scholarly journals Use of rhBMP-2 for adult spinal deformity surgery: patterns of usage and changes over the past decade

2021 ◽  
Vol 50 (6) ◽  
pp. E4
Author(s):  
Mathieu Bannwarth ◽  
Justin S. Smith ◽  
Shay Bess ◽  
Eric O. Klineberg ◽  
Christopher P. Ames ◽  
...  

OBJECTIVE Recombinant human bone morphogenetic protein–2 (rhBMP-2) has been shown to increase fusion rates; however, cost, limited FDA approval, and possible complications impact its use. Decisions regarding rhBMP-2 use and changes over time have not been well defined. In this study, the authors aimed to assess changes in rhBMP-2 use for adult spinal deformity (ASD) surgery over the past decade. METHODS A retrospective review of the International Spine Study Group prospective multicenter database was performed to identify ASD patients treated surgically from 2008 to 2018. For assessment of rhBMP-2 use over time, 3 periods were created: 2008–2011, 2012–2015, and 2016–2018. RESULTS Of the patients identified, 1180 met inclusion criteria, with a mean age 60 years and 30% of patients requiring revision surgery; rhBMP-2 was used in 73.9% of patients overall. The mean rhBMP-2 dose per patient was 23.6 mg. Patients receiving rhBMP-2 were older (61 vs 58 years, p < 0.001) and had more comorbidities (Charlson Comorbidity Index 1.9 vs 1.4, p < 0.001), a higher rate of the Scoliosis Research Society–Schwab pelvic tilt modifier (> 0; 68% vs 62%, p = 0.026), a greater deformity correction (change in pelvic incidence minus lumbar lordosis 15° vs 12°, p = 0.01), and more levels fused (8.9 vs 7.9, p = 0.003). Over the 3 time periods, the overall rate of rhBMP-2 use increased and then stabilized (62.5% vs 79% vs 77%). Stratified analysis showed that after an overall increase in rhBMP-2 use, only patients who were younger than 50 years, those who were smokers, those who received a three-column osteotomy (3CO), and patients who underwent revision sustained an increased rate of rhBMP-2 use between the later two periods. No similar increases were noted for older patients, nonsmokers, primary surgery patients, and patients without a 3CO. The total rhBMP-2 dose decreased over time (26.6 mg vs 24.8 mg vs 20.7 mg, p < 0.001). After matching patients by preoperative alignment, 215 patients were included, and a significantly lower rate of complications leading to revision surgery was observed within the 2012–2015 period compared with the 2008–2011 (21.4% vs 13.0%, p = 0.029) period, while rhBMP-2 was increasingly used (80.5% vs 66.0%, p = 0.001). There was a trend toward a lower rate of pseudarthrosis for patients in the 2012–2015 period, but this difference did not reach statistical significance (7% vs 4.2%, p = 0.283). CONCLUSIONS The authors found that rhBMP-2 was used in the majority of ASD patients and was more commonly used in those with greater deformity correction. Additionally, over the last 10 years, rhBMP-2 was increasingly used for ASD patients, but the dose has decreased.

2018 ◽  
Vol 108 (4) ◽  
pp. 343-351 ◽  
Author(s):  
K. Kyrölä ◽  
H. Kautiainen ◽  
L. Pekkanen ◽  
P. Mäkelä ◽  
I. Kiviranta ◽  
...  

Background and Aims: Adult spinal deformity surgery has increased with the aging population and modern surgical approaches, although it has high complication and reoperation rates. The permanence of radiographic correction, mechanical complications, predictive factors for poor patient-reported outcomes, and patient satisfaction were analyzed. Material and Methods: A total of 79 adult patients were retrospectively analyzed at baseline and 1–9 years after adult spinal deformity correction between 2007 and 2016. Patient-reported outcomes (Oswestry Disability Index, visual analog scale, and Scoliosis Research Society–30 scores), changes in radiographic alignment, indications for reoperation, predictors of poor outcomes according to the Oswestry Disability Index and Scoliosis Research Society–30 scores, and patient satisfaction with management were studied. Results: Oswestry Disability Index and visual analog scale scores (p = 0.001), radiographic correction of thoracic kyphosis, lumbar lordosis, and pelvic retroversion (p ⩽ 0.001) and sagittal vertical axis (p = 0.043) were significantly better at 4–5 years of follow-up than at baseline. The risk for the first reoperation owing to mechanical failure of instrumentation or bone was highest within the first year, at 13.9% (95% confidence interval = 8.0%–23.7%), and 29.8% (95% confidence interval = 19.4%–43.9%) at the 5-year follow-up. Oswestry Disability Index and Scoliosis Research Society–30 total scores had a good correlation (r = −0.78; 95% CI = −0.86 to –0.68; p < 0.001). Satisfaction with management was correlated with patient-reported outcomes. Male sex and depression (p = 0.021 and 0.018, respectively) predicted poor outcomes according to the Oswestry Disability Index and/or Scoliosis Research Society–30 score. Conclusion: The achieved significant radiographic correction was maintained 5 years postoperatively. Despite reoperations, patient satisfaction and clinical outcomes were good. Depression and male sex predicted poor clinical outcomes.


2021 ◽  
pp. 1-9
Author(s):  
Ferran Pellisé ◽  
Miquel Serra-Burriel ◽  
Alba Vila-Casademunt ◽  
Jeffrey L. Gum ◽  
Ibrahim Obeid ◽  
...  

