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1.
RMD Open ; 5(2): e001005, 2019.
Article in English | MEDLINE | ID: mdl-31565244

ABSTRACT

Objective: This study aimed to report end-of-study results on efficacy and safety of secukinumab 150 mg through 5 years in patients with ankylosing spondylitis (AS; MEASURE 1 extension trial (NCT01863732)). Methods: After the 2-year core trial, 274 patients receiving subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) every 4 weeks were invited to enter the 3-year extension study. Dose escalation from 75 to 150 mg (approved dose) was allowed at or after week 156 based on the judgement of the treating physician. Assessments at week 260 (5 years) included Assessment of SpondyloArthritis international Society (ASAS) 20/40 and other efficacy outcomes. Data are presented as observed. Safety assessment included all patients who received ≥1 dose of study treatment. Results: Of the 274 patients who entered the extension study, 84% (230/274) completed 5 years of treatment. ASAS20/40 responses were 78.6/65.2%, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response was 63.4% and mean (±SD) BASDAI total score was 2.6±1.76 with secukinumab 150 mg at 5 years. Improvements in efficacy outcomes were sustained through 5 years. A total of 82 patients on secukinumab 75 mg (56.2%) had their dose escalated to 150 mg after week 168; ASAS40, ASAS-PR, ASAS 5/6 and BASDAI50 responses were improved in patients whose dose was escalated from secukinumab 75 to 150 mg. Secukinumab was well tolerated with a safety profile consistent over the course of the study. Conclusions: Secukinumab 150 mg provided sustained efficacy across multiple domains of AS with a favourable and consistent safety profile through 5-year treatment. Over 50% of patients required dose escalation from 75 to 150 mg and efficacy improved in these patients.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Receptors, Interleukin-17/antagonists & inhibitors , Societies, Medical/organization & administration , Spondylitis, Ankylosing/drug therapy , Administration, Intravenous , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Dose-Response Relationship, Drug , Humans , Injections, Subcutaneous , Male , Patient Safety , Placebos/administration & dosage , Severity of Illness Index , Spondylarthritis/epidemiology , Spondylitis, Ankylosing/diagnostic imaging , Treatment Outcome
2.
Article in English | MEDLINE | ID: mdl-28839448

ABSTRACT

Hyaluronic acid (HA) has been a treatment modality for patients with knee osteoarthritis (OA) for many years now. Since HA was first introduced for the treatment of painful knee OA, much has been elucidated regarding both the etiology of this disease and the mechanisms by which HA may mitigate joint pain and tissue destruction. The objectives of this article are to (1) describe the etiology and pathophysiology of OA including both what is known about the genetics and biochemistry, (2) describe the role of HA on disease progression, (3) detail the antinociceptive and anti-inflammatory actions of HA in OA, and (4) present evidence of disease-modifying effects of HA in the preservation and restoration of the extracellular matrix. These data support that HA is not only just a simple device used for viscosupplementation but also a biologically active molecule that can affect the physiology of articular cartilage.

4.
Adv Ther ; 33(12): 2200-2210, 2017 01.
Article in English | MEDLINE | ID: mdl-27813018

ABSTRACT

INTRODUCTION: Knee osteoarthritis is one of the leading causes of disability in the world. Intra-articular hyaluronic acid (IA-HA) is a treatment modality that provides a minimally invasive treatment option for the management of osteoarthritis-related symptoms. This study examined the current and potential economic impact of using a biologically derived, high molecular weight hyaluronic acid preparation (Euflexxa) on the US population for the management of knee osteoarthritis. METHODS: A model was developed to estimate the total number of patients with symptomatic knee osteoarthritis in the US in 2015, distributed by Kellgren-Lawrence (K-L) grade, and the number of people living with total knee arthroplasty (TKA). The potential utility of Euflexxa was applied to this model population to determine the current and potential impact of the treatment as the total number of quality adjusted life years (QALY) saved within the US population. RESULTS: There are approximately 12 million people currently suffering from symptomatic knee osteoarthritis in the US, and approximately 5 million living with TKA. It was estimated that, with a target treatment group of K-L grades 2-3, there are approximately 4 million patients eligible for treatment with a high molecular weight intra-articular hyaluronic acid injection. With current use, it is estimated that Euflexxa can save 36,730 QALY/year among the US population, and has the potential to save an additional 369,181 QALY/year if used by all eligible patients. CONCLUSIONS: This study demonstrates that more widely used, biologically derived, high molecular weight IA-HAs, such as Euflexxa, have the potential to save a substantial number of QALYs among the US population with symptomatic knee osteoarthritis. FUNDING: Ferring Pharmaceuticals Inc.


