Orthopedic disease burden in adult patients with symptomatic lumbar scoliosis: results from a prospective multicenter study

OBJECTIVE Although the health impact of adult symptomatic lumbar scoliosis (ASLS) is substantial, these patients often have other orthopedic problems that have not been previously quantified. The objective of this study was to assess disease burden of other orthopedic conditions in patients with ASLS based on a retrospective review of a prospective multicenter cohort. METHODS The ASLS-1 study is an NIH-sponsored prospective multicenter study designed to assess operative versus nonoperative treatment for ASLS. Patients were 40–80 years old with ASLS, defined as a lumbar coronal Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20, or Scoliosis Research Society-22 questionnaire score ≤ 4.0 in pain, function, and/or self-image domains. Nonthoracolumbar orthopedic events, defined as fractures and other orthopedic conditions receiving surgical treatment, were assessed from enrollment to the 4-year follow-up. RESULTS Two hundred eighty-six patients (mean age 60.3 years, 90% women) were enrolled, with 173 operative and 113 nonoperative patients, and 81% with 4-year follow-up data. At a mean (± SD) follow-up of 3.8 ± 0.9 years, 104 nonthoracolumbar orthopedic events were reported, affecting 69 patients (24.1%). The most common events were arthroplasty (n = 38), fracture (n = 25), joint ligament/cartilage repair (n = 13), and cervical decompression/fusion (n = 7). Based on the final adjusted model, patients with a nonthoracolumbar orthopedic event were older (HR 1.44 per decade, 95% CI 1.07–1.94), more likely to have a history of tobacco use (HR 1.63, 95% CI 1.00–2.66), and had worse baseline leg pain scores (HR 1.10, 95% CI 1.01–1.19). CONCLUSIONS Patients with ASLS have high orthopedic disease burden, with almost 25% having a fracture or nonthoracolumbar orthopedic condition requiring surgical treatment during the mean 3.8 years following enrollment. Comparisons with previous studies suggest that the rate of total knee arthroplasty was considerably greater and the rates of total hip arthroplasty were at least as high in the ASLS-1 cohort compared with the similarly aged general US population. These conditions may further impact health-related quality of life and outcomes assessments of both nonoperative and operative treatment approaches in patients with ASLS.

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19. Adult symptomatic lumbar scoliosis patients have high orthopedic disease burden beyond their spinal deformities: results from a prospective multicenter study

The Spine Journal ◽

10.1016/j.spinee.2019.05.032 ◽

2019 ◽

Vol 19 (9) ◽

pp. S9-S10

Author(s):

Justin S. Smith ◽

Christopher I. Shaffrey ◽

Christine R. Baldus ◽

Michael P. Kelly ◽

Elizabeth Yanik ◽

...

Keyword(s):

Multicenter Study ◽

Disease Burden ◽

Spinal Deformities ◽

Prospective Multicenter Study ◽

Lumbar Scoliosis

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Surgical treatment of pathological loss of lumbar lordosis (flatback) in patients with normal sagittal vertical axis achieves similar clinical improvement as surgical treatment of elevated sagittal vertical axis

Journal of Neurosurgery Spine ◽

10.3171/2014.3.spine13580 ◽

2014 ◽

Vol 21 (2) ◽

pp. 160-170 ◽

Cited By ~ 56

Author(s):

Justin S. Smith ◽

Manish Singh ◽

Eric Klineberg ◽

Christopher I. Shaffrey ◽

Virginie Lafage ◽

...

Keyword(s):

