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Author Interviews, Orthopedics / 16.03.2017

MedicalResearch.com Interview with: Alexander S. McLawhorn, MD, MBA Orthopedic Surgery, Hip and Knee Replacement Hospital for Special Surgery New York, NY 10021 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hospital for Special Surgery (HSS) researchers saw the need for a shorter, more patient friendly outcome survey for revision knee replacement surgery. This is an area where patient-reported outcomes data are essential to improving quality of care. In fact, knee replacement revisions, which are more complex and heterogeneous than primary knee surgery, are under-studied in this regard. A commonly used knee replacement survey, the KOOS (Knee Injury and Osteoarthritis Outcome Score), is 42 questions and often leaves physicians with partial and unusable information secondary to patient burden and fatigue. Previously, researchers at HSS created the KOOS, JR, which is a shorter, 7-question survey that accurately measures “knee health”, meaning it reflects aspects of pain, symptom severity, and activities of daily living relevant and difficult for patients with knee arthritis. The current research presented at AAOS showed that the KOOS, JR can be extended to knee replacement revision patients and that it is a valid and efficient tool for assessing knee health in this challenging patient population. (more…)
Author Interviews, NYU, Orthopedics / 16.03.2017

MedicalResearch.com Interview with: Dr Aaron J. Buckland Spinal and scoliosis surgeon and Assistant professor Orthopedic surgery NYU Langone Medical Center MedicalResearch.com: What is the background for this study? Response: For decades, surgeons performing hip replacements have placed the acetabular component adjacent to the pelvis in a “safe zone” which has been shown to reduce dislocation risk. However, beginning in residency, I would notice that several of my patients with spinal deformities or lumbar fusions, would experience dislocations despite the safe zone placement of these implants. Our initial research demonstrated that there was an increased dislocation risk in patients with lumbar fusions, particularly if they underwent spinal realignment. We investigated this phenomenon further by retrospectively reviewing 107 patients who met the criteria for sagittal spinal deformity, including 139 hip replacements collectively. (more…)
Author Interviews, General Medicine, Orthopedics / 15.03.2017

MedicalResearch.com Interview with: Darwin Chen, MD Assistant Professor, Orthopaedics Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Total hip and knee replacement surgery are among the most commonly performed orthopaedic procedures today. Although success rates are high, complications can occur and some may be preventable. The goal of our research was to assess the impact of gender on complications within the first 30 days after hip and knee replacement. (more…)
Author Interviews, JAMA, Orthopedics / 14.03.2017

MedicalResearch.com Interview with: Justine M. Naylor, PhD Braeside Hospital, HammondCare, Australia South West Sydney Clinical School, University of New South Wales, Liverpool Hospital South West Sydney Local Health District, Liverpool 2170, NSW, Australia MedicalResearch.com: What is the background for this study? Response: Total knee arthroplasty (replacement) for end-stage arthritis is a very successful procedure for relieving the associated pain and functional impairments. Formalized rehabilitation following the surgery is also considered an essential adjunct to optimise recovery. World-wide, the volume of knee arthroplasty surgeries is increasing each year. In the US, for example, the prevalence of this surgery increased 11-fold from 1980 to 2010. The costs of the procedures (including the acute and rehabilitation costs) are also increasing. Because of these trends, there is concern for the future sustainability of these procedures. Research devoted to identifying the most cost-effective strategies in this field is required. Our group conducted a randomized trial comparing 10-days of inpatient rehabilitation to a simple, clinician-monitored home program in people who underwent total knee arthroplasty for end-stage osteoarthritis. Inpatient rehabilitation in a rehabilitation facility is commonly provided after knee arthroplasty in various countries including Australia, the US and Switzerland, and is comparatively expensive. In particular, it is a commonly available option for people with private healthcare insurance. Essentially, we wanted to compare 2 extremes – a resource-intensive program to one with far less resource requirements. Because patients who experience complications immediately after surgery may require inpatient rehabilitation to aid their recovery, we only included patients who did not experience a significant complication while in hospital, thus, were otherwise deemed able to be discharged directly home. (more…)
Author Interviews, JAMA, Orthopedics, Osteoporosis, Testosterone / 23.02.2017

