Browsing by Author "Carreon, Leah Y"

Now showing 1 - 20 of 36
  • Thumbnail Image
    ItemOpen Access
    A Radiographic Analysis of Lumbar Fusion Status and Instrumentation Failure After Complex Adult Spinal Deformity Surgery With Spinopelvic Fixation: Two-Year Follow-up From the Scoli-Risk-1 Prospective Database.
    (Clinical spine surgery, 2020-12) Shimizu, Takayoshi; Lenke, Lawrence G; Cerpa, Meghan; Beauchamp, Eduardo C; Carreon, Leah Y; Shaffrey, Christopher I; Cheung, Kenneth MC; Fehlings, Michael G

    Study design

    A retrospective review of prospectively collected data.

    Objective

    The objective of this study was to investigate the fusion status of the lumbar spine and lumbosacral junction at 2 years postoperatively after complex adult spinal deformity (ASD) surgery.

    Summary of background data

    Achieving fusion is crucial for maintaining optimal alignment in ASD surgery. However, prospective data assessing fusion status using large patient populations are lacking in this patient population.

    Materials and methods

    Postoperative radiographs of 162 patients from the Scoli-Risk-1 database, who underwent complex ASD surgery with fusion to the sacrum, were evaluated by 3 independent spine surgeons at 6-week, 6-month, and 2-year follow-up. The fusion rate of the lumbar spine segments at a 2-year follow-up was determined by using previously published radiographic grading criteria. We also assessed the prevalence of instrumentation failures.

    Results

    The interrater reliabilities for grading the fusion status were overall fair at each level evaluated (Fleiss κ, 0.337-0.439). Overall, 70.3% (114/162) demonstrated the solid fusion of the entire lumbar spine at a 2-year follow-up. The fusion rates of each segment were L1/L2: 87.0%, L2/L3: 82.0%, L3/L4: 83.9%, L4/L5: 89.5%, and L5/S1: 89.5%. Pedicle screw loosening was the most frequent implant failure throughout the observation period (9.2%, 11.6%, and 11.0% at 6-wk, 6-mo, and 2-y follow-up, respectively). No rod breakage was observed at 6 weeks, increasing to 9.8% at 2-year follow-up. The prevalence of postoperative proximal junctional kyphosis was 5.5% at 6 weeks, showing no difference at 2 years postoperative.

    Conclusions

    In this series of complex ASD surgeries often requiring 3-column osteotomies, 70.3% showed solid fusion of the entire lumbar spine, including the lumbosacral junction. The lumbosacral segments showed a relatively high fusion rate at a 2-year follow-up likely due to the frequent use of anterior column support and graft. The prevalence of rod breakage increased as follow-up proceeded to 9.8%, which was most commonly observed at the lumbosacral junction.

    Level of evidence

    Level IV.
  • Thumbnail Image
    ItemOpen Access
    An Analysis of the Incidence and Outcomes of Major Versus Minor Neurological Decline After Complex Adult Spinal Deformity Surgery: A Subanalysis of Scoli-RISK-1 Study.
    (Spine, 2018-07) Kato, So; Fehlings, Michael G; Lewis, Stephen J; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Y; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Berven, Sigurd H

    Study design

    A subanalysis from a prospective, multicenter, international cohort study in 15 sites (Scoli-RISK-1).

    Objective

    To report detailed information regarding the severity of neurological decline related to complex adult spine deformity (ASD) surgery and to examine outcomes based on severity.

    Summary of background data

    Postoperative neurological decline after ASD surgeries can occur due to nerve root(s) or spinal cord dysfunction. The impact of decline and the pattern of recovery may be related to the anatomic location and the severity of the injury.

    Methods

    An investigation of 272 prospectively enrolled complex ASD surgical patients with neurological status measured by American Spinal Injury Association Lower Extremity Motor Scores (LEMS) was undertaken. Postoperative neurological decline was categorized into "major" (≥5 points loss) versus "minor" (<5 points loss) deficits. Timing and extent of recovery in LEMS were investigated for each group.

    Results

    Among the 265 patients with LEMS available at discharge, 61 patients (23%) had neurological decline, with 20 (33%) experiencing major decline. Of note, 90% of the patients with major decline had deficits in three or more myotomes. Full recovery was seen in 24% at 6 weeks and increased to 65% at 6 months. However, 34% continued to experience some neurological decline at 24 months, with 6% demonstrating no improvement. Of 41 patients (67%) with minor decline, 73% had deficits in one or two myotomes. Full recovery was seen in 49% at 6 weeks and increased to 70% at 6 months. Of note, 26% had persistence of some neurological deficit at 24 months, with 18% demonstrating no recovery.

    Conclusion

    In patients undergoing complex ASD correction, a rate of postoperative neurological decline of 23% was noted with 33% of these being "major." Although most patients showed substantial recovery by 6 months, approximately one-third continued to experience neurological dysfunction.

    Level of evidence

    2.
  • Thumbnail Image
    ItemOpen Access
    Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation.
    (Clinical orthopaedics and related research, 2021-02) Kwan, Kenny Yat Hong; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Qiu, Yong; Schwab, Frank J; Cheung, Kenneth Man Chee; AO Spine Knowledge Forum Deformity

    Background

    The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset.

    Questions/purposes

    After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires?

    Methods

    A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test.

    Results

    At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category.

    Conclusion

    Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications.

