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
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- K2M, Inc.
- Enrollment
- 188
- Primary Endpoint
- Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 11 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar 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. No cervical vertebrae are to be incorporated into the construct.
- •Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
- •Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.
- •Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.
Exclusion Criteria
- •Previous anterior or posterior spine surgery at the index levels.
- •Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
- •Active systemic infection or infection at the operative site.
- •Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
- •Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
- •History of an osteoporotic fracture.
- •History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
- •Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
- •Known allergy to titanium or cobalt chrome.
- •Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
Outcomes
Primary Outcomes
Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Time Frame: Baseline (up to 90 days before surgery), 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.
Number of Participants With Adverse Events
Time Frame: Up to 24 months
Number of participants with SAE and AE for the various intervals
Secondary Outcomes
- Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months(Baseline (up to 90 days before surgery), 24 months)
- Patient Satisfaction(12 months and 24 months)
- Estimated Blood Loss(During surgery)
- Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months(Baseline (up to 90 days before surgery), 24 months)
- Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria(24 months)
- Length of Surgery Time(During surgery)
- Length of Anesthesia Time(During surgery)
- Length of Hospital Stay(Admission to Discharge)
- Change in Percentage of Participants Able to Return to Work/School(Pre-Op to 24 months)
- Use of Narcotics Post-surgery(Pre-Op to 24 months)