MedicalResearch.com Interview with: Tony M. Keaveny, Ph.D. Professor, Departments of Mechanical Engineering and Bioengineering; Co-Director, Berkeley BioMechanics Laboratory University of California Berkeley, CA 94720-1740 MedicalResearch.com: What is the background for this study? Response: As men age, they experience decreased serum testosterone concentrations, decreased bone mineral density (BMD) and increased risk of fracture. While prior studies have been performed to determine the effect of testosterone treatment on bone in older men, for various reasons those studies have been inconclusive. The goal of this study was to overcome past limitations in study design and determine if testosterone treatment — versus a placebo — in older men with low testosterone would improve the bone. Specifically, we used 3D quantitative CT scanning to measure changes in BMD and engineering “finite element analysis” to measure changes in the estimated bone strength, both at the spine and hip. The study was performed on over 200 older men (> age 65) who had confirmed low levels of serum testosterone. (more…)
Author Interviews, Cancer Research, JAMA, MD Anderson, Orthopedics / 12.02.2017

MedicalResearch.com Interview with: Gabriel N. Hortobagyi, MD, FACP, FASCO Professor, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX 77230-1439  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bisphosphonates have been commercially available for several decades as supportive care for patients with bone metastases. They reduce the frequency and severity of bone-related complications. While the optimal dose and short-term scheduling of zoledronic acid (and previously, pamidronate) have been determined, there has been no research to determine how long these drugs need to be maintained nor the optimal dose and schedule beyond the first year of therapy. These questions are particularly important for this family of drugs, since they are incorporated into bone and not excreted from the body for many years. We set out to determine whether a reduction in the frequency of administration of zoledronic acid (every 12 weeks) was able to maintain the therapeutic efficacy of this intervention when compared to the “standard” schedule of administration (every 4 weeks). It was a prospective, randomized, non-inferiority trial that recruited patients with metastatic breast cancer with bone metastases and who had previously received 9 or more doses of zoledronic acid or pamidronate. The primary endpoint was the proportion of patients with one or more skeletal-related events. Four hundred and sixteen patients were randomized in a 1:1 ratio. The two groups were comparable at baseline. After the first year of follow-up, there was no statistically significant difference in SRE rate between the two arms, confirming the non-inferiority fo the every-12-week schedule of zoledronic acid. (more…)
Author Interviews, Hip Fractures, NYU, Orthopedics / 09.02.2017

MedicalResearch.com Interview with: Afshin E. Razi MD Clinical Assistant Professor NYU Hospital for Joint Diseases Department of Orthopaedic Surgery New York, N.Y. 10016 MedicalResearch.com: What is the background for this study? What are the main findings? Response: We did an extensive literature search and through our two previous seminars on this topic we were able to gather information to aid our colleagues on best ways of differentiating causes of hip and back pain. As an orthopaedic surgeon specializing in spine surgery I encounter many patients who present with concomitant back and hip pain. Many of these patients are also referred to me by surgeons who solely take care of hip problems such as total hip replacement or sport medicine specialist who treat younger patients with hip pain. It can be very difficult to properly diagnose the main issue and as such some patients go on to have unnecessary treatments, including surgery, because of their persistent symptoms. It was our goal to try to educate physicians, including orthopaedic surgeons, on the common differential diagnoses, appropriate clinical history and physical examination, diagnostic tools and their evaluations appropriately, as well as treatment options and priorities of which one to be treated first. More recently, it has been noted that some patients who have undergone total hip replacement with significant curvature of the spine had postoperative dislocation of the hip after reconstruction of the spinal malalignment. This article also talks about this newly seen problem. (more…)
Author Interviews, Cognitive Issues, Gender Differences, Hip Fractures, Orthopedics / 09.02.2017

