Disease diagnosis and arthroplasty type are strongly associated with short-term postoperative patient-reported outcomes in patients undergoing primary total shoulder arthroplasty.

BACKGROUND: Prognostic factors for total shoulder arthroplasty (TSA) clinical outcomes are incompletely understood. This study investigates the associations of preoperative patient, disease-specific, and surgical factors with 1-year postoperative PENN Shoulder Score (PSS) in patients undergoing primary TSA. METHODS: Cleveland Clinic patients undergoing primary anatomic TSA (aTSA) or reverse TSA (rTSA) for glenohumeral osteoarthritis (GHOA) or rotator cuff tear arthropathy (CTA) between February 2015 and August 2019, and having complete preoperative and 1-year postoperative patient-reported outcome measures (PROMs), were included. Twenty preselected preoperative patient, disease-specific, and surgical factors were used to fit multivariable models for 1-year PSS and its subscores. RESULTS: Of 1427 eligible primary TSAs, 1174 had 1-year follow-up by PROMs (82%), with 1042 analyzed after additional exclusions, including 30% rTSAs for CTA (n = 308), 26% rTSAs for GHOA (n = 275), and 44% aTSAs for GHOA (n = 459). All PROMs showed statistically significant improvements postoperatively, with 89% of patients reaching an acceptable symptom state. Lower 1-year PSS was associated with younger age, female sex, current smoking, chronic pain diagnosis, history of prior surgery, worker's compensation claim, lower preoperative mental health, lower baseline PSS, absence of glenoid bone loss, and diagnosis-arthroplasty type (CTA-rTSA < GHOA-rTSA < GHOA-aTSA). The most important prognostic factors associated with 1-year PSS were diagnosis-arthroplasty type, baseline mental health status, and insurance status. CONCLUSIONS: Disease diagnosis, arthroplasty type, and several other baseline factors are strongly and individually associated with PROMs following primary TSA, with patients undergoing aTSA for GHOA demonstrating the highest PROM scores at 1-year follow-up. Patient, disease-specific, and surgical factors can be used to guide postoperative prognosis following primary TSA for improved preoperative patient counseling regarding expected outcomes of these procedures.

One-year patient-reported outcomes following primary arthroscopic rotator cuff repair vary little by surgeon.

Background: This study's purpose was to investigate the extent to which differences among operating surgeons may influence 1-year patient-reported outcome measures (PROMs) in patients undergoing rotator cuff repair (RCR) surgery, after controlling for general and disease-specific patient factors. We hypothesized that surgeon would be additionally associated with 1-year PROMs, specifically the baseline to 1-year improvement in Penn Shoulder Score (PSS). Methods: We used mixed multivariable statistical modeling to assess the influence of surgeon (and alternatively surgical case volume) on 1-year PSS improvement in patients undergoing RCR at a single health system in 2018, controlling for eight patient- and six disease-specific preoperative factors as possible confounders. Contributions of predictors to explaining variation in 1-year PSS improvement were measured and compared using Akaike's Information Criterion. Results: 518 cases performed by 28 surgeons met inclusion criteria, with median (quartiles) baseline PSS of 41.9 (31.9, 53.9) and 1-year PSS improvement of 42 (29.1, 55.3) points. Contrary to expectation, surgeon and surgical case volume were neither statistically significantly nor clinically meaningfully associated with 1-year PSS improvement. Baseline PSS and mental health status (VR-12 MCS) were the dominant and only statistically significant predictors of 1-year PSS improvement, with lower baseline PSS and higher VR-12 MCS predicting larger 1-year PSS improvement. Conclusion: Patients generally reported excellent 1-year outcomes following primary RCR. This study did not find evidence that the individual surgeon or surgeon case volume influences 1-year PROMs, independently of case-mix factors, following primary RCR in a large employed hospital system.

A Call to Action for Musculoskeletal Research Funding: The Growing Economic and Disease Burden of Musculoskeletal Conditions in the United States Is Not Reflected in Musculoskeletal Research Funding.

