Augmented Ulnar Collateral Ligament Repair With Structural Bioinductive Scaffold: A Biomechanical Study.

BACKGROUND: Elbow ulnar collateral ligament (UCL) repair with suture brace augmentation shows good time-zero biomechanical strength and a more rapid return to play compared with UCL reconstruction. However, there are concerns about overconstraint or stress shielding with nonabsorbable suture tape. Recently, a collagen-based bioinductive absorbable structural scaffold has been approved by the Food and Drug Administration for augmentation of soft tissue repair. PURPOSE/HYPOTHESIS: This study aimed to assess the initial biomechanical performance of UCL repair augmented with this scaffold. We hypothesized that adding the bioinductive absorbable structural scaffold to primary UCL repair would impart additional time-zero restraint to the valgus opening. STUDY DESIGN: Controlled laboratory study. METHODS: Eight cadaveric elbow specimens-from midforearm to midhumerus-were utilized. In the native state, elbows underwent valgus stress testing at 30o, 60o, and 90o of flexion, with a cyclical valgus rotational torque. Changes in valgus rotation from 2- to 5-N·m torque were recorded as valgus gapping. Testing was then performed in 4 states: (1) native intact UCL-with dissection through skin, fascia, and muscle down to an intact UCL complex; (2) UCL-transected-distal transection of the ligament off the sublime tubercle; (3) augmented repair with bioinductive absorbable scaffold; and (4) repair alone without scaffold. The order of testing of repair states was alternated to account for possible plastic deformation during testing. RESULTS: The UCL-transected state showed the greatest increase in valgus gapping of all states at all flexion angles. Repair alone showed similar valgus gapping to that of the UCL-transected state at 30° (P = .62) and 60° of flexion (P = .11). Bioinductive absorbable scaffold-augmented repair showed less valgus gapping compared with repair alone at all flexion angles (P = .021, P = .024, and P = .024 at 30°, 60°, and 90°, respectively). Scaffold-augmented repair showed greater gapping compared with the native state at 30° (P = .021) and 90° (P = .039) but not at 60° of flexion (P = .059). There was no difference when testing augmented repair or repair alone first. CONCLUSION: UCL repair augmented with a bioinductive, biocomposite absorbable structural scaffold imparts additional biomechanical strength to UCL repair alone, without overconstraint beyond the native state. Further comparative studies are warranted. CLINICAL RELEVANCE: As augmented primary UCL repair becomes more commonly performed, use of an absorbable bioinductive scaffold may allow for improved time-zero mechanical strength, and thus more rapid rehabilitation, while avoiding long-term overconstraint or stress shielding.

High accuracy of intra-articular needle position during anterior landmark guided glenohumeral injections.

OBJECTIVES: Image-guided ultrasound or fluoroscopic glenohumeral injections have high accuracy rates but require training, equipment, cost, and radiation exposure (fluoroscopy). In contrast, landmark-guided glenohumeral injections do not require additional subspecialist referrals or equipment. An optimal technique would be safe and accurate and have few barriers to implementation. The purpose of this study was to define the accuracy of glenohumeral needle placement via an anterior landmark-guided approach as assessed by direct arthroscopic visualization. METHODS: A consecutive series of adult patients undergoing shoulder arthroscopy in the beach chair position were included in this study. Demographic and procedural data were collected. The time required to perform the injection, the precise location of the needle tip, and factors that affected the accuracy of the injection were also assessed. RESULTS: A standardized anterior landmark-guided glenohumeral joint injection was performed in the operating room prior to surgery, and the location of the needle tip was documented by arthroscopic visualization with a low complication profile and few barriers to implementation. A total of 81 patients were enrolled. Successful intra-articular glenohumeral needle placement by sports medicine and shoulder/elbow fellowship-trained orthopedic surgeons was confirmed in 93.8% (76/81) of patients. The average time to complete the procedure was 24.8 â€‹s. There were no patient-related variables associated with nonintra-articular injections in the cohort. CONCLUSIONS: This study demonstrated that the technique of anterior landmark-guided glenohumeral injection has an accuracy of 93.8% and requires less than 30 â€‹s to perform. This method is safe, yields similar accuracy to image-guided procedures, has improved cost and time efficiency, and requires less radiation exposure. No patient-related factors were associated with inaccurate needle placement. Anterior landmark-guided glenohumeral injections may be utilized with confidence by providers in the clinical setting. LEVEL OF EVIDENCE: Level 5. IRB: Approved under Stanford IRB-56323.

