Scoliosis is a spine disorder that affects 2-3% of the population in the United States. Currently, the Boston and Charleston back braces are being used to treat moderate to severe scoliosis in children. The braces help prevent curvature in the spine from progressing, but do not offer the best medical treatment. The new back brace design can treat curvature in the spine and can be adjusted throughout the treatment period, a feature that current braces do not offer. This new brace model addresses the dynamic growth of patients with spinal disorders that current braces do not. This new brace design can positively impact the treatment a patient receives and benefit their health and quality of life. The simple design of this new back brace makes it a great product for commercialization. SPROUT and I-Corps grants will be used to develop better back brace designs based on criteria provided by doctors specializing in orthopedics.
Figure 1. Scoliosis disorder symptoms and treatments. A. Symptoms of scoliosis include a curved spine and uneven hips and shoulders. The disorder usually occurs in children and causes are unknown. Image reproduced from reference 2. B. Charleston and Boston back braces are used to treat scoliosis. Image reproduced from reference 3.
Scoliosis is a musculoskeletal disorder that affects 9 million people in the United States.1 The disorder is characterized by a curved spine and uneven shoulders and hips, as shown in figure 1a. It affects primarily females with an occurrence of 7:1 (girls:boys) and occurs during the adolescence period.1 Braces remain as custom products that have long production times and can lead to ineffective or incorrect treatment. The Boston (daytime) and Charleston (nighttime) back braces, shown in figure 1b and c, are commonly used to treat scoliosis patients. They are one-piece, custom braces that can be outgrown by a patient during the treatment period, but are typically not remade.
Figure 2. Teenage girl wearing a Boston brace to treat her idiopathic scoliosis. Physical and emotional pain is common for girls going through scoliosis treatment. Image reproduced from reference 4.
Figure 3. Manufacturing process for back braces. The process includes making a mold of the patient and the product is specially made to fit one patient. Image reproduced from reference 4.
This new brace model is a modifiable hard plastic brace that can be mass produced and adjusted to provide proper treatment and curvature correction as a patient grows, therefore addressing issues of comfort, affordability, requiring multiple braces throughout development, length of treatment period, and manufacturing delays.
The thoracic curve decreased by 9° and the lumbar by 3° while wearing the brace and standing upright. In the supine position, the thoracic curve decreased by 5° and the lumbar by 12° for the first prototype. In the second prototype, while lying supine, the thoracic decreased by 5° and the lumbar by 15°. The x-rays taken in the supine and upright position show positive results of being able to significantly decrease both curves and that the design is effective. The main curve, found in the upper lumbar region, was not decreased completely because the wearer of the brace (researcher) is skeletally mature. The ability of the spine to bend is based on its flexibility and adult spines are more rigid and have lost the capacity for correction. However, the brace will be more effective if used by children.
The I-Corps grant was used to contact 25 orthopedic specialists and make a business model for the back-brace project. Customers of this product will be physicians and orthopedic surgeons. Most doctors interviewed agreed that current braces do not have high rates of success. Design improvements will focus on making a rigid brace that is more comfortable, attractive, and can potentially reduce the length of the treatment period. These developments will result in a better product that offers a more effective treatment.
The current brace design allows for easy and quick modification of the brace, leading to improved scoliosis treatment. New brace designs will include more bands that can allow for better customization of the brace. Removable interior padding can provide added support for the spine and be much easier to clean and replace after wear and tear occurs. Splitting the brace into multiple parts will lead to improved comfort and decrease any heat caused by wearing the brace. Interesting designs will be created to develop a more attractive brace.