JBJS Will Require Adherence to ARRIVE Guidelines for Animal Research to Reduce Bias and Improve Quality of Reporting No abstract available

Guideline for Preclinical Studies of Bone Infections in Large Animals Based on a Systematic Review of 316 Non-Rodent Models Background: In recent years, animal models of bone infections have been used with increased frequency in order to evaluate novel diagnostic and anti-infective technologies, like antibacterial coating of bone implants or local antibiotic carrier products. Therefore, it is highly relevant to evaluate the scientific quality of existing bone infection models. Methods: We conducted a systematic review of 316 studies of large non-rodent animal models of bone infection (254 rabbit, 16 pig, 23 dog, 11 goat, and 12 sheep) and extracted data on study design, methodological quality, and postmortem evaluation of infection with respect to reporting and quantification of pathology and microbiology. Results: The review demonstrated a substantial lack of study-design information, which hampers reproducibility and continuation of the established work. Furthermore, the methodological study quality was found to be low, as the definition of infection, randomization, power analysis, and blinding were only seldomly reported. The use of histology increased in recent years, but a semi-quantitative scoring of the lesions was often missing, i.e. no objective quantification of outcome. Most of the studies focused on whether the inoculated bacteria were present within the bone tissue post mortem or not. However, very often the bacterial burden was not quantified. In many of the models, different antimicrobial interventions were examined and, although antimicrobial effects were commonly described, a lack of complete sterile outcome was observed in many models. On the basis of the systematic review, we established a study template providing a guideline for the standard reporting of animal models of bone infections, including details related to the animal, pathogen, infected animal, and postmortem analysis that are of crucial importance for validation of results and reproducibility. Conclusions: As the aim of many bone infection models is to examine the effect of an intervention, the guideline emphasizes the importance of objective quantification of outcome, e.g., blinded quantitative scoring of histological findings and quantification of bacterial burden within tissue and on inserted implants. Less than 5% of the analyzed studies adhered completely to the ideal form presented in the study template. Clinical Relevance: Anti-infective interventions must be tested in preclinical animal models before implementation in human patients, and optimal design and validation is essential for a high translational value.

Subtalar Arthrodesis with Use of Adipose-Derived Cellular Bone Matrix Compared with Autologous Bone Graft: A Multicenter, Randomized Controlled Trial Update This article was updated on November 7, 2019, because of a previous error. On page 1909, in the section entitled “Discussion,” the sentence that had read “Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs” now reads “Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do not account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs.” Background: Subtalar arthrodesis effectively treats subtalar joint arthritis when other interventions have failed. Nonunion is a known complication of subtalar arthrodesis, with reported rates ranging from 5% to 45%. Historically, open arthrodesis has been performed with use of autologous bone graft; however, there are inherent disadvantages to autologous bone graft, including donor-site morbidity. Mesenchymal stem cells, when placed on a cellular scaffold, have shown promise as an alternative to autologous bone graft. The purpose of this multicenter, randomized controlled trial was to assess the safety and efficacy of an adipose-derived cellular bone matrix (ACBM) composite made with live cells compared with autograft in subtalar arthrodesis. Methods: A total of 140 patients were enrolled in a prospective, randomized (1:1) controlled trial performed at 6 clinical sites in the U.S. End points, including radiographic, clinical, and functional outcomes, were assessed over 2 years of follow-up. Results: A total of 109 patients underwent arthrodesis with ACBM (52 patients) and autograft (57 patients). At 6 months, fusion was achieved in 16 patients (30.8%) in the ACBM group and 31 patients (54.4%) in the autograft group as measured on computed tomography (p = 0.024), and in 41 patients (78.8%) in the ACBM group and 50 patients (87.7%) in the autograft group as assessed on clinical and radiographic evaluation (p = 0.213). Quality-of-life outcome measures demonstrated significant functional improvement from baseline for both groups. Fewer cases of serious adverse events occurred in the autograft group (10.5%) compared with the ACBM group (23.1%) (p = 0.078). Conclusions: In patients who require subtalar arthrodesis, the use of ACBM demonstrated lower rates of radiographic fusion compared with treatment with autograft. The nonunion rate in the autologous group, as measured on computed tomography, was high. Good clinical outcomes were achieved in spite of the high non-union rates. