One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years
Degenerative Disc Disease
Investigational device exemption
Single level
DOI:
10.14444/6076
Publication Date:
2019-12-31T01:45:17Z
AUTHORS (8)
ABSTRACT
Anterior cervical discectomy and fusion (ACDF) disc arthroplasty (CDA) have been used to treat degenerative disease at single as well multiple levels. This study compares the safety efficacy of 1-level versus 2-level CDA ACDF.In total, 545 397 patients with were studied in Food Drug Administration (FDA)-approved clinical trials, respectively: (n = 280 209), ACDF 265 188). Data from these studies compare 1- procedures: propensity score method was adjust for potential confounding effects, adjusted mean outcome scores 2 7 years postsurgery compared between procedures within treatment type.One-level had similar rates improvement overall success patient-reported outcomes both ACDF. There no statistical differences implant-related adverse events (AEs) or serious AEs CDA. The 7-year rate higher than (27.7% vs 18.9%, P ≤ .036), though groups did not differ significantly. Secondary surgery statistically different (CDA ACDF) index adjacent levels years. Grade IV heterotopic ossification reported 4.6% 8.6%/7.3% superior/inferior levels, respectively, patients.One- appear equally safe effective disease. Two-level appears be but a some long-term follow-up.2.clinicaltrials.gov: NCT00667459, NCT00642876, NCT00637156.
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