Significant Accomplishments

HemiBridge Spine Clip Advances in Clinical Trials

The HemiBridgeTM System has passed a Phase I clinical safety trial, with the device showing immediate post-operative decreases in curvature.  Of the six individuals enrolled in the study, four patients have completed one-year follow-up visits, with early indications of positive performance results. In all six patients, spine deformities are either stable or improved. In one case, a curve correction of 70 percent occurred in one year, with indications of vertebral growth modification and disc height maintenance.

In the US, the FDA has approved a Humanitarian Use Device (HUD) designation for the HemiBridge System. The protocol for a Phase II trial also has been approved. In Europe, the device already has a CE Mark, giving it regulatory clearance to market. Four additional clinical trial sites, two each in England and Germany, have been prepared for a limited and strategic market release. Korean patents were approved.

Results of device effects on spine biomechanics in an in vitro model have been accepted for publication in the journal Spine. A second set of biomechanical tests is in analysis. Computational model growth modification results were presented at the Orthopaedic Research Society. Clinical safety trial results were presented at meetings of the Pediatric Orthopaedic Society of North America and the International Congress on Early Onset Scoliosis. An Instructional Course was presented at the American Academy of Orthopaedic Surgeons.

PRECICE Device Revolutionizes Limb Lengthening Treatment

The PRECICE ™ device is a remote-controlled, magnetic intramedullary nail that can lengthen leg bones without the need for an external device or fixator.  This device is recommended for children whose legs have grown to be different lengths.  James McCarthy, MD, is piloting this new FDA-approved device in a multi-center study to evaluate its safety and effectiveness in children.  So far, the device has been successfully implanted in two patients.

Brachial Plexus Research Coming to Fruition

Roger Cornwall, MD, has received a three-year Career Development Grant from the Orthopaedic Research and Education Foundation (OREF) to pursue a study The entitled “The Role of Muscle Satellite Cells in Contracture Formation Following Neonatal Brachial Plexus Injury.” Cornwall also received the J. Leonard Goldner Pioneer Research Award, which is given to the top research grant application submitted to the American Society for Surgery of the Hand. Cornwall’s study is entitled “Afferent Denervation and Contractures Following Neonatal Brachial Plexus Injury.”

Pediatric Sports Injuries on the Decline

Shital Parikh, MD, presented a study entitled “The Trend of Pediatric Sports and Recreational Injuries in the U.S. in the Last Decade” at the American Academy of Orthopaedic Surgeons Annual Meeting. Results also were highlighted on CNN.com and several local media outlets. The study found that, contrary to popular opinion, the number of sports injuries has decreased in the past decade.  Parikh says the reduction could be caused by a decrease in physical activity among children along with the positive effects of preventive programs and continuing education about sports injury.