    Level of evidence

    Level III, diagnostic study.
  • Thumbnail Image
    ItemOpen Access
    Canadian Spine Society: 23rd Annual Scientific Conference, Wednesday, March 1 - Saturday, March 4, Fairmont Le Château Frontenac, Québec, Que., Canada.
    (Can J Surg, 2023) Birk, Manjot; Sidhu, Kara; Filezio, Marina Rosa; Singh, Vishwajeet; Ferri-de-Barros, Fabio; Chan, Vivien; Shumilak, Geoffrey; Nataraj, Andrew; Langston, Holly; Yee, Nicholas J; Iorio, Carlo; Shkumat, Nicholas; Rocos, Brett; Ertl-Wagner, Birgit; Lebel, David; Camp, Mark W; Dimentberg, Evan; Saran, Neil; Laflamme, Melissa; Ouellet, Jean A; Wenghofer, Jessica; Livock, Holly; Beaton, Luke; Tice, Andrew; Smit, Kevin; Graham, Ryan; Duarte, Matias Pereira; Roy-Beaudry, Marjolaine; Turgeon, Isabelle; Joncas, Julie; Mac-Thiong, Jean-Marc; Labelle, Hubert; Barchi, Soraya; Parent, Stefan; Gholamian, Tara; Livock, Holly; Tice, Andrew; Smit, Kevin; Yoon, Samuel; Zulfiqar, Amna; Rocos, Brett; Murphy, Anne; Bath, Natasha; Moll, Stanley; Sorbara, Julia; Lebel, David; Camp, Mark W; Nallet, Jérémie Arthur; Rocos, Brett; Lebel, David Eduard; Zeller, Reinhard; Dermott, Jennifer A; Kim, Dorothy J; Anthony, Alison; Zeller, Reinhard; Lebel, David E; Wang, Zhi; Shen, Jesse; Kamel, Youssef; Liu, Jia; Shedid, Daniel; Al-Shakfa, Fidaa; Yuh, Sung-Joo; Boubez, Ghassan; Rizkallah, Maroun; Rizkallah, Maroun; Shen, Jesse; Boubez, Ghassan; Kamel, Youssef; Liu, Jia; Shedid, Daniel; Al-Shakfa, Fidaa; Lavoie, Frederic; Yug, Sung-Joo; Wang, Zhi; Alavi, Fatemeh; Nielsen, Christopher; Rampersaud, Raja; Lewis, Stephen; Cheung, Angela M; Cadieux, Chloe; Fernandes, Renan; Brzozowski, Pawel; Zdero, Radovan; Bailey, Chris; Rasoulinejad, Parham; Cherry, Ahmed; Manoharan, Ragavan; Xu, Mark; Srikandarajah, Nisaharan; Iorio, Carlo; Raj, Aditya; Nielsen, Christopher; Rampersaud, Raja; Lewis, Stephen; Beange, Kristen; Graham, Ryan; Livock, Holly; Smit, Kevin; Manoharan, Ragavan; Cherry, Ahmed; Srikandarajah, Nisaharan; Raj, Aditya; Xu, Mark; Iorio, Carlo; Nielsen, Christopher J; Rampersaud, Y Raja; Lewis, Stephen J; Nasrabadi, Ali Asghar Mohammadi; Moammer, Gemah; Phee, John Mc; Walker, Taryn; Urquhart, Jennifer C; Glennie, R Andrew; Rampersaud, Y Raja; Fisher, Charles G; Bailey, Chris S; Herrington, Brandon J; Fernandes, Renan R; Urquhart, Jennifer C; Rasoulinejad, Parham; Siddiqi, Fawaz; Bailey, Christopher S; Urquhart, Jennifer; Fernandes, Renan R; Glennie, R Andrew; Rampersaud, Y Raja; Fisher, Charles G; Bailey, Chris S; Yang, Michael MH; Riva-Cambrin, Jay; Cunningham, Jonathan; Casha, Steven; Cadieux, Chloe N; Urquhart, Jennifer; Fernandes, Renan; Glennie, Andrew; Fisher, Charles; Rampersaud, Raja; Xu, Mark; Manoharan, Ragavan; Cherry, Ahmed; Raj, Aditya; Srikandarajah, Nish; Iorio, Carlo; Nielsen, Christopher; Lewis, Stephen; Rampersaud, Raja; Cherry, Ahmed; Raj, Aditya; McIntosh, Greg; Manoharan, Ragavan; Murray, Jean-Christophe; Nielsen, Christopher; Xu, Mark; Srikandarajah, Nisaharan; Iorio, Carlo; Perruccio, Anthony; Canizares, Mayilee; Rampersaud, Raja; El-Mughayyar, Dana; Bigney, Erin; Richardson, Eden; Manson, Neil; Abraham, Edward; Attabib, Najmedden; Small, Chris; Kolyvas, George; LeRoux, Andre; Outcomes, Canadian Spine; Investigators, Research Network; Hebert, Jeff; Baisamy, Victor; Rizkallah, Maroun; Shen, Jesse; Cresson, Thierry; Vazquez, Carlos; Wang, Zhi; Boubez, Ghassan; Lung, Tiffany; Canizares, Mayilee; Perruccio, Anthony; Rampersaud, Raja; Crawford, Eric J; Ravinsky, Robert A; Perruccio, Anthony V; Rampersaud, Y Raja; Coyte, Peter C; Bond, Michael; Street, John; Fisher, Charles; Charest-Morin, Raphaele; Sutherland, Jason M; Bartolozzi, Arthur R; Barzilai, Ori; Chou, Dean; Laufer, Ilya; Verlaan, Jorrit-Jan; Sahgal, Arjun; Rhines, Laurence D; Scuibba, Daniel M; Lazary, Aron; Weber, Michael H; Schuster, James M; Boriani, Stefano; Bettegowda, Chetan; Arnold, Paul M; Clarke, Michelle J; Fehlings, Michael G; Reynolds, Jeremy J; Gokaslan, Ziya L; Fisher, Charles G; Dea, Nicolas; Versteeg, Anne L; Charest-Morin, Raphaele; Laufer, Ilya; Teixeira, William; Barzilai, Ori; Gasbarrini, Alessandro; Fehlings, Michael G; Chou, Dean; Johnson, Michael G; Gokaslan, Ziya L; Dea, Nicolas; Verlaan, Jorrit-Jan; Goldschlager, Tony; Shin, John H; O'Toole, John E; Sciubba, Daniel M; Bettegowda, Chetan; Clarke, Michelle J; Weber, Michael H; Mesfin, Addisu; Kawahara, Norio; Goodwin, Rory; Disch, Alexander; Lazary, Aron; Boriani, Stefano; Sahgal, Arjun; Rhines, Laurence; Fisher, Charles G; Versteeg, Anne L; Gal, Roxanne; Reich, Leilani; Tsang, Angela; Aludino, Allan; Sahgal, Arjun; Verlaan, Jorrit-Jan; Fisher, Charles G; Verkooijen, Lenny; Rizkallah, Maroun; Wang, Zhi; Yuh, Sung-Joo; Shedid, Daniel; Shen, Jesse; Al-Shakfa, Fidaa; Belguendouz, Céline; AlKafi, Rayan; Boubez, Ghassan; MacLean, Mark A; Georgiopoulos, Miltiadis; Charest-Morin, Raphaele; Germscheid, Niccole; Goodwin, C Rory; Weber, Michael; International, Ao Spine; Rizkallah, Maroun; Boubez, Ghassan; Zhang, Hao; Al-Shakfa, Fidaa; Brindamour, Pamela; Boule, Danielle; Shen, Jesse; Shedid, Daniel; Yuh, Sung-Joo; Wang, Zhi; Correale, Marcia Rebecca; Soever, Leslie Jayne; Rampersaud, Raja; Malic, Claudia Cristina; Dubreuil, Melanie; Duke, Kate; Kingwell, Stephen P; Lin, Zihan; MacLean, Mark A; Julien, Lisa