Naum Simanovsky, MD, Department of Orthopedics, Hadassah University Hospital.
Background
Scoliosis is a complex 3-D deformation of the trunk, spine and rib cage. The most common variant of a scoliotic deformity is idiopathic scoliosis, in particular, adolescent idiopathic scoliosis (AIS) which may affect up to 3% of the adolescent population. The list of clinical problems associated with the affliction includes not only cosmetic distortion of the hips, back and shoulders, but also distortion of abdominal and chest organs, resulting in difficulties breathing, alteration of normal gait with associated pelvic obliquity and many other functional and social difficulties.
Most of the widely accepted methods of treatment are extremely traumatic procedures with considerable morbidity.
The current invention is based on the notion that a rotational malfunction of the trunk and spinal column, occurring regardless of the exact source, is the leading cause for developing and progressing idiopathic scoliosis.
Market
Idiopathic scoliosis afflicts around 1% of the population worldwide, accounting for between 80-90% of all scoliosis cases. Within the US, an estimated 6 million people live with scoliosis. According to the National Scoliosis Foundation, more than 600,000 visits are made each year to private physicians, while an estimated 30,000 children are treated with orthopedic braces and 38,000 undergo spinal fusion surgery. There is no cure for scoliosis; rather treatment focuses on halting the progression of spinal curves via bracing, surgery and exercise.
The Innovation
The current invention is based on the notion that a rotational malfunction of the trunk and spinal column, occurring regardless of the exact source, is the leading cause for developing and progressing idiopathic scoliosis. The Derotation Brace employs a dynamic derotation mechanism to create neutral rotational forces that reverse the rotation of the spine and help correct the scoliosis. The brace consists of two parts that allow for progressive derotation and the improvement of spinal balance in a three dimensional direction.
3 groups of immature patients were enrolled into a clinical study:
- Mild curves (20-25 deg) 5 patients
- Moderate curves (25-39 deg) 10 patients
- Severe curves/refusing surgery (>39 deg) 5 patients
Intermediate results after 32 months:
- Mild group:
- Curve progression (>=5 deg) 1 patient
- Improvement (>=5 deg) 3 patients
- Stable 1 patient
- Moderate group:
- Curve progression (>=5 deg) 3 patients
- Improvement (>=5 deg) 3 patients
- Stable 3 patients
- Wrong enrollment 1 patient
- Moderate group:
- Curve progression (>=5 deg) 2 patients
- Stable 1 patient
- Non-compliance 2 patients
Contact
Stuart Bernstein
Business Development, Medical Devices
Tel: +972-2-6777906
Email: stuart@hadasit.co.il