ABSTRACT: As a result of an aging population, musculoskeletal disease is a growing source of health and economic burden in the United States. In 2019, musculoskeletal conditions affected approximately 127.4 million people (more than a third of the U.S. population); they were the top driver of health-care spending in 2016, with an estimated direct annual cost of $380.9 billion. While musculoskeletal conditions represent a substantial and growing burden in terms of prevalence, disability, and health-care costs, National Institutes of Health (NIH) research funding has remained disproportionately allocated to other disease conditions. Therefore, our purpose was to provide an assessment of the current burden of musculoskeletal disease in terms of prevalence, disability, and health-care costs, and compare the changing burden of disease to trends in NIH funding.

Prevalence of Orthopedic Manifestations in Patients With Cardiac Amyloidosis With a Focus on Shoulder Pathologies.

Transthyretin cardiac amyloidosis (ATTR-CA) is a restrictive cardiomyopathy that has been associated with multiple orthopedic pathologies years before it manifests in the heart. There have been no studies on the prevalence of a wide range of shoulder pathologies in patients with cardiac amyloidosis (CA). Due to the preferential deposition of transthyretin in the soft tissues and joints, we predicted a greater prevalence of shoulder pathologies and other orthopedic manifestations in patients with ATTR-CA. This single-center, retrospective, case-control study, analyzed 1,310 patients with CA, 830 with ATTR-CA, and 480 with light-chain CA (AL-CA) from a dedicated CA REDcap database. Odds ratios comparing patients with CA to the age-matched published estimate of over 300 million patients in the general population were determined for shoulder, hip, and knee arthroplasty. Years between a patient's first shoulder pathology (i.e., shoulder arthroplasty) and the year of their diagnosis with CA were determined using data from patients with a known date of surgery. Overall, patients with ATTR-CA compared with patients with AL-CA presented more frequently with shoulder pathologies (p <0.001) and at least 1 orthopedic manifestation (p <0.001). The odds of patients with ATTR-CA and AL-CA aged 60 years or older who underwent shoulder arthroplasty was 6.05 times greater (95% confidence interval 4.26 to 8.60) and 1.63 times greater (95% confidence interval 0.67 to 3.94), respectively, compared with age-matched controls. Shoulder pathologies and concomitant orthopedic pathologies are common in patients with ATTR-CA and may help identify patients with CA earlier in their disease progression for earlier intervention and treatment.

Agreement between intraoperative and magnetic resonance imaging assessments of rotator cuff pathology and 2 magnetic resonance imaging-based assessments of supraspinatus muscle atrophy.

Background: Magnetic resonance imaging (MRI)-based rotator cuff assessment is often qualitative and subjective; few studies have tried to validate such preoperative assessments. This study investigates relationships of preoperative MRI assessments made by conventional approaches to intraoperative findings of tear type, location, and size or MRI-assessed muscle occupation ratio. Methods: Intraoperatively, surgeons assessed tear type, location, anterior-posterior (AP) width, and medial-lateral length in 102 rotator cuff repair patients. Two musculoskeletal radiologists independently assessed the preoperative MRI scans for these same parameters and supraspinatus muscle atrophy by both Warner classification and quantitative occupation ratio. Exact agreement proportions, kappa statistics, and correlation coefficients were used to quantify agreement relationships. Results: Agreement between MRI readers' and surgeons' observations of tear status averaged 93% with κ = 0.38, and that of tear location averaged 77% with κ = 0.50. Concordance correlations of MRI and intraoperative measures of anterior-posterior and medial-lateral tear length averaged 0.59 and 0.56 across readers, respectively. Despite excellent interrater agreement on Warner classification (exact agreement proportion 0.91) and occupation ratio (concordance correlation 0.93) separately, correlations between these 2 measures were -0.54 and -0.64 for the 2 readers, respectively. Patients with Warner grade 0 had occupation ratios ranging from 0.5 to 1.5. Conclusion: Correlations of preoperative MRI tear dimensions and muscle atrophy assessed by conventional approaches with intraoperatively measured tear dimensions and quantitative occupation ratio, respectively, were only fair. Since tear size and muscle atrophy are known strong predictors of outcomes following rotator cuff repair that may influence treatment decisions, surgeons need to be aware of the limitations of MRI methods. Continued development and validation of quantitative preoperative imaging methods to accurately assess these parameters are needed to improve surgical planning and prognosis.

