NCT02062606

MESA Rail™ AIS Study - Preservation of Curve Correction

Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS) With the Use of the K2M MESA Rail™ Deformity System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 188 (actual)
• Sponsor: K2M, Inc. · Industry
• Sex: All
• Age: 11 Years – 21 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	MESA Rail™ Deformity System	MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Timeline

• Start date: 2014-05-01
• Primary completion: 2020-02-23
• Completion: 2020-02-23
• First posted: 2014-02-13
• Last updated: 2021-04-12
• Results posted: 2021-04-12