MedicalResearch.com Interview with: Ann L. Gruber-Baldini, Ph.D. Professor, Division of Gerontology Director, Program in Epidemiology and Human Genetics Department of Epidemiology & Public Health University of Maryland School of Medicine  MedicalResearch.com: What is the background for this study? Response: While men make up only about 25% of all hip fractures, the number of men who fracture their hip is increasing and we know men are more likely to die than women after a hip fracture. It is also known that those with cognitive impairments, typically due to delirium and Alzheimer's disease and related dementia, are more likely to do more poorly after the fracture. The impact of both sex and cognition on outcomes after hip fracture has not been fully explored. (more…)
Author Interviews, BMJ, Orthopedics, Pain Research, Surgical Research / 08.02.2017

MedicalResearch.com Interview with: Jonas Bloch Thorlund Associate Professor (MSc, PhD) Department of Sports Science and Clinical Biomechanics Research Unit for Musculoskeletal Function and Physiotherapy University of Southern Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: Arthroscopic partial meniscectomy is a very common knee surgery. Research evidence has seriously questioned the effect of this type of surgery for degenerative meniscal tears in middle-aged and older patients. Most young patients with traumatic meniscal injury (from sports or similar) also undergo this type of surgery. There is a general understanding that young patients with traumatic tears experience larger improvements in patient reported pain, function and quality of life. However, evidence for this presumption is sparse. (more…)
Aging, Author Interviews, Depression, Geriatrics, Hip Fractures / 16.01.2017

MedicalResearch.com Interview with: Sanna Torvinen-Kiiskinen MSc (Pharm.), PhD student, Kuopio Research Centre of Geriatric Care and School of Pharmacy University of Eastern Finland MedicalResearch.com: What is the background for this study? Response: Antidepressants are widely used among elderly persons, especially persons with Alzheimer’s disease. They are used not only for treatment for major depression, but for treatment of anxiety, insomnia and chronic pain as well as behavioral symptoms caused by dementia. However, antidepressants, as well as other psychotropic drugs, may cause sedation, confusion, orthostatic hypotension and hyponatremia, which increase the risk of falling and fractures. Because of changes in pharmacodynamics and pharmacokinetics due to aging, older persons are at the higher risk of those adverse events. The aim of our study was to investigate whether antidepressant use is associated with an increased risk of hip fracture among community-dwelling persons with and without Alzheimer’s disease. (more…)
Author Interviews, Cancer Research, JAMA, Orthopedics / 06.01.2017

MedicalResearch.com Interview with: Charles L. Shapiro, MD Professor of Medicine Co-Director of Dubin Breast Center Director of Translational Breast Cancer Research Director of Cancer Survivorship, Tisch Cancer Institute Mount Sinai Health System Division of Hematology / Medical Oncology: Tisch Cancer Institute New York, NY 10029 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Metastases to bone are frequent in many cancers and cause pain, pathological fractures, necessitate surgical and/or radiation treatments, cause spinal chord compression that can lead to paralysis, and significantly increase health care costs. Zoledronic acid, a bisphosphonate that inhibits bone resorption, is used in standard practice because it reduces the risks skeletal-related events including cancer-related pathological fractures, the need for surgery and/or radiation to bone metastases, and spinal chord compression in patients with breast cancer, prostate cancer and multiple myeloma. However, the optimal dosing interval for zoledronic acid is unknown and based on prior studies and empiricism it is administered monthly along with anti-cancer treatments. In this trial, over 1800 breast cancer, prostate cancer and multiple myeloma patients with bone metastases were randomized to the standard dosing interval of monthly zoledronic acid versus every 3-months zoledronic acid for a duration of two years. The results overall, and in each specific disease site, show that giving zoledronic acid once every 3-months as opposed to monthly did not result in any increase in skeletal-related events. (more…)
Author Interviews, Cost of Health Care, JAMA, Medicare, Orthopedics, University of Pennsylvania / 06.01.2017

