Author: Mokhtar

  • When a joint replacement could be the right choice for you

    When a joint replacement could be the right choice for you

    Joint replacement
    Joint replacement

    More than 450,000 hip replacements and a total of more than 790,000 knee replacements are performed in the United States every year. Many patients choose this surgery to provide relief from the pain and suffering they experience due to the aging process. Determining whether you need a joint replacement is a big decision. Fortunately, there are a few ways you can determine if this is the right option for you.

    Determine the available options

    Many patients who undergo joint replacement surgery find that this procedure provides pain relief. It also helps improve their mobility while improving their quality of life.

    Knowing whether you can benefit from this surgery is crucial. In many cases, experiencing any of the following symptoms means that a joint replacement may be beneficial for you.

    • You experience frequent or intense pain in the joint
    • You have problems getting up, sitting or walking
    • You experience joint swelling or stiffness
    • You have osteoarthritis

    Any of these symptoms can be extremely disabling and affect your ability to perform various tasks. If you suffer from any of these symptoms, you may benefit from joint replacement.

    When is joint replacement suitable?

    When deciding whether joint replacement is appropriate, you will likely consider the severity of your condition. If you experience stiffness and soreness that cause you constant pain and limit your ability to perform various tasks, such as climbing stairs or walking, you may be a good candidate for this type of surgery.

    In addition to the amount of pain you experience, your doctor will consider whether there are other lifestyle adjustments, injections, medications, or even physical therapy that may be an effective alternative. Patients who do not experience relief from these treatments may conclude that joint replacement is a suitable alternative.

    Contact a joint replacement specialist today

    If you would like to speak with a specialist to determine if joint replacement can help you, contact the team at Bone & Joint Specialists by calling 219-795-3360. You can make an appointment at their office in Highland, Hobart or Valaspario, IN, to discuss your options.

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  • New research suggests that cannabis shows promise in relieving endometriosis pain

    New research suggests that cannabis shows promise in relieving endometriosis pain

    From a recent study published in the Journal of Clinical Medicineresearchers examined the available literature on cannabis as a self-management strategy in the treatment of pain due to endometriosis. They further investigated the mechanisms by which cannabis interacts with the endocannabinoid system (ECS) and the interactions of gut microbiota and ECS in the treatment of the condition. Their findings show that cannabis-derived endocannabinoids have a protective effect on the intestines, reducing intestinal inflammation and improving its permeability. This in turn suppresses bloating, the most common symptom of endometriosis. Cannabinoids also inherently suppress pain receptors and serve as a natural painkiller. These results highlight the gut microbiota and ECS as future clinical trial targets in the fight against endometriosis.

    Study: Cannabis and endometriosis: the role of the gut microbiota and the endocannabinoid system.  Image credits: Rapeepat Pornsipak / ShutterstockStudy: Cannabis and endometriosis: the role of the gut microbiota and the endocannabinoid system. Image credits: Rapeepat Pornsipak / Shutterstock

    Endometriosis and the benefits of cannabis

    Endometriosis is a disease of sexually mature women (between the first menstrual period and up to menopause) characterized by endometrial tissue-like tissue growing beyond the boundaries of the uterus. It is a common condition, estimated to affect 10% of all women, with symptoms including severe pelvic pain and outcomes including difficulty conceiving.

    In addition to the immediate results, endometriosis-related chronic pelvic pain (CPP) has been associated with several comorbidities, including irritable bowel syndrome (IBS), psoriasis, rheumatoid arthritis, mental health problems (depression and anxiety), and chronic fatigue syndrome. The annual economic loss due to the disease is estimated at between US$1,459 and US$20,239 per woman, highlighting the socio-economic burden of the disease alone and not its treatment.

    Research has shown that progesterone is a common feature of endometriosis patients, suggesting that hormonal imbalances then cause inflammation due to the local infiltration of immune cells. These cells establish new cells that have been found to activate pathways related to invasion, proliferation, metastasis and angiogenesis. Because most hormone resistances arise due to imbalances in the gut microbial system, resulting in changes in the expression levels of estrogen-metabolizing enzymes, recent studies have focused on the associations between the gut microbiome and the disease.

    Current treatment for endometriosis involves a combination of surgery and hormone treatment. Antineuropathic agents, including gabapentin, pregabalin, and amitriptyline, are used to reduce pain and allow normal daily functioning. Unfortunately, these interventions are medically suboptimal given the reduced access of women in developing and underdeveloped countries to surgery and the greatly reduced efficacy of antineuropathic agents in controlling pain in endometriosis patients. Research has shown that endometriosis patients are four times more likely to overuse painkillers, causing dependence and abuse.

    Metabolites from the Hemp gender received extensive attention in the 1990s, resulting in the discovery of the endocannabinoid system (ECS), a complex signaling system consisting of G protein-coupled cannabinoid receptors, ion channel transient receptor potential vanilloid 1, and a cohort of enzymes responsible for endocannabinoid synthesis and catabolism. Cannabidiol (CBD) and tetrahydrocannabinol (THC), the two main active ingredients derived from cannabis consumption, have intrinsic pain-suppressing properties and have been used in other medical research.

    Given its relative cheapness and ease of access, cannabis consumption has become a popular self-medication for endometriosis pain, despite ample research into the pathways and mechanisms through which it can affect the ECG, positively or negatively altering endometriosis outcomes.

