The landmark Scoli-RISK-1 study evaluating the neurologic complications associated with surgical correction of complex adult spinal deformity recently published its two-year results in The Journal of Bone and Joint Surgery (JBJS). Scoli-RISK-1 is an example of successful academic collaboration between two leading societies—the Scoliosis Research Society (SRS) and AOSpine.

 

“Even for someone who has practiced spinal deformity surgery for 27 years, one of the biggest fears is that the patient has neurologic complications during these complex operations,” principal investigator (PI) Lawrence Lenke explains. Co-PI Michael Fehlings agrees that even with the many advances in adult spinal deformity (ASD) techniques, the risk of peri-operative neurologic “Surgeons can already better inform their patients of the risks.”deficits remains high.

 

For the first time, the prospective multicenter observational study Scoli-RISK-1 did a formal neurologic assessment of patients undergoing complex ASD surgery. The 15 participating institutions from North America, Europe, and Asia collected information on all complications and patient reported outcomes from 272 patients. Data was collected before surgery and at various timepoints after surgery up to 2-year postoperative.

 

Data helps understand risks and increases patient satisfaction

 

The Scoli-RISK-1 6-month outcomes were published in Spine in 2016 and established an early complication rate two to three times higher than “If surgeons can identify the individuals that are prone to developing complications, we can take preventative measures.”previously reported. “Nearly one in four patients had neurologic deficits at the point of discharge, and the non-neurologic complication rate was at 60 %,” says Kenneth Cheung, site investigator. The 2-year outcomes recently published in the JBJS showed a significant improvement in neurologic outcomes at 2-years postoperative; more than half the patients having improved their neurologic weakness or deficits.

 

“The rate in neurologic decline was much higher than expected, which gives us a baseline to work off to lower the rate of complications,” Lenke states. Site investigators believe surgeons can already better inform their patients of the risks.

 

Risk factors for postoperative neurologic decline and factors that predict patient reported outcomes were also identified and published in The Spine This will save on health costs and increase patient satisfaction.Journal and Spine Deformity, respectively. “If surgeons can identify the individuals that are prone to developing complications, we can take preventative measures preoperatively. This will not only save on health costs, but with proper counselling, increase patient satisfaction,” Fehlings adds. The data can be used for risk stratification or to strategize how to reduce complications.

 

 

​Larry Lenke and Michael Fehlings leading the Scoli-RISK-1 study meeting (Istanbul, Turkey, 2012).A Global Perspective on Multidisciplinary Spine Deformity Surgery—AOSpine KF Deformity and SRS pre-course at the Global Spine Congress 2018 in Singapore.AOSpine KF Deformity steering committee and associates met at the Global Spine Congress 2018 in Singapore.1 - 3<>

 

Landmark collaboration changing clinical practice

 

All participating surgeons see Scoli-RISK-1 as a great example of a mutually beneficial collaboration between two leading spine societies, the SRS and AOSpine. Many AOSpine Knowledge Forum Deformity members are also The next step is to develop care pathways and guidelines.members of the SRS, so intellectual collaboration is ongoing, and the hope is that such study collaborations will continue whenever opportunity arises.

 

Lenke and Fehlings are proud to describe Scoli-RISK-1 as a landmark and collaborative study that will be referred to as one that changed practice. “It is one of the most detailed, well-orchestrated, and thorough studies ever done on complex ASD for complications and outcomes,” Lenke says and adds AOCID’s expertise was instrumental for its success.

 

The next step is to take this knowledge and research activities to the next level and optimize outcomes by developing care pathways and guidelines for prevention and management of high-risk surgeries.

 

 

​

Awards

 

Scoli-RISK 1 was awarded the Whitecloud Award for Best Clinical Paper at the International Meeting on Advanced Spine Techniques (IMAST) two years in a row (2015 and 2016), won the Russell A. Hibbs Award for the Best Clinical Research Presentation at the SRS Annual Meeting 2013, and was nominated in 2016 and 2017. It was also the winner of the Best Paper Award at the Global Spine Congress 2015.

 

Read more about KF Deformity and the ongoing studies at www.aospine.org/kf-deformity

 

Read the interview with Larry Lenke in the August 2018 issue of the AOSpine newsletter

 

The AOSpine Knowledge Forum Deformity sponsored study was performed with the AO Clinical Investigation and Documentation support.

 

 

​

Publications

 

1. Kwan KYH, Bow C, Samartzis D, Lenke L, Shaffrey C, Carreon L, Dahl B, Fehlings M, Ames C, Boachie-Adjei O, Dekutoski M, Kebaish K, Lewis S, Matsuyama Y, Mehdian H, Pellise F, Qiu Y, Schwab F, Cheung K. Non-neurologic adverse events after complex adult spinal deformity surgery: results from the prospective, multicenter Scoli-RISK-1 study. European Spine Journal, 2018 [under revision].
   
