Epidemiological study using national administrative data.
To evaluate the temporal trends in on-label and off-label bone morphogenetic protein (BMP) usage in primary and revision spine fusion by ...spine region and surgical approach, and nonspine applications in the United States from 2002 to 2007.
The prevalence of BMP usage for spine fusion has been on the rise, but its use has not been stratified by surgical approach, particularly for lumbar fusion where it has only been Food And Drug Administration-approved for anterior lumbar interbody fusion (ALIF).
The prevalence of BMP usage in the United States was evaluated using the Nationwide Inpatient Sample between October 1, 2002 and December 31, 2007. The Nationwide Inpatient Sample is the single largest all-payer inpatient care database in the United States. The principal procedure associated with BMP use was determined, and the prevalence of BMP use was calculated for various population subgroups.
A total of 340,251 inpatient procedures with BMP usage were identified. Between 2003 and 2007, the annual number of procedures involving BMP increased by 4.3-fold from 23,900 to 103,194. Spine fusion accounted for the vast majority (92.8%) of principal procedures with BMP. The predominant use of BMP was in primary posterior lumbar interbody fusion or transforaminal lumbar interbody fusion (PLIF/TLIF) (30.0%), followed by primary posterolateral spine fusion (20.4%), primary ALIF (16.6%), primary cervical fusions (13.6%), and primary thoracolumbar fusions (3.9%). Of primary ALIF with BMP, 19.3% did not involve the implantation of an interbody device.
At least 85% of principal procedures using BMP were for off-label applications. With uncertainty regarding the risks of using BMP in certain off-label applications, further research will be needed to better define the appropriate indications. Our study also demonstrates that disparities in the differential rates of BMP use exist in the spine fusion population.
This study is a retrospective review of the initial enrollment data from a prospective multicentered study of adult spinal deformity.
The purpose of this study is to correlate radiographic measures ...of deformity with patient-based outcome measures in adult scoliosis.
Prior studies of adult scoliosis have attempted to correlate radiographic appearance and clinical symptoms, but it has proven difficult to predict health status based on radiographic measures of deformity alone. The ability to correlate radiographic measures of deformity with symptoms would be useful for decision-making and surgical planning.
The study correlates radiographic measures of deformity with scores on the Short Form-12, Scoliosis Research Society-29, and Oswestry profiles. Radiographic evaluation was performed according to an established positioning protocol for anteroposterior and lateral 36-inch standing radiographs. Radiographic parameters studied were curve type, curve location, curve magnitude, coronal balance, sagittal balance, apical rotation, and rotatory subluxation.
The 298 patients studied include 172 with no prior surgery and 126 who had undergone prior spine fusion. Positive sagittal balance was the most reliable predictor of clinical symptoms in both patient groups. Thoracolumbar and lumbar curves generated less favorable scores than thoracic curves in both patient groups. Significant coronal imbalance of greater than 4 cm was associated with deterioration in pain and function scores for unoperated patients but not in patients with previous surgery.
This study suggests that restoration of a more normal sagittal balance is the critical goal for any reconstructive spine surgery. The study suggests that magnitude of coronal deformity and extent of coronal correction are less critical parameters.
Abstract Background context The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary ...(PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. Purpose This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. Study design This study is a review of prospectively collected patient-reported outcomes data. Patient sample A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. Outcome measures Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. Methods ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). Results Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. Conclusions The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain.
Abstract Background context The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically ...important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment. Purpose Our goal is to review the various definitions of MCID and the methods available to determine MCID. Study design The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail. Methods The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail. Results Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores. Conclusions An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated.
Longitudinal cohort.
To determine the minimum clinically important difference (MCID) of the Scoliosis Research Society (SRS)-22 Appearance, Activity, and Pain domains in patients with adolescent ...idiopathic scoliosis undergoing surgical correction of their spinal deformity.
The MCID, a threshold of improvement that is clinically relevant to the individual patient, is increasingly used to evaluate treatment effectiveness. MCID values for the SRS-22 domains have not been determined.
Patients with adolescent idiopathic scoliosis who underwent surgical correction and had completed SRS-22 before operation and the SRS-30 and Scoliosis Appearance Questionnaire (SAQ) at 1 year after operation from a multicenter database for pediatric scoliosis were identified. The SAQ is a modification of the Walter Reed Visual Assessment Scale and is used to assess the patient's perception of their spinal deformity. Paired sample t tests were used to compare preoperative and 1-year postoperative scores. Spearman correlations were used to evaluate associations between domain scores and summed responses to anchors for Appearance, Activity, and Pain. MCID values for the SRS-22 domains were determined using receiver operating characteristic curve analysis, with summed responses to anchor questions 23 to 30 of the SRS-30 and items 26 and 32 of the SAQ.
There were 735 women and 152 men with a mean age of 14.3 years and a mean Cobb angle of 53°. There was a statistically significant difference between paired preoperative and 1-year SRS domain scores. Analysis of variance showed a statistically significant difference between the summed responses to the anchors. The MCID was 0.20 for the Pain domain (area under the curve AUC = 0.723), 0.08 for Activity (AUC = 0.648), and 0.98 for Appearance (AUC = 0.629). The MCID for activity was less than the standard error of measurement.
The MCID for the Pain domain was 0.20 and 0.98 for Appearance. Because these patients were generally in good health, a minimal though significant change in activity was observed, such that the calculated MCID was within the measurement error. As expected, the largest and most important change was in the Appearance domain. Future studies are needed to determine the MCID for the mental domain and the total SRS score and to further validate the MCID values in this study.
Myxofibrosarcoma: An Unusual Presentation DeBiasio, Celina; Glassman, Steven J.