Changes From Baseline in Patient- Reported Outcomes at 1 Year Versus 2 Years After Rotator Cuff Repair: A Systematic Review and Meta-analysis.

BACKGROUND: Most orthopaedic journals currently require reporting outcomes of surgical interventions for at least 2 postoperative years, but there have been no rigorous studies on this matter. Various patient-reported outcome (PRO) measures (PROMs) have been used to assess the status of the shoulder after rotator cuff repair (RCR). HYPOTHESIS: We hypothesized that the mean shoulder-specific PROMs at 1 year improve substantially over baseline but that there is no clinically meaningful difference between the mean 1- and 2-year PROMs after RCR. STUDY DESIGN: Meta-analysis; Level of evidence, 2. METHODS: We conducted a systematic review of published randomized controlled trials (RCTs) and prospective cohort studies (level of evidence 1 and 2) reporting the shoulder-specific American Shoulder and Elbow Surgeons (ASES), the Constant, or the Western Ontario Rotator Cuff (WORC) Index scores at baseline, 1 year, and 2 years after RCR. The methodologic quality of studies was assessed. Also, the random effects meta-analyses of changes in PROMs for each of the first and second postoperative years were conducted. RESULTS: Fifteen studies (n = 11 RCTs; n = 4 cohort studies) with a total of 1371 patients were included. Studies were highly heterogeneous, but no visual evidence of major publication bias was observed. The weighted means of the baseline PROMs were 46.2 points for the ASES score, 46.4 points for the Constant score, and 38.8 points for the WORC Index. The first-year summary increments were 41.1 (95% CI, 36.0-46.2) points for the ASES score, 34.2 (95% CI, 28.8-39.6) points for the Constant score, and 42.9 (95% CI, 37.3-48.4) points for the WORC Index. In contrast, the second-year summary increments were 2.3 (95% CI, 1-3.6) points for the ASES score, 3.2 (95% CI, 1.9-4.4) points for the Constant score, and 2 (95% CI, -0.1 to 4) points for the WORC Index. CONCLUSION: All PROMs improved considerably from baseline to 1 year, but only very small gains that were below the minimal clinically important differences were observed between 1 year and 2 years after RCR. This study did not find any evidence for requiring a minimum of 2 years of follow-up for publication of PROs after RCR. Our results suggest that focusing on 1-year PROMs after RCR would foster more timely reporting, better control of selection bias, and better allocation of research resources.

Effectiveness of a Web-Based Electronic Prospective Data Collection Tool for Surgical Data in Shoulder Arthroplasty.

BACKGROUND: The purpose of this study was to demonstrate the validity and efficiency of the Outcomes Management and Evaluation (OME) system, a prospectively designed electronic data collection tool, for collecting comprehensive and standardized surgical data in shoulder arthroplasty. METHODS: Surgical data from the first 100 cases of shoulder arthroplasty that were collected into the OME database were analyzed. Surgeons completed a traditional narrative operative note and also an OME case report using an encrypted smartphone. A blinded reviewer extracted data from the operative notes and implant logs in the electronic medical records (EMR) by manual chart review. OME and EMR data were compared with regard to data counts and agreement between 39 variables related to preoperative pathology, including rotator cuff status and glenoid wear, and surgical procedures. Data counts were assessed using both raw percentages and with McNemar's test (with continuity correction). Agreement of nominal variables was analyzed using Cohen's unweighted kappa (κ) and of ordinal variables using the linearly weighted Cohen's test. Efficiency was assessed by calculating the median time needed to complete OME. RESULTS: Compared to the EMR, the OME database had significantly higher data counts for 56% (22 of 39) of the variables assessed. A high level of proportional and statistical agreement was demonstrated between the data in the two datasets. 10 of 39 variables had 100% agreement but could not be statistically compared because both datasets had the same single response under those variables. Among the 29 variables that were compared, 79% (23 of 29) of variables had >80% raw proportional agreement, and 69% (20 of 29) of variables showed at least substantial agreement (κ > 0.6). The median time for completing OME surgery data entry was 92 seconds (IQR 70 - 126). CONCLUSION: The prospectively designed, electronic data entry system (OME) is an efficient and valid tool for collecting comprehensive and standardized surgical data on shoulder arthroplasty. LEVEL OF EVIDENCE: Level IV.

