Extract
Question: In patients with degenerative disc disease (DDD), is total
disc replacement (TDR) with the CHARITE artificial disc at least as good as
anterior lumbar interbody fusion (ALIF)?Design: Randomized (unclear allocation concealment), unblinded,
controlled trial with 24-month follow-up.Setting: 14 centers in the United States.Patients: 304 patients (mean age, 40 y; 52% men) with single-level
discography-confirmed DDD at L4-L5 or L5-L1 who had back or leg pain without
nerve root compression with a score of =40 on a visual analogue scale
(VAS), ranging from 0 to 100, and an Oswestry Disability Index (ODI) score of
=30 for =6 months. Exclusion criteria were multilevel symptomatic DDD,
previous thoracic or lumbar fusion, previous or current lower lumbar fracture,
osteoporosis, spondylolisthesis of >3 mm, spondylosis, or scoliosis of
>11°. 265 patients (87%) were available for clinical success measures
at 24 months.