MedicalResearch.com Interview with: Amol Navathe, MD PhD University of Pennsylvania Staff Physician, CHERP, Philadelphia VA Medical Center Assistant Professor of Medicine and Health Policy, Perelman School of Medicine Senior Fellow, Leonard Davis Institute of Health Economics, The Wharton School Co-Editor-in-Chief, HealthCare: the Journal of Delivery Science and Innovation MedicalResearch.com: What is the background for this study? Response: Bundled payments pay a fixed price for an episode of services that starts at hospital admission (in this case for joint replacement surgery) and extends 30-90 days post discharge (30 days in this study). This includes physician fees, other provider services (e.g. physical therapy), and additional acute hospital care (hospital admissions) in that 30 day window. (more…)
Author Interviews, Dermatology, Orthopedics / 02.01.2017

MedicalResearch.com Interview with: Hsien-Yi Chiu, MD/ Tsen-Fang Tsai, MD Department of Dermatology, National Taiwan University Hospital Taipei, Taiwan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Psoriasis is a chronic, immune-mediated disorder, characterized by red, itchy and scaly skin patches. Over the past several years, accumulating research had shown the effects of psoriasis go far deeper than the skin and psoriasis is associated with multiple comorbidities. Psoriasis shares the inflammatory pathways and several contributing factors with avascular necrosis (AVN), a bone disease presented with death of trabecular bone and collapse of the bony structure. However, previous studies mostly focus on evaluation the increased risk of cardiovascular diseases in patients with psoriasis. No large scale studies have previously explored a potential association between psoriasis and AVN. Our nationwide population-based cohort study investigated this risk in 28268 patients with psoriasis registered in the Taiwan National Health Insurance Research Database. The patients were matched, by age and sex, with 113072 controls without psoriasis. Both the patients and controls were followed to identify those who subsequently diagnosed with an AVN. The results showed that psoriasis was associated with a disease severity–dependent increase in avascular necrosis risk. Moreover, AVN risk was positively associated with male sex, age younger than 30 years, corticosteroid use, severe psoriasis, and concomitant psoriatic arthritis. People with severe psoriasis were 3 times more likely to develop AVN compared with the control group. (more…)
Author Interviews, Heart Disease, Occupational Health, Orthopedics / 31.12.2016

MedicalResearch.com Interview with: Kurt T. Hegmann, M.D., M.P.H. Director, Rocky Mtn. Center for Occupational and Environmental Health Chief, Division of Occupational and Environmental Health The University of Utah Health Care MedicalResearch.com: What is the background for this study? Response: This line of work for us began approximately 20 years ago. Normal tendons never rupture, as the weak point when loading the muscle-tendon unit is either the muscle-tendon junction (i.e., a true muscle strain) or bone-tendon junction. Researchers in the 1960s reported there is poor blood supply in the area of rotator cuff tendon tears, providing one of the two main etiological theories of rotator cuff tears. The other main theory is “impingement syndrome” or a biomechanical impingement in the shoulder joint. Though who experience this might find that they need something similar to this shoulder dislocation surgery. Naturally, both theories could co-exist. Next, we noted rotator cuff tendinitis and shoulder risks from tobacco in other studies. We also reported prior research of increased risks with obesity. These led us to the theory that these rotator cuff tears are likely vascular in etiology. The next problem was to show this. (more…)
Author Interviews, BMJ, Orthopedics / 28.12.2016

MedicalResearch.com Interview with: Daniel Bonanno Lecturer & 3rd Year Podiatry Co-ordinator Discipline of Podiatry, College of Science, Health, and Engineering La Trobe University Victoria Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Foot orthoses and shock-absorbing insoles are commonly used for the prevention of many musculoskeletal disorders of the lower extremity, so this review summarized the findings of existing clinical trials that evaluated their effectiveness for preventing such injuries. The main findings of our review were that foot orthoses were found to be effective for preventing overall injuries and stress fractures, but not soft-tissue injuries. Regarding shock-absorbing insoles, there is no evidence to date to support their use for the prevention of injury. (more…)
Author Interviews, NEJM, Orthopedics, Surgical Research, Thromboembolism / 06.12.2016

