The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Percutaneous Dynamic Stabilization System
Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Willow Grove, Pennsylvania, United States
Improvement in Oswestry Disability Index (ODI)
Time frame: 2 Years
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