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Association Between Rotator Cuff Muscle Size and Glenoid Deformity in Primary Glenohumeral Osteoarthritis Background: Although glenoid morphology has been associated with fatty infiltration of the rotator cuff in arthritic shoulders, the association of rotator cuff muscle area with specific patterns of glenoid wear has not been studied. The purpose of our study was to assess the associations of glenoid deformity in primary glenohumeral osteoarthritis and rotator cuff muscle area. Methods: A retrospective study of 370 computed tomographic (CT) scans of osteoarthritic shoulders was performed. Glenoid deformity according to the modified Walch classification was determined, and retroversion, inclination, and humeral-head subluxation were calculated using automated 3-dimensional software. Rotator cuff muscle area was measured on sagittal CT scan reconstructions. A ratio of the area of the posterior rotator cuff muscles to the subscapularis was calculated to approximate axial plane potential force imbalance. Univariate and multivariate analyses to determine associations with glenoid bone deformity and rotator cuff measurements were performed. Results: Patient age and sex were significantly related to cuff muscle area across glenoid types. Multivariate analysis did not find significant differences in individual rotator cuff cross-sectional areas across glenoid types, with the exception of a larger supraspinatus area in Type-B2 glenoids compared with Type-A glenoids (odds ratio [OR], 1.5; p = 0.04). An increased ratio of the posterior cuff area to the subscapularis area was associated with increased odds of a Type-B2 deformity (OR, 1.3; p = 0.002). Similarly, an increase in this ratio was significantly associated with increased glenoid retroversion (beta = 0.92; p = 0.01) and humeral-head subluxation (beta = 1.48; p = 0.001). Within the Type-B glenoids, only posterior humeral subluxation was related to the ratio of the posterior cuff to the subscapularis (beta = 1.15; p = 0.001). Conclusions: Age and sex are significantly associated with cuff muscle area in arthritic shoulders. Asymmetric glenoid wear and humeral-head subluxation in osteoarthritis are associated with asymmetric atrophy within the rotator cuff transverse plane. Increased posterior rotator cuff muscle area compared with anterior rotator cuff muscle area is associated with greater posterior glenoid wear and subluxation. It is unclear if the results are causative or associative; further research is required to clarify the relationship. Level of Evidence: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Five-Year Follow-up of Arthroscopic Superior Capsule Reconstruction for Irreparable Rotator Cuff Tears Background: Arthroscopic superior capsule reconstruction was developed to restore superior stability, muscle balance, and function in the shoulder joint after an irreparable rotator cuff tear. Our objective was to assess the functional and radiographic results of superior capsule reconstruction after 5 years of follow-up. Methods: Thirty patients who underwent arthroscopic superior capsule reconstruction using fascia lata autograft were enrolled in this study. The inclusion criteria were an irreparable rotator cuff tear confirmed by shoulder arthroscopy and 5 years of postoperative follow-up. Shoulder range of motion, American Shoulder and Elbow Surgeons (ASES) and Japanese Orthopaedic Association (JOA) scores, rates of return to sport and physical work, acromiohumeral distance, Goutallier grade of all rotator cuff muscles, graft healing and thickness, and postoperative cuff tear arthropathy were investigated. Results: Compared with preoperative values, ASES and JOA scores, active elevation, and acromiohumeral distance increased postoperatively at both 1 year (p < 0.001) and 5 years (p < 0.001); the 1-year values increased by 54.0 points for the ASES score, 34.4 points for the JOA score, 53° for active elevation, and 5.7 mm for acromiohumeral distance, and the 5-year values increased by 63.3 points for the ASES score, 39.9 points for the JOA score, 66° for active elevation, and 4.7 mm for acromiohumeral distance. The ASES score was greater at 5 years postoperatively than it was at 1 year postoperatively (mean difference, 9.3 points; p = 0.03). At 5 years postoperatively, 11 of 12 patients returned to physical work, a