   
2. Tuchman A, Lenke LG, Cerpa M, Fehlings MG, Lewis SJ, Shaffrey CI, Cheung KMC, Carreon LY, Dekutoski MB, Schwab FJ, Boachie-Adjei O, Kebaish K, Ames CP, Qiu Y, Matsuyama Y, Dahl BT, Mehdian H, Pellise F, Berven SH. Unilateral vs. Bilateral Lower Extremity Motor Deficit Following Complex Adult Spinal Deformity Surgery: Is there a Difference in Recovery Up to 2 Year F/U? Spine J, 2018.
   
   
3. Fehlings MG, Kato S, Lenke LG, Nakashima H, Nagoshi N, Shaffrey CI, Cheung KMC, Carreon L, Dekutoski MB, Schwab FJ, Boachie-Adjei O, Kebaish KM, Ames CP, Qiu Y, Matsuyama Y, Dahl BT, Mehdian H, Pellise-Urquiza F, Lewis SJ, Berven SH. Incidence and risk factors of postoperative neurologic decline after complex adult spinal deformity surgery: results of the Scoli-RISK 1 study. Spine J, 2018.
   
   
4. Lenke LG, Shaffrey CI, Carreon LY, Cheung KMC, Dahl BT, Fehlings MG, Ames CP, Boachie-Adjei O, Dekutoski MB, Kebaish KM, Lewis SJ, Matsuyama Y, Mehdian H, Pellise F, Qiu Y, Schwab FJ, International A, Group SS-R-S. Lower Extremity Motor Function Following Complex Adult Spinal Deformity Surgery: Two-Year Follow-up in the Scoli-RISK 1 Prospective, Multicenter, International Study. J Bone Joint Surg Am 100(8): 656-665, 2018.
   
   
5. Miller EK, Lenke LG, Neuman BJ, Sciubba DM, Kebaish KM, Smith JS, Qiu Y, Dahl BT, Pellise F, Matsuyama Y, Carreon LY, Fehlings MG, Cheung KM, Lewis S, Dekutoski MB, Schwab FJ, Boachie-Adjei O, Mehdian H, Bess S, Shaffrey CI, Ames CP, Aospine Knowledge Forum Deformity TISSG. External Validation of the Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) in the Scoli-RISK 1 Patient Database. Spine (Phila Pa 1976), 2018.
   
   
6. Carreon LY, Glassman SD, Shaffrey CI, Fehlings MG, Dahl B, Ames CP, Matsuyama Y, Qiu Y, Mehdian H, Cheung KM, Schwab FJ, Pellise F, Kebaish KM, Lenke LG. Predictors of Health-Related Quality-of-Life After Complex Adult Spinal Deformity Surgery: A Scoli-RISK 1 Secondary Analysis. Spine Deform 5(2): 139-144, 2017.
   
   
7. Kato S, Fehlings MG, Lewis SJ, Lenke LG, Shaffrey CI, Cheung KMC, Carreon L, Dekutoski MB, Schwab FJ, Boachie-Adjei O, Kebaish KM, Ames CP, Qiu Y, Matsuyama Y, Dahl BT, Mehdian H, Pellise F, Berven SH. An Analysis of the Incidence and Outcomes of Major vs. Minor Neurological Decline after Complex Adult Spinal Deformity Surgery: A Sub-analysis of Scoli-RISK 1 Study. Spine (Phila Pa 1976), 2017.
   
   
8. Kelly MP, Lenke LG, Godzik J, Pellise F, Shaffrey CI, Smith JS, Lewis SJ, Ames CP, Carreon LY, Fehlings MG, Schwab F, Shimer AL. Retrospective analysis underestimates neurological deficits in complex spinal deformity surgery: a Scoli-RISK 1 Study. J Neurosurg Spine 27(1): 68-73, 2017.
   
   
9. Lenke LG, Fehlings MG, Shaffrey CI, Cheung KM, Carreon L, Dekutoski MB, Schwab FJ, Boachie-Adjei O, Kebaish KM, Ames CP, Qiu Y, Matsuyama Y, Dahl BT, Mehdian H, Pellise-Urquiza F, Lewis SJ, Berven SH. Neurologic outcomes of complex adult spinal deformity surgery: results of the prospective, multicenter Scoli-Risk 1 study. Spine (Phila Pa 1976) 41(3): 204-212, 2016.