Clinical spine surgery · 2022
Cervical Total Disk Replacement: Available Implant Size Matters.
СтатьяНазвание и аннотация: Перевод в очереди
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Guyer Richard D, Coric Domagoj, Nunley Pierce D, Ohnmeiss Donna D
Аннотация
STUDY DESIGN: This study was a post hoc analysis of data collected from 2 Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials.
OBJECTIVE: The purposes of this study were to: (1) measure disk space heights adjacent to the level to be treated with a total disk replacement (TDR); (2) analyze cervical disk space heights to be replaced with TDR; and (3) investigate the frequency of use of a smaller height TDR when available.
SUMMARY OF BACKGROUND DATA: Cervical TDR produces outcomes noninferior or superior to anterior cervical discectomy and fusion. While the restoration of the height of a collapsed, degenerated disk is a surgical goal, there are potential problems with overdistracting the segment with an implant.
METHODS: Disk heights were measured using radiographs from the 1-level Simplify Cervical Artificial Disk IDE trial, producing values for 259 levels adjacent to the treated level and 162 treated levels. The device is available in 4, 5, and 6 mm heights. The 4 mm height became available only after treatment was 13% complete in the single-level trial and was available for all of the 2-level trial.
RESULTS: Measurements of 259 adjacent levels found that 55.2% of disk spaces had a height of <4 mm. Among operated levels, 82.7% were <4 mm. When a 4 mm TDR was available, it was used in 38.4% of operated levels in the 1-level trial and 54.3% of levels in the 2-level trial.
CONCLUSIONS: Among nonoperated levels, 55.2% were of height <4 mm, suggesting that TDRs of greater heights may potentially overdistract the disk space. The 4 mm TDR was selected by surgeons in 49.4% of all implanted levels, suggesting a preference for smaller TDR height. Further investigation is warranted to determine if the lower height implants are related to clinical and/or radiographic outcomes.
LEVEL OF EVIDENCE: Level III.
OBJECTIVE: The purposes of this study were to: (1) measure disk space heights adjacent to the level to be treated with a total disk replacement (TDR); (2) analyze cervical disk space heights to be replaced with TDR; and (3) investigate the frequency of use of a smaller height TDR when available.
SUMMARY OF BACKGROUND DATA: Cervical TDR produces outcomes noninferior or superior to anterior cervical discectomy and fusion. While the restoration of the height of a collapsed, degenerated disk is a surgical goal, there are potential problems with overdistracting the segment with an implant.
METHODS: Disk heights were measured using radiographs from the 1-level Simplify Cervical Artificial Disk IDE trial, producing values for 259 levels adjacent to the treated level and 162 treated levels. The device is available in 4, 5, and 6 mm heights. The 4 mm height became available only after treatment was 13% complete in the single-level trial and was available for all of the 2-level trial.
RESULTS: Measurements of 259 adjacent levels found that 55.2% of disk spaces had a height of <4 mm. Among operated levels, 82.7% were <4 mm. When a 4 mm TDR was available, it was used in 38.4% of operated levels in the 1-level trial and 54.3% of levels in the 2-level trial.
CONCLUSIONS: Among nonoperated levels, 55.2% were of height <4 mm, suggesting that TDRs of greater heights may potentially overdistract the disk space. The 4 mm TDR was selected by surgeons in 49.4% of all implanted levels, suggesting a preference for smaller TDR height. Further investigation is warranted to determine if the lower height implants are related to clinical and/or radiographic outcomes.
LEVEL OF EVIDENCE: Level III.