Surgical Treatment ◽

Spinal Deformity ◽

Short Form ◽

Vertical Axis ◽

Research Society ◽

Physical Component Score ◽

Sagittal Vertical Axis ◽

Short Form 36 ◽

Scoliosis Research Society

Object Increased sagittal vertical axis (SVA) correlates strongly with pain and disability for adults with spinal deformity. A subset of patients with sagittal spinopelvic malalignment (SSM) have flatback deformity (pelvic incidence–lumbar lordosis [PI-LL] mismatch > 10°) but remain sagittally compensated with normal SVA. Few data exist for SSM patients with flatback deformity and normal SVA. The authors' objective was to compare baseline disability and treatment outcomes for patients with compensated (SVA < 5 cm and PI-LL mismatch > 10°) and decompensated (SVA > 5 cm) SSM. Methods The study was a multicenter, prospective analysis of adults with spinal deformity who consecutively underwent surgical treatment for SSM. Inclusion criteria included age older than 18 years, presence of adult spinal deformity with SSM, plan for surgical treatment, and minimum 1-year follow-up data. Patients with SSM were divided into 2 groups: those with compensated SSM (SVA < 5 cm and PI-LL mismatch > 10°) and those with decompensated SSM (SVA ≥ 5 cm). Baseline and 1-year follow-up radiographic and health-related quality of life (HRQOL) outcomes included Oswestry Disability Index, Short Form–36 scores, and Scoliosis Research Society–22 scores. Percentages of patients achieving minimal clinically important difference (MCID) were also assessed. Results A total of 125 patients (27 compensated and 98 decompensated) met inclusion criteria. Compared with patients in the compensated group, patients in the decompensated group were older (62.9 vs 55.1 years; p = 0.004) and had less scoliosis (43° vs 54°; p = 0.002), greater SVA (12.0 cm vs 1.7 cm; p < 0.001), greater PI-LL mismatch (26° vs 20°; p = 0.013), and poorer HRQOL scores (Oswestry Disability Index, Short Form-36 physical component score, Scoliosis Research Society-22 total; p ≤ 0.016). Although these baseline HRQOL differences between the groups reached statistical significance, only the mean difference in Short Form–36 physical component score reached threshold for MCID. Compared with baseline assessment, at 1 year after surgery improvement was noted for patients in both groups for mean SVA (compensated –1.1 cm, decompensated +4.8 cm; p ≤ 0.009), mean PI-LL mismatch (compensated 6°, decompensated 5°; p < 0.001), and all HRQOL measures assessed (p ≤ 0.005). No significant differences were found between the compensated and decompensated groups in the magnitude of HRQOL score improvement or in the percentages of patients achieving MCID for each of the outcome measures assessed. Conclusions Decompensated SSM patients with elevated SVA experience significant disability; however, the amount of disability in compensated SSM patients with flatback deformity caused by PI-LL mismatch but normal SVA is underappreciated. Surgical correction of SSM demonstrated similar radiographic and HRQOL score improvements for patients in both groups. Evaluation of SSM should extend beyond measuring SVA. Among patients with concordant pain and disability, PI-LL mismatch must be evaluated for SSM patients and can be considered a primary indication for surgery.

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Outcomes of Operative and Nonoperative Treatment for Adult Spinal Deformity

Neurosurgery ◽

10.1227/neu.0000000000001116 ◽

2016 ◽

Vol 78 (6) ◽

pp. 851-861 ◽

Cited By ~ 92

Author(s):

◽

Justin S. Smith ◽

Virginie Lafage ◽

Christopher I. Shaffrey ◽

Frank Schwab ◽

...

Keyword(s):

Spinal Deformity ◽

Lumbar Lordosis ◽

Pelvic Incidence ◽

Short Form ◽

Adult Spinal Deformity ◽

Research Society ◽

Nonoperative Treatment ◽

Leg Pain ◽

Scoliosis Research Society

Abstract BACKGROUND: High-quality studies that compare operative and nonoperative treatment for adult spinal deformity (ASD) are needed. OBJECTIVE: To compare outcomes of operative and nonoperative treatment for ASD. METHODS: This is a multicenter, prospective analysis of consecutive ASD patients opting for operative or nonoperative care. Inclusion criteria were age >18 years and ASD. Operative and nonoperative patients were propensity matched with the baseline Oswestry Disability Index, Scoliosis Research Society-22r, thoracolumbar/lumbar Cobb angle, pelvic incidence–to–lumbar lordosis mismatch (PI-LL), and leg pain score. Analyses were confined to patients with a minimum of 2 years of follow-up. RESULTS: Two hundred eighty-six operative and 403 nonoperative patients met the criteria, with mean ages of 53 and 55 years, 2-year follow-up rates of 86% and 55%, and mean follow-up of 24.7 and 24.8 months, respectively. At baseline, operative patients had significantly worse health-related quality of life (HRQOL) based on all measures assessed (P < .001) and had worse deformity based on pelvic tilt, pelvic incidence–to–lumbar lordosis mismatch, and sagittal vertical axis (P ⩽ .002). At the minimum 2-year follow-up, all HRQOL measures assessed significantly improved for operative patients (P < .001), but none improved significantly for nonoperative patients except for modest improvements in the Scoliosis Research Society-22r pain (P = .04) and satisfaction (P < .001) domains. On the basis of matched operative-nonoperative cohorts (97 in each group), operative patients had significantly better HRQOL at follow-up for all measures assessed (P < .001), except Short Form-36 mental component score (P = .06). At the minimum 2-year follow-up, 71.5% of operative patients had ≥1 complications. CONCLUSION: Operative treatment for ASD can provide significant improvement of HRQOL at a minimum 2-year follow-up. In contrast, nonoperative treatment on average maintains presenting levels of pain and disability.