MedicalResearch.com Interview with: Suzanne C. Cannegieter, M.D., Ph.D. Einthoven Laboratory Leiden University Medical Center The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients who undergo arthroscopic knee surgery and patients who are treated with casting of the lower leg are at increased risk for venous thromboembolism (VTE). It is uncertain whether thromboprophylaxis is effective in these situations to prevent VTE. For both indications, several trials have been performed to evaluate the effectiveness of anticoagulant prophylaxis. However, an overall risk–benefit balance could not be established because of methodologic shortcomings; hence, there has been reluctance to establish international guidelines regarding the use of anticoagulant therapy for either of these indications. (more…)
Author Interviews, Blood Pressure - Hypertension, Bone Density, JAMA, Kaiser Permanente, Osteoporosis, Pharmacology / 22.11.2016

MedicalResearch.com Interview with: Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096 MedicalResearch.com: What is the background for this study? Response: Hypertension (HTN) and osteoporosis (OP) are age-related disorders. Both increase rapidly in prevalence after age 65 years. Prior retrospective, post hoc studies have suggested that thiazide diuretics may decrease the risk of osteoporosis. These studies, by their nature, are open to bias. Moreover, these studies have not examined the effects of other anti HTN medications on osteoporosis. Here we used a prospective blood pressure study of ~5 years duration to examine the effects of a thiazide diuretic, a calcium channel blocker and an ACE inhibitor on hip and pelvic fractures. We chose these fractures since they are almost always associated with hospitalization and thus their occurrence can be verified. After the conclusion of the study we added another several years of follow up by querying medicare data sets for hip and pelvic fractures in those participants with medicare coverage after the study conclusion. (more…)
Author Interviews, Endocrinology, Hormone Therapy, JCEM, Menopause, Osteoporosis / 20.11.2016

MedicalResearch.com Interview with: Dr Georgios Papadakis FMH, Médecin InternenMédecin assistant Service d'endocrinologie, diabétologie et métabolisme Lausanne MedicalResearch.com: What is the background for this study? Response: This study was mainly motivated by the absence of available data on the effect of menopausal hormone therapy (MHT) on bone microarchitecture, as well as contradictory results of previous trials regarding the persistence of a residual effect after MHT withdrawal. We performed a cross-sectional analysis of 1279 postmenopausal women aged 50-80 years participating in OsteoLaus cohort of Lausanne University Hospital. Participants had bone mineral density (BMD) measurement by dual X-ray absorptiometry (DXA) at lumbar spine, femoral neck and total hip, as well as assessment of trabecular bone score (TBS), a textural index that evaluates pixel grey-level variations in the lumbar spine DXA image, providing an indirect index of trabecular microarchitecture. (more…)
Author Interviews, Orthopedics, Pain Research, Smoking, Surgical Research / 31.10.2016

MedicalResearch.com Interview with: Dr. David Kusin MD University of Nebraska Medical Center Omaha MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is a wealth of research showing that cigarette smoking impairs healing through various mechanisms, including microvascular injury. Some evidence also suggests that tobacco use results in direct neurological injury to the peripheral and central nervous systems. Many studies have also shown that smoking reduces fusion rates and time to fusion in orthopedic surgery, including cervical surgery. Prior to our work, only a few high quality studies had been conducted to investigate prognostic factors in patients undergoing surgery for cervical myelopathy, and these identified smoking as a risk factor for a poorer outcome. The purpose of our study was to investigate this relationship further. We conducted a retrospective cohort study of 87 nonsmokers and 47 smokers and correlated postoperative change in Nurick score (a measure of severity of cervical myelopathy from 0-5 with 5 being the worst) with smoking status. After controlling for age, sex, diabetes, duration of preoperative symptoms, severity of preoperative symptoms, signal change on MRI, surgical approach, number of spinal levels operated on, and alcohol use, we found that smokers had a significantly decreased improvement in Nurick score. Nonsmokers improved by 1.5 points whereas smokers only improved by 0.6 points. We also found that this was a dose response relationship, such that those with a history of greater tobacco use by pack years or packs per day had a greater decrease in improvement postoperatively. Interestingly, we found no correlation between tobacco use and preoperative severity of symptoms. (more…)
Author Interviews, Hip Fractures, Orthopedics, Surgical Research / 27.10.2016