Stepped Augmented Glenoid Component in Anatomic Total Shoulder Arthroplasty for B2 and B3 Glenoid Pathology: A Study of Early Outcomes.

BACKGROUND: Posterior glenoid bone loss is commonly associated with primary glenohumeral osteoarthritis. Surgical management of bone loss in anatomic total shoulder arthroplasty (aTSA) remains controversial. We studied the use of a stepped augmented glenoid component for management of Walch B2 and B3 glenoids and compared the radiographic and clinical outcomes at short-term follow-up with those achieved with a non-augmented component of the same design in Walch A1 glenoids. METHODS: Ninety-two patients (42 A1, 29 B2, and 21 B3 glenoids) were prospectively followed after aTSA. Sequential 3-dimensional (3D) computed tomography (CT) imaging was performed preoperatively, within 3 months postoperatively with metal artifact reduction (MAR) to define implant position, and at a minimum of 2 years postoperatively with MAR. Scapular 3D registration with implant registration allowed 3D measurement of glenoid implant position, implant shift, and central peg osteolysis (CPO). RESULTS: CPO with or without implant shift occurred in a higher percentage of B3 glenoids treated with the augmented glenoid component (29%) than A1 glenoids treated with a standard component (5%) (p = 0.028). There was no significant difference in the frequency of CPO between B2 glenoids with the augmented component (10%) and A1 glenoids with the standard component. There was no difference in postoperative glenoid component version and inclination between groups. B3 glenoids were associated with more component medialization relative to the premorbid joint line compared with A1 and B2 glenoids (p < 0.001). CONCLUSIONS: A stepped augmented glenoid component can restore premorbid glenoid anatomy in patients with asymmetric biconcave glenoid bone loss (Walch B2), with short-term clinical and radiographic results equivalent to those for patients without glenoid bone loss (Walch A1) treated with a non-augmented component. There is a greater risk of CPO in patients with moderate-to-severe B3 glenoid pathology with this stepped augmented glenoid component. Longer follow-up will help define the clinical implications of CPO over time. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Inter-rater agreement of rotator cuff tendon and muscle magnetic resonance imaging parameters evaluated preoperatively and during the first postoperative year following rotator cuff repair.

BACKGROUND: Magnetic resonance imaging (MRI) is standard of care for rotator cuff evaluation, with clinical interpretation usually limited to qualitative judgments. The reliability of MRI-based measurements and scoring systems has been evaluated only preoperatively or ≥6 months following rotator cuff repair, when repairs are in the later stages of healing. This study describes the MRI assessments and inter-rater agreement of various rotator cuff tendon and muscle parameters evaluated preoperatively and 4 times during the first postoperative year. METHODS: Two musculoskeletal radiologists independently assessed MRI scans of 42 patients preoperatively and 3, 12, 26, and 52 weeks after rotator cuff repair. Using standardized reading rules, readers assessed tendon integrity (5-point Sugaya classification), tear dimensions, muscle fat (5-point Goutallier classification) and atrophy (4-point Warner classification), muscle cross-sectional areas, and myotendinous junction distance. Raw exact agreement proportions, κ statistics, and correlation coefficients were used to quantify inter-rater agreement. RESULTS: Readers showed moderate to substantial above-chance agreement in scoring rotator cuff tendon integrity and supraspinatus muscle atrophy and good to excellent agreement on tear dimensions and muscle cross-sectional areas but only fair to moderate agreement for fatty infiltration and myotendinous junction distance. Only fatty infiltration grades evidenced observer bias. Inter-rater agreement did not appear time dependent. CONCLUSION: By use of defined reading rules in a research setting, MRI evaluations of rotator cuff tendon integrity, tear dimensions, muscle atrophy, and cross-sectional areas have reasonable reliability at all time points in the first postoperative year. However, the presence of clinically significant disagreements, even in such favorable circumstances, indicates the need for improved imaging tools for precise rotator cuff evaluation.