    Findings of the study

    The current study is a descriptive review of current scientific knowledge on endometriosis, focusing on the impact of endocannabinoids on disease outcomes and the associations between ECS, gut microbiota and endometriosis. Although no publication screening methodologies were reported, the citation list suggests that more than 140 scientific articles were reviewed during the synthesis of this work.

    Research has shown that the ECS is mainly involved in pain modulation and inflammation suppression. Endocannabinoids or exogenous cannabinoids have been shown to activate the CB1 and C.B2 receptors, critical components of the G protein-coupled system, suppressing nociceptive processing and inducing analgesia.

    “In a prospective randomized, placebo-controlled trial, smoked cannabis (3.56% delta-9-tetrahydrocannabinol (THC) – participants smoked three cigarettes per day for a four-day period) reduced the daily pain experienced by adults with HIV-associated sensory neuropathy .”

    ECS is further hypothesized to play a central role in the pathology of endometriosis, with some researchers calling the disease an “endocannabinoid deficiency.” Strong correlations have been observed between circulating plasma endocannabinoid levels and the severity of endometriosis, with lower levels of endocannabinoids being associated with increased pain. However, other studies have suggested that endometriosis and the ECS may have complex associations with the onset of the former, initiating a feedback loop in the latter. This indicates that the role of ECS in endometriosis may extend beyond inflammation and pain suppression and warrants further investigation into the mechanisms underlining these interactions.

    Can external cannabis consumption help?

    The role of cannabis derivatives in endometriosis, especially regarding their pain-suppressing properties, has led to investigations into cannabis use as a potential natural alternative to current anti-neuropathic therapies. An ongoing clinical trial is testing the efficacy of CBD isolate oil and vaporized THC in pain modulation in women admitted to hospitals and clinics reporting severe endometrial pain. In vivo mouse models have paved the way for these types of studies, given the positive effects of CBD against not only endometrial pain, but also the observed growth-inhibitory effects on the surface of endometrial implants.

    These promising findings highlight the potential therapeutic benefits of CBD and THC for endometriosis-associated pain, justifying the need for human studies.

    What about the gut microbiota?

    The intestines are part of the ECS, and enzymes secreted by the intestines have been shown to significantly alter ECS hormones, potentially having a regulatory effect on endometriosis. However, research in this area is still in its infancy. So far, the findings suggest a bidirectional relationship between the gut microbiota, the ECS and endometriosis, influencing both the risk and severity of the disease.

    “Endocannabinoids and exogenous cannabinoids have opposite effects on intestinal permeability. For example, in research on decreased permeability due to inflammation, it was shown that 2-AG and AEA increased permeability, while THC and CBD decreased permeability.”

    Although research on the direct effects of cannabinoids on endometriosis remains scarce, preclinical models have demonstrated the positive impact of the former on the comorbidities of the latter, especially irritable bowel disorder (IBD). Interestingly, the gut microbiota has been implicated in these associations Lactobacillus acidophilus intestinal inoculations in mice were shown to result in endogenous upregulation of the CB2 expression in intestinal cells, resulting in analgesic effects and reduced visceral pain in the mice. Additionally, research in athletes has linked cannabinoids to pain suppression, anti-inflammatory effects, and improved intestinal absorption.

    “Studies have also examined the relationship between the ECS and microbial metabolites in the gut. For example, endocannabinoids have been found to mediate the anti-inflammatory effects of SCFAs. This association was observed in an exercise intervention where an increase in SCFAs (including butyrate) and SCFA-producing bacteria (such as Bifidobacterium) was correlated with a decrease in pro-inflammatory cytokines TNF-α and IL-6.”

    Conclusions

    The current study compiles currently available information on research on cannabinoids, the ECS, the gut microbiota and their collective (potentially bidirectional) association with endometriosis. The findings are largely positive, with research confirming the beneficial effects of cannabinoids, both endogenous and exogenous, on endometriosis outcomes and comorbidities of the disease. However, further research is needed to assess the safety of THC and CBD administrations in the treatment of endometriosis and the mechanisms underlying these preclinically observed benefits. Fortunately, at least one clinical trial is already underway to achieve this.

    Magazine reference:

    • Farooqi, T., Bhuyan, D.J., Low, M., Sinclair, J., Leonardi, M., & Armor, M. (2022). Cannabis and endometriosis: the role of the gut microbiota and the endocannabinoid system. Journal of Clinical Medicine, 12(22), 7071, DOI – https://doi.org/10.3390/jcm12227071, https://www.mdpi.com/2077-0383/12/22/7071

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  • OrthoConnecticut announces partnership with HOPCo

    OrthoConnecticut announces partnership with HOPCo

    HOPCo expands its East Coast footprint with one of the largest MSK platforms in the region

    DANBURY, Conn. , Nov. 14, 2023 /PRNewswire/ — OrthoConnecticut, one of Connecticut’s largest MSK multi-specialty practices, announced they are partnering with Healthcare Outcomes Performance Company (HOPCo), the national leader in musculoskeletal practices and clinical results management solutions and the nation’s largest orthopedic value-based healthcare organization.

    OrthoConnecticut is a leader in MSK care throughout the region and consists of 48 musculoskeletal providers with 9 locations in Connecticut. The practice’s Centers of Excellence provide integrated treatment by a team of orthopedic surgeons, physician assistants, imaging specialists and support staff. The practice helps patients regain their mobility, live an active life and achieve optimal health.

