Background: Cervical artificial disc replacement (C-ADR) has become a common and accepted surgical treatment for many patients with cervical disc degeneration/herniation and radiculopathy who have failed nonoperative treatment. Midterm follow-up studies of the original investigational device exemption trials comparing C-ADR to traditional anterior cervical discectomy and fusion (ACDF) have revealed C-ADR patients have less adjacent-level disease and fewer reoperations at 5 to 7 years. The purpose of this study was to examine the relationship of radiographic adjacent-level disease (R-ALD) with the amount of index-level segmental range of motion (ROM) in C-ADR patients using the long-term follow-up data from the ProDisc-C investigational device exemption trial.
Methods: This was a post hoc analysis of a 1:1 randomized controlled trial. The initial previously described Food and Drug Administration-approved 2-year study was extended, and consenting patients in the original study were followed at annual intervals up to 7 years. Logistic regression was used to assess any progression in adjacent-level disease (ALD). Ordinal logistic regression was also used to assess the relationship between any progressive R-ALD and final flexion extension (F/E) ROM in C-ADR patients. Spearman's rank-order correlation was used when R-ALD was kept as an ordinal variable to assess the same relationship.
Results: At the last follow-up visit, the rate of progressive R-ALD was significantly higher in ACDF patients than in C-ADR patients. When C-ADR patients were divided into 3 groups based on final F/E ROM, those with 0° to 3° ( = 19), 4° to 6° ( = 15), and 7° ( = 42) of segmental motion at the index procedure level, the rate of progressive R-ALD trended significantly with final ROM ( = 0.01).
Conclusions: C-ADR leads to a significant decrease in R-ALD compared to ACDF. The difference in R-ALD is related to the preservation of motion at the index level and resultant preservation of kinematics and forces across the adjacent disc space.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9519082 | PMC |
http://dx.doi.org/10.14444/8187 | DOI Listing |
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