C; Patriquin, Glenn; LeBlanc, Jason; Green, Ryan; Alant, Jacob; Barry, Sean; Glennie, R Andrew; Oxney, William; Christie, Sean D; Sarraj, Mohamed; Alqahtani, Abdullah; Thornley, Patrick; Koziarz, Frank; Bailey, Christopher S; Freire-Archer, Millaray; Bhanot, Kunal; Kachur, Edward; Bhandari, Mohit; Oitment, Colby; Malhotra, Armaan K; Balas, Michael; Jaja, Blessing NR; Harrington, Erin M; Hofereiter, Johann; Jaffe, Rachael H; He, Yingshi; Byrne, James P; Wilson, Jefferson R; Witiw, Christopher D; Brittain, Kennedy CM; Christie, Sean; Pillai, Saranyan; Dvorak, Marcel F; Evaniew, Nathan; Chen, Melody; Waheed, Zeina; Rotem-Kohavi, Naama; Fallah, Nader; Noonan, Vanessa K; Fisher, Charles G; Charest-Morin, Raphaële; Dea, Nicolas; Ailon, Tamir; Street, John; Kwon, Brian K; Sandarage, Ryan V; Galuta, Ahmad; Ghinda, Diana; Kwan, Jason CS; TsaI, Eve C; Hachem, Laureen D; Hong, James; Velumian, Alexander; Mothe, Andrea J; Tator, Charles H; Fehlings, Michael G; Shakil, Husain; Jaja, Blessing NR; Zhang, Peng; Jaffe, Rachael; Malhotra, Armaan K; Wilson, Jefferson R; Witiw, Christopher D; Rotem-Kohavi, Naama; Dvorak, Marcel F; Dea, Nicolas; Evaniew, Nathan; Chen, Melody; Waheed, Zeina; Xu, Jijie; Fallah, Nader; Noonan, Vanessa; Kwon, Brian; Dandurand, Charlotte; Muijs, Sander; Dvorak, Marcel; Schnake, Klaus; Cumhur; Ouml Ner; Greene, Ryan; Furlong, Bradley; Smith-Forrester, Jenna; Swab, Michelle; Christie, Sean D; Hall, Amanda; Leck, Erika; Marshall, Emily; Christie, Sean; Dvorak, Marcel F; Cumhur, F; Ouml Ner; Vaccaro, Alexander R; Benneker, Lorin M; Rajasekaran, Shanmuganathan; El-Sharkawi, Mohammad; Popescu, Eugen Cezar; Tee, Jin Wee; Paquet, Jerome; France, John C; Allen, Richard; Lavelle, William F; Hirschfeld, Miguel; Pneumaticos, Spyros; Dandurand, Charlotte; Cumhur; Ouml Ner; Muijs, Sander; Schnake, Klaus; Dvorak, Marcel; Fernandes, Renan Rodrigues; Thornley, Patrick; Urquhart, Jennifer; Kelly, Sean; Alenezi, Nasser; Alahmari, Abdulmajeed; Siddiqi, Fawaz; Singh, Supriya; Rasoulinejad, Parham; Bailey, Christopher; Evaniew, Nathan; Burger, Lukas D; Dea, Nicolas; Cadotte, David W; McIntosh, Greg; Jacobs, Bradley; St-Laurent-Lebeux, Loïc; Bourassa-Moreau, Étienne; Sarraj, Mohamed; Majeed, Meerab; Guha, Daipayan; Pahuta, Markian; Laflamme, Mathieu; McIntosh, Greg; Dea, Nicolas; Bak, Alex B; Alvi, Mohammed A; Moghaddamjou, Ali; Fehlings, Michael G; Silva, Yan Gabriel Morais David; Goulet, Julien; McIntosh, Greg; Bedard, Sonia; Pimenta, Newton; Blanchard, Jocelyn; Couture, Jerome; LaRue, Bernard; Investigators, Csorn; Adams, Tyler; Cunningham, Erin; El-Mughayyar, Dana; Bigney, Erin; Vandewint, Amanda; Manson, Niel; Abraham, Edward; Small, Chris; Attabib, Najmedden; Richardson, Eden; Hebert, Jeffery; Bond, Michael; Street, John; Fisher, Charles; Charest-Morin, Raphaele; Sutherland, Jason M; Hillier, Troy; Bailey, Chris S; Fisher, Charles; Rampersaud, Raja; Koto, Prosper; Glennie, R Andrew; Soroceanu, Alex; Nicholls, Fred; Thomas, Ken; Evaniew, Nathan; Lewkonia, Peter; Bouchard, Jacques; Jacobs, Brad; Ben-Israel, David; Crawford, Eric J; Fisher, Charles; Dea, Nicolas; Spackman, Eldon; Rampersaud, Raja; Thomas, Kenneth C; Srikandarajah, Nisaharan; Murray, Jean-Christophe; Nielsen, Christopher; Manoharan, Ragavan; Cherry, Ahmed; Raj, Aditiya; Xu, Mark; Iorio, Carlo; Bailey, Chris; Dea, Nicolas; Fisher, Charles; Hall, Hamilton; Manson, Neil; Thomas, Kenneth; Canizares, Mayilee; Rampersaud, Yoga Raja; Urquhart, Jennifer; Fernandes, Renan R; Glennie, R Andrew; Rampersaud, Y Raja; Fisher, Charles G; Bailey, Chris; Yang, Michael MH; Far, Rena; Sajobi, Tolulope; Riva-Cambrin, Jay; Casha, Steven; Bond, Michael; Street, John; Fisher, Charles; Charest-Morin, Raphaele; Sutherland, Jason M; Silva, Yan; Pimenta, Newton Godoy; LaRue, Bernard; Bedard, Sonia; Oviedo, Sonia Cheng; Goulet, Julien; Couture, Jerome; Blanchard, Jocelyn; McDonald, James; Al-Jahdali, Fares; Urquhart, Jennifer; Alahmari, Abdulmajeed; Rampersaud, Raja; Fisher, Charles; Bailey, Chris; Glennie, Andrew; Evaniew, Nathan; Coyle, Matthew; Rampersaud, Y Raja; Bailey, Christopher S; Jacobs, W Bradley; Cadotte, David W; Thomas, Kenneth C; Attabib, Najmedden; Paquet, Jérôme; Nataraj, Andrew; Christie, Sean D; Weber, Michael H; Phan, Philippe; Charest-Morin, Raphaële; Fisher, Charles G; Hall, Hamilton; McIntosh, Greg; Dea, Nicolas; Malhotra, Armaan K; Davis, Aileen M; He, Yingshi; Harrington, Erin M; Jaja, Blessing NR; Zhu, Mary P; Shakil, Husain; Dea, Nicolas; Jacobs, W Bradley; Cadotte, David W; Paquet, Jérôme; Weber, Michael H; Phan, Philippe; Christie, Sean D; Nataraj, Andrew; Bailey, Christopher S; Johnson, Michael G; Fisher, Charles G; Manson, Neil; Rampersaud, Y Raja; Thomas, Kenneth C; Hall, Hamilton; Fehlings, Michael G; Ahn, Henry; Ginsberg, Howard J; Witiw, Christopher D; Wilson, Jefferson R; Althagafi, Alwalaa; McIntosh, Greg; Charest-Morin, Raphaële; Rizzuto, Michael A; Ailon, Tamir; Dea, Nicolas; Evaniew, Nathan; Jacobs, Bradley W; Paquet, Jerome; Rampersaud, Raja; Hall, Hamilton; Bailey, Christopher S; Weber, Michael; Johnson, Michael G; Nataraj, Andrew; Attabib, Najmedden; Cadotte, David W; Manson, Neil; Stratton, Alexandra; Christie, Sean D; Thomas, Kenneth C; Wilson, Jefferson R; Fisher, Charles G; Charest-Morin, Raphaele; Bak, Alex B; Alvi, Mohammed A; Moghaddamjou, Ali; Fehlings, Michael G; Bak, Alex B; Alvi, Mohammed A; Moghaddamjou, Ali; Fehlings, Michael G; Soroceanu, Alex; Nicholls, Fred; Thomas, Ken; Evaniew, Nathan; Salo, Paul; Bouchard, Jacques; Jacobs, Brad; Dandurand, Charlotte; Laghaei, Pedram Farimani; Ailon, Tamir; Charest-Morin, Raphaele; Dea, Nicolas; Dvorak, Marcel; Fisher, Charles; Kwon, Brian K; Paquette, Scott; Street, John; Soroceanu, Alex; Nicholls, Fred; Thomas, Ken; Evaniew, Nathan; Bouchard, Jacques; Salo, Paul; Jacobs, Brad; Varshney, Vishal P; Sahjpaul, Ramesh; Paquette, Scott; Osborn, Jill; Bak, Alex B; Moghaddamjou, Ali; Fehlings, Michael G; Leck, Erika; Marshall, Emily; Christie, Sean; Elkaim, Lior M; Lasry, Oliver J; Raj, Aditya; Murray, Jean-Christophe; Cherry, Ahmed; McIntosh, Greg; Nielsen, Christopher; Srikandarajah, Nisaharan; Manoharan, Ragavan; Iorio, Carlo; Xu, Mark; Perruccio, Anthony; Canizares, Mayilee; Rampersaud, Yoga Raja; Stratton, Alexandra; Tierney, Sarah; Wai, Eugene K; Phan, Philippe; Kingwell, Stephen; Magnan, Marie-Claude; Soroceanu, Alex; Nicholls, Fred; Thomas, Ken; Evaniew, Nathan; Salo, Paul; Bouchard, Jacques; Jacobs, Brad; Spanninga, Barend; Hoelen, Thomáy-Claire A; Johnson, Scott; Arts, Jacobus JC; Bailey, Chris S; Urquhart, Jennifer C; Glennie, R Andrew; Rampersaud, Y Raja; Fisher, Charles G; Levett, Jordan J; Elkaim, Lior M; Alotaibi, Naif M; Weber, Michael H; Dea, Nicolas; Abd-El-Barr, Muhammad M; Cherry, Ahmed; Yee, Albert; Jaber, Nadia; Fehlings, Michael; Cunningham, Erin; Adams, Tyler; El-Mughayyar, Dana; Bigney, Erin; Vandewint, Amanda; Manson, Neil; Abraham, Edward; Small, Chris; Attabib, Najmedden; Richardson, Eden; Hebert, Jeffery; Werier, Joel; Smit, Kevin; Villeneuve, James; Sachs, Adam; Abdelbary, Hesham; Al-Mosuli, Yusra Kassim; Rakhra, Kawan; Phan, Philippe; Nagata, Kosei; Gum, Jeffrey L; Brown, Morgan E; Daniels, Christy L; Carreon, Leah Y; Bonello, John-Peter; Koucheki, Robert; Abbas, Aazad; Lex, Johnathan; Nucci, Nicholas; Whyne, Cari; Larouche, Jeremie; Ahn, Henry; Finkelstein, Joel; Lewis, Stephen; Toor, Jay; Lee, Nathan J; Orosz, Lindsay D; Gum, Jeffrey L; Poulter, Gregory T; Jazini, Ehsan; Haines, Colin M; Good, Christopher R; Lehman, Ronald A; Crawford, Eric J; Ravinsky, Robert A; Perruccio, Anthony V; Coyte, Peter C; Rampersaud, Y Raja; Freire-Archer, Millaray; Sarraj, Mohamed; AlShaalan, Fawaz; Koziarz, Alex; Thornley, Patrick; Alnemari, Haitham; Oitment, Colby; Bharadwaj, Lalita; El-Mughayyar, Dana; Bigney, Erin; Manson, Neil; Abraham, Edward; Small, Chris; Attabib, Najmedden; Richardson, Eden; Kearney, Jill; Kundap, Uday; Investigators, Csorn; Hebert, Jeffrey; Elkaim, Lior M; Levett, Jordan J; Niazi, Farbod; Bokhari, Rakan; Alotaibi, Naif M; Lasry, Oliver J; Bissonnette, Vincent; Yen, David; Muddaluru, Varun S; Gandhi, Pranjan; Mastrolonardo, Alexander; Guha, Daipayan; Pahuta, Markian A; Christie, Sean D; Vandertuin, Trevor; Ritcey, Gillian; Rainham, Daniel; Alhawsawi, Mamdoh; Mumtaz, Rohail; Abdelnour, Mark; Qumquji, Feras; Soroceanu, Alex; Swamy, Ganesh; Thomas, Kenneth; Wai, Eugene; Phan, Philippe; Bhatt, Fenil R; Orosz, Lindsay D; Yamout, Tarek; Good, Christopher R; Schuler, Thomas C; Nguyen, Tiffany; Jazini, Ehsan; Haines, Colin M; Oppermann, Marcelo; Gupta, Shaurya; Ramjist, Joel; Oppermann, Priscila Santos; Yang, Victor XD; Levett, Jordan J; Elkaim, Lior M; Niazi, Farbod; Weber, Michael H; Ioro-Morin, Christian; Bonizzato, Marco; Weil, Alexander G; Oppermann, Marcelo; Ramjist, Joel; Gupta, Shaurya; Oppermann, Priscila S; Yang, Victor XD; Jung, Youngkyung; Muddalaru, Varun; Gandhi, Pranjan; Guha, Daipayan; Koucheki, Robert; Bonello, John-Peter; Abbas, Aazad; Lex, Johnathan R; Nucci, Nicholas; Whyne, Cari; Yee, Albert; Ahn, Henry; Finkelstein, Joel; Larouche, Jeremie; Lewis, Stephen; Toor, Jay; Dhawan, Alaina; Dhawan, Jillian; Sharma, Ajay N; Azzam, Daniel B; Cherry, Ahmed; Fehlings, Michael G; Orosz, Lindsay D; Lee, Nathan J; Yamout, Tarek; Gum, Jeffrey L; Lehman, Ronald A; Poulter, Gregory T; Haines, Colin M; Jazini, Ehsan; Good, Christopher R; Ridha, Barzany B; Persad, Amit; Fourney, Daryl; Byers, Elizabeth; Gallagher, Michelle; Sugar, James; Brown, Justin L; Wang, Zhi; Shen, Jesse; Boubez, Ghassan; Al-Shakfa, Fidaa; Yuh, Sung-Joo; Shedid, Daniel; Rizkallah, Maroun; Singh, Manmohan; Singh, Pankaj Kumar; Lawrence, Peyton Lloyd; Dell, Shevaughn; Goodluck-Tyndall, Ronette; Wade, Kevin; Morgan, Mark; Bruce, Carl; Silva, Yan Gabriel Morais David; Pimenta, Newton; LaRue, Bernard; Aldakhil, Salman; Blanchard, Jocelyn; Couture, Jerome; Goulet, Julien; Bednar, Drew A; Raj, Ruheksh; Urquhart, Jennifer; Bailey, Chris; Christie, Sean D; Greene, Ryan; Chaves, Jennyfer Paulla Galdino; Zarrabian, Mohammed; Sigurdson, Leif; Manoharan, Ragavan; Cherry, Ahmed; Iorio, Carlo; Srikandarajah, Nisaharan; Xu, Mark; Raj, Aditya; Nielsen, Christopher J; Rampersaud, Yoga Raja; Lewis, Stephen J
  • Thumbnail Image
    ItemOpen Access
    Clinical and radiographic parameters that distinguish between the best and worst outcomes of scoliosis surgery for adults.
    (European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2013-02) Smith, Justin S; Shaffrey, Christopher I; Glassman, Steven D; Carreon, Leah Y; Schwab, Frank J; Lafage, Virginie; Arlet, Vincent; Fu, Kai-Ming G; Bridwell, Keith H; Spinal Deformity Study Group