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Prospective, Multicenter Study Of The Mtor Inhibitor Everolimus (RAD001) As Primary Therapy In Waldenstrom’s Macroglobulinemia

Blood ◽

10.1182/blood.v122.21.1822.1822 ◽

2013 ◽

Vol 122 (21) ◽

pp. 1822-1822 ◽

Cited By ~ 10

Author(s):

Steven Peter Treon ◽

Christina K Tripsas ◽

Kirsten Meid ◽

Christopher Patterson ◽

Leonard T Heffner ◽

...

Keyword(s):

Bone Marrow ◽

Multicenter Study ◽

Disease Burden ◽

Response Rate ◽

Response Assessment ◽

M Protein ◽

Primary Therapy ◽

Prospective Multicenter Study ◽

Unacceptable Toxicity

Abstract Introduction Everolimus (RAD001) is an inhibitor of MTORC1 and exhibits activity in WM patients with relapsed/refractory disease (JCO 2010; 28:1408-14). We therefore initiated this multicenter, prospective study to delineate the efficacy and tolerability of Everolimus as primary therapy in WM. Patients and Methods Patients with symptomatic WM, with adequate organ function, who were not previously treated, and who did not have symptomatic hyperviscosity were eligible. Intended therapy consisted of 10 mg of oral Everolimus daily, with sequential dose de-escalation to 7.5 mg daily, 5 mg daily, and 5 mg every other day permitted for toxicity. Patients were treated until progression or unacceptable toxicity. Patients were encouraged to use an oral dexamethasone solution to swish and spit up to 4 times daily for prevention of oral ulcerations. Study participants were assessed monthly for the first three months, and thereafter every 3 months which included a physical examination, complete blood counts, chemistries, and serum IgM monitoring. Bone marrow (BM) biopsies and aspirations were performed at baseline, at months 6 and 12, and as required for response assessment. Patients who received at least one cycle of therapy were evaluable for response. Results 33 patients were enrolled on this prospective, multicenter study and are evaluable for response. Median baseline characteristics for all patients: Age 62 (range 41-80 years); Hematocrit 31.3% (range 24.5-44.2%); Hemoglobin 10.8 (range 7.8-15.7 g/dL); serum IgM 4,440 (range 959-10,256 mg/dL), with 23 (69.7%) patients demonstrating an IgM level ≥3,000 mg/dL; serum M-protein 2.60 g/dL (range 0.31-5.31 g/dL), B2M 3 mg/L (1.6-6.7 mg/L). The median baseline BM disease burden was 70% (range 7.5-95%), and 21 patients (63.6%) demonstrated adenopathy or splenomegaly by CT scans at baseline. At best response, median serum IgM levels declined from 4,440 to 1,360 (p<0.0001), and serum M-protein decreased from 2.60 to 0.93 g/dL (p<0.0001). The median time to best serum IgM response was 6 months (range 6-36 months). Median hematocrit and hemoglobin levels increased from 31.3% to 34.5% (p=0.0112) and 10.8 to 11.8 g/dL (p= 0.009), respectively. Twenty-two patients were evaluable for response by both BM biopsy and IgM level determination at 6 months, at which time BM disease burden remained unchanged with a median of 65% involvement (range 10-95%; p=0.3595). The best overall response rate utilizing consensus criteria was 72.2% (2 Very Good Partial Responses, 18 Partial Responses, 4 Minor Responses, and 9 Stable Disease), and the major response rate (PR or better) was 60.6%. However, discordance between serum IgM levels upon which consensus criteria for response are based, and BM disease response were common and complicated response assessment. At 6 month assessments, 10 of 22 (45.5%) patients for whom both serum IgM and BM assessments were performed, discordance between serum IgM and BM disease involvement were observed. Among these patients, 2 had no change, and 8 had increased bone marrow disease involvement despite decreases in serum IgM levels. Grade ≥2 hematologic and non-hematologic toxicities possibly, probably or definitively associated with Everolimus included anemia (n=13, 39.4%), thrombocytopenia (n=4, 12%), neutropenia (n=6, 18.2%), hyperglycemia (n=3, 9.1%), oral ulcerations (n=9, 27.3%), pneumonitis (n=5, 15%), fatigue (n=5, 15.2%), rash (n=9, 27.3%), cellulitis (n=2, 6%), nausea (n=1, 3%), and diarrhea (n=1, 3%). With a median follow-up of 9 months (range 1-45 months), 6 patients remain on study. Reasons for study discontinuation included non-response or disease progression (n=17), unacceptable toxicity (n=6, including 5 for pneumonitis and 1 for neutropenia), noncompliance (n=2), and loss of follow-up (n=2). Conclusions Everolimus is active in the primary therapy of WM, with rapid reductions observed in serum IgM levels in most patients. Serum IgM discordance to underlying BM disease burden is common, and serial BM assessments are important for response monitoring in WM patients receiving Everolimus.) Disclosures: No relevant conflicts of interest to declare.

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