    OrthoConnecticut was founded following the merger of Coastal Orthopedics, Danbury Orthopedics, New Milford Orthopedics and Connecticut Pain Care. “Our intent in joining forces and becoming OrthoConnecticut has always been to combine best practices to provide the best possible outcomes and experience for our patients,” said Dr. Michael Brand, president of OrthoConnecticut. “Now that we have consolidated into one platform, we knew we would benefit from an experienced partner who could provide proven infrastructure for continued growth and accelerated market transformation. We witnessed how HOPCo helped improve practices similar to ours with the value they bring, so we knew this was the best choice as a partner.”

    The partnership between HOPCo and OrthoConnecticut will continue to develop unique clinically integrated partnerships with other leading musculoskeletal practices, physicians, healthcare systems and payers throughout Connecticut and the surrounding regions.

    OrthoConnecticut will be equipped with HOPCo’s proven clinical, quality, outcomes, digital patient engagement and claims analytics infrastructure to drive performance, growth and value-driven market transformation in the musculoskeletal space. Leveraging HOPCo’s proprietary care management platform, software tools and analytics, the partnership will deliver value-based healthcare solutions that improve healthcare outcomes, patient access, healthcare equity and the patient experience.

    “OrthoConnecticut is a shining example of a practice leading the transition to value-based care in their market,” said Dr. Wael Barsoum, President and Chief Transformation Officer at HOPCo. “Their decision to become OrthoConnecticut signaled to the community their commitment to expanding access to excellent care. As they partner with HOPCo, we want to help them accelerate their growth, improve outcomes and reduce costs for patients and payers, while still providing unparalleled patient access and personalized care.”

    OrthoConnecticut is the latest addition to HOPCo’s growing national MSK market transformation platform. Over the past twelve months, HOPCo has entered into multiple partnerships in Philadelphia and five new partnerships in Florida, including a partnership to manage MSK spending for 2 million insured lives. HOPCo has also entered into multiple practice partnerships in Nevada and additional partnerships in Michigan and Arizona. HOPCo also partners with healthcare systems and physician practices in more than 30 states and continues to collaborate with payers across the U.S. on advanced value-based care programs.

    About Healthcare Outcomes Performance Company (HOPCo)
    Healthcare Outcomes Performance Company (HOPCo) is the national leader in integrated, value-based health outcomes management, practice management and service line management for healthcare systems. This includes extensive expertise in all MSK specialties including orthopedics, spine, neurosurgery, hand, pain management, rehabilitation and neurology. HOPCo’s integrated care, analytics, and facility development and management platforms are proven to increase the quality of patient care while reliably reducing the total cost of care across the care continuum for practices, healthcare systems and payers alike. HOPCo’s affiliated payers, practices and healthcare systems successfully participate in highly efficient, value-based contracting (bundled payments, chronic episodes of care initiatives, population health programs and other advanced risk-based arrangements), using HOPCo’s proprietary platforms, IT solutions, digital patient care, engagement platform, integrated analytics and evidence-based, comprehensive care pathways. Visit www.hopco.com for more information.

    About OrthoConnecticut
    OrthoConnecticut is a multispecialty practice staffed by leaders in orthopedics and pain care, and is the unified practice of Coastal Orthopedics, Danbury Orthopedics, New Milford Orthopedics and Connecticut Pain Care. The practice-trained physicians offer appointments at 9 office locations. The practice’s goal is to help patients regain their mobility, live active lives and achieve optimal health. Offices in Danbury, Darien, Litchfield, New Milford, Norwalk, Ridgefield, Sharon, Southbury and Westport. For my information, visit www.myorthoct.com

    SOURCE Healthcare Results Performance Company

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  • Vy Spine Announces FDA Approval for its ClariVy OsteoVy PEKK Cervical IBF

    Vy Spine Announces FDA Approval for its ClariVy OsteoVy PEKK Cervical IBF

    Tallahassee, Florida, November 14, 2023 – OrthoSpineNews – Vy Spine, a leader in spine innovation using differentiated materials and designs, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).

    The new ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the OXPEKK material and the OsteoVy lattice structure unique to Vy Spine. PEKK implants (as opposed to PEEK) implants exhibit bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time, and a significantly higher push-out force compared to standard PEEK.

    Vy Spine’s patented OsteoVy lattice structure helps with bone integration and fluid drainage, because PEKK is a hydrophilic material, to provide even more benefits as an interbody implant.

    “The ClariVy OsteoVy PEKK approval is the first in a long line of Vy Spine implants that will leverage the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, president of Product Development for Vy Spine. “As we researched OXPEKK and its unique characteristics, we began to realize that its composition achieves what we as an industry had always hoped PEEK would achieve. But PEEK fell short. We are very excited about the OXPEKK material and our collaboration with Oxford Performance Materials to make this new device possible.”

    “We are thrilled that Vy Spine has achieved this important milestone,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s new, 3D printed OsteoFab technology and Vy Spine’s innovative designs and experience in the spine market will drive substantial adoption of this best-in-class solution.”

    About Vy Spine, LLC.

    VySpine was created through active internal development and licensing of several proven technologies using innovative materials and designs. The company strives to outperform its competitors by partnering with key spine innovators while providing a flexible, cost-effective approach to spine care. More information can be found at www.vyspine.com.

    About Oxford Performance Materials, Inc.

