MESA Rail™ AIS Study - Preservation of Curve Correction

Status Terminated

Clinical Trial Summary

To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Clinical Trial Description

Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had: Diagnosis of AIS requiring surgical treatment for selective non-cervical fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive). Age at time of surgery of ≥ 11 years old and ≤ 21 years old. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02062606
Study type	Observational
Source	K2M, Inc.
Contact
Status	Terminated
Phase
Start date	May 2014
Completion date	February 23, 2020

View Details

See also
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