High Tibial Osteotomy in Knee Reconstruction and Joint Preservation.

High tibial osteotomy is a dynamic operation, used as an effective procedure in both joint preservation and knee stability. Applications and indications are expanding, with good results in the treatment of malalignment associated with arthrosis, knee instability, meniscus deficiency or transplants, and/or cartilage restoration. Appropriate patient selection and preoperative planning are critical to achieving good outcomes after surgery. Coronal and sagittal plane corrections made through the proximal tibia can effectively alter joint mechanics creating a more favorable environment for cartilage, meniscus, and ligamentous structures about the knee. Advancing techniques and technologies have allowed for more precise planning and execution of osteotomies.

Editorial Commentary: Absent Extreme Bony Malalignment: Medial Patellofemoral Reconstruction Is a Sufficient Primary Surgery for Adolescents With Recurrent Patella Instability.

When planning an adolescent's primary surgery for recurrent patella instability, the surgeon must weigh the failure risk of performing medial patellofemoral reconstruction (MPFLR) versus the potential morbidity of adding a concomitant bony procedure, such as tibial tubercle osteotomy. In this age group, isolated MPFLR is an excellent operation with high clinical success, low failure rates, and favorable complication profile. Patients with high grade J-sign and severe trochlea dysplasia, apprehension into deep flexion, and extremes of bony malalignment, including elevated tibial tubercle-trochlear groove distance, may benefit from "doing more" than MPFLR alone. Other factors to be considered include patella alta, generalized ligament laxity, femoral rotation, tibial torsion, and valgus malalignment. In challenging situations, such as syndromic patients (e.g., neuromuscular disorders), congenital (habitual) patella dislocation, fixed dislocations, and failed prior to MPFLR, a combined surgical approach is likely needed. Patients who require "unloading" for symptomatic chondrosis also benefit from combined bony and soft tissue surgery. However, for the majority of patients with recurrent instability and no prior surgery, an isolated soft tissue reconstruction is a rational, safe, efficient, and evidence-based selection.

Experts Achieve Consensus on a Majority of Statements Regarding Platelet-Rich Plasma Treatments for Treatment of Musculoskeletal Pathology.

PURPOSE: To establish consensus statements on platelet-rich plasma (PRP) for the treatment of musculoskeletal pathologies. METHODS: A consensus process on the treatment of PRP using a modified Delphi technique was conducted. Thirty-five orthopaedic surgeons and sports medicine physicians participated in these consensus statements on PRP. The participants were composed of representatives of the Biologic Association, representing 9 international orthopaedic and musculoskeletal professional societies invited due to their active interest in the study of orthobiologics. Consensus was defined as achieving 80% to 89% agreement, strong consensus was defined as 90% to 99% agreement, and unanimous consensus was indicated by 100% agreement with a proposed statement. RESULTS: There was consensus on 62% of statements about PRP. CONCLUSIONS: (1) PRP should be classified based on platelet count, leukocyte count, red blood count, activation method, and pure-plasma versus fibrin matrix; (2) PRP characteristics for reporting in research studies are platelet count, leukocyte count, neutrophil count, red blood cell count, total volume, the volume of injection, delivery method, and the number of injections; (3) the prognostic factors for those undergoing PRP injections are age, body mass index, severity/grade of pathology, chronicity of pathology, prior injections and response, primary diagnosis (primary vs postsurgery vs post-trauma vs psoriatic), comorbidities, and smoking; (4) regarding age and body mass index, there is no minimum or maximum, but clinical judgment should be used at extremes of either; (5) the ideal dose of PRP is undetermined; and (6) the minimal volume required is unclear and may depend on the pathology. LEVEL OF EVIDENCE: Level V, expert opinion.

Infra-patellar fat pad-derived mesenchymal stem cells maintain their chondrogenic differentiation potential after arthroscopic harvest with blood-product supplementation.