    Oxford Performance Materials, Inc. was founded in 2000 to exploit and market the world’s highest performing thermoplastic plastic, PEKK (polyether-ketone-ketone). OPM’s Materials division has developed a range of proprietary technologies for the synthesis and modification of a range of PAEK polymers sold under the OXPEKK® brand, including coating technologies for a range of industrial and biomedical applications. The company is a pioneer in the field of 3D printing. OPM’s OsteoFab® technology is commercially produced in numerous orthopedic implant applications, including cranial, facial, spinal and sports medicine devices, and OPM’s OXFAB® production parts are designed for highly demanding industrial applications.

    “Vy Spine”, “ClaiVy” and “OsteoVy” are registered trademarks of Vy Spine.

    Media contact: Paul Williams, 310-569-0023, paul@medialinecommunications.com

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  • Do cool shirts make a difference?  The effects of upper body clothing on health, fluid balance and performance during exercise in the heat |  BMC Sports sciences, medicine and rehabilitation

    Do cool shirts make a difference? The effects of upper body clothing on health, fluid balance and performance during exercise in the heat | BMC Sports sciences, medicine and rehabilitation

    This study was conducted as a randomized, controlled, parallel-group experiment. The local ethics committee declared that the trial was in accordance with the ethical standards laid down in the Declaration of Helsinki, including its amendments [20]. An informed consent was signed by each participant prior to enrollment in the study.

    Adult volunteers were recruited through public tenders in a university setting. All participants were healthy, not acclimated to heat and reported regular physical activity (>150 minutes per week). Exclusion criteria included functionally restrictive metabolic or acute diseases. Chronic diseases affecting the cardiopulmonary system, infections or drug abuse are also excluded from participation.

    A total of 34 participants were included (age = 25; 4 years, height = 1.73; 0.09 m, body weight = 70.3; 13.3 kg).

    The trial included a baseline examination on day 1, including documentation of medical history, questionnaire-based recording of participants’ health and fitness status, as well as anthropometric assessments and a cardiopulmonary exercise test to voluntary exhaustion.

    The main study on day 2 (2-7 day washout between days 1 and 2) was a fixed intensity endurance exercise test for a maximum period of 45 minutes. During both exams, participants trained on a bicycle ergometer (Excalibur-Sport, Lode, Groningen, The Netherlands). The workload measured in Watts was automatically recorded. Heart rate (HR) was measured continuously via the chest strap and recorded as a 5-second average value on a corresponding watch (RS800/CX, S810i, S610i, Polar Electro). Breathing gas parameters were recorded using a breath-by-breath analyzer (Oxycon Mobile, Viasys Healthcare GmbH, Würzburg, Germany). Again, the five-second average values ​​were analyzed. Patients wore a rubber face mask through which the inhaled air was transferred to a ventilation turbine and further directed to the portable device with O2 and co2 gas analyzers. Relative oxygen consumption (VO2) and carbon dioxide emissions (VCO2) data was sent telemetrically to a computer. Before each test, the mobile gas analyzer is calibrated with reference gases (ambient air, 5% CO216% O2) and automated standard volume. The breath-by-breath analyzer was successfully tested for reliability (coefficient of variation for VO2 = 3.4, and for VCO2= 4.3) and was compared to the gold standard method to assess validity (difference of -4.1, 3.1% and -2.8, 3.5% compared to the Douglas Bag method) [21]. According to Perret and Mueller’s recommendation, the same spirometry system was used in all studies [22]. In addition, in both studies the degree of perceived exertion was assessed using the Borg Scale (RPE; 6 [no exertion] up to 20 [maximal exertion]) [23].

    Two types of short-sleeved shirts and a cooling vest were chosen for the experiment. One of the short-sleeved shirts was made of 100% cotton, while the other was made of 100% polyester with moisture-wicking finish (Decathlon, France). Participants were instructed to wear a shirt with a close-fitting but comfortable cut and chose the shirt size ad libitum (ranging from XXS to XL).

    The third experimental garment was a sleeveless cooling vest (Idenixx, Germany) that provided a tight fit to the torso and integrated cooling elements at the front and back. The vest’s upper material was a polyester (83%) elastane (17%) blend and the cooling elements were made of a polyester fleece. Cooling elements were activated by immersion in water. The evaporation of the vest is intended to enhance the endogenous evaporative cooling of the body.

    Volunteers were required to undergo a spirometer-based cardiopulmonary exercise test on a cycle ergometer to determine individual performance. A ramp-shaped protocol, adapted to an individual’s fitness level, was applied to reach voluntary exhaustion within 10-12 minutes. The initial workload was set at 50 W and was individually increased by 10, 15, 20, or 25 W every minute based on participants’ questionnaire-based report of fitness status. The testing protocol was in line with ACSM guidelines for exercise testing and prescribing [24]. Participants were introduced to the bicycle ergometer and the test protocol.

    Criteria defining maximum exhaustion are: (1) Respiratory Exchange Ratio (RER) > 1.10, (2) Reaching an age-related maximum heart rate, (3) Rate of Perceived Exertion (RPE) via Borg scale ≥ 17 [17,18,19,20](4) maximum O2 respiratory equivalent (< 30) [25].

    Maximum oxygen uptake (VO2max) was determined by the software by identifying the highest thirty second floating average of oxygen uptake throughout the test [26]. Verification was done manually by the researcher. The parameter was used to ensure homogeneous assignment of test conditions. The participants were ranked based on their VO2maximum Groups of three are formed from above. These groups of three participants were used as stratification grouping for the subsequent block randomization in the three test conditions.

