Degenerative Disc Disease Clinical Trial
Official title:
Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.
The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine (either L4/L5 or L5/S1).
Treatments for disc degeneration have historically included conservative modalities, such as
rest, heat, electrotherapy, physical therapy, and analgesics to surgery. Currently, there
are two main surgical techniques for treatment of disc degeneration: (1) nucleotomy or
diskectomy, i.e., excision of part or all of the degenerated disc, which is typically
performed for treatment of radicular syndrome in the case of disc herniation; and (2) spinal
fusion, i.e., grafting bone between the vertebrae adjacent to the degenerated disc to
eliminate articulation at the damaged segment, which is typically performed for treatment of
degeneration together with instability and reduction of the intervertebral space. Rigid
internal fixation may also be used to promote fusion.
The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of
degenerative disc disease as an alternative to spinal fusion to preserve function in the
lumbar vertebral region. Each institution participating in the study was to treat the first
5 consecutive study participants with the CHARITE to as it involves a modification to the
technique used for anterior fusion. Data will be collected on these "training" cases but
will not be included in the comparison with the control (fusion) treatment.
Comparison: Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared
to outcomes for patients treated with anterior lumbar interbody fusion.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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