Subject(s)
Hyaluronic Acid/therapeutic use , Osteoarthritis, Knee/drug therapy , Quality of Life , Adult , Aged , Aged, 80 and over , Female , Humans , Injections, Intra-Articular , Male , Middle Aged , Osteoarthritis, Knee/epidemiology , United States/epidemiology
5.
Cartilage ; 7(3): 229-37, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27375838

ABSTRACT

INTRODUCTION: Intra-articular hyaluronic acid (IA-HA) injections are a treatment for knee osteoarthritis (OA), although current literature provides mixed results with regard to their efficacy. We will review a randomized controlled trial (RCT) and subsequent extension trial in order to identify factors that are associated with outcomes in patients with knee OA who received IA-HA. METHODS: We used data recorded by the FLEXX trial and extension trial for secondary analysis of potential prognostic factors. Linear regression was used to examine the predictors of outcomes at 6- and 12-month follow-up visits. RESULTS: Sixty percent of all patients presented with a Kellgren Lawrence (K-L) grade 3. Patients with high baseline outcome scores and a K-L grade 3 demonstrated less response than individuals within an earlier stage of knee OA, although results for both K-L grade 2 and K-L grade 3 patients still showed benefit. Those with more severe radiographic change K-L grade 3 often had a better response with the second series of IA-HA injections. Significantly greater positive response in all outcomes was demonstrated for the patient subgroup classified as K-L grade 2, when compared with K-L grade 3 patients. CONCLUSIONS: The results demonstrate that IA-HA for knee OA was of greater benefit in those with less severe radiographic changes. However, those with more severe radiographic change often had a better response with the second course of IA-HA. Similar analyses are required in order to determine if these results are unique to Euflexxa, or if these results are consistent with other available IA-HA agents.

6.
Adv Ther ; 33(6): 998-1011, 2016 06.
Article in English | MEDLINE | ID: mdl-27146676

ABSTRACT

INTRODUCTION: Osteoarthritis (OA), as one of the leading causes of disability, decreases the quality of life for those suffering from the disease and creates a substantial financial burden. Intra-articular hyaluronic acid (HA) can provide relief from the symptoms of OA and multiple HA products are prescribed. The purpose of this study is to examine the single payer cost-effectiveness of various HA products in the treatment of knee OA. METHODS: A single payer economic evaluation was conducted comparing Synvisc(®) (Sanofi, USA), Durolane(®) (Bioventus, USA), Hyalgan(®) (Fidia Pharma Inc., USA), Supartz™ (Bioventus, USA), and Euflexxa(®) (Ferring Pharmaceuticals Inc., USA). Utility scores for HA products were obtained by extracting Western Ontario and McMaster Universities Arthritis Index pain, stiffness and function from randomized controlled trials and converting them to health utilities index mark 3 scores. The cost of a treatment included the cost of the HA injection, cost of a knee injection procedure and cost of a doctor's visit for each required injection. Cost-utility in 2015 USD per quality-adjusted life years (QALY) saved was calculated for each HA product, and incremental cost-effectiveness ratios were calculated to compare the effectiveness of HA products to one another and to conventional care. RESULTS: When compared to conventional care, all investigated HA products were cost-effective, assuming a willingness-to-pay threshold of $50,000/QALY gained. The HA product Euflexxa had the most favorable cost-utility ratio ($5785.52/QALY) when compared to all other HA brands. CONCLUSION: The present study showed several HA products to be cost-effective in comparison to conventional care, with Euflexxa having the most favorable cost/QALY gained ratio compared to the other HA products. FUNDING: Ferring Pharmaceutics Inc.