    The respiratory compensation point (RCP) was detected for each participant using the 9 Panels Board and identifying (1) non-linear increase in ventilation (VE ) compared to linearly increasing or non-increasing carbon dioxide emissions (VCO2); (2) non-linearly decreasing end-tidal CO2partial pressure (PANDCO2) as well as an increase in the respiratory equivalent for CO2 [27, 28]. Interpretation of graphics, as described above, is a well-established approach [27, 28] and was executed by two independent investigators.

    Before the main study, all participants were instructed to prepare for exercise in the heat by providing adequate hydration (minimum 1.5 L/day; pretest 0.5 L). During the test, volunteers were not allowed to drink water. After a 5-minute rest phase, Bioimpedance Analysis (BIA) was performed using a tetrapolar device (Nutriguard-MS, Data Input, Darmstadt, Germany) with single frequency (50 kHz). Resistance (R) and reactance (Xc) in Ohms (Ω) were processed by Nutriplus software (Data Input, Darmstadt, Germany). Body weight in kg was then determined using a conventional digital scale. Probands were weighed only while wearing underwear and socks. Sports shorts and the randomly assigned upper body clothing option were weighed separately.

    The endurance exercise test on day 2 was performed in an air-conditioned and humidified room. We applied standardized warm environmental conditions, defined by a temperature of 30.5 °C (acceptable range of 1 °C) and a relative humidity of 43% (acceptable range of 13%). Humidity and temperature were monitored using a thermometer and a hygrometer. During the endurance test, the upper body was covered by one of three experimental garments. Due to its decisive feel and weight, the test garment could not be blind to the participant and the experimenter. Participants performed on the same cycle ergometer as at the baseline study with identical bike settings as documented during the initial study. They attempted to complete a 45-minute ride with a workload of 80% of the RCP. Volunteers are instructed to keep the cadence above 60 rpm. If this limit was permanently undershot, the test had to be classified as terminated due to voluntary exhaustion. The corresponding termination time was recorded as the outcome (exercise performance in minutes). The time limit to a maximum of 45 minutes of practice was imposed for safety reasons.

    In addition to heart rate (beats per minute [bpm]) and oxygen uptake (milliliter per kg body weight per minute). [ml/kg/min]) Inner ear temperature was measured using a digital infrared ear thermometer (Braun ThermoScan, Mexico) to display the core temperature outcome (degrees Celsius) [°C]). All measurements at all time points were performed by the same researcher using the same thermometer. As self-reported data results, we recorded the level of perceived exertion via the Borg scale (6 [no exertion] up to 20 [maximal exertion]) [23] and feelings scale (+ 5 [very good] to -5 [very bad]). In addition, there are sensations related to temperature (0 [unbearably cold] to 8 [unbearably hot]), sweating (0 [not at all] to 3 [heavily sweating]), clothing moisture (0 [no sensation] to 3 [wet]) and skin moisture (0 [dry] to 3 [too wet]) [14] were assessed. All outcomes, except exercise performance, were documented at rest before testing, at 5-min intervals during cycling, and at trial termination. To create a realistic scenario (outdoor exercise simulating cycling speed), airflow was simulated using a fan, located 49 cm in front of the ergometer, which directed an airflow of 20 km/h to the upper body. [29]. The air flow was controlled using a wind sensor.

    Statistical analysis was performed using Prism (version 9.1.0, GraphPad Software, LLC) and Jamovi (version 1.6.23.0). A survival time analysis was implemented using a 3-group Kaplan-Meier estimator. A Log-Rank test was requested between the groups. For both analyses, the dependent variable was the duration of the individual test termination. Basic data (cardiopulmonary exercise test, anthropometric measurements), pre- and post-exercise data for objective variables (heart rate, inner ear temperature, VO2) as well as self-reported parameters (RPE, feeling scale, thermal, sweating, clothing wetness and skin wetness feeling) were analyzed using Kruskal Wallis tests (non-parametric analysis of variance due to non-normal distribution of residuals) and Dwass-Steel-Critchlow pairwise comparisons -Fligner (post hoc test). Time series analysis for objective and self-reported outcomes during exercise was performed based on 95% confidence interval comparisons for up to nine time points (5, 10, 15, 20, 25, 30, 35, 40, and 45 minutes). ) [30]. The differences in body and clothing weight before and after training were analyzed using Student’s t-test. A p-value cutoff of 0.05 was set for significance testing.

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  • Paragon 28 launches BEAST™ Cortical Fibers to expand its biological portfolio

    Paragon 28 launches BEAST™ Cortical Fibers to expand its biological portfolio

    ENGLEWOOD, Colo., November 14, 2023–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its BEAST™ Cortical Fibers which provide an osteoinductive porous structure for cellular adhesion and osteoinductive potential to aid in cellular differentiation and bone formation. Designed to complement specific surgical applications in the foot and ankle, these loose cortical fibers are flexible with hydration, allowing application even to extremely challenging fusion sites. The cortical matrix absorbs bioactive fluid, including bone marrow aspirate, and supports cellular infiltration to stimulate efficient bone remodeling. Powerful processing capacity enables the retention of natural bone morphological proteins (BMPs) and other growth factors necessary to promote bone formation.

    The addition of the BEAST™ Cortical Fibers strengthens Paragon 28’s biological product offering, including the PRESERVE™ Bone Wedge System, V92™ and V92™-FC+ Cellular Bone Matrices, MgNum™ Bone Void Filler, Paraderm™ Dermal Matrix, BEAST™ Demineralized Bone Matrices and Pro3™ Placenta and Umbilical Cord Regenerative Tissue Matrices. With this extensive portfolio, Paragon 28® offers its customers innovative biological solutions for reconstruction and trauma.

