MESA Rail™ AIS Study - Preservation of Curve Correction
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis With the Use of the K2M MESA Rail™ Deformity System|
- Change from baseline in Cobb Angles on x-ray at 24 months [ Time Frame: Baseline (up to 90 days before surgery), 24 months ]
- Number of participants with adverse events [ Time Frame: Up to 24 months ]
- Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months [ Time Frame: Baseline (up to 90 days before surgery), 24 months ]
- Change from baseline in quality of life scores on the SRS-22r at 24 months [ Time Frame: Baseline (up to 90 days before surgery), 24 months ]
- Patient Satisfaction [ Time Frame: 12 months, 24 months ]
- Investigator's rating of subject's clinical disposition using Odom's Criteria [ Time Frame: 24 months ]
- Length of Surgery Time [ Time Frame: At time of surgery ]The length of the surgical procedure from the initial incision to final closure will be captured.
- Length of Anesthesia Time [ Time Frame: At time of surgery ]The length of time the patient is under anesthesia will be captured.
- Estimated Blood Loss [ Time Frame: At time of surgery ]The amount of blood loss over the entire length of the surgery will be captured.
- Length of Hospital Stay [ Time Frame: An expected average of 5 days after the date of surgery ]The length of the hospital stay from the date of admission to the date of discharge.
- Time to Return to Work/School [ Time Frame: Up to 24 months ]The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery will be documented.
- Use of narcotics post-surgery [ Time Frame: Up to 24 months ]The types and dosages of any narcotics taken by the patient post-surgery will be documented.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||March 2020|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Surgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS).
Device: MESA Rail™ Deformity System
MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature
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.