Relationship Between Glenoid Component Shift and Osteolysis After Anatomic Total Shoulder Arthroplasty: Three-Dimensional Computed Tomography Analysis.

BACKGROUND: The purpose of this study was to evaluate glenoid component position and radiolucency following anatomic total shoulder arthroplasty (TSA) using sequential 3-dimensional computed tomography (3D CT) analysis. METHODS: In a series of 152 patients (42 Walch A1, 16 A2, 7 B1, 49 B2, 29 B3, 3 C1, 3 C2, and 3 D glenoids) undergoing anatomic TSA with a polyethylene glenoid component, sequential 3D CT analysis was performed preoperatively (CT1), early postoperatively (CT2), and at a minimum 2-year follow-up (CT3). Glenoid component shift was defined as a change in component version or inclination of ≥3° from CT2 to CT3. Glenoid component central anchor peg osteolysis (CPO) was assessed at CT3. Factors associated with glenoid component shift and CPO were evaluated. RESULTS: Glenoid component shift occurred from CT2 to CT3 in 78 (51%) of the 152 patients. CPO was seen at CT3 in 19 (13%) of the 152 patients, including 15 (19%) of the 78 with component shift. Walch B2 glenoids with a standard component and glenoids with higher preoperative retroversion were associated with a higher rate of shift, but not of CPO. B3 glenoids with an augmented component and glenoids with greater preoperative joint-line medialization were associated with CPO, but not with shift. More glenoid component joint-line medialization from CT2 to CT3 was associated with higher rates of shift and CPO. A greater absolute change in glenoid component inclination from CT2 to CT3 and a combined absolute glenoid component version and inclination change from CT2 to CT3 were associated with CPO. Neither glenoid component shift nor CPO was associated with worse clinical outcomes. CONCLUSIONS: Postoperative 3D CT analysis demonstrated that glenoid component shift commonly occurs following anatomic TSA, with increased inclination the most common direction. Most (81%) of the patients with glenoid component shift did not develop CPO. Longer follow-up is needed to determine the relationships of glenoid component shift and CPO with loosening over time. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Three-dimensional computed tomography analysis of pathologic correction in total shoulder arthroplasty based on severity of preoperative pathology.

BACKGROUND: The purpose of this study was to quantify correction of glenoid deformity and humeral head alignment in anatomic total shoulder arthroplasty as a function of preoperative pathology (modified Walch classification) and glenoid implant type in a clinical cohort using 3-dimensional computed tomography (CT) analysis. METHODS: Patients undergoing anatomic total shoulder arthroplasty with a standard glenoid (SG) (n = 110) or posteriorly stepped augmented glenoid (AG) (n = 62) component were evaluated with a preoperative CT scan and a postoperative CT scan within 3 months of surgery. Glenoid version, inclination, and medial-lateral (ML) joint line position, as well as humeral head alignment, were assessed on both CT scans, with preoperative-to-postoperative changes analyzed relative to pathology and premorbid anatomy based on the modified Walch classification and glenoid implant type. RESULTS: On average, correction to the premorbid ML joint line position was significantly less in type A2 glenoids than in type A1 glenoids (-2.3 ± 2.1 mm vs. 1.1 ± 0.9 mm, P < .001). Correction to premorbid version was not different between type B2 glenoids with AG components and type A1 glenoids with SG components (-1.7° ± 6.6° vs. -1.0° ± 4.0°, P = .57), and the premorbid ML joint line position was restored on average in both groups (0.3 ± 1.6 mm vs. 1.1 ± 0.9 mm, P = .006). Correction to premorbid version was not different between type B3 glenoids with AG components and type A1 glenoids with SG components (-0.6° ± 5.1° vs. -1.0° ± 4.0°, P = .72), but correction relative to the premorbid ML joint line position was significantly less in type B3 glenoids with AG components than in type A1 glenoids with SG components (-2.2 ± 2.1 mm vs. 1.1 ± 0.9 mm, P < .001). Postoperative humeral glenoid alignment was not different in any group comparisons. DISCUSSION: In cases with posterior glenoid bone loss and retroversion (type B2 or B3 glenoids), an AG component can better correct retroversion and the glenoid ML joint line position compared with an SG component, with correction to premorbid version comparable to a type A1 glenoid with an SG component. However, restoration of the premorbid ML joint line position may not always be possible with SG or AG components in cases with more advanced central glenoid bone loss (type A2 or B3 glenoids). Further follow-up is needed to determine the clinical consequences of these findings.