rate of 92% (95% confidence interval [CI], 73% to 100%), and 8 of 8 patients returned to sports, a rate of 100% (95% CI, 79% to 100%). None of the 27 patients who had graft healing showed progression of cuff tear arthropathy, but all 3 patients with a graft tear (10% [95% CI, 0% to 22%]) had severe cuff tear arthropathy at 5 years postoperatively. In the 27 patients whose grafts remained intact, the graft thicknesses at 3 months, 1 year, and 5 years postoperatively did not differ (p = 0.67). Conclusions: In this 5-year follow-up study, healed arthroscopic superior capsule reconstruction restored shoulder function and resulted in high rates of return to recreational sport and work. In patients with postoperative graft failure, severe cuff tear arthropathy was present at 5 years. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Use of Natural Language Processing Algorithms to Identify Common Data Elements in Operative Notes for Total Hip Arthroplasty Background: Manual chart review is labor-intensive and requires specialized knowledge possessed by highly trained medical professionals. Natural language processing (NLP) tools are distinctive in their ability to extract critical information from raw text in electronic health records (EHRs). As a proof of concept for the potential application of this technology, we examined the ability of NLP to correctly identify common elements described by surgeons in operative notes for total hip arthroplasty (THA). Methods: We evaluated primary THAs that had been performed at a single academic institution from 2000 to 2015. A training sample of operative reports was randomly selected to develop prototype NLP algorithms, and additional operative reports were randomly selected as the test sample. Three separate algorithms were created with rules aimed at capturing (1) the operative approach, (2) the fixation method, and (3) the bearing surface category. The algorithms were applied to operative notes to evaluate the language used by 29 different surgeons at our center and were applied to EHR data from outside facilities to determine external validity. Accuracy statistics were calculated with use of manual chart review as the gold standard. Results: The operative approach algorithm demonstrated an accuracy of 99.2% (95% confidence interval [CI], 97.1% to 99.9%). The fixation technique algorithm demonstrated an accuracy of 90.7% (95% CI, 86.8% to 93.8%). The bearing surface algorithm demonstrated an accuracy of 95.8% (95% CI, 92.7% to 97.8%). Additionally, the NLP algorithms applied to operative reports from other institutions yielded comparable performance, demonstrating external validity. Conclusions: NLP-enabled algorithms are a promising alternative to the current gold standard of manual chart review for identifying common data elements from orthopaedic operative notes. The present study provides a proof of concept for use of NLP techniques in clinical research studies and registry-development endeavors to reliably extract data of interest in an expeditious and cost-effective manner.

TCIRG1 Transgenic Rescue of Osteoclast Function Using Induced Pluripotent Stem Cells Derived from Patients with Infantile Malignant Autosomal Recessive Osteopetrosis Background: Osteoclasts are hematopoietic stem cell-derived multinucleated cells necessary for bone remodeling and resorption. TCIRG1 encodes a protein that is an adenosine triphosphate (ATP)-dependent vacuolar proton pump required for this process. Recessive loss-of-function mutations in both copies of this gene lead to impairment of osteoclast function, with increased bone density, increased skeletal mass, and early mortality. Methods: We isolated fibroblasts from a patient with the compound heterozygous TCIRG1 mutations c.1549G>A (p.517D>N) and c.2236C>T (p.746Q>X), and reprogrammed them into iPS (induced pluripotent stem) cells. The function of osteoclasts derived from these cells was then rescued by transgenic expression of TCIRG1 cDNA. Results: In addition to the known effects of TCIRG1 loss of function, iPS cell-derived osteoclasts from this patient had reduced expression of the bone remodeling enzymes cathepsin K (CTSK) and tartrate-resistant acid phosphatase (TRAP), leading to reduced in vitro bone remodeling. Expression of both genes and pit formation were restored in iPS cell-derived osteoclasts following transgenic restoration of TCIRG1 expression. Conclusions: Transgenic overexpression of TCIRG1 was sufficient to restore osteoclast function in iPS cell-derived osteoclasts from a patient with infantile malignant autosomal-recessive osteopetrosis. Clinical Relevance: This work provides a proof of concept for an autologous approach to treating osteopetrosis, potentially avoiding the risks associated with hematopoietic stem cell transplantation in a young patient population.