PURPOSE: Mesenchymal stem cells/medicinal signaling cells (MSCs) possess therapeutic potential and are used in regenerative orthopaedics. The infra-patellar fat pad (IFP) is partially resected during knee arthroscopy (KASC) and contains MSCs. Heat, irrigation, and mechanical stress during KASC may decrease MSC's therapeutic potential. This study assessed MSCs' regenerative potential after arthroscopic IFP harvest and potential effects of two blood products (BP) (platelet-rich plasma (PRP), hyperacute serum (HAS)) on MSCs' viability and chondrogenic differentiation capacity. METHODS: IFP was arthroscopically harvested, isolated, and counted (n = 5). Flow cytometry was used to assess cell viability via staining with annexin V/7-AAD and stemness markers via staining for CD90, CD73, and CD105. MSCs were incubated with blood products, and metabolic activity was determined via an XTT assay. Deposition of cartilage extracellular matrix was determined in histologic sections of chondrogenically differentiated 3D pellet cultures via staining with Alcian Blue. Expression of cartilage-specific genes (SOX9, MMP3/13, ACAN, COL1/2) was analyzed via quantitative PCR. RESULTS: MSC isolation from IFP yielded 2.66*106 ± 1.49*106 viable cells from 2.7 (0.748) g of tissue. MSC markers (CD 90/105/73) were successfully detected and annexin V staining showed 81.5% viable cells. XTT showed increased metabolic activity. Within the BP groups, this increase was significant (days 0-14, p < 0.05). PCR showed expression of cartilage-specific genes in each group. COL2 (p < 0.01) as well as ACAN (p < 0.001) expression levels were significantly higher in the HAS group. Histology showed successful differentiation. CONCLUSION: Arthroscopic harvest of IFP-MSCs yields sufficient cells with maintained regenerative potential and viability. Blood products further enhance MSCs' viability.

Editorial Commentary: Evaluation of Patellofemoral Instability Is Complex and Multifactorial.

The work-up of patellofemoral instability is complex and multifactorial. Patient factors (i.e., age, activity demand, goals/expectations), clinical presentation (pain, instability, or both), and physical examination (i.e., J-sign, apprehension into flexion), must be correlated with imaging findings (radiographs, magnetic resonance imaging, computed tomography) and anatomic risk factors, including patella alta, trochlear dysplasia, patellar tilt, lateralized force vector, valgus, femoral anteversion, and tibial torsion. Thus, developing a standard battery of reliable and reproducible radiographic measures of patellofemoral instability is a challenge. Imaging cut-offs provide insight into relative risk of recurrent instability. We still fall short in using imaging parameters to predict when to operate, what procedure(s) to perform, and how the patient might do. Future directions include the use of artificial intelligence and 3-dimensional measurements to help simplify a complex problem.

Association of Hip Dysplasia With Trochlear Dysplasia in Skeletally Mature Patients.

Background: Developmental dysplasia of the hip (DDH) and trochlear dysplasia (TD) are distinct pathologies with several important features in common. In addition to shared risk factors, both forms of dysplasia cause abnormal joint kinematics and force transmission, predisposing patients to pain, injuries to cartilage and soft tissue stabilizers, and ultimately arthritis. Purpose: To evaluate for an association between hip dysplasia and TD in skeletally mature patients with symptomatic hip dysplasia. Study Design: Cross-sectional study; Level of evidence, 3. Methods: A total of 48 patients with DDH who underwent periacetabular osteotomy were compared with 48 sex-matched patients who underwent hip arthroscopy for femoroacetabular impingement (FAI) between July 2014 and February 2021. All patients were skeletally mature. The Tönnis angle and lateral center-edge angle were measured on preoperative pelvis radiographs. Femoral version, trochlear depth, lateral trochlear inclination (LTI), tibial tubercle-trochlear groove distance (TTTG-d), and posterior lateral condylar angle (PLCA) were measured on preoperative magnetic resonance imaging scans of the symptomatic hip and ipsilateral knee. Continuous variables were compared between the patient groups using 2-sample t tests. Interobserver reliability was measured using the intraclass correlation coefficient. Results: Patients with DDH demonstrated a reduced trochlear depth compared with patients with FAI (3.6 vs 4.6 mm; P < .001). There were no differences between groups in femoral anteversion, LTI, TTTG-d, or PLCA. Two (4.2%) patients with FAI and 17 (35.4%) patients with DDH had a trochlear depth <3 mm (P < .001). One (2.1%) patient with FAI and 7 (14.6%) patients with DDH had an LTI <11° (P = .027). There was no difference between groups in frequency of a convex proximal trochlea, patient-reported ipsilateral knee pain, or ipsilateral knee procedures. Conclusion: Patients with DDH had reduced trochlear depth compared with patients with FAI, demonstrating a higher incidence of dysplastic trochlear features that may predispose patients to patellofemoral joint disease. Further research is needed to determine whether screening at-risk patients and treating TD will help to prevent symptomatic patellofemoral disease.