Associations of preoperative patient mental health status and sociodemographic and clinical characteristics with baseline pain, function, and satisfaction in patients undergoing primary shoulder arthroplasty.

HYPOTHESIS AND BACKGROUND: Shoulder pain and dysfunction are common indications for shoulder arthroplasty, yet the factors that are associated with these symptoms are not fully understood. This study aimed to investigate the associations of patient and disease-specific factors with preoperative patient-reported outcome measures (PROMs) in patients undergoing primary shoulder arthroplasty. We hypothesized that worse mental health status assessed by the Veterans RAND 12-Item Health Survey (VR-12) mental component score (MCS), glenoid bone loss, and increasing rotator cuff tear severity would be associated with lower values for the preoperative total Penn Shoulder Score (PSS) and its pain, function, and satisfaction subscores. METHODS: We prospectively identified 12 patient factors and 4 disease-specific factors as possible statistical predictors of preoperative PROMs in patients undergoing primary shoulder arthroplasty at a single institution over a 3-year period. Multivariable statistical modeling and Akaike information criterion comparisons were used to investigate the unique associations with, and relative importance of, these factors in accounting for variation in the preoperative PSS and its subscores. RESULTS: A total of 788 cases performed by 12 surgeons met the inclusion criteria, with a preoperative median total PSS of 31 points (pain, 10 points; function, 18 points; and satisfaction, 1 point). As hypothesized, a lower VR-12 MCS was associated with lower preoperative PSS pain, function, and total scores, but patients with intact status or small to medium rotator cuff tears had modestly lower PSS pain subscores (ie, more pain) than patients with large to massive superior-posterior rotator cuff tears. Glenoid bone loss was not associated with the preoperative PSS. Female sex and fewer years of education (for all 4 outcomes), lower VR-12 MCS and preoperative opioid use (for all outcomes but satisfaction), and rotator cuff tear severity (for pain only) were the factors most prominently associated with preoperative PROMs. CONCLUSION: In addition to mental health status and rotator cuff tear status, patient sex, years of education, and preoperative opioid use were most prominently associated with preoperative PROMs in patients undergoing shoulder arthroplasty. Further studies are needed to investigate whether these factors will also predict postoperative PROMs.

Variability of glenohumeral positioning and bone-to-tendon marker length measurements in repaired rotator cuffs from longitudinal computed tomographic imaging.

BACKGROUND: To address the need for more objective and quantitative measures of tendon healing in research studies, we intend to use computed tomography (CT) with implanted radiopaque markers on the repaired tendon to measure tendon retraction following rotator cuff repair. In our small prior study, retraction at 1-year follow-up averaged 16.1± 5.3 mm and exceeded 10.0 mm in 12 of 13 patients, and thus tendon retraction appears to be a common clinical phenomenon. This study's objectives were to assess, using 5 longitudinal CT scans obtained over 1 year following rotator cuff repair, the variability in glenohumeral positioning because of pragmatic variations in achieving perfect arm repositioning and to estimate the associated measurement variability in bone-to-tendon marker length measurements. METHODS: Forty-eight patients underwent rotator cuff repair with intraoperative placement of radiopaque tendon markers at the repair site. All patients had a CT scan with their arms at the side on the day of surgery and at 3, 12, 26, and 52 weeks postoperatively. Glenohumeral position (defined by the orientation and distance of the humerus with respect to the scapula) and bone-to-tendon marker lengths were measured from each scan. Within-patient variation in glenohumeral position measurements was described by their pooled within-patient standard deviations (SDs), and variation in bone-to-tendon marker lengths by their standard errors of measurement (SEMs) and 95% confidence level minimally detectable distances (MDD95) and changes (MDC95). RESULTS: The mean glenohumeral orientation from the 5 longitudinal CT scans averaged across the 48 patients was 12.6° abduction, 0.4° flexion, and -0.1° internal rotation. Within-patient SDs (95% confidence intervals) of glenohumeral orientation were 3.0° (2.7°-3.4°) in extension/flexion, 5.2° (4.6°-5.8°) in abduction/adduction, and 8.2° (7.3°-9.2°) in internal/external rotation. The SDs of glenohumeral distances were less than 1 mm in any direction. The estimated SEMs of bone-to-tendon lengths were consistent with a common value of 2.4 mm for any of the tendon markers placed across the repair, with MDD95 of 4.7 mm and MDC95 of 6.7 mm. CONCLUSION: Apparent tendon retraction of 5 mm or more, when measured as the distance from a tendon marker's day of surgery location to its new location on a volumetrically registered longitudinal CT scan, may be considered above the usual range of measurement variation. Tendon retraction measured using implanted radiopaque tendon markers offers an objective and sufficiently reliable means for quantifying the commonly expected changes in structural healing following rotator cuff repair.