MedicalResearch.com Interview with: Tom Withers Research Student, School of Health Sciences University East Anglia Norwich, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is a lot of subjective evidence to suggest that physical activity does not improve following hip replacement we wanted to therefore synthesise the current evidence to come to a more objective conclusion. The main finding from this study is that physical activity does not significantly change pre-operatively compared to up to one year post-operatively. (more…)
Author Interviews, Endocrinology, Menopause, Osteoporosis / 27.10.2016

MedicalResearch.com Interview with: Pauline Camacho, MD, FACE Professor, Endocrinology Director, Loyola University Osteoporosis and Metabolic Bone Disease Center, Fellowship Program Director, Endocrinology, Medical Director, Osteoporosis Center MedicalResearch.com: What is the background for this report? What is the prevalence and significance of osteoporosis in US women? Response: Osteoporosis is widely prevalent and is increasing in prevalence not only in the US but also around the world. 10.2 million Americans have osteoporosis and that an additional 43.4 million have low bone mass. More than 2 million osteoporosis-related fractures occur annually in the US, more than 70% of these occur in women ( from National Osteoporosis Foundation (NOF) estimates). (more…)
Author Interviews, Cost of Health Care, Orthopedics / 26.10.2016

MedicalResearch.com Interview with: Kelechi Okoroha, M.D. Orthopaedic Surgery House Officer Henry Ford Health System MedicalResearch.com: What is the background for this study? What are the main findings? Response: Historically, patient perceptions of surgeon reimbursement have been exaggerated compared with actual reimbursement. Currently there has been an increased focus or reducing health care cost, increasing access to health care and a shift to tie Medicare and insurance reimbursement to quality outcomes. Among these changes was the reduction in reimbursement payments for orthopedic surgeons. When we polled over 200 of our clinic patients, we found that most patients don’t think an orthopedic surgeon is overpaid but they greatly exaggerate how much a surgeon is reimbursed by Medicare for performing knee surgery. When told of the reimbursement payments, patients found them too be low and said they would be willing to pay more out-of-pocket costs. Patients also believe a surgeon should be compensated more for having fellowship training. • Nearly 90 percent of patients say physicians are not overpaid and their salaries should not be cut. • 61 percent of patients say a surgeon’s salary should not be tied to outcomes. • 79 percent of patients say reimbursement to drug and device companies should be reduced. (more…)
Author Interviews, BMJ, Orthopedics, Technology / 26.10.2016

MedicalResearch.com Interview with: Jason Busse PhD Associate Professor, Department of Anesthesia McMaster University Hamilton, ON MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our group previously reviewed the evidence regarding the effectiveness of low-intensity pulsed ultrasound (LIPUS) for fracture healing. We found moderate to very low quality evidence for LIPUS in accelerating functional recovery among patients with fracture, and that most trials only explored effects on surrogate outcomes (e.g. radiographic healing); only five of 13 trials directly assessed functional end points - of these, one was positive. We concluded that large trials of high methodological quality, focusing on patient important outcomes such as quality of life and return to function, were needed to establish the role of LIPUS in fracture healing. We have now completed such a study. Our large, international trial of LIPUS for surgically managed tibial fractures found the addition of LIPUS does not improve functional recovery or accelerate radiographic healing. (more…)
Author Interviews, Lancet, Orthopedics, Stem Cells / 21.10.2016

MedicalResearch.com Interview with: Professor Ivan Martin, PhD Department of Surgery and Department of Biomedicine University Hospital Basel University of Basel Basel, Switzerland MedicalResearch.com: What is the background for this study and new use of autologous nasal chondrocytes? Response: We previously demonstrated that nasal chondrocytes, harvested from the nasal septum, have a larger and more reproducible capacity to form new cartilage than articular chondrocytes, harvested from the knee joint. We further established that the cartilage tissue generated by nasal chondrocytes can respond to physical forces (mechanical loads) similar to articular cartilage and has the ‘plasticity’ to adapt to a joint environment, since it efficiently integrated with surrounding articular cartilage when implanted in goat joints. This was the rationale for using nasal chondrocytes for articular cartilage repair. (more…)
Author Interviews, Columbia, NEJM, Orthopedics, Osteoporosis / 21.09.2016

