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.

Public Health Relevance

Spinal deformity fusion treatment involves some of the most costly and invasive procedures in orthopaedics. The development of an effective treatment method to avoid fusion is needed. Many pediatric spine specialists concur that growth modulation displays compelling pre-clinical and clinical data that must be studied further. While bracing is the only non-operative modality with any evidence of effectiveness for idiopathic scoliosis, its level of effectiveness compared to observation or natural history remains inconclusive. Providing patients with a surgical alternative that is superior to the current non-operative standard of care is a paradigm shift that must be studied further to determine its safety and indications for use.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project (R01)
Project #
1R01FD004144-01
Application #
8217983
Study Section
Special Emphasis Panel (ZFD1-OPD-N (S1))
Project Start
2012-09-05
Project End
2013-08-31
Budget Start
2012-09-05
Budget End
2013-08-31
Support Year
1
Fiscal Year
2012
Total Cost
Indirect Cost
Name
Spineform, LLC
Department
Type
DUNS #
627796894
City
Cincinnati
State
OH
Country
United States
Zip Code
45242