The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.
Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Expandable interbody spacer
South Florida Spine Institute at Mt Sinai Medical Center
Miami Beach, Florida, United States
Carolina NeuroSurgery and Spine Associates
Charlotte, North Carolina, United States
Fusion and Disc Height Maintenance
Inter-vertebral disc height in millimetres at 24 month follow up.
Time frame: 24 months
Fusion Assessment
An assessment of the fusion status of surgically treated spinal levels.
Time frame: 24 months
Patient Self Assessment
Oswestry Disability Index. A 10 item questionnaire with responses scored 0 to 5 and then presented as a percentage score from 0 to 100, with higher scores denoting more disability.
Time frame: Upto 24 mo
Visual Analog Scale for Back Pain
A visual scale from 0 to 100 in which the patient responds with their pain level by marking on the line, higher as more severe pain.
Time frame: 24 months
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