MedicalResearch.com Interview with: Felicia Cosman, M.D. Medical Director of the Clinical Research Center Helen Hayes Hospital Professor of Medicine Columbia University College of Physician and Surgeons New York Editor-in-Chief, Osteoporosis International MedicalResearch.com: What is the background for this study? What are the main findings? Response: Amgen and UCB presented detailed data from the Phase 3 FRAME study in an oral session at ASBMR 2016, and the data were also published in the New England Journal of Medicine. Additionally, the FRAME abstract has been awarded the 2016 ASBMR Most Outstanding Clinical Abstract Award. The FRAME data show significant reductions in both new vertebral and clinical fractures in postmenopausal women with osteoporosis. Patients receiving a monthly subcutaneous 210 mg dose of romosozumab experienced a statistically significant 73 percent reduction in the relative risk of a vertebral (spine) fracture through 12 months, the co-primary endpoint, compared to those receiving placebo (fracture incidence 0.5 percent vs. 1.8 percent, respectively [p<0.001]). By six months, new vertebral fractures occurred in 14 romosozumab and 26 placebo patients; between six to 12 months, fractures occurred in two versus 33 additional patients in each group, respectively. Patients receiving romosozumab experienced a statistically significant 36 percent reduction in the relative risk of a clinical fracture, a secondary endpoint, through 12 months compared to those receiving placebo (fracture incidence 1.6 percent vs. 2.5 percent, respectively [p=0.008]). In patients who received romosozumab in year one, fracture risk reduction continued through month 24 after both groups transitioned to denosumab treatment through the second year of the study: there was a statistically significant 75 percent reduction in the risk of vertebral fracture at month 24 (the other co-primary endpoint) in patients who received romosozumab followed by denosumab vs. placebo followed by denosumab (fracture incidence 0.6 percent vs. 2.5 percent, respectively [p<0.001]). Clinical fractures encompass all symptomatic fractures (both non-vertebral and painful vertebral fractures; all clinical fractures assessed in the FRAME study were symptomatic fragility fractures. A 33 percent reduction in relative risk of clinical fracture was observed through 24 months after patients transitioned from romosozumab to denosumab compared to patients transitioning from placebo to denosumab (nominal p=0.002, adjusted p=0.096). (more…)
Author Interviews, MRI, Orthopedics, Radiology / 15.09.2016

MedicalResearch.com Interview with: Muyibat Adelani, MD Assistant Professor of Orthopaedic Surgery Washington University St. Louis MedicalResearch.com: What is the background for this study? What are the main findings? Response: In our practice, we noticed that more patients are coming in already having had MRIs. We wanted to know how many people actually had weight-bearing knee x-rays before the MRI. We found that only a quarter of patients had weight-bearing x-rays before the MRI. We found that half of the MRIs obtained prior to referral to an orthopaedic surgeon did not contribute to the patient's treatment. (more…)
Author Interviews, JAMA, Orthopedics / 12.09.2016