    About Paragon 28, Inc.

    Based in Englewood, CO., Paragon 28 is a leading medical device company focused exclusively on the foot and ankle orthopedic market and committed to improving the lives of patients. Since its inception, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and devices covering a wide range of foot and ankle conditions, including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flat foot, Charcot foot and orthobiological agents . The company designs products with both the patient and surgeon in mind, with the goals of improving outcomes, reducing recurrences of disease and complications, and making procedures simpler, more consistent and reproducible.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates and assumptions, which speak only as of the date on which they are made, and are subject to risks and uncertainties, some of which we are not currently aware of. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at or at which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Paragon 28’s business generally, see the current and future reports from Paragon 28 filed with the Securities and Exchange Commission. Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements . except as required by law.

    Disclaimer

    Nothing in this material is intended to provide specific medical advice or take the place of written law or regulation.

    Contacts

    Contact person for investors

    Matthew Brinckman
    Senior Vice President, Strategy and Investor Relations
    Phone: (720) 912-1332
    mbrinckman@paragon28.com

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  • First implantation of the MOVE®-C cervical artificial disc prosthesis from NGMedical GmbH in Taiwan

    First implantation of the MOVE®-C cervical artificial disc prosthesis from NGMedical GmbH in Taiwan

    MOVE®-C cervical artificial disc replacement

    NONNWEILER, SAARLAND, GERMANY, November 14, 2023 /OrthoSpineNews/ — NGMedical GmbH, a medical device manufacturer focused exclusively on creating innovative technologies for spinal applications, announces the first implantation of its MOVE®-C cervical artificial disc replacement in Taiwan.

    MOVEMENT®-C combines the features of a second-generation viscoelastic disc prosthesis with the simple implantation technique of a cervical cage. The prosthesis provides physiological movement in all six planes, including axial damping with progressive movement resistance. MOVEMENT®-C is the first prosthesis with additively manufactured titanium end plates and avoids the use of PE.

    “The first implantation of our MOVE®-C cervical artificial disc replacement in Taiwan marks another important milestone for NGMedical. The market launch in Taiwan is the next step in the global commercialization of our MOVE®-C artificial disc prosthesis. Taiwan is a very active spine market and we are proud to see how MOVE®-C is even more widely used and accepted by experienced spine surgeons in many countries.” says Peter Weiland, CEO of NGMedical.

    About NGMedical
    We are an owner-managed company specializing in the development of innovative spinal implants. Many years of experience, combined with a high degree of creativity, give us the impetus to significantly advance the development of spine surgery.

    The NGMedical team has been developing innovative product systems since 2001. NGMedical emerged from the company Advanced Medical Technologies AG, which was acquired by Medtronic Inc. in 2012. NGMedical exploits this many years of experience combined with a high degree of creativity and know-how for the development of further innovative product concepts. Both in the past and now, collaboration with a team of experienced surgeons and scientists forms the basis for the market-driven orientation. Many product solutions, which are accepted as standard and widely used today, come from our team.

    Peter Weiland
    NGMedical GmbH
    +49 6873 999970
    email us here
    Visit us on social media:
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  • Knee Injuries

    Knee Injuries

    Treating and Recovering from Knee Injuries

    Introduction:
    Knee injuries are an extremely common problem that can happen to athletes, weekend warriors, and even sedentary individuals. The knee joint is complex and vulnerable to various forms of trauma and overuse. Knee problems can develop at any age and affect day-to-day activities. This comprehensive guide covers the most prevalent knee injuries, their typical symptoms and diagnosis, all the treatment options available, as well as the rehabilitation process. Read on to learn how to identify knee issues, seek proper medical care, and safely return to activities after sustaining a knee injury.

    Most Common Knee Injuries:

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    There are several injuries that frequently occur around the knee joint. These include sprains, strains, tears in ligaments or tendons, fractures, dislocations, and inflammatory conditions.

    Knee sprains and strains involve overstretching or partial tears of the ligaments and tendons. The most commonly affected ligaments are the ACL, MCL, and LCL. Knee strains can happen to muscles like the quadriceps or hamstrings. These injuries cause pain, swelling, and instability in the knee.

    More serious knee injuries involve complete tears of key ligaments like the anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL). Tears can also occur in shock-absorbing structures like the menisci cartilage or patellar tendon. Knee dislocations are when the knee cap slips out of position. Fractures around the knee may occur in the patella, tibia, or femur.

    Inflammatory conditions like tendinitis, bursitis, and arthritis can develop over time with overuse or anatomical issues. Patellar tendinitis (jumper’s knee) involves irritation of the tendon below the kneecap. Bursitis affects the small fluid-filled sacs around the knee joint. Arthritis causes progressive cartilage damage and bone spur formation.  

    Causes and Risk Factors:

    Knee injuries can result from sudden trauma or impact to the joint, like a sports tackle or fall. Twisting the knee forcefully can also damage ligaments. Prolonged overuse through repetitive motions, improper training, or imbalance in strength and flexibility increases injury risk. Some anatomical factors that predispose people include being bow-legged or knock-kneed, having flat feet, or a previous knee injury.

    Signs and Symptoms:

    – Pain – This may be focal or diffuse depending on the injury. Severe initial pain suggests serious trauma. Chronic, progressive pain indicates an overuse injury or degenerative arthritis.  

