19.0 per 100,000 persons in 2000 to 2005. Sex, age, and types of rotator cuff pathology did not significantly change over the 26-year period. There was a dramatic shift from use of the open approach to the arthroscopic approach over this time period (P < .001) and a decrease in the concomitant performance of distal clavicle resection (P < .001). CONCLUSIONS: The frequency of anterior acromioplasty has dramatically increased over time. Increasing knowledge about this syndrome, including better imaging, has facilitated patient treatment for a stable spectrum of rotator cuff pathology (inflammation or fibrosis, partial-thickness tearing, full-thickness tearing undergoing debridement), as has the application of endoscopic surgery. LEVEL OF EVIDENCE: Level III, epidemiologic study.

Integrity and function of the subscapularis after total shoulder arthroplasty.

BACKGROUND: Reported healing rates of a subscapularis tenotomy have been extremely variable in the literature. The purpose of this study was to document the subscapularis healing rate after subscapularis tenotomy using ultrasound, and to correlate healing with physical examination findings and shoulder internal rotation strength. METHODS: Fifteen patients who underwent total shoulder arthroplasty due to unilateral osteoarthritis were evaluated after a minimum of 6 months follow-up with ultrasound, physical examination, and internal rotation strength testing. At surgery, a subscapularis tenotomy utilized to approach the shoulder. Postoperatively, no formal physical therapy program was utilized. RESULTS: Seven of the 15 shoulders had a complete tear of the repaired subscapularis tendon based on ultrasound examination. The lift-off and abdominal compression tests correlated poorly with the ultrasonographic condition of the subscapularis. The bear hug test using dynamometry did correlate with tendon integrity. Patients with a subscapularis tear after arthroplasty experienced significant weakness in isometric (P = .01) and isokinetic (P < .01) internal rotation strength testing, as well as significantly worse DASH scores (P = .04). No patient demonstrated anterior subluxation on examination or by radiograph. CONCLUSION: Subscapularis tear after total shoulder arthroplasty is a common finding, which cannot be diagnosed reliably by physical examination or radiographs. In this population, subscapularis integrity did not correlate with pain or subjective patient outcome. Failure to heal the subscapularis tenotomy is probably more common than has been previously reported based on only physical examination testing.

Survivorship of the humeral component in shoulder arthroplasty.

BACKGROUND: Loosening of the humeral component is rarely a cause for revision. This study was conducted to determine long-term survivorship of humeral components and investigate the risk factors associated with humeral component removal or revision. MATERIALS AND METHODS: From 1984 to 2004, 1423 patients underwent 1584 primary Neer and Cofield shoulder arthroplasties. The Kaplan-Meier method was used to estimate implant survival. Cox proportional hazards regression was used to assess the effects of age, gender, etiology of the disease, surgery type (hemi vs total), fixation (cemented vs noncemented), and the humeral component design (Neer II, Cofield 1 or 2) with survival free of revision or removal of the humeral component. RESULTS: There were 108 revisions and 17 removals of the humeral component. Estimates of survivorship free of revision or removal of the humeral component for any reason was 94.8% (95% confidence interval [CI], 93.6-96.0) at 5 years, 92.0% (95% CI, 90.4-93.6) at 10 years, 86.7% (95% CI, 84.2-89.4) at 15 years, and 82.8% (95% CI, 78.5-87.5) at 20 years. Younger age, male gender, replacement due to posttraumatic arthritis, an uncemented component, and use of a metal-backed glenoid component increased the likelihood of humeral component failure. CONCLUSIONS: The need for revision of the humeral component is commonly related to glenoid or glenoid component issues. Patient and diagnostic factors play a role in implant survival; implant type and method of fixation are less important. LEVEL OF EVIDENCE: Level 4; Case series, treatment study.