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.

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.

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.

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.

Tear characteristics and surgeon influence repair technique and suture anchor use in repair of superior-posterior rotator cuff tendon tears.

BACKGROUND: The factors that associate with surgical decisions about repair technique and the number of suture anchors used in rotator cuff repair have not been previously investigated. This study investigated the extent to which patient, surgeon, and surgical factors associate with performing single-row vs. double-row repair technique and ultimately with the number of suture anchors used. METHODS: Our institution's prospective surgical cohort was queried for patients undergoing suture anchor repair of superior-posterior rotator cuff tendon tears between February 2015 and August 2017. Exclusion criteria were patients with isolated subscapularis tears, tears that were not repaired, repairs without suture anchors, repairs involving graft augmentation, and repairs by surgeons with fewer than 10 cases. Multivariable statistical modeling was used to investigate associations between patient and surgical factors and the choice of repair technique and number of suture anchors used. RESULTS: A total of 925 cases performed by 13 surgeons met inclusion criteria. Tear type (full thickness), tear size (medium, large, and massive), a greater number of torn tendons, repair type (arthroscopic), and surgeon were significantly associated with performing a double-row over a single-row repair. Tear size, a greater number of torn tendons, double-row repair technique, and surgeon were significantly associated with a greater number of anchors used for repair. CONCLUSIONS: Our findings suggest that in the absence of data to conclusively support a clinical benefit of one repair technique over another, surgeons' training, experience, and inherent practice patterns become the primary factors that define their surgical methods.

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.

Development of a critical-sized ventral hernia model in the pig.

BACKGROUND: The pig is commonly used as a preclinical model for ventral hernia repair. However, no study has verified that an unrepaired surgically induced hernia (control) in the pig does not heal spontaneously but rather develops a persistent hernia. Without such verification in any given model, one cannot draw conclusions on the efficacy of the repair technique investigated. MATERIALS AND METHODS: Three surgically induced hernia models with increasing severity were created in eight pigs. These included 10-cm retrorectus partial-thickness (model 1) and 15-cm preperitoneal full-thickness (model 2) incisional defects and an 8 × 8 cm preperitoneal full-thickness excisional defect (model 3). Postoperative management included use of an abdominal binder, and in some cases, suction drainage, for 2 wk to support the repair and prevent seroma. Models were evaluated for persistence of hernia at 5 wk using clinical and radiographic assessments. RESULTS: All pigs developed clinical hernias after 2 wk of defect creation, but only models 1 and 3 had clinically persistent hernias at 5 wk. At 5 wk, the average defect area was 97 cm2 in model 1, 66 cm2 in model 2, and 245 cm2 in model 3. Dense fibrotic scarring was observed in the models with resolved hernias. CONCLUSIONS: Our results highlight the need to verify an unrepaired hernia injury model does not heal spontaneously prior to using it for hernia repair studies. The partial-thickness incisional model 1 and full-thickness excisional model 3 formed persistent hernias in pigs at 5 wk and should be further explored as models for investigating hernia repair strategies.

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.

Effect of pretension and suture needle type on mechanical properties of acellular human dermis patches for rotator cuff repair.

BACKGROUND: Dermal grafts are used for rotator cuff repair and augmentation. Although the in vitro biomechanical properties of dermal grafts have been reported previously, clinical questions related to their biomechanical performance as a surgical construct and the effect of surgical variables that could potentially improve repair outcomes have not been studied. METHODS: This study evaluated the failure and fatigue biomechanics of acellular dermis constructs tested in a clinically relevant size (4 × 4 cm patches) and manner (loaded via sutures) for rotator cuff repair. Also investigated were the effect of 2 surgical variables: (1) the fixation of grafts under varying magnitudes of pretension (0, 10, 20N), and (2) the use of reverse-cutting vs tapered needles for suturing grafts. RESULTS: Dermis constructs stretched ∼25% before bearing significant loads in the high stiffness region. Although 91% of the patches withstood 2500 cycles of loading to 150 N, the constructs stretched 13 to 19 mm after fatigue loading. This elongation could be reduced by 20% to 32% when reverse-cutting needles were used to prepare constructs or by applying 20 N of in situ circumferential pretension to the constructs before loading. CONCLUSIONS: Although dermis patches demonstrated robustness for use in rotator cuff repair, the patches underwent significant, substantial, and presumably nonrecoverable elongation, even at low physiologic loads. This study indicates that use of reverse-cutting needles for suture passage, preconditioning (cyclically stretching several times), and/or surgical fixation under at least 20 N of circumferential pretension could be developed as strategies to reduce compliance of dermis for its use for rotator cuff repair.

