Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant.

ABSTRACT:

Study design

Prospective pilot clinical safety study of novel treatment, consecutive case series from first human use in patients with early adolescent idiopathic scoliosis (AIS).

Objective

The primary purpose was to determine the initial safety of a titanium clip-screw implant system for spine growth modulation. The secondary aim was to document curvatures to 2 years postoperatively.

Summary of background data

Spinal growth modulation was documented in preclinical studies. A prospective pilot clinical safety study was then performed under a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) (www.clinicaltrials.gov Identifier: NCT01465295).

Methods

Six subjects with early AIS underwent thoracoscopic placement of titanium clip-screw device

SUBMITTER: Wall EJ 

PROVIDER: S-EPMC8491975 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature