Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1
The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patient should have completed at least six (6) months of non-operative treatment. Patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Lumbar Interbody Fusion
Lumbar Interbody Fusion
Upstate Orthopedics
East Syracuse, New York, United States
Fusion rates
Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans
Time frame: 24 Months
Subsidence
disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans
Time frame: 24 Months
Patient Reported Outcomes: Visual Analog Scale (VAS)
Comparison of pre-operative to post-operative evaluations
Time frame: Through 24 Months
Patient Reported Outcomes: Oswestry Disability Index
Comparison of pre-operative to post-operative evaluations
Time frame: Through 24 Months
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L
Comparison of pre-operative to post-operative evaluations
Time frame: Through 24 Months
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