The Principles of Knee Joint Preservation: Operative Treatment Strategies.

➤ Joint alignment, meniscal status, and ligament stability are codependent factors involved in knee joint preservation, and any injury or imbalance can impact the knee articular cartilage status and can result in adverse clinical outcomes.➤ Cartilage preservation procedures in the knee will not result in optimal outcomes if there is joint malalignment, meniscal deficiency, or ligamentous instability.➤ Lower-extremity varus or valgus malalignment is a risk factor for the failure of an anterior cruciate ligament (ACL) reconstruction. It represents an indication for a high tibial osteotomy or distal femoral osteotomy in the setting of failed ACL reconstruction, and may even be considered in patients who have an initial ACL injury and severe malalignment.➤ An elevated posterior tibial slope increases the risk of failure of ACL reconstruction, whereas a decreased posterior tibial slope increases the risk of failure of posterior cruciate ligament reconstruction.

Discordant pathologic diagnoses of myelodysplastic neoplasms and their implications for registries and therapies.

Myelodysplastic neoplasms (MDS) are a collection of hematopoietic disorders with widely variable prognoses and treatment options. Accurate pathologic diagnoses present challenges because of interobserver variability in interpreting morphology and quantifying dysplasia. We compared local clinical site diagnoses with central, adjudicated review from 918 participants enrolled in the ongoing National Heart, Lung, and Blood Institute National MDS Natural History Study, a prospective observational cohort study of participants with suspected MDS or MDS/myeloproliferative neoplasms (MPNs). Locally, 264 (29%) were diagnosed as having MDS, 15 (2%) MDS/MPN overlap, 62 (7%) idiopathic cytopenia of undetermined significance (ICUS), 0 (0%) acute myeloid leukemia (AML) with <30% blasts, and 577 (63%) as other. Approximately one-third of cases were reclassified after central review, with 266 (29%) diagnosed as MDS, 45 (5%) MDS/MPN overlap, 49 (5%) ICUS, 15 (2%) AML with <30%, and 543 (59%) as other. Site miscoding errors accounted for more than half (53%) of the local misdiagnoses, leaving a true misdiagnosis rate of 15% overall, 21% for MDS. Therapies were reported in 37% of patients, including 43% of patients with MDS, 49% of patients with MDS/MPN, and 86% of patients with AML with <30% blasts. Treatment rates were lower (25%) in cases with true discordance in diagnosis compared with those for whom local and central diagnoses agreed (40%), and receipt of inappropriate therapy occurred in 7% of misdiagnosed cases. Discordant diagnoses were frequent, which has implications for the accuracy of study-related and national registries and can lead to inappropriate therapy. This trial was registered at www.clinicaltrials.gov as #NCT05074550.

Knee MRI: Meniscus Roots, Ramps, Repairs, and Repercussions.

Menisci play an essential role in maintaining normal pain-free function of the knee. While there are decades of MRI literature on the tears involving the meniscus body and horns, there is now a surge in knowledge regarding injuries at the meniscus roots and periphery. The authors briefly highlight new insights into meniscus anatomy and then summarize recent developments in the understanding of meniscus injuries that matter, emphasizing meniscus injuries at the root and peripheral (eg, ramp) regions that may be missed easily at MRI and arthroscopy. Root and ramp tears are important to diagnose because they may be amenable to repair. However, if these tears are left untreated, ongoing pain and accelerated cartilage degeneration may ensue. The posterior roots of the medial and lateral menisci are most commonly affected by injury, and each of these injuries is associated with distinctive clinical profiles, MRI findings, and tear patterns. Specific diagnostic pitfalls can make the roots challenging to evaluate, including MRI artifacts and anatomic variations. As with root tears, MRI interpretation and orthopedic treatment have important differences for injuries at the medial versus lateral meniscus (LM) periphery (located at or near the meniscocapsular junction). Medially, ramp lesions typically occur in the setting of an anterior cruciate ligament rupture and are generally classified into five patterns. Laterally, the meniscocapsular junction may be injured in association with tibial plateau fractures, but disruption of the popliteomeniscal fascicles may also result in a hypermobile LM. Updated knowledge of the meniscus root and ramp tears is crucial in optimizing diagnostic imaging before repair and understanding the clinical repercussions. ©RSNA, 2023 Online supplemental material is available for this article. Quiz questions for this article are available in the Online Learning Center.

