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In 2008, Harrop et al. published a systematic review of lumbar disc replacement data and reported that in patients with three to 22 years of follow-up, total disc replacement resulted in a 9% adjacent segment degeneration rate, whereas lumbar fusion resulted in a 34% rate. Later, in 2012, Zigler et al. worked with Medical Metrics Incorporated (MMI) to conduct a post-hoc analysis on ProDisc-L IDE subjects and found a three-fold reduction in ASD rates between lumbar TDR and fusion at five years. MMI employed the same methods used in Zigler et al., 2012 to analyze the ASD outcomes from the activL Artificial Disc IDE trial. Until recently, patient access to lumbar arthroplasty, or total disc replacement, for patients suffering from symptomatic degenerative disc disease has been a challenge due to the lack of coverage on many insurance policies. However, outcomes such as those presented by Dr. Guyer have caused payers to reconsider their policies. In May, national insurer Humana, which is responsible for insuring more than six million American lives, overturned their coverage determination for lumbar total disc replacement. This policy change, along with others, resulted in now nearly one in two privately-insured Americans having access to lumbar disc replacement. Additional long-term evidence will likely cause more payers to reconsider their stance in the coming months. A group of surgeon investigators from the activL Artificial Disc IDE trial are currently compiling the full outcomes of this ASD analysis and are expected to seek publication of the full data set later this year. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-long-term-data-on-the-effect-of-lumbar-total-disc-replacement-on-adjacent-level-degeneration-reinforces-outcomes-from-previous-studies-300453436.html

The present disclosure describes a method for determining spinal instability, more particularly, a method for quantifying the type and extent of spinal instability in a standardized way. The disclosure also describes a method comprising measurement of the intervertebral rotation and intervertebral translation between a vertebrae pair using simple images, and from these measurements, determining if one or more vertebrae pair of the spine is unstable. Finally, the disclosure describes software that may be used to quantify the type and extent of spinal instability.

News Article | May 16, 2017
Site: www.businesswire.com

LEXINGTON, Ky.--(BUSINESS WIRE)--Additional findings at the six-month juncture from its early safety and feasibility study, Intralink-Spine, Inc. (ILS) indicates that the Réjuve™ System effectively eliminates or reduces low back pain. “We’ve demonstrated the safety of this device, and it has performed as expected. The dramatic pain reduction in these patients correlated with some objective measures: there was an average increase in lumbar range of motion of 9 degrees and there was a statistically significant 25% increase in treated level lordosis, based on kinematic data analysis performed by Medical Metrics Inc. Decreased lumbar lordosis is known to be related to disc degeneration and back pain, especially when standing,” states Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky. “I was also excited to see that the only symptomatic disc in these first few low back pain patients that was shown to be clinically unstable pre-treatment (QSI = 2.5, meaning the instability as quantified by translation per degree of rotation (TPDR) was 2.5 standard deviations above the mean for an asymptomatic, radiographically normal population) was effectively stabilized by the Réjuve treatment. This previously symptomatic and unstable segment was asymptomatic (no pain and no disability at 1 month through 6 months) and stable with a normal TPDR (QSI = -0.1). This result illustrates and affirms one of the mechanisms for pain relief associated with this product,” says Dr. Hedman. “After a six-month period, 80% of patients had excellent results (pain and disability reduced >50%). Patient data are also showing the Réjuve Treatment is “fast acting” – treatment effects seen at 2-weeks post-procedure continued or improved through 6-months in 80% of patients treated. Think of it, the positive effects of Réjuve are both rapid and long-lasting,” says Lyle Hawkins, CEO of Intralink-Spine, Inc. “Low back pain (LBP) is a challenging condition to treat, which is why we’re excited about our data thus far and another reason we’re excited about our studies underway in Malaysia and Canada.” About Intralink Spine, Inc.(ILS): formed to manufacture and exclusively sell the Réjuve™ injectable medical device to treat Degenerative Disc Disease (DDD), low back pain, and related spinal diseases such as scoliosis. ILS is currently conducting a Round C for qualified investors.