    Purpose

    Predictors of marked improvement versus failure to improve following surgery for adult scoliosis have not been identified. Our objective was to identify factors that distinguish between patients with the best and worst outcomes following surgery for adult scoliosis.

    Methods

    This is a secondary analysis of a prospective, multicenter spinal deformity database. Inclusion criteria included: age 18-85, scoliosis (Cobb ≥ 30°), and 2-year follow-up. Based on the Oswestry Disability Index (ODI) and the SRS-22 at 2-year follow-up, patients with the best and worst outcomes were identified for younger (18-45) and older (46-85) adults with scoliosis. Clinical and radiographic factors were compared between patients with the best and worst outcomes.

    Results

    276 patients met inclusion criteria (89 younger and 187 older patients). Among younger patients, predictors of poor outcome included: depression/anxiety, smoking, narcotic medication use, older age, greater body mass index (BMI) and greater severity of pain prior to surgery. Among older patients, predictors of poor outcome included: depression/anxiety, narcotic medication use, greater BMI and greater severity of pain prior to surgery. None of the other baseline or peri-operative factors assessed distinguished the best and worst outcomes for younger or older patients, including severity of deformity, operative parameters, or the occurrence of complications.

    Conclusions

    Not all patients achieve favorable outcomes following surgery for adult scoliosis. Baseline and peri-operative factors distinguishing between patients with the best and worst outcomes were predominantly patient factors, including BMI, depression/anxiety, smoking, and pain severity; not comorbidities, severity of deformity, operative parameters, or complications.
  • Thumbnail Image
    ItemOpen Access
    Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.
    (Spine deformity, 2020-12) Glassman, Steven D; Carreon, Leah Y; Shaffrey, Christopher I; Kelly, Michael P; Crawford, Charles H; Yanik, Elizabeth L; Lurie, Jon D; Bess, R Shay; Baldus, Christine R; Bridwell, Keith H

    Study design

    Longitudinal comparative cohort.

    Objective

    The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis.

    Methods

    Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D.

    Results

    Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment.

    Conclusion

    This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis.

    Level of evidence

    II.
  • Thumbnail Image
    ItemOpen Access
    Cost-effectiveness of Operative versus Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis an Intent-to-treat Analysis at 5-year Follow-up.
    (Spine, 2019-11) Carreon, Leah Y; Glassman, Steven D; Lurie, Jon; Shaffrey, Christopher I; Kelly, Michael P; Baldus, Christine R; Bratcher, Kelly R; Crawford, Charles H; Yanik, Elizabeth L; Bridwell, Keith H
    STUDY DESIGN:Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms. OBJECTIVE:The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS. SUMMARY OF BACKGROUND DATA:The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates. METHODS:Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D. RESULTS:There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain. CONCLUSION:In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years. LEVEL OF EVIDENCE:2.
  • Thumbnail Image
    ItemOpen Access
    Cost-effectiveness of Surgical Treatment of Adult Spinal Deformity: Comparison of Posterior-only versus Antero-posterior Approach.
    (The spine journal : official journal of the North American Spine Society, 2020-04-11) Ogura, Yoji; Gum, Jeffrey L; Hostin, Richard A; Robinson, Chessie; Ames, Christopher P; Glassman, Steven D; Burton, Douglas C; Bess, R Shay; Shaffrey, Christopher I; Smith, Justin S; Yeramaneni, Samrat; Lafage, Virginie F; Protopsaltis, Themistocles; Passias, Peter G; Schwab, Frank J; Carreon, Leah Y; International Spine Study Group (ISSG)
    BACKGROUND CONTEXT:Considerable debate exists regarding the optimal surgical approach for adult spinal deformity (ASD). It remains unclear which approach, posterior-only or combined anterior-posterior (AP), is more cost-effective. Our goal is to determine the 2-year cost per quality-adjusted life year (QALY) for each approach. PURPOSE:To compare the 2-year cost-effectiveness of surgical treatment for ASD between the posterior-only approach and combined AP approach. STUDY DESIGN:Retrospective economic analysis of a prospective, multicenter database PATIENT SAMPLE: From a prospective, multicenter surgical database of ASD, patients undergoing 5 or more level fusions through a posterior-only or AP approach were identified and compared. METHODS:QALYs gained were determined using baseline, 1-year, and 2-year post-operative Short Form 6D. Cost was calculated from actual, direct hospital costs including any subsequent readmission or revision. Cost-effectiveness was determined using cost/QALY gained. RESULTS:The AP approach showed significantly higher index cost than the posterior-only approach ($84,329 vs $64,281). This margin decreased at 2-year follow-up with total costs of $89,824 and $73,904, respectively. QALYs gained at two years were similar with 0.21 and 0.17 in the posterior-only and the AP approaches, respectively. The cost/QALY at two years after surgery was significantly higher in the AP approach ($525,080) than in the posterior-only approach ($351,086). CONCLUSIONS:We assessed 2-year cost-effectiveness for the surgical treatment through posterior-only and AP approaches. The posterior-only approach is less expensive both for the index surgery and at 2-year follow-up. The QALY gained at 2-years was similar between the two approaches. Thus, posterior-only approach was more cost-effective than the AP approach under our study parameters. However, both approaches were not cost-effective at 2-year follow-up.
  • Thumbnail Image
    ItemOpen Access
    Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.
    (Spine, 2020-07) Jain, Amit; Yeramaneni, Samrat; Kebaish, Khaled M; Raad, Micheal; Gum, Jeffrey L; Klineberg, Eric O; Hassanzadeh, Hamid; Kelly, Michael P; Passias, Peter G; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Bess, Shay; Lafage, Virginie; Glassman, Steve; Carreon, Leah Y; Hostin, Richard A; International Spine Study Group

    Study design

    Economic modeling of data from a multicenter, prospective registry.

    Objective

    The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery.

    Summary of background data

    ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis.

    Methods

    Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05).

    Results

    BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients.

    Conclusion

    BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research.

    Level of evidence

    2.
  • Thumbnail Image
    ItemOpen Access
    Does prior short-segment surgery for adult scoliosis impact perioperative complication rates and clinical outcome among patients undergoing scoliosis correction?
    (Journal of neurosurgery. Spine, 2012-08) Kasliwal, Manish K; Smith, Justin S; Shaffrey, Christopher I; Carreon, Leah Y; Glassman, Steven D; Schwab, Frank; Lafage, Virginie; Fu, Kai-Ming G; Bridwell, Keith H

    Object

    In many adults with scoliosis, symptoms can be principally referable to focal pathology and can be addressed with short-segment procedures, such as decompression with or without fusion. A number of patients subsequently require more extensive scoliosis correction. However, there is a paucity of data on the impact of prior short-segment surgeries on the outcome of subsequent major scoliosis correction, which could be useful in preoperative counseling and surgical decision making. The authors' objective was to assess whether prior focal decompression or short-segment fusion of a limited portion of a larger spinal deformity impacts surgical parameters and clinical outcomes in patients who subsequently require more extensive scoliosis correction surgery.

    Methods

    The authors conducted a retrospective cohort analysis with propensity scoring, based on a prospective multicenter deformity database. Study inclusion criteria included a patient age ≥ 21 years, a primary diagnosis of untreated adult idiopathic or degenerative scoliosis with a Cobb angle ≥ 20°, and available clinical outcome measures at a minimum of 2 years after scoliosis surgery. Patients with prior short-segment surgery (< 5 levels) were propensity matched to patients with no prior surgery based on patient age, Oswestry Disability Index (ODI), Cobb angle, and sagittal vertical axis.

    Results

    Thirty matched pairs were identified. Among those patients who had undergone previous spine surgery, 30% received instrumentation, 40% underwent arthrodesis, and the mean number of operated levels was 2.4 ± 0.9 (mean ± SD). As compared with patients with no history of spine surgery, those who did have a history of prior spine surgery trended toward greater blood loss and an increased number of instrumented levels and did not differ significantly in terms of complication rates, duration of surgery, or clinical outcome based on the ODI, Scoliosis Research Society-22r, or 12-Item Short Form Health Survey Physical Component Score (p > 0.05).

