Prospective Trial to Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis

Detailed Summary

The purpose of this clinical trial is to study a new method of treatment for patients who are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine. The treatment consists of the surgical implantation of a new medical device called the "HemiBridge™ Clip". This medical implant device has never been used in humans. SpineForm, LLC, the developer of the HemiBridgeTM System has designed this scientific clinical trial, to evaluate the safety of the use of this device in humans. Information collected from patients treated with this new device shall be used to determine the initial safety of the new device. The FDA has approved the use of the HemibridgeTM System for this research study in 6 (six) pediatric patients who have idiopathic scoliosis. This procedure is intended to stop additional curvature of the spine by redirecting growth of the bones of the spine (vertebrae). To accomplish this, the patient undergoes a surgical procedure to securely attach small metal clips (HemiBridge™ Clips) to the outer side of each vertebra involved in the curvature. The HemiBridge™ Clip forms a "bridge" between each vertebra and is intended to hold the vertebrae in place to prevent the spine from curving any further.

Study Details

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Interventions