Effects of A2 Pulley Venting on Bowstringing and Tendon Slack: A Biomechanical Investigation.

BACKGROUND: A2 pulley release is often needed for exposure of the lacerated tendon, retrieval of retracted tendons, placement of core sutures, or to permit full motion and gliding of the repaired and edematous tendon. However, there is no agreement in the literature on the specific quantity of pulley venting that can be performed and recommendations are limited to an undefined "judicious release" of the pulleys when necessary. METHODS: Following a previously developed testing protocols, finger kinematics, tendon excursion, and bowstringing were evaluated on cadaveric hands for venting in increments of 20% of the pulley length. RESULTS: In our study, we found a statistically significant influence of venting on bowstringing, although no difference was found between fingers, and a significant difference in tendon slack, which was variable depending on the finger. Bowstringing started increasing at 20% of A2 venting and peaked at full release. Tendon slack did not start until 40% of A2 venting on the index finger, but started at 20% on the middle, ring, and small fingers. CONCLUSIONS: Venting of the A2 pulley leads to an incremental increase in tendon bowstringing and tendon slack. However, differences in metacarpophalangeal flexion angle were not observed until full A2 pulley release, and only observed in the index finger, and no differences were observed in proximal interphalangeal flexion angles. Therefore, the benefit of releasing the A2 pulley when clinically necessary will likely outweigh the risks of loss of motion or strength.

Biomechanical evaluation of the modified lasso technique.

BACKGROUND: The Terrible Triad of the elbow is a constellation of elbow dislocation, radial head fracture and coronoid process fracture. A common type of coronoid fracture documented with this triad is type II Regan-Morrey coronoid fractures. The preferred fixation method for this fracture type is the lasso technique, medial-lateral tunnel orientation being the traditional approach. Considering elbow anatomy, we saw an opportunity to potentially improve fixation by altering the suture lasso tunnel orientation to a proximal-distal orientation. HYPOTHESIS: Two tunnels in the proximal-distal direction would result in greater biomechanical stability as compared to the traditional lasso technique. MATERIAL AND METHODS: A type 2 Regan-Morrey fracture was created in 12 fresh frozen cadaveric elbows at 50% of the coronoid height using an oscillating saw. The humero-ulnar joint was placed in 0 degrees flexion then loaded at a rate of 10mm/min to failure. RESULTS: The control technique (medio-lateral tunnels) showed failure load of 150±81N that was not significantly different (p=0.825) than the 134±116N measured for the modified technique (distal-proximal tunnels). The portion of the load-displacement curve used to calculate stiffness was linear (R^2=0.94±0.04) with determination coefficients that did not differ between the two groups (p=0.351). For stiffness, we measured 17±13N/mm and 14±12N/mm respectively for control and modified techniques that did not result in a significant difference (p=0.674). CONCLUSION: In this attempt to improve the shortcomings of the lasso technique, we found that changing from medio-lateral to proximal-distal drilling directions did not result in an appreciable biomechanical benefit. LEVEL OF EVIDENCE: Basic science study; Biomechanics.

Systematic endoscopic staging of mediastinum to guide radiotherapy planning in patients with locally advanced non-small-cell lung cancer (SEISMIC): an international, multicentre, single-arm, clinical trial.