    – Swelling – Fluid accumulation indicates inflammation or bleeding inside the joint. Localized swelling affects specific structures.

    – Instability – A feeling that the knee will buckle or give out. Significant instability points to ligament tears.

    – Locking or catching – Impaired mobility suggesting loose cartilage or tears is blocking joint motion.

    – Redness and warmth – The knee appears flushed and inflamed.

    – Limited range of motion – The knee lacks full extension or flexion due to pain, swelling, or structural damage.

    – Popping or crunching sounds – Results from cartilage and bone rubbing abnormally.

    Diagnosis and Testing:

    A physician gathers a medical history and performs a physical exam assessing knee range of motion, strength, alignment, swelling, and sites of pain. Imaging tests help evaluate soft tissue and bone structures. X-rays show fractures and arthritis. MRI scans visualize ligaments, tendons, and cartilage in detail. CT scans also assess bony anatomy. Joint fluid analysis under a microscope can identify inflammatory conditions. Assessing walking and alignment helps identify biomechanical issues.

    Treatment Options:

    – RICE – Rest, ice packs, compression, and elevating the knee reduces swelling and pain.

    – Medications – Anti-inflammatories and targeted injections provide pain relief and reduce inflammation.

    Physical therapy – Exercises strengthen muscles, improve range of motion, and promote proprioception.

    – Assistive devices – Braces, sleeves, crutches, or canes help immobilize and offload the knee.

    – Surgery – Repairing torn ligaments or resurfacing damaged cartilage can restore function.

    – Alternative medicine – Treatments like acupuncture, massage, cryotherapy, or prolotherapy may augment conventional care.

    Rehabilitation and Recovery:

    The initial rehab goals are to control pain and swelling while regaining passive knee mobility. Later, the focus shifts to building muscle strength, endurance, and stability. Sport-specific drills prepare the patient for returning to full activity. Recovery timelines vary based on the injury. Most knee issues require at least 4-6 weeks of rehab. Severe ligament tears may need 3-9 months. Patience during rehab is key to prevent re-injury.

    Outlook and Prevention:

    With appropriate treatment, most knee injuries can fully recover within 3-12 months depending on severity. However, some may lead to lasting issues like osteoarthritis later in life. Preventive measures include building muscular strength, proprioception, and flexibility through training. Use proper technique when exercising. Wear protective knee pads if necessary. Taping or bracing can also stabilize vulnerable knees during activities.  

    Conclusion:

    Knee injuries are diverse, encompassing everything from minor sprains to severe fractures and ligament tears. Prompt diagnosis and treatment tailored to the specific injury leads to an optimal recovery. A well-structured rehabilitation program further helps restore knee mobility and strength. While knees are susceptible to injury, focusing on prevention and prompt care when problems arise allows most people to return to an active lifestyle.

  • Paragon 28 Launches JAWS™ Great White Staple System and Further Expands Its Nitinol Staple Offering

    Paragon 28 Launches JAWS™ Great White Staple System and Further Expands Its Nitinol Staple Offering

    JAWS Great White Staple System (includes 12, 15, 18, 20 and 25 mm staples)

    ENGLEWOOD, Colo., November 14, 2023–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its JAWS™ Great White Staple System, which is designed to provide greater strength and stability to the osteotomy or fusion site compared to traditional stapling systems. The staples feature an ultra-low profile bridge with a larger surface area to improve stability and minimize soft tissue irritation. The newly designed staple has a 400 times longer fatigue life compared to a competitive nitinol staple subjected to the same loading parameters.1 The shoulders of the staple work together with the inserter, allowing the staple to fully seat before compression is activated, limiting the need for tamping. The staples are designed to provide a uniform compression profile across the entire osteotomy and provide a 169% higher compressive force compared to the average of a competitive marketing-leading two-pin nitinol staple.1

    Paragon 28 CEO Albert DaCosta said: “We are excited to further expand our JAWS™ base offering, allowing surgeons to address the complexities of midfoot and hindfoot reconstruction. Our development team has designed implants that provide greater fatigue resistance and increased compression compared to leading nitinol stacking systems. We look forward to expanding our market position in the midfoot and rearfoot segments with this exciting offering.”

    The addition of the JAWS™ Great White Staple System strengthens Paragon 28’s product offering of rearfoot solutions, including the Gorilla® Ankle Fracture Plating System, APEX 3D™ Total Ankle Replacement, Silverback™ Ankle Fusion Plating System, Phantom® TTC Nail System and Phantom ® ActivCore™ nail system. With this extensive portfolio, Paragon 28® offers its customers innovative ankle solutions for trauma, arthritis and limb rescue.

    About Paragon 28, Inc.

    Based in Englewood, CO., Paragon 28 is a leading medical device company focused exclusively on the foot and ankle orthopedic market and committed to improving the lives of patients. Since its inception, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and devices covering a wide range of foot and ankle conditions, including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flat foot, Charcot foot and orthobiological agents . The company designs products with both the patient and surgeon in mind, with the goals of improving outcomes, reducing recurrences of disease and complications, and making procedures simpler, more consistent and reproducible.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates and assumptions, which speak only as of the date on which they are made, and are subject to risks and uncertainties, some of which we are not currently aware of. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at or at which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Paragon 28’s business generally, see the current and future reports from Paragon 28 filed with the Securities and Exchange Commission. Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements . except as required by law.

    Disclaimer

    Nothing in this material is intended to provide specific medical advice or take the place of written law or regulation.