Subject(s)
Hyaluronic Acid , Injections, Intra-Articular , Osteoarthritis, Knee , Cost-Benefit Analysis , Humans , Hyaluronic Acid/economics , Hyaluronic Acid/therapeutic use , Injections, Intra-Articular/economics , Injections, Intra-Articular/methods , Injections, Intra-Articular/statistics & numerical data , Osteoarthritis, Knee/drug therapy , Osteoarthritis, Knee/economics , Quality-Adjusted Life Years , Treatment Outcome , United States , Utilization Review , Viscosupplements/classification , Viscosupplements/economics , Viscosupplements/therapeutic use
7.
Semin Arthritis Rheum ; 46(2): 151-159, 2016 10.
Article in English | MEDLINE | ID: mdl-27238876

ABSTRACT

OBJECTIVES: Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm. Using a systematic review and meta-analysis, our objective was to assess the clinical benefit associated with use of IA saline in trials of IA therapies in the treatment of patients with painful knee OA. METHODS: MEDLINE and Embase databases were searched for articles published up to and including August 14th, 2014. Two reviewers assessed the eligibility of potential reports and the risk of bias of included trials. We analyzed short (≤3 months) and long-term (6-12 months) pain reduction of the saline arm of included trials using standardized mean differences (SMDs; estimated assuming a null effect in a comparator group) that were combined and weighted using a random effects model. Treatment-related adverse events (AEs) were tabulated and presented using descriptive statistics. RESULTS: From 40 randomized controlled trials (RCTs) eligible for inclusion only 38 provided sufficient data to be included in the meta-analysis. Based on data with moderate inconsistency IA saline was found to significantly improve short-term knee pain in 32 studies involving 1705 patients (SMD = -0.68; 95% CI: -0.78 to -0.57; P < 0.001; I(2) = 50%). Long-term knee pain was significantly decreased following IA injection with saline in 19 studies involving 1445 patients (SMD = -0.61; 95% CI: -0.76 to -0.45; P < 0.001) with a substantial degree of inconsistency (I(2) = 74%). Overall, 29 of the included trials reported on adverse events, none of which found any serious treatment-related AEs following IA injection with saline. CONCLUSIONS: Pain relief observed with IA saline should prompt health care providers to consider the additional effectiveness of current IA treatments that use saline comparators in clinical studies, and challenges of identifying IA saline injection as a "placebo."


Subject(s)
Osteoarthritis, Knee/drug therapy , Pain/drug therapy , Sodium Chloride/therapeutic use , Humans , Injections, Intra-Articular , Knee Joint/drug effects , Randomized Controlled Trials as Topic , Sodium Chloride/administration & dosage , Treatment Outcome
8.
Article in English | MEDLINE | ID: mdl-26917981

ABSTRACT

INTRODUCTION: This study aims to describe the perceptions of orthopedic surgeons on the efficacy of intra-articular hyaluronic acid (IA-HA), the influence of IA-HA product characteristics on its efficacy, and to identify patterns and factors related to the use of IA-HA. Additionally, this study examines factors that influence IA-HA brand selection, focusing on Euflexxa(®) (1% sodium hyaluronate). METHODS: We developed survey questions by reviewing the current literature and consulting with experts on the use of IA-HA in the management of knee osteoarthritis (OA). The survey included questions on demographics, previous experience with knee OA treatment, opinions on different treatment methods, and where information regarding treatments is obtained. Additionally, questions specific to opinions regarding IA-HA and the reasoning behind these opinions were asked. RESULTS: A total of 117 orthopedic surgeons and physicians completed the survey. IA-HA is most frequently prescribed to patients with early-stage (82%) or mid-stage (82.8%) OA, while fewer orthopedic surgeons and physicians use IA-HA for patients with late-stage OA (57.4%). Respondents were generally uncertain of the effects that intrinsic characteristics, such as molecular weight, cross-linking, and production process, had on patient outcomes. Respondents typically use their own clinical experience and results as a deciding factor in utilizing IA-HA treatment, as well as in choosing an IA-HA brand. CONCLUSION: Uncertainty regarding the efficacy of IA-HA treatments is likely due to inconsistency within clinical guidelines and the current literature. Additional research investigating the efficacy of IA-HA treatment and how product characteristics affect outcome and safety is required to provide clarity to the controversy surrounding IA-HA treatment for knee OA.