BACKGROUND: Systematic mediastinal lymph node staging by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) improves accuracy of staging in patients with early-stage non-small-cell lung cancer (NSCLC). However, patients with locally advanced NSCLC commonly undergo only selective lymph node sampling. This study aimed to determine the proportion of patients with locally advanced NSCLC in whom systematic endoscopic mediastinal staging identified PET-occult lymph node metastases, and to describe the consequences of PET-occult disease on radiotherapy planning. METHODS: This prospective, international, multicentre, single-arm, international study was conducted at seven tertiary lung cancer centres in four countries (Australia, Canada, the Netherlands, and the USA). Patients aged 18 years or older with suspected or known locally advanced NSCLC underwent systematic endoscopic mediastinal lymph node staging before combination chemoradiotherapy or high-dose palliative radiotherapy. The primary endpoint was the proportion of participants with PET-occult mediastinal lymph node metastases shown following systematic endoscopic staging. The study was prospectively registered with Australian New Zealand Clinical Trials Registry, ACTRN12617000333314. FINDINGS: From Jan 30, 2018, to March 23, 2022, 155 patients underwent systematic endoscopic mediastinal lymph node staging and were eligible for analysis. 58 (37%) of patients were female and 97 (63%) were male. Discrepancy in extent of mediastinal disease identified by PET and EBUS-TBNA was observed in 57 (37% [95% CI 29-44]) patients. PET-occult lymph node metastases were identified in 18 (12% [7-17]) participants, including 16 (13% [7-19]) of 123 participants with clinical stage IIIA or cN2 NSCLC. Contralateral PET-occult N3 disease was identified in nine (7% [2-12]) of 128 participants staged cN0, cN1, or cN2. Identification of PET-occult disease resulted in clinically significant changes to treatment in all 18 patients. In silico dosimetry studies showed the median volume of PET-occult lymph nodes receiving the prescription dose of 60 Gy was only 10·1% (IQR 0·1-52·3). No serious adverse events following endoscopic staging were reported. INTERPRETATION: Our findings suggests that systematic endoscopic mediastinal staging in patients with locally advanced or unresectable NSCLC is more accurate than PET alone in defining extent of mediastinal involvement. Standard guideline-recommended PET-based radiotherapy planning results in suboptimal tumour coverage. Our findings indicate that systematic endoscopic staging should be routinely performed in patients with locally advanced NSCLC being considered for radiotherapy to accurately inform radiation planning and treatment decision making in patients with locally advanced NSCLC. FUNDING: None.

Arthroscopic Simulation-Based Training of Orthopaedic Surgery Residents: Past, Present, and Future.

Simulation-based training is required by many medical specialties. Barriers, however, have prevented widespread implementation of simulators for arthroscopic training. The advantages of arthroscopic simulator-based training of residents include decreased errors, decreased cost of training, and improved patient care. Before an educational program can focus on the type of simulator, it is essential to have a validated curriculum and framework for how to use those simulators. One of the most validated systems is called proficiency-based progression training. Proficiency-based progression is essentially a paradigm in which basic skills must be mastered and demonstrated via objective evaluation, before moving on to more advanced skills. There are a variety of different validation methods and tools that have been described, with the Arthroscopic Surgical Skill Evaluation Tool being the most widely used tool. It is essential that any simulator has evidence and validation that it will ultimately improve surgical skills in the operating room. In the future, emerging technologies such as virtual reality, augmented reality, and three-dimensional printing will likely play a major role in the creation of newer simulators and may improve access to residents throughout the world.

Acetabular Wall Weakening in Total Hip Arthroplasty: A Pilot Study.

Total hip arthroplasty is a widely performed operation allowing disabled patients to improve their quality of life to a degree greater than any other elective procedure. Planning for a THA requires adequate patient assessment and preoperative characterizations of acetabular bone loss via radiographs and specific classification schemes. Some surgeons may be inclined to ream at a larger diameter thinking it would lead to a more stable press-fit, but this could be detrimental to the acetabular wall, leading to intraoperative fracture. In the attempt to reduce the incidence of intraoperative fractures, the current study aims to identify how increased reaming diameter degrades and weakens the acetabular rim strength. We hypothesized that there is proportionality between the reaming diameter and the reduction in acetabular strength. To test this hypothesis, this study used bone surrogates, templated from CT scans, and reamed at different diameters. The obtained bone surrogate models were then tested using an Intron 8874 mechanical testing machine (Instron, Norwood, MA) equipped with a custom-made fixture. Analysis of variance (ANOVA) was used to identify differences among reamed diameters while linear regression was used to identify the relationship between reamed diameters and acetabular strength. We found a moderate correlation between increasing reaming diameter that induced thinning of the acetabular wall and radial load damage. For the simplified acetabular model used in this study, it supported our hypothesis and is a promising first attempt in providing quantitative data for acetabular weakening induced by reaming.

ACU193, a Monoclonal Antibody that Selectively Binds Soluble Aß Oligomers: Development Rationale, Phase 1 Trial Design, and Clinical Development Plan.