Patellar Tracking: An Old Problem with New Insights.

Patellofemoral pain and instability are common indications for imaging that are encountered in everyday practice. The authors comprehensively review key aspects of patellofemoral instability pertinent to radiologists that can be seen before the onset of osteoarthritis, highlighting the anatomy, clinical evaluation, diagnostic imaging, and treatment. Regarding the anatomy, the medial patellofemoral ligament (MPFL) is the primary static soft-tissue restraint to lateral patellar displacement and is commonly reconstructed surgically in patients with MPFL dysfunction and patellar instability. Osteoarticular abnormalities that predispose individuals to patellar instability include patellar malalignment, trochlear dysplasia, and tibial tubercle lateralization. Clinically, patients with patellar instability may be divided into two broad groups with imaging findings that sometimes overlap: patients with a history of overt patellar instability after a traumatic event (eg, dislocation, subluxation) and patients without such a history. In terms of imaging, radiography is generally the initial examination of choice, and MRI is the most common cross-sectional examination performed preoperatively. For all imaging techniques, there has been a proliferation of published radiologic measurement methods. The authors summarize the most common validated measurements for patellar malalignment, trochlear dysplasia, and tibial tubercle lateralization. Given that static imaging is inherently limited in the evaluation of patellar motion, dynamic imaging with US, CT, or MRI may be requested by some surgeons. The primary treatment strategy for patellofemoral pain is conservative. Surgical treatment options include MPFL reconstruction with or without osseous corrections such as trochleoplasty and tibial tubercle osteotomy. Postoperative complications evaluated at imaging include patellar fracture, graft failure, graft malposition, and medial patellar subluxation. ©RSNA, 2023 Quiz questions for this article are available in the supplemental material.

Medial Patellofemoral Ligament Reconstruction in Obese Patients Results in Low Complication Rates and Improved Subjective Outcomes.

Purpose: To compare outcomes, activity scores, and complication rates of obese and non-obese patients undergoing medial patellofemoral ligament (MPFL) reconstruction. Methods: A retrospective review identified patients undergoing MPFL reconstruction for recurrent patellofemoral instability. Patients were included if they had undergone MPFL reconstruction and had follow-up for a minimum of 6 months. Patients were excluded if they underwent surgery less than 6 months earlier, had no outcome data recorded, or underwent concomitant bony procedures. Patients were divided into 2 groups based on body mass index (BMI): BMI of 30 or greater and BMI less than 30. Presurgical and postsurgical patient-reported outcomes including Knee Injury and Osteoarthritis Outcome Score (KOOS) domains and the Tegner score were collected. Complications requiring reoperation were recorded. P < .05 was defined as a statistically significant difference. Results: A total of 55 patients (57 knees) were included. There were 26 knees with a BMI of 30 or greater and 31 knees with a BMI less than 30. There were no differences in patient demographic characteristics between the 2 groups. Preoperatively, no significant differences were found in KOOS subscores or Tegner scores (P = .21) between groups. At minimum 6-month follow-up (range, 6.1-70.5 months), patients with a BMI of 30 or greater showed statistically significant improvements in the KOOS Pain, Activities of Daily Living, Symptoms, and Sport/Recreation subscores. Patients with a BMI less than 30 showed a statistically significant improvement in the KOOS Quality of Life subscore. The group with a BMI of 30 or greater had significantly lower KOOS Quality of Life (33.34 ± 19.10 vs 54.47 ± 28.00, P = .03) and Tegner (2.56 ± 1.59 vs 4.78 ± 2.68, P = .05) scores. Complication rates were low, with 2 knees (7.69%) requiring reoperation in the cohort with a BMI of 30 or greater and 4 knees (12.90%) requiring reoperation in the cohort with a BMI less than 30, including 1 reoperation for recurrent patellofemoral instability (P = .68). Conclusions: In this study, MPFL reconstruction in obese patients was safe and effective, with low complication rates and improvements in most patient-reported outcomes. Compared with patients with a BMI less than 30, obese patients had lower quality-of-life and activity scores at final follow-up. Level of Evidence: Level III, retrospective cohort study.