OBJECTIVE The reported rate of complications and cost of adult spinal deformity (ASD) surgery, associated with an exponential increase in the number of surgeries, cause alarm among healthcare payers and providers worldwide. The authors conjointly analyzed the largest prospective available ASD data sets to define trends in quality-of-care indicators (complications, reinterventions, and health-related quality of life [HRQOL] outcomes) since 2010. METHODS This is an observational prospective longitudinal cohort study. Patients underwent surgery between January 2010 and December 2016, with > 2 years of follow-up data. Demographic, surgical, radiological, and HRQOL (i.e., Oswestry Disability Index, SF-36, Scoliosis Research Society-22r) data obtained preoperatively and at 3, 6, 12, and 24 months after surgery were evaluated. Trends and changes in indicators were analyzed using local regression (i.e., locally estimated scatterplot smoothing [LOESS]) and adjusted odds ratio (OR). RESULTS Of the 2286 patients included in the 2 registries, 1520 underwent surgery between 2010 and 2016. A total of 1151 (75.7%) patients who were treated surgically at 23 centers in 5 countries met inclusion criteria. Patient recruitment increased progressively (2010–2011 vs 2015–2016: OR 1.64, p < 0.01), whereas baseline clinical characteristics (age, American Society of Anesthesiologists class, HRQOL scores, sagittal deformity) did not change. Since 2010 there has been a sustained reduction in major and minor postoperative complications observed at 90 days (major: OR 0.59; minor: OR 0.65; p < 0.01); at 1 year (major: OR 0.52; minor: 0.75; p < 0.01); and at 2 years of follow-up (major: OR 0.4; minor: 0.80; p < 0.01) as well as in the 2-year reintervention rate (OR 0.41, p < 0.01). Simultaneously, there has been a slight improvement in the correction of sagittal deformity (i.e., pelvic incidence–lumbar lordosis mismatch: OR 1.11, p = 0.19) and a greater gain in quality of life (i.e., Oswestry Disability Index 26% vs 40%, p = 0.02; Scoliosis Research Society-22r, self-image domain OR 1.16, p = 0.13), and these are associated with a progressive reduction of surgical aggressiveness (number of fused segments: OR 0.81, p < 0.01; percent pelvic fixation: OR 0.66, p < 0.01; percent 3-column osteotomies: OR 0.63, p < 0.01). CONCLUSIONS The best available data show a robust global improvement in quality metrics in ASD surgery over the last decade. Surgical complications and reoperations have been reduced by half, while improvement in disability increased and correction rates were maintained, in patients with similar baseline characteristics.


2019 ◽  
Vol 7 (2) ◽  
pp. 319-324 ◽  
Author(s):  
Neel Anand ◽  
Aniruddh Agrawal ◽  
Evalina L. Burger ◽  
Emmanuelle Ferrero ◽  
Jeremy L. Fogelson ◽  
...  

2013 ◽  
Vol 24 (2) ◽  
pp. 185-193 ◽  
Author(s):  
Shay Bess ◽  
Frank Schwab ◽  
Virginie Lafage ◽  
Christopher I. Shaffrey ◽  
Christopher P. Ames

2014 ◽  
Vol 2 (1) ◽  
pp. 40-47 ◽  
Author(s):  
Dennis H. Nielsen ◽  
Martin Gehrchen ◽  
Lars V. Hansen ◽  
Jonas Walbom ◽  
Benny Dahl

2014 ◽  
Vol 36 (5) ◽  
pp. E2 ◽  
Author(s):  
Kseniya Slobodyanyuk ◽  
Caroline E. Poorman ◽  
Justin S. Smith ◽  
Themistocles S. Protopsaltis ◽  
Richard Hostin ◽  
...  

Object The goal of this study was to determine the outcome and risk factors in patients with adult spinal deformity (ASD) who elected to receive nonoperative care. Methods In this retrospective study the authors reviewed a nonoperative branch of the International Spine Study Group database, derived from 10 sites across the US. Specific inclusion criteria included nonoperative treatment for ASD and the availability of Scoliosis Research Society (SRS)-22 scores and radiographic data at baseline (BL) and at 1-year (1Y) follow-up. Health-related quality of life measures were assessed using the SRS-22 and radiographic data. Changes in SRS-22 scores were evaluated by domain and expressed in number of minimum clinically important differences (MCIDs) gained or lost; BL and 1Y scores were also compared with age- and sex-matched normative references. Results One hundred eighty-nine patients (mean age 53 years, 86% female) met inclusion criteria. Pain was the domain with the largest offset for 43% of patients, followed by the Appearance (23%), Activity (18%), and Mental (15%) domains. On average, patients improved 0.3 MCID in Pain over 1Y, without changes in Activity or Appearance. Baseline scores significantly impacted 1Y outcomes, with up to 85% of patients in the mildest category of deformity being classified as < 1 MCID of normative reference at 1Y, versus 0% of patients with the most severe initial deformity. Baseline radiographic parameters did not correlate with outcome. Conclusions Patients who received nonoperative care are significantly more disabled than age- and sex-matched normative references. The likelihood for a patient to reach SRS scores similar to the normative reference at 1Y decreases with increased BL disability. Nonoperative treatment is a viable option for certain patients with ASD, and up to 24% of patients demonstrated significant improvement over 1Y with nonoperative care.


Spine ◽  
2012 ◽  
Vol 37 (12) ◽  
pp. 1077-1082 ◽  
Author(s):  
Frank Schwab ◽  
Benjamin Ungar ◽  
Benjamin Blondel ◽  
Jacob Buchowski ◽  
Jeffrey Coe ◽  
...  

Neurosurgery ◽  
2016 ◽  
Vol 78 (6) ◽  
pp. 851-861 ◽  
Author(s):  
◽  
Justin S. Smith ◽  
Virginie Lafage ◽  
Christopher I. Shaffrey ◽  
Frank Schwab ◽  
...  

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 &gt;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 &lt; .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 &lt; .001), but none improved significantly for nonoperative patients except for modest improvements in the Scoliosis Research Society-22r pain (P = .04) and satisfaction (P &lt; .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 &lt; .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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