9.
J Arthroplasty ; 31(8): 1667-73, 2016 08.
Article in English | MEDLINE | ID: mdl-26895820

ABSTRACT

BACKGROUND: Few nonoperative treatment options for knee osteoarthritis (OA) are available, but there is ongoing debate about the effectiveness of intra-articular (IA) hyaluronic acid (HA) injections. We investigated whether the formulation of IA HA, or its combined use with IA corticosteroid (CS), may be contributing to some of the reported variation in clinical outcomes. METHODS: The 5% Part B Medicare data (2005-2012) were used to identify knee OA patients who underwent knee arthroplasty (KA). The time from diagnosis of OA to KA was compared between patients with (HA) and without (no HA) IA HA use, using quantile regression with propensity score adjustment. These were further stratified by type of IA HA. Patient factors associated with time to KA were also assessed using Cox regression. RESULTS: The "HA" cohort was associated with a longer time to KA of 8.7 months (95% confidence interval: 8.3-9.1 months; P < .001) compared with the "no HA" cohort, with extended time to KA in the bioengineered Euflexxa IA HA cohort. Patient factors associated with longer time to KA included women, younger patients, minority patients, patients with fewer comorbidities, and IA CS injection use. Patients with both IA HA and IA CS had an additional 6.3 months (95% confidence interval: 5.5-7.0 months; P < .001) to KA over those with only IA HA. CONCLUSION: In a large cohort of elderly patients undergoing KA, there was a significant longer time from diagnosis of OA to KA in those receiving IA HA. It is unclear if the extended time may lead to less KA utilization.


Subject(s)
Hyaluronic Acid/administration & dosage , Osteoarthritis, Knee/drug therapy , Viscosupplements/administration & dosage , Aged , Aged, 80 and over , Arthroplasty, Replacement, Knee , Female , Glucocorticoids/administration & dosage , Humans , Injections, Intra-Articular , Male , Medicare Part B , Osteoarthritis, Knee/surgery , Propensity Score , Retrospective Studies , United States
10.
J Med Econ ; 17(5): 326-37, 2014 May.
Article in English | MEDLINE | ID: mdl-24625229

ABSTRACT

OBJECTIVE: To determine the cost-effectiveness of bioengineered hyaluronic acid (BioHA, 1% sodium hyaluronate) intra-articular injections in treating osteoarthritis knee pain in poor responders to conventional care (CC) including non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics. METHODS: Two decision analytic models compared BioHA treatment with either continuation of patient's baseline CC with no assumption of disease progression (Model 1), or CC including escalating care costs due to disease progression (NSAIDs and analgesics, corticosteroid injections, and surgery; Model 2). Analyses were based on patients who received two courses of 3-weekly intra-articular BioHA (26-week FLEXX Trial + 26-week Extension Study). BioHA group costs included fees for physician assessment and injection regimen, plus half of CC costs. Cost-effectiveness ratios were expressed as averages and incremental costs per QALY. One-way sensitivity analyses used the 95% confidence interval (CI) of QALYs gained in BioHA-treated patients, and ±20% of BioHA treatment and CC costs. Probabilistic sensitivity analyses were performed for Model 2. RESULTS: For 214 BioHA patients, the average utility gain was 0.163 QALYs (95% CI = -0.162 to 0.488) over 52 weeks. Model 1 treatment costs were $3469 and $4562 for the BioHA and CC groups, respectively; sensitivity analyses showed BioHA to be the dominant treatment strategy, except when at the lower end of the 95% CI. Model 2 annual treatment costs per QALY gained were $1446 and $516 for the BioHA and CC groups, respectively. Using CC as baseline strategy, the incremental cost-effectiveness ratio (ICER) of BioHA was $38,741/QALY gained, and was sensitive to response rates in either the BioHA or CC groups. CONCLUSION: BioHA is less costly and more effective than CC with NSAIDs and analgesics, and is the dominant treatment strategy. Compared with escalating CC, the $38,741/QALY ICER of BioHA remains within the $50,000 per QALY willingness-to-pay threshold to adopt a new technology.