    Conclusions

    Patients with adult scoliosis and a history of short-segment spine surgery who later undergo more extensive scoliosis correction do not appear to have significantly different complication rates or clinical improvements as compared with patients who have not had prior short-segment surgical procedures. These findings should serve as a basis for future prospective study.
  • Thumbnail Image
    ItemOpen Access
    Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis.
    (Spine, 2019-09) Smith, Justin S; Shaffrey, Christopher I; Kelly, Michael P; Yanik, Elizabeth L; Lurie, Jon D; Baldus, Christine R; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Bridwell, Keith H

    Study design

    Secondary analysis of prospective multicenter cohort.

    Objective

    To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).

    Summary of background data

    Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.

    Methods

    The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.

    Results

    Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).

    Conclusion

    Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.

    Level of evidence

    2.
  • Thumbnail Image
    ItemOpen Access
    Evaluation of complications and neurological deficits with three-column spine reconstructions for complex spinal deformity: a retrospective Scoli-RISK-1 study.
    (Neurosurgical focus, 2014-05) Kelly, Michael P; Lenke, Lawrence G; Shaffrey, Christopher I; Ames, Christopher P; Carreon, Leah Y; Lafage, Virginie; Smith, Justin S; Shimer, Adam L

    Object

    The goal in this study was to evaluate the risk factors for complications, including new neurological deficits, in the largest cohort of patients with adult spinal deformity to date.

    Methods

    The Scoli-RISK-1 inclusion criteria were used to identify eligible patients from 5 centers who were treated between June 1, 2009, and June 1, 2011. Records were reviewed for patient demographic information, surgical data, and reports of perioperative complications. Neurological deficits were recorded as preexisting or as new deficits. Patients who underwent 3-column osteotomies (3COs) were compared with those who did not (posterior spinal fusion [PSF]). Between-group comparisons were performed using independent samples t-tests and chi-square analyses.

    Results

    Two hundred seven patients were identified-75 who underwent PSF and 132 treated with 3CO. In the latter group, patients were older (58.9 vs 49.4 years, p < 0.001), had a higher body mass index (29.0 vs 25.8, p = 0.029), smaller preoperative coronal Cobb measurements (33.8° vs 56.4°, p < 0.001), more preoperative sagittal malalignment (11.7 cm vs 5.4 cm, p < 0.001), and similar sagittal Cobb measurements (45.8° vs 57.7°, p = 0.113). Operating times were similar (393 vs 423 minutes, p = 0.130), although patients in the 3CO group sustained higher estimated blood loss (2120 vs 1700 ml, p = 0.066). Rates of new neurological deficits were similar (PSF: 6.7% vs 3CO: 9.9%, p = 0.389), and rates of any perioperative medical complication were similar (PSF: 46.7% vs 3CO: 50.8%, p = 0.571). Patients who underwent vertebral column resection (VCR) were more likely to sustain medical complications than those treated with pedicle subtraction osteotomy (73.7% vs 46.9%, p = 0.031), although new neurological deficits were similar (15.8% vs 8.8%, p = 0.348). Regression analysis did not reveal significant predictors of neurological injury or complication from collected data.

    Conclusions

    Despite higher estimated blood loss, rates of all complications (49.3%) and new neurological deficits (8.7%) did not vary for patients who underwent complex reconstruction, whether or not a 3CO was performed. Patients who underwent VCR sustained more medical complications without an increase in new neurological deficits. Prospective studies of patient factors, provider factors, and refined surgical data are needed to define and optimize risk factors for complication and neurological deficits.
  • Thumbnail Image
    ItemOpen Access
    External validation of the adult spinal deformity (ASD) frailty index (ASD-FI)
    (European Spine Journal, 2018-09-01) Miller, Emily K; Vila-Casademunt, Alba; Neuman, Brian J; Sciubba, Daniel M; Kebaish, Khaled M; Smith, Justin S; Alanay, Ahmet; Acaroglu, Emre R; Kleinstück, Frank; Obeid, Ibrahim; Sánchez Pérez-Grueso, Francisco Javier; Carreon, Leah Y; Schwab, Frank J; Bess, Shay; Scheer, Justin K; Lafage, Virginie; Shaffrey, Christopher I; Pellisé, Ferran; Ames, Christopher P; European Spine Study Group; International Spine Study Group
    © 2018, Springer-Verlag GmbH Germany, part of Springer Nature. Purpose: To assess the ability of the recently developed adult spinal deformity frailty index (ASD-FI) to predict odds of perioperative complications, odds of reoperation, and length of hospital stay after adult spinal deformity (ASD) surgery using a database other than the one used to create the index. Methods: We used the ASD-FI to calculate frailty scores for 266 ASD patients who had minimum postoperative follow-up of 2 years in the European Spine Study Group (ESSG) database. Patients were enrolled from 2012 through 2013. Using ASD-FI scores, we categorized patients as not frail (NF) (< 0.3 points), frail (0.3–0.5 points), or severely frail (SF) (> 0.5 points). Multivariable logistic regression, adjusted for preoperative and surgical factors such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and odds of major complications, odds of reoperation, and length of hospital stay. Results: We categorized 135 patients (51%) as NF, 90 patients (34%) as frail, and 41 patients (15%) as SF. Overall mean ASD-FI score was 0.29 (range 0–0.8). The adjusted odds of experiencing a major intraoperative or postoperative complication (OR 4.5, 95% CI 2.0–10) or having a reoperation (OR 3.9, 95% CI 1.7–8.9) were higher for SF patients compared with NF patients. Mean hospital stay was 2.1 times longer (95% CI 1.8–2.4) for SF patients compared with NF patients. Conclusions: Greater patient frailty, as measured by the ASD-FI, is associated with longer hospital stays and greater odds of major complications and reoperation. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.].
  • Thumbnail Image
    ItemOpen Access
    External Validation of the Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) in the Scoli-RISK-1 Patient Database.
    (Spine, 2018-10) Miller, Emily K; Lenke, Lawrence G; Neuman, Brian J; Sciubba, Daniel M; Kebaish, Khaled M; Smith, Justin S; Qiu, Yong; Dahl, Benny T; Pellisé, Ferran; Matsuyama, Yukihiro; Carreon, Leah Y; Fehlings, Michael G; Cheung, Kenneth M; Lewis, Stephen; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Mehdian, Hossein; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P; AOSpine Knowledge Forum Deformity, the International Spine Study Group

    Study design

    Analysis of a prospective multicenter database.

    Objective

    To assess the ability of the recently created Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) to predict odds of major complications and length of hospital stay for patients who had more severe preoperative deformity and underwent more invasive ASD surgery compared with patients in the database used to create the index.

    Summary of background data

    Accurate preoperative estimates of risk are necessary given the high complication rates currently associated with ASD surgery.

    Methods

    Patients were enrolled by participating institutions in Europe, Asia, and North America from 2009 to 2011. ASD-FI scores were used to classify 267 patients as not frail (NF) (<0.3), frail (0.3-0. 5), or severely frail (SF) (>0.5). Multivariable logistic regression, adjusted for preoperative and surgical covariates such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and incidence of major complications, overall incidence of complications, and length of hospital stay.