Comparison of Payment Margins Between the Bundled Payments for Care Improvement Initiative and the Comprehensive Care for Joint Replacement Model Shows a Marked Reduction for a Successful Program Background: The Comprehensive Care for Joint Replacement (CJR) model was implemented to address the 2 most commonly billed inpatient surgical procedures, total hip arthroplasty and total knee arthroplasty. The primary purpose of this study was to review the economic implications of 1 institution’s mandatory involvement in the CJR in comparison with prior involvement in the Bundled Payments for Care Improvement (BPCI) initiative. Methods: The mean cost per episode of care was calculated using our institution’s historical data. The target prices, projected savings or losses per episode of care, and projected annual savings for both BPCI and CJR were established and were comparatively analyzed. Results: The CJR target prices will decrease in comparison with BPCI target prices by 24.0% for Medicare Severity-Diagnosis Related Group (MS-DRG) 469 without fracture, 22.8% for MS-DRG 469 with fracture, 26.1% for MS-DRG 470 without fracture, and 27.7% for MS-DRG 470 with fracture, resulting in a reduction in savings per episode of care by 92.8% for MS-DRG 469 without fracture, 166.0% for MS-DRG 469 with fracture, 94.9% for MS-DRG 470 without fracture, and 61.7% for MS-DRG 470 with fracture. Our institution’s projected annual savings under CJR will decrease by 83.3%. Conclusions: These results suggest that the margin for savings in the CJR will be substantially reduced compared with the margin for savings in the BPCI. In hospitals that had previously devoted resources, these will have far less impact in the CJR, and hospitals new to the CJR that have not made these investments previously will require even greater resources for developing cost reduction and quality control strategies to remain financially solvent. Level of Evidence: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The Ponseti Method Decreased the Surgical Incidence in Children with Congenital Clubfoot: A Population-Based, 8 Birth-Year Cohort Study Background: With the introduction of the Ponseti method for congenital clubfoot, the relapse rate and the surgical rate have been remarkably reduced. However, data from population studies for patients up to 10 years of age are still lacking. This study aimed to survey the relapse and surgery rates in the first 10 years of life in children with congenital clubfoot before and after introduction of the Ponseti method in Taiwan using the National Health Insurance Research Database (NHIRD). Methods: We retrieved clubfoot cases and related surgical procedures determined by International Classification of Diseases, Ninth Revision (ICD-9) 754.51 from the 1999-2016 NHIRD. Foot and ankle surgical procedures coded as ICD-9 754.51 for patients who were older than 6 months of age were regarded as surgical procedures for relapsed or residual deformities. The rate of clubfoot release when the patients were 0.5 to 1 year of age and extensive surgical procedures in the first 10 years of life were assessed among 8 birth-year cohorts (1999 to 2006) with a 10-year follow-up. Results: Among 622 children with idiopathic congenital clubfoot diagnosis, 301 underwent a total of 367 surgical procedures for clubfoot between 6 months and 10 years of age. Disease incidence of 0.32 per 1,000 live births remained stable in the 8 birth-year cohorts. After the Ponseti method was introduced in 2002, there was a decrease in the clubfoot release rate in the 0.5 to 1-year age group (25.8% in the 1999 to 2002 birth-year cohorts compared with 17.6% in the 2003 to 2006 birth-year cohorts) and the rate of extensive surgical procedures (41.5% in the 1999 to 2002 birth-year cohorts compared with 31.3% in the 2003 to 2006 birth-year cohorts), both determined to be significant at p < 0.05 using the chi-square test. A significant decreasing trend (p < 0.05) was revealed in the rate of clubfoot release in patients who were 0.5 to 1 year of age by polynomial correlation, with an increasing negative slope after a turning point around 2002. The Ponseti method increased the ratio of minor to extensive surgical procedures when a surgical procedure was required. Conclusions: The Ponseti method decreased subsequent extensive surgical procedures for clubfoot, especially in the group that was 0.5 to 1 year of age. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Risk of Arterial Injury During Hip Internal Fixation Background: Injury to femoral arterial vessels is a risk with internal fixation of the hip. Understanding the anatomy of proximate vessels, particularly medial vessels not directly visualized, may reduce intraoperative and postoperative complications. Methods: We analyzed 47 patients (29 men and 18 women) using a computed tomographic (CT) angiogram of the lower limbs. The mean age of our patients was 69 years (range, 46 to 88 years). The distance from the tip of the greater trochanter to the profunda femoris and its perforators within 5 mm of the medial femoral shaft was measured along the length of the expected placement of typical dynamic hip screw constructs and other proximal femoral fracture fixation methods. Results: All patients were found to have 2 perforator vessels within 5 mm of the medial femoral shaft along the line of dynamic hip screw insertion (up to 200 mm from the tip of the greater trochanter). The first perforator was found at a mean distance of 112.6 mm (median, 110 mm) in women and at 123.4 mm (median, 122 mm) in men (p = 0.0066) from the tip of the greater trochanter. The second perforator appeared at a mean distance of 159.7 mm (median, 159 mm) in women and 178.9 mm (median, 180 mm) in men (p = 0.0028) from the tip of the greater trochanter. Conclusions: Surgeons should be aware of the presence of 2 arteries within 5 mm of the medial femoral shaft during femoral internal fixation procedures. We suggest avoiding the overdrilling of the medial cortex and the insertion of overlong screws along the femoral shaft from 110 to 120 mm in women and 120 to 130 mm in men (as measured from the tip of the greater trochanter) to prevent vascular injury during proximal femoral fracture fixation. Clinical Relevance: This article can assist orthopaedic surgeons in planning for procedures involving internal fixation of the hip and may reduce vascular complications from such procedures.