The Scoliosis Research Society (SRS) has partnered with Globus Medical, K2M, Medtronic, NuVasive, Zimmer Biomet, and the International Spine Study Group Foundation (ISSGF) to provide continued funding and research infrastructure for the Adult Symptomatic Lumbar Scoliosis (ASLS) II study.
The ASLS II is continuation of the ASLS I study, which was a prospective, randomised National Institutes of Health (NIH) funded study that evaluated the two-year treatment outcomes of operative and non-operative treatment for adult patients aged 40 to 80 with symptomatic lumbar scoliosis. ASLS I began patient enrollment in 2009 and consisted of both prospective randomised and observational arms (observational participation for patents not consenting to treatment randomisation). ASLS II will allow for longer-term (eight-year) follow up of the 258 patients remaining from the ASLS I study.
The study aims for ASLS II include evaluation of long-term treatment outcomes and cost-effectiveness analysis of operative vs. non-operative treatment. Other study goals include optimal patient profiling for treatment efficacy, long-term functional assessment of patients using functional treadmill testing, and assessment of treatment durability for operative and non-operative treatment.
Patients will complete basic follow-up every six months; full data sets (involving patient reported outcomes, medical assessments, and radiographs) at years four, five and eight; with interim patient reported outcomes in years six and seven. Full data sets will also be collected prior to and approximately three months after any crossover or revision surgery. The eight-year assessment will also include a repeat functional treadmill test (FTT). The study is currently underway at ten centres from around the USA and Canada. The ISSGF will act as the clinical research organisation for the ASLS II study, and will serve to provide a research platform for the ASLS II study investigators for research organisation, funding acquisition and distribution, as well as study updates and data analysis. The study is scheduled to conclude in 2023.