    1. Internal test data saved

    Contacts

    Contact person for investors
    Matthew Brinckman
    Senior Vice President, Strategy and Investor Relations
    Phone: (720) 912-1332
    mbrinckman@paragon28.com

    Photo: Business Wire

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  • New SPR therapeutic data presented at ASRA Pain Medicine Meeting 2023

    New SPR therapeutic data presented at ASRA Pain Medicine Meeting 2023

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    Three posters accepted, including a President’s Choice Award for new data from a randomized controlled trial of postoperative pain in total knee replacement

    CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) — At the 22nd annual American Society of Regional Anesthesia (ASRA) Pain Medicine Meeting in New Orleans, three posters about the SPRINT® PNS system was shared for the first time.

    The first poster, “Percutaneous PNS relieves persistent postoperative pain and improves function after TKA: results from a placebo-controlled randomized controlled trial” was recognized with a President’s Choice Award from ASRA. This poster highlights the results of a prospective study evaluating the impact of SPRINT peripheral nerve stimulation (PNS) used for chronic knee pain after total knee arthroplasty (TKA). This study not only demonstrated that the majority (60 percent) of the SPRINT PNS treatment group (n=12/20) experienced ≥50 percent pain relief at the end of treatment compared to baseline, it also provided objective functional data, measured with a six-minute walk test. The SPRINT PNS treatment group (n=18) showed a 47 percent improvement in walking ability as measured by a six-minute walk test, while the placebo group (n=20) showed a nine percent decrease. This is an important finding for the large number of TKA patients who experience persistent postoperative neuropathic TKA pain (up to 20 percent of the 800,000 patients undergoing TKA surgery annually in the US). There were no study-related serious or unexpected adverse events.

    The second poster, “60 Days PNS for Pain Management in a Medicare Eligible Population: Real-World Results from a Retrospective Analysis” is a review of outcomes in a subset of 1,763 Medicare-eligible patients from the recently published SPRINT PNS real-world retrospective data of more than 6,000 patients. The Medicare eligible population is important because it has been reported that 78 percent of Medicare beneficiaries may experience chronic pain, and this retrospective review supports the use of 60-day PNS as a safe and effective option for chronic pain management in the Medicare eligible upcoming population. In this retrospective analysis, 70 percent of patients (n=1,226/1,763) were defined as responders at end of treatment (≥50 percent pain relief and/or clinically significant improvement of ≥1 in Patient Global Impression of Change) for all nerve targets . , consistent with recent prospective studies. The total rate of adverse events reported for this Medicare-eligible cohort was four percent, with skin irritation being the most common event, usually due to bandages or adhesives.

    Additional retrospective real-world data on the treatment of chronic low back pain in patients with lumbar spondylosis (a degenerative condition affecting the intervertebral discs, vertebrae and joints of the spine) are analyzed in the third poster, “Retrospective review of 60-day PNS targeting lumbar medial branches in subjects with spondylosis without radiculopathy.” In this study, 65 percent of patients with a suspected and/or confirmed diagnosis of spondylosis (n=173/265) were defined as responders (≥50 percent pain relief and/or clinically significant improvement of ≥1 in Patient Global Impression of Change in function). Although safety was not directly evaluated in this analysis, previously published studies have shown that the most common adverse reactions are skin irritation due to dressings or adhesives and discomfort from the lead placement procedure.

    “The addition of new functional data and SPRINT’s impressive, stable performance across multiple nerve targets and pain areas is exciting and confirms our belief that this treatment can have a tremendous impact on pain relief and quality of life improvement without opioids or the need for permanent implants,” said Maria Bennett, President, CEO and Founder of SPR Therapeutics.

    About the SPRINT PNS system
    The SPRINT® PNS system, by SPR® Therapeutics marks an innovative shift in the treatment of pain. Our breakthrough 60-day treatment is a first-line PNS option uniquely proposed to repair the central nervous system to provide significant and long-lasting relief from chronic pain – without a permanent implant, nerve damage or the risk of addiction. The system has been extensively researched for low back pain, shoulder pain, post-amputation pain and chronic and acute postoperative pain, is approved for use up to 60 days and is recognized by leading pain management centers. Market research shows that this groundbreaking neuromodulation treatment is a patient-preferred alternative to more invasive options.

    The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, postoperative and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended for placement in the area innervated by the cranial and facial nerves.

    Clinicians should use common sense when deciding when to use the SPRINT PNS System. See the SPRINT PNS system instructions for use for more information. The most common side effects are skin irritation and erythema. Results may vary. Rx only.

    For additional safety and efficacy information, please visit: SPR Safety Information.

    About SPR Therapeutics, Inc.
    SPR Therapeutics is a privately held medical device company that offers patients a non-opioid, minimally invasive pain treatment option. Our SPRINT® The PNS System fills a critical unmet need for a drug-free, surgery-free option for millions of people suffering from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and laid an incredibly strong foundation for commercial growth. Headquartered in Cleveland, Ohio with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s senior management team consists of experienced industry veterans with nearly 200 years of collective pain market and MedTech experience, all driven by our goal: improve the quality of patients. ‘ lives by offering them a minimally invasive, drug-free and surgery-free solution to manage their acute and chronic pain.

    More information can be found at www.SPRTherapeutics.com.

    Contact details

    SPR contacts:
    Michelle McDonald
    Vice President – ​​​​Marketing
    844-378-9108

    Dave Folkens
    Public relations
    612-978-6547

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