MedicalResearch.com Interview with: R. Grant Steen, PhD Medical Affairs, Bioventus LLC Durham, North Carolina MedicalResearch.com: What is the background for this study? What are the main findings? Response: When we started this research, it was really only guesswork as to how big a problem fracture nonunion really is. What we've done is to work with an enormous database of patient health claims, with two goals. First, we wanted to characterize how common fracture nonunion is among patients across a wide age range. Second, we wanted to identify risk factors that make a patient more likely to have problems healing. We've now succeeded in both aims. We know that roughly 5% of fracture patients will go to nonunion, and we know a whole host of risk factors that predispose them to do so. Most of the risk factors that we've identified—with a few exceptions—would not be a surprise to physicians who treat fracture patients. However, what we've done is to put all of these risk factors in a broader context, so that we know which risk factors are most important and which are less so. For example, it has been known for a long time that smoking is a risk factor for nonunion. What we've shown is that, in the scheme of things, it's not all that important. Let me be more precise here, because this is an important point. If all you know about a patient is that they smoke, we've shown that smoking is associated with a 62% increase in risk of nonunion. That's a lot. But, as you learn more about that patient and can factor that new knowledge into a risk prediction, it turns out that smoking, all by itself, increases the risk of nonunion by only about 20%. However, smoking is a surrogate marker for a range of other risk factors that also increase risk, including male gender, cardiovascular disease, obesity, vitamin D deficiency, alcoholism, and so on. Once you factor these separate risk factors into your new nonunion prediction, you have a much more nuanced—and probably much more accurate—prediction of nonunion risk. (more…)
Author Interviews, Columbia, Depression, Nature, Orthopedics, Pharmacology / 09.09.2016

MedicalResearch.com Interview with: Patricia Ducy, PhD Associate Professor Department of Pathology & Cell Biology Columbia University New York, NY 10032 MedicalResearch.com: What is the background for this study? Response: In the past few years, several large clinical studies have reported an association between the use of selective serotonin reuptake inhibitors (SSRIs) and an increased risk of bone fractures. Yet, a few studies conducted on small cohorts using these drugs for a short time showed a decrease in bone resorption parameters and thus minor bone gain. To understand this paradox and to define how the deleterious effect of SSRIs could be prevented we conducted a series of studies in mice treated with fluoxetine, the active molecule of the widely prescribed SSRI Prozac. (more…)
Author Interviews, Orthopedics / 26.08.2016

MedicalResearch.com Interview with: Brandon J. Erickson, MD Midwest Orthopaedics Rush, Rush University Medical Center Chicago, IL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Ulnar collateral ligament reconstruction (UCLR), also known as Tommy John surgery has become a common procedure amongst major league baseball (MLB) pitchers. It is unclear if a limit on innings pitched following Tommy John surgery should be instituted to prevent revision Tommy John surgery. The purpose of this study was to determine if innings pitched following Tommy John surgery is associated with an increased risk of revision Tommy John surgery amongst MLB pitchers. To answer this question we located all MLB pitchers between 1974-2015 who pitched at least one full season following their Tommy John surgery and included them in our analysis. Pitch counts and innings pitched for the first full season following Tommy John surgery as well as total pitch count and total innings pitched over the course of the player’s career were recorded. Pitch counts and innings pitched were compared amongst players who required revision Tommy John surgery and those who did not. We were able to include 154 pitchers. Of these, 135 pitchers did not require revision Tommy John surgery while 19 underwent revision Tommy John surgery.  No significant difference existed between pitchers who underwent revision Tommy John surgery and those who did not when comparing number of innings pitched in the season following Tommy John surgery,  number of pitches thrown in the season following Tommy John surgery,  number of innings pitched in the pitcher’s career following Tommy John surgery and number of pitches thrown in the pitcher’s career following Tommy John surgery.  Furthermore, no difference existed in revision rate between pitchers who pitched more or less than 180 innings in the first full season following Tommy John surgery. (more…)
Author Interviews, Frailty, Hip Fractures, JAMA, Pharmacology / 22.08.2016

MedicalResearch.com Interview with: Jeffrey Munson, MD, MSCE Assistant Professor The Dartmouth Institute for Health Policy & Clinical Practice Assistant Professor, Department of Medicine Geisel School of Medicine at Dartmouth MedicalResearch.com: What is the background for this study?  Response: Fragility fractures due to osteoporosis are a common and costly event among older Americans. Patients who experience one fragility fracture are at increased risk to have a second fracture. Our group is interested in exploring ways in which the risk of a second fracture could be reduced. In this paper, we studied prescription drug use both before and after fracture. We know many prescription drugs have been shown to increase the risk of fracture, but we don’t know whether doctors try to reduce the use of these drugs after a fracture has occurred. Our study was designed to answer this question. (more…)