Development of a Conservative Care and Bracing Registry (CCBR)

Idiopathic scoliosis (IS) is the most common form of scoliosis, defined as a lateral curvature of the spine of at least 10°. When left untreated in growing children, curves can progress leading to back pain, cardiopulmonary dysfunction, and substantial deformity affecting both physical and psychosocial functioning. IS is common, affecting approximately 3% of the population; nearly 10% of those patients require treatment and 0.1% meet surgical indications. Treatment options, including observation, bracing, physiotherapy, and surgery, are patient specific depending on risk factors for progression including skeletal maturity, curve magnitude, and family history.

Surgery is typically recommended for patients whose curves reach 50° or greater. The goal of surgical correction is to permanently improve the alignment and balance of the trunk. The most common procedure is a posterior spinal fusion where rigid rods are used to successfully achieve these outcomes, but at the cost of loss of flexibility in the operated segment. Unfortunately, surgery exposes patients to risk through complications. Studies have reported a surgical complication rate of 0%-15.4%, with reoperation rates reported between 12.9% and 47.5%. Complications include infections, wound healing problems, neurologic injury, skin breakdown, implant failure and poor cosmesis creating physical and mental health burdens for patients and their caregivers.

Besides the negative impact of complications due to surgery, surgical correction of IS is quite expensive. Vigneswaran et al reported that hospital charges for IS surgery more than tripled from approximately $55,000 in 1997 to over $177,000 in 2012. These numbers do not include the consequences of complications and re-operations which add to these costs and increase the burdens on patients, their families, and the healthcare system as a whole.

The goal of non-operative therapy for IS, bracing and physiotherapy, is to prevent or limit curve progression and obviate the need for surgery, thus avoiding these costs and potential complications. This is the critical goal of managing IS, and bracing, the mainstay of conservative management in IS, has been shown in many studies to reduce the risk of curve progression and need for surgery over natural history. The 2013 BrAIST study, a randomized clinical trial, has provided the most compelling evidence in favor of bracing to date, and this landmark study dramatically increased the interest and utilization of bracing globally. Yet, over a decade later, strong, evidence-based guidelines for brace treatment are still missing.

Yes, the current literature consistently demonstrates that improved brace outcomes are seen in older patients with smaller curves and better brace compliance, but when one tries to distill specific criteria from these general statements (e.g. how small a curve to brace, or how many hours in the brace is enough), the literature is tremendously variable; details are not well understood nor well agreed upon. Variability is seen throughout the brace literature with little consistency in indications for brace treatment, brace types, brace prescriptions, use of monitors, timing of radiographs, goals of bracing, and evaluation of skeletal maturity. A recent best practice guideline on bracing in AIS, published in 2020 by Roye et al., highlighted this challenge by demonstrating wide variability in such basic factors as initiating brace care, brace prescriptions, brace types, use of compliance monitoring, and how and when to discontinue treatment. These findings were replicated in a recent SRS Member survey that demonstrated variability in all aspects of brace management from initiation to discontinuation, evaluation of brace quality and objective brace monitoring. The many unknowns and the many gaps in the current literature demonstrate a clear and urgent need for a large bracing registry to evaluate bracing regimens and ultimately optimize outcomes.