Journal of cutaneous medicine and surgery,
05/2024, Letnik:
28, Številka:
3
Journal Article
This study is a retrospective review of 752 patients with adult spinal deformity enrolled in a multicenter prospective database in 2002 and 2003. Patients with positive sagittal balance (N = 352) ...were further evaluated regarding radiographic parameters and health status measures, including the Scoliosis Research Society patient questionnaire, MOS short form-12, and Oswestry Disability Index.
To examine patients with adult deformity with positive sagittal balance to define parameters within that group that might differentially predict clinical impact.
In a multicenter study of 298 adults with spinal deformity, positive sagittal balance was identified as the radiographic parameter most highly correlated with adverse health status outcomes.
Radiographic evaluation was performed according to a standardized protocol for 36-inch standing radiographs. Magnitude of positive sagittal balance and regional sagittal Cobb angle measures were recorded. Statistical correlation between radiographic parameters and health status measures were performed. Potentially confounding variables were assessed.
Positive sagittal balance was identified in 352 patients. The C7 plumb line deviation ranged from 1 to 271 mm. All measures of health status showed significantly poorer scores as C7 plumb line deviation increased. Patients with relative kyphosis in the lumbar region had significantly more disability than patients with normal or lordotic lumbar sagittal Cobb measures.
This study shows that although even mildly positive sagittal balance is somewhat detrimental, severity of symptoms increases in a linear fashion with progressive sagittal imbalance. The results also show that kyphosis is more favorable in the upper thoracic region but very poorly tolerated in the lumbar spine.
Patients undergoing primary total hip arthroplasty (THA) following lumbar spine fusion have an increased incidence of dislocation compared to those without prior lumbar fusion. The purpose of this ...study is to determine if timing of THA prior to or after lumbar fusion would have an effect on dislocation and revision incidence in patients with both hip and lumbar spine pathology.
One hundred percent Medicare inpatient claims data from 2005 to 2015 were used to compare dislocation and revision risks in patients with primary THA with pre-existing lumbar spine fusion vs THA with subsequent lumbar spine fusion within 1, 2, and 5 years after the index THA. A total of 42,300 patients met inclusion criteria, 28,668 patients of which underwent THA with pre-existing lumbar spinal fusion (LSF) and 13,632 patients who had prior THA and subsequent LSF. Patients who had THA first followed by LSF were further stratified based on the interval between index THA and subsequent LSF (1, 2, and 5 years), making 4 total groups for comparison. Multivariate cox regression analysis was performed adjusting for age, socioeconomic status, race, census region, gender, Charlson score, pre-existing conditions, discharge status, length of stay, and hospital characteristics.
Patients with prior LSF undergoing THA had a 106% increased risk of dislocation compared to those with LSF done 5 years after THA (P < .001). Risk of revision THA was greater in the pre-existing LSF group by 43%, 41%, and 49% at 1, 2, and 5 years post THA compared to the groups with THA done first with subsequent LSF. Dislocation was the most common etiology for revision THA in all groups, but significantly higher in the prior LSF group (26.6%).
Results of this study demonstrate that sequence of surgical intervention for concomitant lumbar and hip pathology requiring LSF and THA respectively significantly impacts the fate of the THA performed. Patients with prior LSF undergoing THA are at significantly higher risk of dislocation and subsequent revision compared to those with THA first followed by delayed LSF.
3.
Retrospective review of a prospective, multicenter database.
The purpose of this study was to assess whether elderly patients undergoing scoliosis surgery had an incidence of complications and ...improvement in outcome measures comparable with younger patients.
Complications increase with age for adults undergoing scoliosis surgery, but whether this impacts the outcomes of older patients is largely unknown.
This is a retrospective review of a prospective, multicenter spinal deformity database. Patients complete the Oswestry Disability Index (ODI), SF-12, Scoliosis Research Society-22 (SRS-22), and numerical rating scale (NRS; 0-10) for back and leg pain. Inclusion criteria included age 25 to 85 years, scoliosis (Cobb ≥ 30°), plan for scoliosis surgery, and 2-year follow-up.
Two hundred six of 453 patients (45%) completed 2-year follow-up, which is distributed among age groups as follows: 25 to 44 (n = 47), 45 to 64 (n = 121), and 65 to 85 (n = 38) years. The percentages of patients with 2-year follow-up by age group were as follows: 25 to 44 (45%), 45 to 64 (48%), and 65 to 85 (40%) years. These groups had perioperative complication rates of 17%, 42%, and 71%, respectively (P < 0.001). At baseline, elderly patients (65-85 years) had greater disability (ODI, P = 0.001), worse health status (SF-12 physical component score (PCS), P < 0.001), and more severe back and leg pain (NRS, P = 0.04 and P = 0.01, respectively) than younger patients. Mean SRS-22 did not differ significantly at baseline. Within each age group, at 2-year follow-up there were significant improvements in ODI (P ≤ 0.004), SRS-22 (P ≤ 0.001), back pain (P < 0.001), and leg pain (P ≤ 0.04). SF-12 PCS did not improve significantly for patients aged 25 to 44 years but did among those aged 45 to 64 (P < 0.001) and 65 to 85 years (P = 0.001). Improvement in ODI and leg pain NRS were significantly greater among elderly patients (P = 0.003, P = 0.02, respectively), and there were trends for greater improvements in SF-12 PCS (P = 0.07), SRS-22 (P = 0.048), and back pain NRS (P = 0.06) among elderly patients, when compared with younger patients.
Collectively, these data demonstrate the potential benefits of surgical treatment for adult scoliosis and suggest that the elderly, despite facing the greatest risk of complications, may stand to gain a disproportionately greater improvement in disability and pain with surgery.