TORONTO, ON--(Marketwired - April 12, 2017) - During a live broadcast on Wednesday, April 26, 2017, a panel of experts will discuss and examine embolic protection devices and the potential impact these may have on TAVR patients. Transcatheter aortic valve replacement (TAVR) or implantation (TAVI) demonstrably changed the treatment of high-risk patients with severe aortic stenosis, particularly those at high risk for surgical replacement of the aortic valve. However, greater acceptance of TAVR also raised concerns of complications, particularly increased risks for stroke or neurological and cognitive impairments from embolic events. The entry of embolic protection devices (EPD) into the European market, with designs that deflect or collect potentially damaging micro-debris associated with TAVR, presents an evolving risk-reduction safety strategy to manage patients with frail health or existing comorbidities. This webinar explores the potential for EPDs as well as factors Novella Clinical and Medical Metrics believe sponsors should consider when developing or using EPDs in clinical trials. To learn more about this complimentary event visit: Clinical Trial Considerations in Cerebral Protection for TAVR Patients -- An Examination of Study Design, Endpoints and Imaging Methods Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit: http://xtalks.com

Sasso R.C.,Indiana University | Metcalf N.H.,Medtronic Inc. | Hipp J.A.,Medical Metrics Inc. | Wharton N.D.,Medical Metrics Inc. | Anderson P.A.,University of Wisconsin - Milwaukee
Spine | Year: 2011

Study Design.: Prospective, randomized, Food and Drug Administration Investigational Device Exemption trial from one study site. Objective.: Examine the radiographic sagittal alignment of the Bryan cervical disc for one-level disease. Summary of Background Data.: Prospective, randomized studies demonstrate Bryan arthroplasty provides statistically better functional outcomes than anterior cervical discectomy and fusion. Uncontrolled case reports describe kyphosis after disc replacement. No prospective study has critically assessed sagittal alignment after cervical arthroplasty. Methods.: Forty-eight patients reviewed with a minimum follow-up of 2 years. Quantitative motion analysis determined the change in overall (C2-C7) and treatment-level sagittal alignment, disc space heights, and range of motion. Results.: Preoperatively, overall sagittal alignment was equivalent in the two groups. At 24-month follow-up, overall lordosis for the cohorts was not statistically different from preoperative values for each group. In addition, overall lordosis was not significantly different at 24 months when comparing Bryan patients with the fusion patients. The average change in disc angle from preoperative to immediate postoperative at the treated level in the Bryan disc group was a nonsignificant increase in lordosis of 0.92°. The anterior disc height was the same at all time points, but the posterior disc height was slightly (0.7 mm) more in the Bryan than in the fusion patients (P = 0.04). The angular range of motion in the Bryan group was statistically equivalent at all time points. At the fused levels, average range of motion decreased from 6.4° to 0.9° at 24 months (P < 0.0001). Conclusion.: With the Bryan disc, there was an insignificant increase in lordosis of 0.9° at immediate postoperative time point. Overall cervical sagittal alignment is not different between the experimental and control populations. This prospective study does not demonstrate a clinically significant increase in segmental kyphosis after Bryan disc arthroplasty. Global cervical lordosis is statistically equivalent between arthroplasty and fusion groups at 2 years follow-up. Copyright © 2011 Lippincott Williams & Wilkins.

Ghiselli G.,Rose Spine Institute | Wharton N.,Medical Metrics Inc | Hipp J.A.,Medical Metrics Inc | Wong D.A.,DenverSpine | Jatana S.,DenverSpine
Spine | Year: 2011

