Entity

Time filter

Source Type

San Francisco, CA, United States

Miller L.E.,Miller Scientific Consulting Inc. | Block J.E.,The Jon Block Group
Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders | Year: 2013

We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and effcacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07-1.37 (all P< 0.001). Compared to saline controls, SMDs with IAHA ranged from 0.38-0.43 for knee pain and 0.32-0.34 for knee function (all P<0.001). There were no statistically significant differences between IAHA and saline controls for any safety outcome, including serious adverse events (SAEs) (P = 0.12), treatment-related SAEs (P = 1.0), study withdrawal (P = 1.0), and AE-related study withdrawal (P = 0.46). We conclude that intra-articular injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis. © the author(s), publisher and licensee Libertas Academica Ltd. Source


London N.J.,Harrogate District Foundation Trust | Miller L.E.,Miller Scientific Consulting Inc. | Miller L.E.,The Jon Block Group | Block J.E.,The Jon Block Group
Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders | Year: 2013

The purpose of this study was to (1) evaluate joint pain and function in knee osteoarthritis (OA) patients treated with a joint-sparing, extracapsular implant and (2) identify patient characteristics that influenced clinical outcomes. This study included 99 patients with symptomatic medial knee OA refractory to conservative care who were treated with the KineSpring Knee Implant System and followed for a mean of 17 months (range, 1.5 to 48 months). All devices were successfully implanted and activated with no intraoperative complications. Statistically significant mean improvements of 56%, 50%, and 38% were observed for Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Function, and Stiffness scales, respectively (all P < 0.001). Regardless of gender, age group, body mass index classification, or disease severity, all WOMAC domain scores significantly improved during the postoperative follow-up period. WOMAC clinical success rates were 77.8% for Pain, 77.8% for Function, and 68.7% for Stiffness. Neither gender, age group, body mass index classification, nor disease severity predicted clinical success in any WOMAC domain. In conclusion, the KineSpring System yields clinically meaningful improvements in joint pain and function in patients with medial knee OA. Additionally, unlike joint-altering procedures such as knee arthroplasty or high tibial osteotomy, patient characteristics had little association with postoperative clinical outcomes. © the author(s), publisher and licensee Libertas Academica Ltd. Source


Bhandari M.,McMaster University | Miller L.E.,Miller Scientific Consulting Inc. | Miller L.E.,The Jon Block Group | Block J.E.,The Jon Block Group
Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders | Year: 2012

Surgery is indicated for symptomatic knee osteoarthritis (OA) when conservative measures are unsuccessful. High tibial osteotomy (HTO), unicompartmental knee arthroplasty (UKA), and total knee arthroplasty (TKA) are surgical options intended to relieve knee OA pain and dysfunction. The choice of surgical intervention is dependent on several factors such as disease location, patient age, comorbidities, and activity levels. Regardless of surgical treatment, complications such as infection, loosening or lysis, periprosthetic fracture, and postoperative pain are known risks and are indications for revision surgery. The clinical and economic implications for revision surgery are underappreciated. Over 55,000 revision surgeries were performed in 2010 in the US, with 48% of these revisions in patients under 65 years. Total costs associated with each revision TKA surgery have been estimated to be in excess of $49,000. The current annual economic burden of revision knee OA surgery is $2.7 billion for hospital charges alone. By 2030, assuming a 5-fold increase in the number of revision procedures, this economic burden will exceed $13 billion annually. It is appealing to envision a therapy that could delay or obviate the need for arthroplasty. From an actuarial standpoint, this would have the theoretical downstream effect of substantially reducing the number of revision procedures. Although no known therapies currently meet these criteria, such a breakthrough would have a tremendous impact in lessening the clinical and economic burden of knee OA revision surgery. © the author(s), publisher and licensee Libertas Academica Ltd. Source


Miller L.E.,Miller Scientific Consulting Inc. | Miller L.E.,The Jon Block Group | Carlton Reckling W.,Si Bone Inc. | Block J.E.,The Jon Block Group
Medical Devices: Evidence and Research | Year: 2013

Background: The sacroiliac joint is a common but under-recognized source of low back and gluteal pain. Patients with degenerative sacroiliitis or sacroiliac joint disruption resistant to nonsurgical treatments may undergo open surgery with sacroiliac joint arthrodesis, although outcomes are mixed and risks are significant. Minimally invasive sacroiliac joint arthrodesis was developed to minimize the risk of iatrogenic injury and to improve patient outcomes compared with open surgery. Methods: Between April 2009 and January 2013, 5319 patients were treated with the iFuse SI Joint Fusion System® for conditions including sacroiliac joint disruption and degenerative sacroiliitis. A database was prospectively developed to record all complaints reported to the manufacturer in patients treated with the iFuse device. Complaints were collected through spontaneous reporting mechanisms in support of ongoing mandatory postmarket surveillance efforts. Results: Complaints were reported in 204 (3.8%) patients treated with the iFuse system. Pain was the most commonly reported clinical complaint (n = 119, 2.2%), with nerve impingement (n = 48, 0.9%) and recurrent sacroiliac joint pain (n = 43, 0.8%) most frequently cited. All other clinical complaints were rare (<0.2%). Ninety-six revision surgeries were performed in 94 (1.8%) patients at a median follow-up of four (range 0-30) months. Revisions were typically performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n = 46, 0.9%) or to correct an improperly sized implant in an asymptomatic patient (n = 10, 0.2%). Revisions in the late postoperative period were performed to treat symptom recurrence (n = 34, 0.6%) or for continued pain of undetermined etiology (n = 6, 0.1%). Conclusion: Analysis of a postmarket product complaints database demonstrates an overall low risk of complaints with the iFuse SI Joint Fusion System in patients with degenerative sacroiliitis or sacroiliac joint disruption. © 2013 Miller et al, publisher and licensee Dove Medical Press Ltd. Source


Miller L.E.,Miller Scientific Consulting Inc. | Miller L.E.,The Jon Block Group | Block J.E.,The Jon Block Group
Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders | Year: 2014

Numerous nonsurgical interventions have been reported to improve symptoms of knee osteoarthritis (OA) over the short term. However, longer follow-up is required to accurately characterize outcomes such as cost effectiveness and delayed arthroplasty. A total of 553 patients with symptomatic knee OA who previously underwent a single 8-week multimodal treatment program were contacted at 1 year (n = 336) or 2 years (n = 217) follow-up. The percentage of patients who underwent knee arthroplasty was 10% at 1 year and 18% at 2 years following program completion. The treatment program was highly cost effective at $12,800 per quality-adjusted life year at 2 years. Cost effectiveness was maintained under a variety of plausible assumptions and regardless of gender, age, body mass index, disease severity, or knee pain severity. In summary, a single 8-week multimodal knee OA treatment program is cost effective and may lower knee arthroplasty utilization through 2 years follow-up. © the authors, publisher and licensee Libertas Academica Limited. Source

Discover hidden collaborations