Subject(s)
Hyaluronic Acid/economics , Hyaluronic Acid/therapeutic use , Osteoarthritis, Knee/drug therapy , Viscosupplements/economics , Viscosupplements/therapeutic use , Aged , Analgesics/economics , Analgesics/therapeutic use , Anti-Inflammatory Agents/economics , Anti-Inflammatory Agents/therapeutic use , Arthroplasty, Replacement, Knee/economics , Cost-Benefit Analysis , Decision Support Techniques , Female , Humans , Hyaluronic Acid/chemistry , Injections, Intra-Articular , Male , Middle Aged , Models, Economic , Molecular Weight , Osteoarthritis, Knee/economics , Osteoarthritis, Knee/surgery , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Viscosupplements/chemistry
11.
J Bone Miner Res ; 25(2): 404-14, 2010 Feb.
Article in English | MEDLINE | ID: mdl-19594305

ABSTRACT

Animal experiments show a dramatic improvement in skeletal repair by teriparatide. We tested the hypothesis that recombinant teriparatide, at the 20 microg dose normally used for osteoporosis treatment or higher, would accelerate fracture repair in humans. Postmenopausal women (45 to 85 years of age) who had sustained a dorsally angulated distal radial fracture in need of closed reduction but no surgery were randomly assigned to 8 weeks of once-daily injections of placebo (n = 34) or teriparatide 20 microg (n = 34) or teriparatide 40 microg (n = 34) within 10 days of fracture. Hypotheses were tested sequentially, beginning with the teriparatide 40 microg versus placebo comparison, using a gatekeeping strategy. The estimated median time from fracture to first radiographic evidence of complete cortical bridging in three of four cortices was 9.1, 7.4, and 8.8 weeks for placebo and teriparatide 20 microg and 40 microg, respectively (overall p = .015). There was no significant difference between the teriparatide 40 microg versus placebo groups (p = .523). In post hoc analyses, there was no significant difference between teriparatide 40 microg versus 20 microg (p = .053); however, the time to healing was shorter in teriparatide 20 microg than placebo (p = .006). The primary hypothesis that teriparatide 40 microg would shorten the time to cortical bridging was not supported. The shortened time to healing for teriparatide 20 microg compared with placebo still may suggest that fracture repair can be accelerated by teriparatide, but this result should be interpreted with caution and warrants further study.


Subject(s)
Bone Density Conservation Agents/therapeutic use , Fractures, Bone/drug therapy , Teriparatide/therapeutic use , Aged , Aged, 80 and over , Bone Density/drug effects , Bone Density Conservation Agents/pharmacology , Double-Blind Method , Female , Fracture Healing/drug effects , Fractures, Bone/etiology , Humans , Injections, Subcutaneous , Middle Aged , Osteoporosis, Postmenopausal/complications , Osteoporosis, Postmenopausal/drug therapy , Radius Fractures/drug therapy , Radius Fractures/etiology , Teriparatide/pharmacology , Time Factors , Treatment Outcome
12.
J Orthop Trauma ; 22(8 Suppl): S83-90, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18753895

ABSTRACT

Fractures of the distal radius are one of the most common injuries presented to orthopaedic surgeons. A variety of treatment options are available for the vast array of fracture patterns. Research that explores bone fragility and fracture healing has led to new treatment modalities. As new products and methods are derived to aid in fracture healing it is essential to develop noninvasive and/or nondestructive techniques to assess structural information about bone. Quantitative assessment of macro-structural characteristics such as geometry, and microstructural features such as relative trabecular volume, trabecular spacing, and connectivity may improve our ability to estimate bone strength. Methods for quantitatively assessing macrostructure include (besides conventional radiographs) dual x-ray absorptiometry (DXA) and computed tomography (CT), particularly volumetric quantitative computed tomography (vQCT). Methods for assessing microstructure of trabecular bone include high resolution computed tomography (hrCT), micro computed tomography (microCT), high resolution magnetic resonance (hrMR), and micro magnetic resonance microMR. Volumetric QCT, hrCT and hrMR are generally applicable in vivo; microCT and microMR are principally applicable in vitro. Clinically, the challenges for bone imaging include balancing the advantages of simple bone densitometry versus the more complex architectural features of bone, or the deeper research requirements versus the broader clinical needs.