Associations of Preoperative Patient Mental Health and Sociodemographic and Clinical Characteristics With Baseline Pain, Function, and Satisfaction in Patients Undergoing Rotator Cuff Repairs.

BACKGROUND: Shoulder pain and dysfunction are common indications for rotator cuff repair surgery, yet the factors that are associated with these symptoms are not fully understood. PURPOSE/HYPOTHESIS: This study aimed to investigate the associations of patient and disease-specific factors with baseline patient-reported outcome measures (PROMs) in patients undergoing rotator cuff repair. We hypothesized that tear size and mental health status, as assessed by the Veterans RAND 12-Item Health Survey mental component score (VR-12 MCS), would be associated with baseline total Penn Shoulder Score (PSS) and its pain, function, and satisfaction subscale scores. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: We prospectively identified 12 patient factors and 12 disease-specific factors as possible statistical predictors for baseline PROMs in patients undergoing surgical repair of superior-posterior rotator cuff tears at a single institution over a 3-year period. Multivariable statistical modeling and Akaike information criterion comparisons were used to investigate the unique associations with, and relative importance of, these factors in accounting for variation in baseline PSS and its subscale scores. RESULTS: A total of 1442 patients who had undergone surgery by 23 surgeons met inclusion criteria, with a baseline median total PSS of 38.5 (pain, 12; function, 24.2; satisfaction, 2). Adjusted R2 in multivariable models demonstrated that the 24 general patient and disease-specific factors accounted for 22% to 24% of the variability in total PSS and its pain and function subscale scores. Large/massive tear size was significantly associated with worse PSS total score and function score but not pain or satisfaction scores. Lower VR-12 MCS was significantly associated with worse total PSS and all 3 subscale scores. Among other factors significantly associated with baseline PROMs were sex, race, preoperative opioid use, years of education, employment status, acromion status, and adhesive capsulitis. Lower VR-12 MCS, preoperative opioid use, female sex, and black race were the factors most strongly associated with baseline PROMs. CONCLUSION: Large/massive tear size, lower VR-12 MCS, and several additional patient and disease-specific factors are associated with baseline PROMs in patients undergoing rotator cuff repair. Further studies are needed to investigate whether these factors will also predict poor postoperative PROMs.

A novel radiopaque tissue marker for soft tissue localization and in vivo length and area measurements.

