CINCINNATI — Scientists at Cincinnati Children's Hospital Medical Center have developed a "spine staple" that could eliminate the need for thousands of invasive spine surgeries in children each year.
The spine staple is intended to correct scoliosis, a curvature of the spine. Typically, orthopaedic surgeons track patients as they grow to determine whether the curvature progresses to a point where surgery is necessary. In recent years, however, surgeons have learned to predict rates of curvature progression based on the child's age and the angle of curvature.
The spine staple would be implanted in a minimally invasive procedure in children who are at high risk of needing surgery in adolescence. The staple would slow progression of the curvature or actually decrease the curvature as the child grows.
Cincinnati Children's has signed a license agreement with E-Prime, a Blue Ash, Ohio, company that takes ideas and concepts into product development and clinical trials and prepares them for commercialization. E-Prime will help with advancing development of the staples in collaboration with Cincinnati Children's.
"The spine staple re-directs growth of the spine — slowing growth on the outside of the curve so that the inside can catch up," says Eric Wall, M.D., an orthopaedic surgeon at Cincinnati Children's and co-inventor of the staple. "Surgery will be minimally invasive, safe, relatively simple and at lower cost than current procedures. It will reduce pain and length of hospital stay. And, it will help surgeons, for whom current techniques are like building a ship in a bottle."
Approximately 20,000 children undergo scoliosis surgery each year. The most common form of scoliosis is called idiopathic and usually occurs in otherwise normal children around puberty. Orthopaedists typically recommend braces for spinal curvatures greater than 25-30 degrees and surgical correction for curves greater than 40-50 degrees.
Although current surgical techniques for correction of scoliosis have excellent long-term success rates with few complications, these surgeries involve extensive exposure of the spine, frequent blood transfusions, significant post-operative pain, lengthy hospitalizations and slow rehabilitations. Surgical treatments for adolescents are among the most invasive and expensive. Moreover, standard surgical treatment involves the insertion of rods and a bone graft to fuse the spine into a straightened position.
The spine staple is intended to correct typical scoliosis curvatures. Surgeons will make three or four, one-inch incisions on the side of the body, under the arm. Approximately six spine staples will be inserted through these "portals" and into the spine, across the growth plates. Loss of blood will be minimal, "just drops as opposed to pints," according to Dr. Wall. Rods and spine fusion will be unnecessary.
Dr. Wall developed the spine staples with Donita Bylski-Austrow, Ph.D., an orthopaedic researcher at Cincinnati Children's. A study to determine the staples' safety and effectiveness in children could begin at Cincinnati Children's within the next year.
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