BACKGROUND: Alzheimer's disease is a large and growing unmet medical need. Clinical trial designs need to assess disease-related outcomes earlier to accelerate the development of better treatments for Alzheimer's disease. ACU193 is a monoclonal antibody that selectively targets amyloid ß oligomers, thought to be the most toxic species of Aß that accumulates early in AD and contributes to downstream pathological effects. Nonclinical data indicate that ACU193 can reduce the toxic effects of amyloid ß oligomers. ACU193 is currently being investigated in a phase 1 clinical trial designed with the properties described in this report. This phase 1 trial is designed to provide data to enable a go/no-go decision regarding the initiation of a subsequent phase 2/3 study. OBJECTIVES: To design a phase 1 study that assesses target engagement and incorporates novel measures to support more rapid development of a potential disease-modifying treatment for Alzheimer's disease. DESIGN: The INTERCEPT-AD trial for ACU193 is an ongoing randomized, placebo-controlled phase 1a/b study that assesses safety, tolerability, pharmacokinetics, target engagement, clinical measures, and several Alzheimer's disease biomarkers, including novel digital and imaging biomarkers. SETTING: For INTERCEPT-AD, brief inpatient stays for patients in the single ascending dose portion of the study, with the remainder of the evaluations being performed as outpatients at multiple clinical trial sites in the U.S. PARTICIPANTS: Patients with early Alzheimer's disease (mild cognitive impairment or mild dementia with a positive florbetapir positron emission tomography scan). INTERVENTION: ACU193 administered intravenously at doses of 2- 60 mg/kg. MEASUREMENTS: Safety assessments including magnetic resonance imaging for the presence of amyloid-related imaging abnormalities, clinical assessments for Alzheimer's disease including the Alzheimer's Disease Rating Scale-cognition and Clinical Dementia Rating scale, pharmacokinetics, a measure of target engagement, and digital and imaging biomarkers, including a computerized cognitive test battery and a measure of cerebral blood flow using arterial spin labelling magnetic resonance imaging. RESULTS: A phase 1 study design was developed for ACU193 that allows collection of data that will enable a go/no-go decision for initiation of a subsequent adaptive phase 2/3 study. CONCLUSIONS: A phase 1a/b trial and an overall clinical development plan for an Alzheimer's disease treatment can be designed that maintains patient safety, allows informed decision-making, and achieves an accelerated timeline by using novel biomarkers and adaptive study designs.

Low Mortality of Orthopedic Trauma Patients With Asymptomatic COVID-19: A Level I Trauma Center Pandemic Experience.

Background: Early (2020) reports on mortality in patients with coronavirus disease 2019 (COVID-19) who underwent orthopedic surgery ranged from 20.5% to 56%, but these studies included elderly patients with multiple comorbidities. The mortality rate for younger and asymptomatic COVID-19-positive patients undergoing orthopedic surgery after high-energy trauma is underreported. The purpose of this study was to compare the 30-day mortality of asymptomatic COVID-19-positive patients and COVID-19-negative patients surgically treated for orthopedic trauma at a Level I trauma center during the coronavirus pandemic. A secondary objective was to compare the patients' postoperative hospital course and length of stay. Methods: This study is a single-center retrospective review of all patients who underwent an orthopedic surgical procedure at a Level I trauma center during a 3-month period early in the COVID-19 pandemic. All patients received a preoperative nasopharyngeal swab to determine COVID-19 infection status. Preoperative demographic variables, perioperative and postoperative mortality within 30 days, length of stay, and intensive care unit days were compared between COVID-19-positive and COVID-19-negative patients. Results: Of the 471 total patients, 13 were COVID-19-positive and 458 were COVID-19-negative prior to surgery. The average age of all patients was 40.5 ± 19.8 years. The mortality rate in the COVID-19-positive group was 0% vs 0.7% in the COVID-19-negative group, with no significant difference between groups (P=0.77). The COVID-19-positive group vs the COVID-19-negative group had no significant difference in hospital length of stay (7.4 days vs 4.4 days, respectively, P=0.12). Conclusion: Asymptomatic COVID-19-positive orthopedic trauma patients treated with surgery at a Level I trauma center in a 3-month period during the COVID-19 pandemic had a 0% mortality rate, and we found no differences between COVID-19-positive and COVID-19-negative patients with respect to mortality and hospital length of stay.

