Designed as a prospective multicenter study to evaluate neurological complications in complex adult spinal deformity (ASD) surgery, Scoli-Risk-1 involved 15 centers in eight countries and was a landmark study conducted by the AO Spine Knowledge Forum Deformity in collaboration with the Scoliosis Research Society (SRS). The extension study, spine surgeons can now be confident of the durability of the beneficial outcome of the surgery up to five years or longer.
Due to the general lack of information on the long-term outcomes of surgical management in this patient population, after the completion of the original study with a follow-up period of two years, Scoli-Risk-1 was extended to include follow-up data up to five years. As the Principal Investigator Larry Lenke tells us, "…adults having spinal deformity surgery may encounter complications in the 2 to 5-year period (after surgery) at a much higher rate (than in younger, pediatric patients) and the patients need to understand that possibility."
The Scoli-Risk-1 5-year extension study is now completed and have come to an important main conclusion: patients that underwent complex ASD surgery on average significantly improved postoperatively, as assessed by a panel of patient-reported outcomes (PROs).
"Patients that underwent complex ASD surgery on average significantly improved postoperatively."
Surprisingly, major surgery-related complications did not significantly influence the outcome, ie, the PRO scores and the proportion of patients achieving the MCID (minimum clinically important difference) did not differ significantly between patients with or without major surgery-related complications. The detailed results are published in the Global Spine Journal (https://journals.sagepub.com/doi/10.1177/2192568220988276).
The frequency and types of complications (both neurological and non-neurological) and the changes of lower extremity motor functions between two to five years after surgery were also analyzed and evaluated. Analyses showed that, although some changes (both increase and decrease) in the LEMS were observed in a small number of patients, the mean LEMS did not change significantly. However, in patients with neurologic surgery-related complications, lower LEMS was seen at 5 years. These results have been submitted for publication.
To summarize the lessons learned from the now-concluded Scoli-Risk-1 extension study, spine surgeons can now be confident of the durability of the beneficial outcome of the surgery up to five years or longer. Lenke says, "…most of these complications encountered are treatable. Even with the complications, the overall outcomes were still favorable, and that the patients are still experiencing a better quality of life following their surgery than the alternative".
"Spine surgeons can now be confident of the durability of the beneficial outcome of the surgery up to five years or longer."
The study was initiated over 10 years ago and the overall surgical treatment of the ASD patients has changed over the past decade. The impact of the newer treatments, such as predictive modeling, artificial intelligence, patient specific implants, and less invasive surgical approaches are unknown and may need to be assessed to help us take better care of the ASD patients.
More information on the AO Spine Knowledge Forum Deformity and their clinical research projects can be found here.
Some of the awards the study received
ClinicalTrials.gov Identifier: NCT02949245