Study Design. A prospective comparison of quantitative motion analyzed (QMA) flexion/extension radiographs versus computed tomography (CT) as an analytical predictor of cervical pseudarthrosis. Intraoperative confirmation of the fusion was performed. Objective. To prospectively compare motion analyzed flexion/extension radiographs to CT to predict pseudarthroses. Define motion thresholds on flexion/extension radiographs to define pseudarthroses. Summary Of Background Data. Assessment of postoperative fusion success is an important factor in assessing success after anterior cervical spine fusion. Gross intervertebral motion can be used as a measure; however, the current "gold standard" for determining fusion status is a CT to assess bridging bone. Defining the amount of intervertebral motion at the fusion site has been previously addressed and definitions have varied widely. Methods. Data were analyzed at 47 fusion segments. Intervertebral motion at the fusion site was measured from flexion/extension radiographs taken at least 1 year after the cervical spine fusion. Motion was quantified from digitized radiographs by an independent researcher using proprietary quantitative motion analysis (QMA) software. CT scans on all patients were analyzed for fusion status by a neuroradiologist. Those patients determined to have a symptomatic pseudarthrosis were revised and intraoperative motion at the facet joints was documented. Correlation between intraoperative findings, CT and QMA was performed. Results. Using greater than 4° of measured motion on flexion/extension radiographs resulted in a Spearman correlation P-value of 0.096 (95% confidence interval:-0.06 to 0.66). Using greater than 1° of motion, the Spearman correlation P < 0.0001 (95% CI: 0.54-0.90). The positive predictive value (PPV) using 4° of motion as the criterion was 100%, indicating a high specificity. The negative predictive value (NPV) was 52%, indicating a low sensitivity. Using greater than 1° of motion, the PPV was 100% and the NPV was 73%. Findings from CT showed an identical PPV and NPV to assessments made using greater than 1° of rotation. Specificity and positive predictive value were 100% for all criteria. Using a lack of bridging on CT or more than 1° of intervertebral motion during flexion/extension increased the sensitivity to 85% and the negative predictive value to 85%. Conclusion. A threshold level of 4° of motion is commonly used to identify a pseudarthrosis. Our prospective study suggests that this value has a high PPV, but a low specificity and would miss many of the pseudarthroses that have angular motion less than 4° (sensitivity 23%). By lowering the threshold for angular motion to 1°, the sensitivity improves to 77%. CT scan has been touted as the gold standard, and it has a high positive predictive value of 100%. However, its NPV was slightly lower than using 1° of motion on QMA analyzed flexion-extension films (73% vs. 79%). In conclusion, although CT scan has long been regarded as the gold standard for determining a pseudarthrosis in the cervical spine, the interpretation is subjective and vulnerable to both type I and type II errors. Analysis of motion using Quantitative Motion Analysis is seemingly less subjective than CT and in our prospective study was more predictive of an operatively confirmed pseudarthrosis. Copyright © 2011 Lippincott Williams &Wilkins.

Anderson P.A.,University of Wisconsin - Madison | Sasso R.C.,Indiana University | Hipp J.,Medical Metrics Inc | Norvell D.C.,Spectrum Research Inc | And 2 more authors.
Spine | Year: 2012