A scoping review of portable sensing for out-of-lab anterior cruciate ligament injury prevention and rehabilitation.

Anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) surgery are common. Laboratory-based biomechanical assessment can evaluate ACL injury risk and rehabilitation progress after ACLR; however, lab-based measurements are expensive and inaccessible to most people. Portable sensors such as wearables and cameras can be deployed during sporting activities, in clinics, and in patient homes. Although many portable sensing approaches have demonstrated promising results during various assessments related to ACL injury, they have not yet been widely adopted as tools for out-of-lab assessment. The purpose of this review is to summarize research on out-of-lab portable sensing applied to ACL and ACLR and offer our perspectives on new opportunities for future research and development. We identified 49 original research articles on out-of-lab ACL-related assessment; the most common sensing modalities were inertial measurement units, depth cameras, and RGB cameras. The studies combined portable sensors with direct feature extraction, physics-based modeling, or machine learning to estimate a range of biomechanical parameters (e.g., knee kinematics and kinetics) during jump-landing tasks, cutting, squats, and gait. Many of the reviewed studies depict proof-of-concept methods for potential future clinical applications including ACL injury risk screening, injury prevention training, and rehabilitation assessment. By synthesizing these results, we describe important opportunities that exist for clinical validation of existing approaches, using sophisticated modeling techniques, standardization of data collection, and creation of large benchmark datasets. If successful, these advances will enable widespread use of portable-sensing approaches to identify ACL injury risk factors, mitigate high-risk movements prior to injury, and optimize rehabilitation paradigms.

Survival analyses and their applications in orthopaedics.

Survival analyses are a powerful statistical tool used to analyse data when the outcome of interest involves the time until an event. There is an array of models fit for this goal; however, there are subtle differences in assumptions, as well as a number of pitfalls, that can lead to biased results if researchers are unaware of the subtleties. As larger amounts of data become available, and more survival analyses are published every year, it is important that healthcare professionals understand how to evaluate these models and apply them into their practice. Therefore, the purpose of this study was to present an overview of survival analyses, including required assumptions and important pitfalls, as well as examples of their use within orthopaedic surgery.

Asthma Medication Regimens in Pregnancy: Longitudinal Changes in Asthma Status.

OBJECTIVE: This study aimed to assess the impact of common asthma medication regimens on asthma symptoms, exacerbations, lung function, and inflammation during pregnancy. STUDY DESIGN: A total of 311 women with asthma were enrolled in a prospective pregnancy cohort. Asthma medication regimen was categorized into short-acting ß agonist (SABA) alone, SABA + inhaled corticosteroid (ICS), SABA + ICS + long-acting ß agonist (LABA), and no asthma medications (reference). We evaluated asthma control at enrollment (< 15 weeks' gestation) and its change into trimesters 2 and 3, including per cent predicted forced expiratory volume in 1 second (%FEV1) and peak expiratory flow (%PEF), pulse oximetry, fractional exhaled nitric oxide (FeNO), asthma symptoms (asthma attacks/month, night symptoms/week), and severe exacerbations. Linear mixed models adjusted for site, age, race, annual income, gestational age, body mass index, and smoking, and propensity scores accounted for asthma control status at baseline. RESULTS: Women taking SABA + ICS and SABA + ICS + LABA had better first trimester %PEF (83.5% [75.7-91.3] and 84.6% [76.9-92.3], respectively) compared with women taking no asthma medications (72.7% [66.0-79.3]). Women taking SABA + ICS + LABA also experienced improvements in %FEV1 (+11.1%, p < 0.01) in the third trimester and FeNO in the second (-12.3 parts per billion [ppb], p < 0.01) and third (-11.0 ppb, p < 0.01) trimesters as compared with the trajectory of women taking no medications. SABA + ICS use was associated with increased odds of severe exacerbations in the first (odds ratio [OR]: 2.22 [1.10-4.46]) and second (OR: 3.15 [1.11-8.96]) trimesters, and SABA + ICS + LABA use in the second trimester (OR: 7.89 [2.75-21.47]). Women taking SABA alone were similar to those taking no medication. CONCLUSION: Pregnant women taking SABA + ICS and SABA + ICS + LABA had better lung function in the first trimester. SABA + ICS + LABA was associated with improvements in lung function and inflammation across gestation. However, both the SABA + ICS and SABA + ICS + LABA groups had a higher risk of severe exacerbation during early to mid-pregnancy. KEY POINTS: · Medication regimens may affect perinatal asthma control.. · Intensive regimens improved lung function/inflammation.. · Women on intensive regimens had more acute asthma events..