COVID-19 pandemic: Hospital preparedness in a tertiary care hospital in North East India.

Background: The first case of Coronavirus was reported by World Health Organisation (WHO) on 31 December 2019. Due to its high infectivity and increasing mortality, WHO on 30 January 2020 declared the infection as public health emergency of international concern. Various measures were initiated and carried out by health care facilities to tackle the pandemic. Our experiences of hospital preparedness may help future health policies to tackle the pandemics. Method: Various guidelines given by Ministry of Health and Family Welfare, Centre for Disease Control, Indian Council of Medical Research were studied and analysed. The hospital lay out plan was studied, modifications in the physical structure of the hospital as planned by the hospital authorities were observed and recorded. The impact of the new planning on patient management was recorded by the investigators. Results: It was observed that proper planning on the basis of laid down guidelines and the modifiable initial layout is very effective in the prevention and management of the pandemic. A total of 130 beds of the hospital under study could be separated from the main building with little modifications. Another important observation was dedicated leadership and coordination among different specialities ensuring successful planning. The investigators concluded that the new hospitals should be planned and constructed in such a way so that a major part of the hospital building can be converted to an isolation area with little modifications in the physical structure of the hospital at the time of pandemics.

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.

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.

Bioactive nanofibers for fibroblastic differentiation of mesenchymal precursor cells for ligament/tendon tissue engineering applications.

Mesenchymal stem cells and precursor cells are ideal candidates for tendon and ligament tissue engineering; however, for the stem cell-based approach to succeed, these cells would be required to proliferate and differentiate into tendon/ligament fibroblasts on the tissue engineering scaffold. Among the various fiber-based scaffolds that have been used in tendon/ligament tissue engineering, hybrid fibrous scaffolds comprising both microfibers and nanofibers have been recently shown to be particularly promising. With the nanofibrous coating presenting a biomimetic surface, the scaffolds can also potentially mimic the natural extracellular matrix in function by acting as a depot for sustained release of growth factors. In this study, we demonstrate that basic fibroblast growth factor (bFGF) could be successfully incorporated, randomly dispersed within blend-electrospun nanofibers and released in a bioactive form over 1 week. The released bioactive bFGF activated tyrosine phosphorylation signaling within seeded BMSCs. The bFGF-releasing nanofibrous scaffolds facilitated BMSC proliferation, upregulated gene expression of tendon/ligament-specific ECM proteins, increased production and deposition of collagen and tenascin-C, reduced multipotency of the BMSCs and induced tendon/ligament-like fibroblastic differentiation, indicating their potential in tendon/ligament tissue engineering applications.

The Changing Pattern of the Quantum of Biomedical Waste Generated from a Tertiary Care Hospital in Delhi.

Background As a consequence of growth and advancement in health care, production of health care waste has seen an exponential upward trend. Waste from individual health care facilities can vary based on the nature and scope of health care services they provide. Objectives To analyze the amount of biomedical waste generated by a tertiary care hospital. Methods Biomedical waste generated by the hospital from 2005 to 2019 was quantified and analyzed to calculate the total amount of incinerable waste, recyclable plastic waste, and sharp and glass waste. The amount of waste generated per bed per day and the compound annual growth rate (CAGR) were also calculated. Results The total amount of biomedical waste generated in 2005 was 65,658 kg, which has substantially increased to 374,712 kg in 2019, with a CAGR of 12.5%. The hospital was producing average biomedical waste of 0.179 kg/bed/day in 2005, which has increased four times in 2019 to reach 0.709 kg/bed/day. The overall estimated plastic waste was 31% of the total biomedical waste in 2005 and 53% in 2019. Conclusion The generation of biomedical waste is likely to see significant upward trends unless diligent deliberations are held between different stakeholders in regard to the reintroduction of reusable materials and waste reduction strategies.