Study Design. Systematic review and meta-analysis. Objective. To determine the kinematics of the adjacent segments and global cervical spine after cervical arthroplasty compared with anterior cervical discectomy and fusion (ACDF). Summary of Background Data: Adjacent segment pathology after ACDF is a significant concern. Arthroplasty may decrease the risk of adjacent segment degeneration by maintaining normal spinal kinematics compared with fusion. However, the differences in the in vivo kinematics of the adjacent segments after cervical fusion versus arthroplasty have not been clearly established. Methods. A systematic literature review of studies comparing adjacent segment kinematic changes between fusion and arthroplasty was performed. We included randomized controlled trials and cohort studies that compared cervical arthroplasty with ACDF in adults with degenerative disease and reported on at least 1 outcome of interest. Meta-analysis was performed using a random-effects model where appropriate. The standardized mean difference of changes from baseline to follow-up between treatment groups was determined. Recommendations were made using Grades of Recommendation Assessment, Development, and Evaluation criteria. Results. We identified 12 studies, including 7 randomized controlled trials, 4 cohort studies, and 1 case-control study that evaluated kinematic measurements at the adjacent segments or the global cervical spine (C2-C7) after cervical arthroplasty compared with ACDF. We found no statistically significant differences between treatment groups in the change in range of motion (ROM) at the cranial or caudal adjacent segments from baseline to 2 years of follow-up. However, there was low evidence that the global cervical spine (C2-C7) had significantly greater change in ROM after arthroplasty compared with ACDF: patients had a greater angular ROM as measured up to 2 years after arthroplasty. We found no statistically significant differences between treatment groups in the change in the horizontal or vertical centers of rotation at the adjacent segments as measured up to 2 years after surgery. Regarding sagittal alignment, the cranial and caudal adjacent segments both became significantly more lordotic after arthroplasty compared with fusion at 1 to 2 years after surgery. However, there was no statistically significant difference between treatment groups in the change in global cervical sagittal alignment from baseline to 2 years. Conclusion. There is no statistically or clinically significant difference in the adjacent segment ROM or centers of rotation after cervical arthroplasty compared with ACDF. However, the change in sagittal alignment at the cranial and caudal adjacent segments was significantly more lordotic after arthroplasty compared with fusion. In addition, although we found that there was no statistically significant difference between treatment groups in the change in global cervical (C2-C7) sagittal alignment, there was a significantly greater change in the angular ROM of the cervical spine at up to 2 years after arthroplasty than occurred after fusion. Consensus Statement: Patients can be advised that single-level arthroplasty and ACDF result in clinically similar kinematic changes at short-term follow-up.Strength of Statement: Strong. Copyright © 2012 Lippincott Williams & Wilkins.

Medical Metrics Inc. | Date: 2011-02-14

Computer software for providing enhanced visualization, interpretation, and detection of differences between medical images.

Trautwein F.T.,Paradigm Spine | Lowery G.L.,Paradigm Spine | Wharton N.D.,Medical Metrics Inc. | Hipp J.A.,Medical Metrics Inc. | Chomiak R.J.,Paradigm Spine
Spine Journal | Year: 2010

Background context: The in vivo loading environment of load-bearing implants is generally largely unknown. Loads are typically approximated from cadaver tests or biomechanical calculations for the preclinical assessment of a device's safety and efficacy. Purpose: To determine the actual in vivo loading environment of an elastic interlaminar-interspinous implant (Coflex). Study design: A retrospective radiographic study to noninvasively measure the in vivo implant loads of 176 patients. Methods: For this study, neutral, flexion, and extension radiographs were quantitatively analyzed using validated image analysis technology. The angle between the Coflex arms was measured for each radiograph and statistically evaluated. Separately, the Coflex implant was characterized using mechanical test data and finite element analysis, which resulted in a load-deformation formula that describes the implant load as a function of its size and elastic deformation. Using the formula and the elastic implant deformation data obtained from the radiographic analysis, the exact implant load was calculated for each patient and each posture. For statistical analysis, the patients were grouped by indication and procedure, which resulted in 12 different groups. The determined loads were compared with the strength of the posterior lumbar spinal elements obtained from the literature and with the static and dynamic mechanical limits of the Coflex interlaminar-interspinous implant. Results: The force data were independent of implant size, diagnosis (with one exception), number of levels of the decompression procedure, number of levels of implantations (one or two), and follow-up time. The median compressive force acting on the Coflex implant was found to be 45.8 N. The maximum load change between flexion and extension was 140 N; the maximum overall load exceeded 239 N in extension. Conclusions: The average loads exerted by the Coflex implant on the spinous process and lamina are 11.3% and 7.0% of their respective static failure load. The implant fatigue strength is significantly higher than the measured median force, which explains the extremely rare observation of a Coflex fatigue failure. © 2010 Elsevier Inc. All rights reserved.

The present disclosure describes a method for determining spinal instability, more particularly, a method for quantifying the type and extent of spinal instability in a standardized way. The disclosure also describes a method comprising measurement of the intervertebral rotation and intervertebral translation between a vertebrae pair using simple images, and from these measurements, determining if one or more vertebrae pair of the spine is unstable. Finally, the disclosure describes software that may be used to quantify the type and extent of spinal instability.

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