PURPOSE: The purpose of the study was to describe the characteristics and demonstrate proof-of-concept and clinical use of a barium sulfate infused polypropylene radiopaque tissue marker for soft tissue localization and in vivo measurement of lengths and areas. METHODS: Marker mechanical properties were evaluated by tensile tests. Biocompatibility was evaluated following 8-12 weeks' implantation in a pig model. Proof-of-concept of marker application was performed in a human cadaveric shoulder model, and methods for CT imaging and measurement of dimensions were established. Lastly, the method of clinical use of the markers was described in one patient undergoing arthroscopic rotator cuff repair (RCR). RESULTS: The radiopaque markers had a tensile strength of 28 ±4.7 N and were associated with minimal to mild inflammatory tissue reaction similar to polypropylene control. CT-based measurements showed relatively high precisions for lengths (0.66 mm), areas (6.97 mm2), and humeral orientation angles (2.1°) in the cadaveric model, and demonstrated 19 ±3 mm medio-lateral tendon retraction and 227 ±3 mm2 increase in tendon area in the patient during 26 weeks following RCR. No radiographic leaching, calcification or local adverse events were observed. CONCLUSIONS: The radiopaque tissue marker was biocompatible and had adequate strength for handling and affixation to soft tissues using standard suturing techniques. The marker could be used with low-dose, sequential CT imaging to quantitatively measure rotator cuff tendon retractions with clinically acceptable accuracy. We envision the radiopaque tissue marker to be useful for soft tissue localization and in vivo measurement of tissue and organ dimensions following surgery.

Validity and efficiency of a smartphone-based electronic data collection tool for operative data in rotator cuff repair.

BACKGROUND: This study tested validity and efficiency of Orthopaedic Minimal Data Set (OrthoMiDaS) Episode of Care (OME). METHODS: We analyzed 100 isolated rotator cuff repair cases in the OME database. Surgeons completed a traditional operative note and OME report. A blinded reviewer extracted data from operative notes and implant logs in electronic medical records by manual chart review. OME and electronic medical record data were compared with data counts and agreement between 40 variables of rotator cuff disease and repair procedures. Data counts were assessed using raw percentages and McNemar test (with continuity correction). Agreement of categorical variables was analyzed using Cohen κ (unweighted) and of numerical variables using the concordance correlation coefficient (CCC). Efficiency was assessed by median time to complete. RESULTS: OME database had significantly higher data counts for 25% (10/40) of variables. A high level of proportional and statistical agreement was demonstrated between the data. Among 35 categorical variables, proportional agreement was perfect for 17%, almost perfect (0.81 ≤ κ ≤ 1.00) for 37%, substantial (0.61 ≤ κ ≤ 0.80) for 20%, moderate (0.41 ≤ κ ≤ 0.60) for 14%, fair (0.21 ≤ κ ≤ 0.40) for 6%, and slight (0.0 ≤ κ ≤ 0.20) for 6%. Of 5 numerical variables, agreement was almost perfect (CCC > 0.99) for 20% and poor (CCC < 0.90) for 80%. Median OME completion time was 161.5 seconds (interquartile range, 116-224.5). CONCLUSION: OME is an efficient, valid tool for collecting comprehensive, standardized data on rotator cuff repair.

Biodegradable hyaluronan hydrogel coatings on acellular dermis grafts-A potential strategy to improve biologic graft durability in hernia repair application.

Biologic grafts used in hernia repair undergo rapid cellular infiltration and remodeling, but their premature degradation often results in hernia recurrence. We hypothesize that a temporary barrier that prevents infiltration of acute inflammatory cells into the graft during the initial 4 weeks of implantation could mitigate graft degradation. The purpose of this study is to design tyramine-substituted hyaluronan (THA) hydrogel coatings with tunable degradation properties, as a means to develop a resorbable barrier for human acellular dermis grafts (HADM). THA plugs prepared at different cross-linking densities, by varying cross-linking agent concentration (0.0001-0.0075% H2 O2 ), demonstrated varying rates of in vitro degradation (25 U/mL hyaluronidase, 48 h). Based on these results, HADM grafts were coated with THA at three cross-linking densities (0.0001%, 0.00075%, and 0.003% H2 O2 ) and THA coating degradation was evaluated in vitro (25 U/mL hyaluronidase, 48 h) and in vivo (rat intraperitoneal implantation, 1-4 weeks). THA coatings degraded in vitro and in vivo with the lowest cross-linking density (0.0001% H2 O2 ), generally showing greater degradation as evidenced by significant decrease in coating cross-sectional area. However, all three coatings remained partially degraded after 4 weeks of in vivo implantation. Alternate strategies to accelerate in vivo degradation of THA coatings are required to allow investigation of the study hypothesis. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B:2664-2672, 2019.