Subject(s)
Densitometry/methods , Diagnostic Imaging/methods , Fracture Healing , Fractures, Bone/diagnosis , Osteoporosis/diagnosis , Wrist Injuries/diagnosis , Fractures, Spontaneous/diagnosis , Humans , Image Interpretation, Computer-Assisted/methods
13.
Orthopedics ; 28(8): 740-3, 2005 Aug.
Article in English | MEDLINE | ID: mdl-16119736

ABSTRACT

This study describes an instrument that is simple to use when measuring angles in spine radiographs. Compared to the conventional method, measurements obtained with this instrument are reproducible and are less time-consuming.


Subject(s)
Anthropometry/instrumentation , Body Weights and Measures/instrumentation , Spine/diagnostic imaging , Humans , Radiography , Reproducibility of Results , Spine/anatomy & histology
14.
Eur Radiol ; 15(2): 356-9, 2005 Feb.
Article in English | MEDLINE | ID: mdl-15503040

ABSTRACT

Stress fractures are common injuries frequently overlooked on first radiographs, especially in the early course. The gold standard for accurate diagnosis is MRI and scintigraphy. We report six cases of stress fractures of the lower limb diagnosed with sonography and describe typical sonographic features.


Subject(s)
Fractures, Stress/diagnostic imaging , Lower Extremity/diagnostic imaging , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Ultrasonography
15.
J Orthop Res ; 22(2): 362-7, 2004 Mar.
Article in English | MEDLINE | ID: mdl-15013097

ABSTRACT

Currently, there are no in vivo techniques for quantifying healing within fractures involving mainly trabecular bone. Methods for quantitatively assessing healing would aid the investigation of new treatment regimes, and might also be useful for predicting whether a patient may be undergoing delayed union. Using CT and automated image registration, we have developed an image processing technique for measuring changes in CT image intensity at fracture sites. The technique focuses on quantifying the formation of new mineralised tissue within fracture gaps, while ignoring loss of bone mineral due to disuse osteoporosis. Seven patients with fractures of the distal radius were examined for 12 weeks following fracture. To assess reproducibility of measurements of change in CT intensity at the fracture line, measurements were performed on two separate occasions, by each of two independent readers. Reproducibility was compared to rates of change over time, to determine detectable differences in individual progression. Scans were scored qualitatively for features of healing and scores compared to the quantitative measurements. The mean (SD) change in CT intensity was +128 (65) Hounsfield Units (HU) over the 12 week follow-up. Inter- and intra-observer reproducibilities were both similar (+/- 17 HU), 1/7 of the change seen during the study. In this small patient cohort, a significant increase in CT intensity was seen 2 weeks post-fracture. Large early increases in CT intensity were associated with early visual appearance of sclerosis and blurring of the fracture line. In this preliminary, prospective study, we have developed a reproducible quantitative technique for measuring changes in CT intensity of trabecular bone at the fracture line in the distal radius. Further work is required to determine whether it can be used to identify, or monitor patients who are undergoing delayed fracture repair. The technique appears sensitive for measuring changes immediately post-fracture, and could have a role in examining potential effects of new therapies in patient cohorts.