    Results

    The mean ASD-FI score was 0.3 (range, 0-0.7). We categorized 105 patients as NF, 103 as frail, and 59 as SF. The adjusted odds of developing a major complication were higher for SF patients (odds ratio = 4.4; 95% CI 2.0, 9.9) compared with NF patients. After adjusting for covariates, length of hospital stay for SF patients increased by 19% (95% CI 1.4%, 39%) compared with NF patients. The odds of developing a major complication or having increased length of stay were similar between frail and NF patients.

    Conclusion

    Greater patient frailty, as measured by the ASD-FI, is associated with a longer hospital stay and greater risk of major complications among patients who have severe preoperative deformity and undergo invasive surgical procedures.

    Level of evidence

    2.
  • Thumbnail Image
    ItemOpen Access
    Health-Related Quality of Life Scores Underestimate the Impact of Major Complications in Lumbar Degenerative Scoliosis Surgery.
    (Spine deformity, 2018-01) Glassman, Steven D; Bridwell, Keith H; Shaffrey, Christopher I; Edwards, Charles C; Lurie, Jon D; Baldus, Christine R; Carreon, Leah Y

    Study design

    Retrospective cohort.

    Objective

    To examine Charlson Comorbidity Index (CCMI) as a marker for deterioration in health status not reflected in standard Health Related Quality of Life (HRQOL) measures.

    Summary of background data

    HRQOL has become a primary metric for assessing outcomes following spinal deformity surgery. However, studies have reported limited impact of complications on postoperative HRQOL outcomes.

    Methods

    We examined serial CCMI, complications, and HRQOL outcomes for 138 adult lumbar deformity patients treated surgically with a minimum two-year follow-up that included 126 females (91%) with a mean age of 59.8 years (range, 40.2-78.5). Patients with no, minor, or major complications were compared at baseline and at one and two years postoperation.

    Results

    Minor complications were observed in 26 patients (19%) and major complications in 15 (11%). Major complications included motor deficit (7), deep vein thrombosis (4), and respiratory failure (3). There was no difference in preoperative SF-36 Physical Component Summary or Scoliosis Research Society-22R (SRS-22R) scores among the groups at baseline. Preoperative CCMI was lowest in the No Complication group (3.52 ± 1.70) followed by the Major (4.00 ± 1.13) and Minor Complication groups (4.15 ± 1.71, p = .165). At one year, there was a significantly greater CCMI deterioration in the Major Complication group (0.80 ± 1.01) compared to both the Minor (0.08 ± 0.27) and No Complication groups (0.27 ± 0.47, p < .001). There was no significant difference in SF-36 Physical Component Summary or SRS-22R scores among the three groups. Similar findings were observed at two years.

    Conclusions

    Despite similar one- and two-year HRQOL improvement, patients with major complications had greater deterioration in CCMI. As CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including any subsequent spinal surgery. Although this increased risk may not alter the patient's perception of his or her current health status, it may be important, and should be recognized as part of the shared decision-making process.

    Level of evidence

    Level II, high-quality prognostic study.
  • Thumbnail Image
    ItemOpen Access
    Impact of obesity on complications and outcomes: a comparison of fusion and nonfusion lumbar spine surgery.
    (Journal of neurosurgery. Spine, 2017-02) Onyekwelu, Ikemefuna; Glassman, Steven D; Asher, Anthony L; Shaffrey, Christopher I; Mummaneni, Praveen V; Carreon, Leah Y
    OBJECTIVE Prior studies have shown obesity to be associated with higher complication rates but equivalent clinical outcomes following lumbar spine surgery. These findings have been reproducible across lumbar spine surgery in general and for lumbar fusion specifically. Nevertheless, surgeons seem inclined to limit the extent of surgery, perhaps opting for decompression alone rather than decompression plus fusion, in obese patients. The purpose of this study was to ascertain any difference in clinical improvement or complication rates between obese and nonobese patients following decompression alone compared with decompression plus fusion for lumbar spinal stenosis (LSS). METHODS The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality and Outcomes Database (N2QOD), was queried for patients who had undergone decompression plus fusion (D+F group) versus decompression alone (D+0 group) for LSS and were stratified by a body mass index (BMI) ≥ 30 kg/m2 (obese) or < 30 kg/m2 (nonobese). Demographic, surgical, and health-related quality of life data were compared. RESULTS In the nonobese cohort, 947 patients underwent decompression alone and 319 underwent decompression plus fusion. In the obese cohort, 844 patients had decompression alone and 337 had decompression plus fusion. There were no significant differences in the Oswestry Disability Index score or in leg pain improvement at 12 months when comparing decompression with fusion to decompression without fusion in either obese or nonobese cohorts. However, absolute improvement in back pain was less in the obese group when decompression alone had been performed. Blood loss and operative time were lowest in the nonobese D+0 cohort and were higher in obese patients with or without fusion. Obese patients had a longer hospital stay (4.1 days) than the nonobese patients (3.3 days) when fusion had been performed. In-hospital stay was similar in both obese and nonobese D+0 cohorts. No significant differences were seen in 30-day readmission rates among the 4 cohorts. CONCLUSIONS Consistent with the prior literature, equivalent clinical outcomes were found among obese and non-obese patients treated for LSS. In addition, no difference in clinical outcomes as related to the extent of the surgical procedure was observed between obese and nonobese patients. Within the D+0 group, the nonobese patients had slightly better back pain scores at 2 years postoperatively. There may be a higher blood product requirement in obese patients following spine surgery, as well as an extended hospital stay, when fusion is performed. While obesity may influence the decision for or against surgery, the data suggest that obesity should not necessarily alter the appropriate procedure for well-selected surgical candidates.
  • Thumbnail Image
    ItemOpen Access
    Improvement in SRS-22R Self-Image Correlate Most with Patient Satisfaction after 3-Column Osteotomy.
    (Spine, 2021-06) Gum, Jeffrey L; Shasti, Mark; Yeramaneni, Samrat; Carreon, Leah Y; Hostin, Richard A; Kelly, Michael P; Lafage, Virginie; Smith, Justin S; Passias, Peter G; Kebaish, Khaled; Shaffrey, Christopher I; Burton, Douglas L; Ames, Christopher P; Schwab, Frank J; Protopsaltis, Themistocles; Bess, R Shay; ISSG

    Study design

    Longitudinal cohort.

    Objectives

    The aim of this study was to examine the relationship between patient satisfaction, patient-reported outcome measures (PROMs) and radiographic parameters in adult spine deformity (ASD) patients undergoing three-column osteotomies (3CO).

    Summary of background data

    Identifying factors that influence patient satisfaction in ASD is important. Evidence suggests Scoliosis Research Society-22R (SRS-22R) Self-Image domain correlates with patient satisfaction in patients with ASD.

    Methods

    This is a retrospective review of ASD patients enrolled in a prospective, multicenter database undergoing a 3CO with complete SRS-22R pre-op and minimum 2-years postop. Spearman correlations were used to evaluate associations between the 2-year SRS Satisfaction score and changes in SRS-22R domain scores, Oswestry Disability Index (ODI), and radiographic parameters.

    Results

    Of 135 patients eligible for 2-year follow-up, 98 patients (73%) had complete pre- and 2-year postop data. The cohort was mostly female (69%) with mean BMI of 29.7 kg/m2 and age of 61.0 years. Mean levels fused was 12.9 with estimated blood loss of 2695 cc and OR time of 407 minutes; 27% were revision surgeries. There was a statistically significant improvement between pre- and 2-year post-op PROMs and all radiographic parameters except Coronal Vertical Axis. The majority of patients had an SRS Satisfaction score of ≥3.0 (90%) or ≥4.0 (68%), consistent with a moderate ceiling effect. Correlations of patient satisfaction was significant for Pain (0.43, P < 0.001), Activity (0.39, P < 0.001), Mental (0.38, P = 0.001) Self-Image (0.52, P < 0.001). ODI and Short-Form-36 Physical component summary had a moderate correlation as well, with mental component summary being weak. There was no statistically significant correlation between any radiographic or operative parameters and patient satisfaction.

