This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
The evaluation is based on the following elements. 1. Safety as measured by the rate of serious operative and post-operative complications. 2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline. 3. Global and segmental lumbar lordosis (LL) Patients will be followed upto 24 months post-operative
Study Type
OBSERVATIONAL
degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis
Rush University Medical Center
Chicago, Illinois, United States
Change in Radiographic Analysis
Global and Segmental Lumbar Lordosis in degrees
Time frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Complications
Surgical or device related complications
Time frame: Intra-operative, any time post-op upto 24 months
Change in Patient Reported Outcomes as a number score
Visual Analog Scale, Oswestry Disability Index, Short Form 12, PROMIS
Time frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Peri operative clinical parameters
Estimated Blood Loss in cc
Time frame: Intra-Operative
Clinical parameters in days
Length of Hospital Stay
Time frame: Immediate Post-operative
Peri operative clinical parameters in mgs
Narcotic Consumption
Time frame: Immediate Post-operative
Intra-Operative clinical parameters in minutes
Operative Time
Time frame: Intra-Operative
Changes in Radiographic Analysis in percentage
Fusion Rates
Time frame: 6weeks, 12 weeks, 6months, 12 months, 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.