Subject(s)
Fracture Healing , Image Processing, Computer-Assisted , Imaging, Three-Dimensional , Radius Fractures/diagnostic imaging , Radius Fractures/pathology , Tomography, X-Ray Computed , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Reproducibility of Results , Time Factors
16.
Acad Radiol ; 10(11): 1267-73, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14626301

ABSTRACT

RATIONALE AND OBJECTIVES: Development of new agents to induce fracture healing requires more sensitive methods to detect early changes in fracture repair. The aims of this study were to determine quantitative and qualitative features of fracture healing using volumetric computed tomography (CT) and to compare them with conventional radiography during the weeks following uncomplicated fractures of the appendicular skeleton. MATERIALS AND METHODS: 39 otherwise healthy men and women with acute, closed fractures of the distal radius, tibial and/or fibular malleoli, or tibial shaft, were enrolled and underwent CT and X-ray imaging at 1, 2, 4, 8, 12, and 16 (tibial shaft only) weeks post fracture. Qualitative assessment included fracture line/margins, fracture gap, external callus appearance, callus-to-cortex ratio, bridging, and radiologic union. Quantitative assessment of CT density changes (Hounsfield units [HU]) in the fracture gap was performed in a subset of 8 fracture patients using MEDx multimodality image analysis software (Sterling,VA). The analysis was performed by drawing free form regions of interest (ROI) covering the fracture gap on baseline (week 1) images and by automated registration of the follow-up images to the baseline co-ordinate system. RESULTS: The mean time to achieve radiologic union on CT was slightly shorter than on X-rays for radial and tibial shaft fractures (7.3 vs. 8.0 weeks, P = .1). Blurring of the fracture margins and reactive sclerosis were the earliest signs of healing in both modalities. External callus formation was evident in 11 cases and was detected earlier with CT technique. Overall, CT images allowed for more complete and detailed visualization of healing compared with conventional X-rays, which were limited by cast and fixation hardware superimposition, especially in subjects with malleolar and distal radial fractures. Quantitative evaluation showed good intraobserver and interobserver reproducibility and a statistically significant correlation to qualitative changes. CONCLUSION: Our methods of fracture healing assessment are reliable tools that are able to detect early changes in normal bone healing and may serve as useful additions to subjective image analysis in monitoring fracture healing in clinical trials. CT shows some advantages over conventional X-rays in evaluation of early fracture healing.


Subject(s)
Fracture Healing/physiology , Fractures, Closed/diagnostic imaging , Tomography, X-Ray Computed , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged
17.
Radiology ; 223(2): 410-6, 2002 May.
Article in English | MEDLINE | ID: mdl-11997546

ABSTRACT

PURPOSE: To assess the use of combined color Doppler ultrasonography (US), power Doppler US, and spectral wave analysis (SWA) in differentiating malignant and benign musculoskeletal tumors. MATERIALS AND METHODS: Seventy-nine musculoskeletal tumors (34 malignant, 45 benign) were examined with color and power Doppler US and SWA. Two radiologists independently assessed US images and SWA findings. Echotexture and vessel characteristics such as stenoses, occlusions, loops, shunts, trifurcations, vascular pattern, and resistive index were evaluated. All tumors were subject to US-guided or open biopsy for histologic correlation. RESULTS: Combined color and power Doppler US and SWA revealed four major (stenosis, occlusion, trifurcation, vascular pattern) and three minor (shunt, self loop, resistive index) vessel characteristics, which proved helpful in differentiating benign from malignant lesions. Echotexture showed moderate sensitivity (82% [28 of 34 tumors]) and low specificity (38% [17 of 45 tumors]). When comparing several combinations of vessel characteristics, a combination of any two major characteristics demonstrated the best results (sensitivity, 94% [33 of 39 tumors]; specificity, 93% [three of 45 tumors]). Combining more than two characteristics resulted in lower sensitivity. CONCLUSION: Combined color and power Doppler US and SWA may enable assessment of vascular architecture and altered flow of musculoskeletal tumors. Vascular architecture analysis enables differentiation of benign and malignant lesions and evaluation of musculoskeletal tumors.


Subject(s)
Bone Neoplasms/diagnostic imaging , Muscle Neoplasms/diagnostic imaging , Ultrasonography, Doppler/methods , Adolescent , Adult , Aged , Bone Neoplasms/pathology , Chi-Square Distribution , Child , Diagnosis, Differential , Female , Humans , Logistic Models , Male , Middle Aged , Muscle Neoplasms/pathology , ROC Curve , Reproducibility of Results , Sensitivity and Specificity , Ultrasonography, Doppler, Color
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