This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).
Primary endpoints: * Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded. * Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)
Spine Surgery Department, Meir Hospital, Israel
Kfar Saba, Israel
Fusion rate
Primary radiographic effectiveness outcome parameter: evaluations of fusion. Fusion will be evaluated at 6 months, 12 months and 24 months post-op using plain radiographs (AP, lateral and flexion/extension films) and at 24 months using CT scan as well
Time frame: 24 months follow up
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