Prospective Randomized Controlled Clinical Trial Comparing Hyperosmolar Saline to Standard Isotonic Irrigation Fluid for Arthroscopic Knee Surgery: Initial Clinical Outcomes.

Numerous in vitro studies suggest higher osmolarity irrigation fluids potentiate a chondroprotective environment, and a recent clinical study using hyperosmolar saline for shoulder arthroscopy reported potential clinical advantages. This prospective randomized double-blind controlled clinical trial was designed to assess initial clinical outcomes associated with use of a hyperosmolar irrigation solution in patients undergoing arthroscopic knee surgery. With institutional review board approval and informed consent, patients scheduled for arthroscopic knee surgery were randomized to surgery with either isotonic lactated Ringer's (273 mOsm/L) or hyperosmolar saline (593 mOsm/L) irrigation solution. Outcomes included perioperative blood pressure, knee girth, visual analogue scale (VAS) pain scores, and narcotic pain medication consumption. Forty-six patients underwent arthroscopic knee surgery with isotonic (n = 23) or hyperosmolar (n = 23) irrigation fluids. There were 11 males and 12 females (mean age = 44.0 years) in the isotonic cohort and 8 males and 15 females (mean age = 40.2 years) in the hyperosmolar cohort. There were no significant differences with respect to surgical duration (pump time) or amount of irrigation fluid used between the two cohorts. There were no significant differences with respect to change in knee girth, blood pressure, or VAS pain scores. However, patients treated with hyperosmolar saline consumed less narcotic medication on postoperative day 3 (4.0 ± 7.6 vs. 15.5 ± 17.4 mg, p = 0.01). The results of this randomized clinical trial suggest that a hyperosmolar irrigation solution is safe and relatively inexpensive for use in patients undergoing arthroscopic knee surgery and contributes to a reduction in initial postoperative narcotic pain medication consumption. A hyperosmolar saline irrigation fluid was not associated with any detrimental effects on the execution of the surgical procedure, postoperative pain, or periarticular fluid extravasation. Taken together with previous basic science, translational, and clinical studies, hyperosmolar saline irrigation fluid is promising alternative to traditional isotonic irrigation fluids for knee arthroscopy. This study is a prospective trial and reflects level of evidence I.

An Initial Injection and a Crossover Injection of Amniotic Suspension Allograft Following Failed Treatment with Hyaluronic Acid or Saline Are Equally Effective in the Treatment of Moderate Symptomatic Knee Osteoarthritis Over 12 Months.

PURPOSE: The purpose of this crossover study was to determine the efficacy of amniotic suspension allograft (ASA) for moderate symptomatic knee osteoarthritis following failed treatment with hyaluronic acid (HA) or saline through 12 months' postcrossover injection using patient-reported and safety outcomes. METHODS: In this multicenter study, 95 patients from a 200-patient single-blind randomized controlled trial were eligible to crossover and receive a single injection of ASA 3 months after failed treatment with HA or saline. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS), were collected out to 12 months postcrossover to determine pain and function. Radiographs and blood were collected for assessment of changes. Statistical analyses were performed using mixed effects model for repeated measures. RESULTS: Treatment with ASA following failed treatment with HA or saline resulted in significant improvements in KOOS and VAS scores compared with crossover baseline. There were no differences in radiographic measures or anti-human leukocyte antigen serum levels compared with baseline and no severe adverse events reported. In addition, more than 55% of patients were responders at months 3, 6, and 12 as measured by the Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International simplified responder criteria. There were no significant differences between the original ASA randomized group and crossover cohorts at any of the time points evaluated, suggesting that prior failed treatment with HA or saline did not significantly impact outcomes following treatment with ASA. CONCLUSIONS: This study showed that patients who previously failed treatment with HA or saline had statistically significant improvements in pain and function scores following a crossover injection of ASA that was sustained for 12 months, as measured by KOOS and VAS. There were no serious adverse events reported, and the injection was safe. LEVEL OF EVIDENCE: II, prospective cohort study.