Bio-electrospraying: A potentially safe technique for delivering progenitor cells.

Bio-electrospraying is fast becoming an attractive tool for in situ cell delivery into scaffolds for tissue engineering applications, with several cell types been successfully electrosprayed. Bone marrow derived mesenchymal progenitor/stem cells (BMSC), which are an important cell source for tissue engineering, have not been explored in detail and the effect of electrospraying on their "stemness" is not known. This study therefore investigates the effects of electrospraying on BMSC viability, proliferation, and multilineage differentiation potential. Electrospraying a BMSC suspension at flow rate of 6 mL/h and voltages of 7.5-15 kV could successfully generate a continuous, stable and linearly directed electrospray of cells. Morphological observation, trypan blue tests and alamar blue based metabolic assays revealed about 88% of these electrosprayed cells were viable, and proliferated at rates similar to native BMSCs. However, at higher voltages, electrospraying became unstable and reduced cell viability, possibly due to electrical or thermal damage to the cells. BMSCs electrosprayed at 7.5 kV also retained their multipotency and could be successfully differentiated into adipogenic, chondrogenic, and osteogenic lineages, demonstrating similar morphology and gene expression levels as induced native BMSCs. These results indicate that bio-electrospraying could be safely used as a progenitor/stem cell delivery technique for tissue engineering and regenerative medicine applications.

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.

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.

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.

Assessment of Human Acellular Dermis Graft in Porcine Models for Ventral Hernia Repair.

OBJECTIVE: Preclinical evaluation of hernia meshes is commonly performed in porcine models. We recently developed two surgically induced porcine hernia models-an incisional and an excisional model-that formed persistent hernias in the absence of graft repair. Herein, we investigate if these models will continue to form a hernia after graft repair. MATERIALS AND METHODS: Ten pigs were used to create two hernia models-a 10-cm partial-thickness incisional defect (n = 5) and an 8 × 8-cm full-thickness excisional defect (n = 5). The defects were repaired using a 12 × 12-cm human acellular dermis graft placed in a preperitoneal/retrorectus sublay position and fixed using transfascial sutures. Postoperative management included the use of suction drainage for 1 week and an abdominal binder for 4 weeks in the more severe excisional model. Hernia development was assessed clinically, and hernia defect size and volume were measured using postoperative computed tomography (CT) imaging over 12 weeks. Radiographic inflation testing (2 L inflation), biaxial mechanical testing, and histological evaluation were also performed at 12 weeks. RESULTS: All pigs with the excisional model, but none with the incisional model, developed a clinically relevant hernia. At the end of 12 weeks, the excisional model had a significantly greater hernia defect size (259 ± 51 cm2 vs. 47 ± 16 cm2) and repair volume (865 ± 414 cm3 vs. 85 ± 52 cm3) compared with the incisional model. The excisional model also showed an order of magnitude greater increase in repair volume (280 cm3 vs. 47 cm3) compared with the incisional model upon 2 L inflation. Furthermore, the excisional model showed a trend of having higher dilatational strain at average biaxial load of 250 N and lower stiffness compared with the incisional model. The excisional model had a thin, hypercellular hernia sac spanning the defect, whereas the incisional model had a thick densely fibrotic scar bridging the defect. CONCLUSION: The 8 × 8-cm excisional defect model, together with appropriate postoperative wound management, in the pig model is recommended for preclinical investigation of different grafts for hernia repair. Novel CT imaging and biomechanical testing methods are recommended to measure functional outcomes of hernia repair in preclinical models.