    Conclusion

    There was statistically significant improvement in all PROMs and radiographic parameters, except coronal vertical axis at 2 years in ASD patients undergoing 3CO. Improvement in SRS Self-Image domain has the strongest correlation with patient satisfaction.Level of Evidence: 3.
  • Thumbnail Image
    ItemOpen Access
    Improvements in Outcomes and Cost After Adult Spinal Deformity Corrective Surgery Between 2008 and 2019.
    (Spine, 2023-02) Passias, Peter G; Kummer, Nicholas; Imbo, Bailey; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Line, Breton; Vira, Shaleen; Schoenfeld, Andrew J; Gum, Jeffrey L; Daniels, Alan H; Klineberg, Eric O; Gupta, Munish C; Kebaish, Khaled M; Jain, Amit; Neuman, Brian J; Chou, Dean; Carreon, Leah Y; Hart, Robert A; Burton, Douglas C; Shaffrey, Christopher I; Ames, Christopher P; Schwab, Frank J; Hostin, Richard A; Bess, Shay; , on behalf of the International Spine Study Group

    Study design

    A retrospective cohort study.

    Objective

    To assess whether patient outcomes and cost-effectiveness of adult spinal deformity (ASD) surgery have improved over the past decade.

    Background

    Surgery for ASD is an effective intervention, but one that is also associated with large initial healthcare expenditures. Changes in the cost profile for ASD surgery over the last decade has not been evaluated previously.

    Materials and methods

    ASD patients who received surgery between 2008 and 2019 were included. Analysis of covariance was used to establish estimated marginal means for outcome measures [complication rates, reoperations, health-related quality of life, total cost, utility gained, quality adjusted life years (QALYs), cost-efficiency (cost per QALY)] by year of initial surgery. Cost was calculated using the PearlDiver database and represented national averages of Medicare reimbursement for services within a 30-day window including length of stay and death differentiated by complication/comorbidity, revision, and surgical approach. Internal cost data was based on individual patient diagnosis-related group codes, limiting revisions to those within two years (2Y) of the initial surgery. Cost per QALY over the course of 2008-2019 were then calculated.

    Results

    There were 1236 patients included. There was an overall decrease in rates of any complication (0.78 vs . 0.61), any reoperation (0.25 vs . 0.10), and minor complication (0.54 vs . 0.37) between 2009 and 2018 (all P <0.05). National average 2Y cost decreased at an annual rate of $3194 ( R2 =0.6602), 2Y utility gained increased at an annual rate of 0.0041 ( R2 =0.57), 2Y QALYs gained increased annually by 0.008 ( R2 =0.57), and 2Y cost per QALY decreased per year by $39,953 ( R2 =0.6778).

    Conclusion

    Between 2008 and 2019, rates of complications have decreased concurrently with improvements in patient reported outcomes, resulting in improved cost effectiveness according to national Medicare average and individual patient cost data. The value of ASD surgery has improved substantially over the course of the last decade.
  • Thumbnail Image
    ItemOpen Access
    Lower Extremity Motor Function Following Complex Adult Spinal Deformity Surgery: Two-Year Follow-up in the Scoli-RISK-1 Prospective, Multicenter, International Study.
    (The Journal of bone and joint surgery. American volume, 2018-04) Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; AO Spine International and SRS Scoli-RISK-1 Study Group
    BACKGROUND:The reported neurologic complication rate following surgery for complex adult spinal deformity (ASD) is variable due to several factors. Most series have been retrospective with heterogeneous patient populations and use of nonuniform neurologic assessments. The aim of this study was to prospectively document lower extremity motor function by means of the American Spinal Injury Association (ASIA) lower extremity motor score (LEMS) before and through 2 years after surgical correction of complex ASD. METHODS:The Scoli-RISK-1 study enrolled 272 patients with ASD, from 15 centers, who had undergone primary or revision surgery for a major Cobb angle of ≥80°, corrective osteotomy for congenital spinal deformity or as a revision procedure for any type of deformity, and/or a complex 3-column osteotomy. RESULTS:One of 272 patients lacked preoperative data and was excluded from the analysis, and 62 (22.9%) of the remaining 271 patients, who were included, lacked a 2-year postoperative assessment. Patients with no preoperative motor impairment (normal LEMS group; n = 203) had a small but significant decline from the mean preoperative LEMS value (50) to that at 2 years postoperatively (49.66 [95% confidence interval = 49.46 to 49.85]; p = 0.002). Patients who did have a motor deficit preoperatively (n = 68; mean LEMS, 43.79) had significant LEMS improvement at 6 months (47.21, p < 0.001) and 2 years (46.12, p = 0.003) postoperatively. The overall percentage of patients (in both groups combined) who had a postoperative LEMS decline, compared with the preoperative value, was 23.0% at discharge, 17.1% at 6 weeks, 9.9% at 6 months, and 10.0% at 2 years. CONCLUSIONS:The percentage of patients who had a LEMS decline (compared with the preoperative score) after undergoing complex spinal reconstructive surgery for ASD was 23.0% at discharge, which improved to 10.0% at 2 years postoperatively. These rates are higher than previously reported, which we concluded was due to the prospective, strict nature of the LEMS testing of patients with these challenging deformities. LEVEL OF EVIDENCE:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
  • Thumbnail Image
    ItemOpen Access
    Non-neurologic adverse events after complex adult spinal deformity surgery: results from the prospective, multicenter Scoli-RISK-1 study.
    (European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2019-01) Kwan, Kenny Yat Hong; Bow, Cora; Samartzis, Dino; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Cheung, Kenneth Man Chee

    Purpose

    Accurate information regarding the expected complications of complex adult spinal deformity (ASD) is important for shared decision making and informed consent. The purpose of the present study was to investigate the rate and types of non-neurologic adverse events after complex ASD surgeries, and to identify risk factors that affect their occurrence.

    Methods

    The details and occurrence of all non-neurologic adverse events were reviewed in a prospective cohort of 272 patients after complex ASD surgical correction in a mulitcentre database of the Scoli-RISK-1 study with a planned follow-up of 2 years. Logistic regression analyses were used to identify potential risk factors for non-neurologic adverse events.

    Results

    Of the 272 patients, 184 experienced a total of 515 non-neurologic adverse events for an incidence of 67.6%. 121 (44.5%) patients suffered from more than one adverse event. The most frequent non-neurologic adverse events were surgically related (27.6%), of which implant failure and dural tear were most common. In the unadjusted analyses, significant factors for non-neurologic adverse events were age, previous spine surgery performed, number of documented non-neurologic comorbidities and ASA grade. On multivariable logistic regression analysis, previous spine surgery was the only independent risk factor for non-neurologic adverse events.

    Conclusions

    The incidence of non-neurologic adverse events for patients undergoing corrective surgeries for ASD was 67.6%. Previous spinal surgery was the only independent risk factor predicting the occurrence of non-neurologic adverse events. These findings complement the earlier report of neurologic complications after ASD surgeries from the Scoli-RISK-1 study. These slides can be retrieved under Electronic Supplementary Material.