Phase 1 Study of the HemiBridge System for Treatment of Idiopathic Scoliosis

Spineform, Llc, Cincinnati OH

Investigators

Abstract

DESCRIPTION (provided by applicant): The treatment of progressive late juvenile and adolescent idiopathic scoliosis remains controversial, with most spine specialists agreeing that alternatives to the standard of care in treating moderate yet progressing spinal deformity must be clinically studied. Research has revealed that moderate compression influences the natural history of a vertebral growth plate. The proposed study device is a set of spinal implants designed to arrest progression by applying pressure on the convex side of the deformity and relieving compression on the concave side to redirect vertebral growth. This technique of growth modulation has been termed hemiepiphysiodesis, as the implant and its effect on the structure of growth plate are similar to those of techniques long used in the knee to correct long bone deformities such as knock-knees. The purpose of this study is to conduct a prospective trial to evaluate the initial safety of the HemiBridge System designed to guide the growth of the spine in a subgroup of scoliosis patients. The test article is intended for anterior-lateral fixation across the growth plates from T3 to L1 with placement through video-assisted thoracoscopic surgery. The endpoint of the study is completion of surgery of at least 4 cases with documented follow up of one month, absence of any unresolved stopping rule and Data Monitoring Committee (DMC) recommendation to continue to the larger pilot study.