Systematic endoscopic staging of mediastinum to determine impact on radiotherapy for locally advanced lung cancer (SEISMIC): protocol for a prospective single arm multicentre interventional study.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is established as the preferred method of mediastinal lymph node (LN) staging in non-small cell lung cancer (NSCLC). Selective (targeted) LN sampling is most commonly performed however studies in early stage NSCLC and locally advanced NSCLC confirm systematic EBUS-TBNA evaluation improves accuracy of mediastinal staging. This study aims to establish the rate of detection of positron emission tomography (PET)-occult LN metastases following systematic LN staging by EBUS-TBNA, and to determine the utility of systematic mediastinal staging for accurate delineation of radiation treatment fields in patients with locally advanced NSCLC. METHODS: Consecutive patients undergoing EBUS-TBNA for diagnosis/staging of locally advanced NSCLC will be enrolled in this international multi-centre single arm study. Systematic mediastinal LN evaluation will be performed, with all LN exceeding 6 mm to be sampled by TBNA. Where feasible, endoscopic ultrasound staging (EUS-B) may also be performed. Results of minimally invasive staging will be compared to FDG-PET. The primary end-point is proportion of patients in whom systematic LN staging identified PET-occult NSCLC metastases. Secondary outcome measures include (i) rate of nodal upstaging, (ii) false positive rate of PET for mediastinal LN assessment, (iii) analysis of clinicoradiologic risk factors for presence of PET-occult LN metastases, (iv) impact of systematic LN staging in patients with discrepant findings on PET and EBUS-TBNA on target coverage and dose to organs at risk (OAR) in patients undergoing radiotherapy. DISCUSSION: With specificity of PET of 90%, guidelines recommend tissue confirmation of positive mediastinal LN to ensure potentially early stage patients are not erroneously denied potentially curative resection. However, while confirmation of pathologic LN is routinely sought, the exact extent of mediastinal LN involvement in NSCLC in patient with Stage III NSCLC is rarely established. Studies examining systematic LN staging in early stage NSCLC report a significant discordance between PET and EBUS-TBNA. In patients with locally advanced disease this has significant implications for radiation field planning, with risk of geographic miss in the event of PET-occult mediastinal LN metastases. The SEISMIC study will examine both diagnostic outcomes following systematic LN staging with EBUS-TBNA, and impact on radiation treatment planning. TRIAL REGISTRATION: ACTRN12617000333314, ANZCTR, Registered on 3 March 2017.

Case report: unique failure of a Synthes TFNA fenestrated lag screw in a peritrochanteric nonunion.

Background: Intertrochanteric femur fractures are a common orthopaedic injury that are often treated surgically. Cephalomedullary nails (CMN) are frequently the implant of choice for intertrochanteric femur fractures, resulting in low complication rates. Implant failure is a rare but reported complication. Common locations of failure include the proximal nail aperture, distal screw holes, and implant shaft. In this case report, we describe a CMN failure pattern through fenestrated cephalic screw holes. Case: A 70-year-old female sustained an OTA 31A-2.2 peritrochanteric fracture during a motor vehicle collision. She was treated the following day with a Synthes Trochanteric Fixation Nail-Advanced CMN utilizing a fenestrated cephalic screw. There were no intraoperative complications. She was made non-weight bearing for 8 weeks after the procedure due to ipsilateral foot fractures. At 6 months follow-up she was noted to have a delayed union. 11 months postoperatively she suffered a ground level fall and the cephalic lag screw failed through its fenestrations, resulting in varus collapse of her fracture at the femoral neck. The patient then underwent nail extraction and salvage total hip arthroplasty. Conclusion: Cephalomedullary nail implant failure is presented with implant fracture propagation through a fenestrated cephalic screw. Cephalomedullary lag screw failure is rare and can be difficult to manage. It is important to monitor new implants for unique failure mechanisms.

Earlier Return to Light Duty Is Associated With Successful Return to Full Duty of Workers' Compensation Patients Treated With Shoulder Arthroscopic Surgery.

Purpose: To evaluate Workers' Compensation (WC) patients who underwent arthroscopic shoulder surgery for workplace shoulder injuries and to determine whether there was an association between earlier return to light duty and earlier return to full duty. Methods: After receiving institutional review board approval, we performed a retrospective chart review of all WC patients treated with shoulder arthroscopic surgery by 2 senior authors between 2011 and 2018. The patients were divided into 2 groups: Group 1 went back to light-duty work within the first 100 days after surgery, whereas group 2 performed light-duty work after 100 days or performed no light-duty work. The primary outcomes included the length of time from surgery to light-duty work and the length of time from surgery to return to the full-duty work level. Results: A total of 59 patients met the inclusion criteria. There was a moderate correlation between the number of days at which the patients were released to light duty and the days they were able to be released to full duty (r = 0.35). In group 1 (light duty ≤ 100 days), 18 patients (75%) went back to full duty, whereas only 16 patients (46%) in group 2 were able to return to full-duty work (P = .025). Conclusions: Earlier return to light duty is associated with earlier return to full duty after shoulder arthroscopic surgery in patients with a Workers' Compensation claim. Additionally, WC patients who returned to early light duty in the first 100 days postoperatively had a higher rate of return to full duty than did patients who did not return to early light duty. Level of Evidence: Level III, case-control study.