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).
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 Type
OBSERVATIONAL
Enrollment
188
MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature
Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.
Time frame: Baseline (up to 90 days before surgery), 24 months
Number of Participants With Adverse Events
Number of participants with SAE and AE for the various intervals
Time frame: Up to 24 months
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness /tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 100mm with the 100mm accounting for the highest level of pain.
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
The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.
Time frame: Baseline (up to 90 days before surgery), 24 months
Patient Satisfaction
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At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).
Time frame: 12 months and 24 months
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria
At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worsened.
Time frame: 24 months
Length of Surgery Time
The length of the surgical procedure from the initial incision to final closure were captured.
Time frame: During surgery
Length of Anesthesia Time
The length of time the patient is under anesthesia was captured.
Time frame: During surgery
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery was captured.
Time frame: During surgery
Length of Hospital Stay
The length of the hospital stay from the date of admission to the date of discharge.
Time frame: Admission to Discharge
Change in Percentage of Participants Able to Return to Work/School
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions
Time frame: Pre-Op to 24 months
Use of Narcotics Post-surgery
The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented.
Time frame: Pre-Op to 24 months