Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis
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 Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Trial to Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis|
- Acute Safety: Incidence, relatedness (relationship to procedure and device), seriousness and severity of Adverse Events By Participant [ Time Frame: 1 month post-operative ] [ Designated as safety issue: No ]Incidence, relatedness (relationship to procedure and device), seriousness and severity of Adverse Events By Participant
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||January 2021|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Patients meeting eligibility criteria will be treated with the HemiBridge System.
Device: Mechanical hemiepiphysiodesis using the HemiBridge System
Surgical application of mechanical hemiepiphysiodesis using the HemiBridge device.
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|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital|
|Cleveland, Ohio, United States, 44115|
|Study Director:||Joseph E Reynolds, MBA||SpineForm LLC|
|Principal Investigator:||Eric J Wall, MD||Children's Hospital Medical Center, Cincinnati|