Interim 1-Year Radiographic and Clinical Outcomes Following Anterior Cervical Discectomy and Fusion Using Hydroxyapatite-Infused Polyetheretherketone Interbody Cages

Michael J. Kelly; Bradley Gelfand; Kris Radcliff; Fred F. Mo; Brox A. Felix; S. Babak Kalantar

doi:10.14444/8585

Abstract

Background This is a multicenter observational registry analysis of 1-year radiographic and clinical outcomes following anterior cervical discectomy and fusion (ACDF) using hydroxyapatite (HA)-infused polyetheretherketone (PEEK) intervertebral cages.

Methods Radiographic and clinical outcome data were collected preoperatively and at 6 weeks, 3 months, 6 months, and 12 months postoperatively. To assess fusion, dynamic flexion-extension radiographs were independently evaluated with a validated method. Clinical outcomes were assessed using the following disease-specific measures: Neck Disability Index (NDI) and visual analog scale (VAS) for neck, left arm, and right arm pain. Patient satisfaction was also evaluated.

Results A total of 789 ACDF patients (men: 51.5%/women: 48.5%; mean body mass index: 29.9 kg/m²) were included at the time of analysis, and 1565 segments have been operated. Successful fusion was confirmed in 91.3% of all operated levels after 6 months and 92.2% after 12 months. Mean NDI scores improved significantly (P < 0.01) preoperatively (46.3, n = 771) to postoperatively (12 months: 25.2, n = 281). Consistently, mean VAS neck (preoperative: 64.2, n = 770; 12 months: 28.6, n = 278), VAS right arm (preoperative: 42.6, n = 766; 12 months: 20.4, n = 277), and VAS left arm (preoperative: 41.1, n = 768; 12 months: 20.8, n = 277) decreased significantly (P < 0.01). Patients reported high satisfaction rates after surgery with no significant changes in postoperative patient satisfaction between 6 weeks and 12 months (95.1%, n = 273).

Conclusions ACDF with HA-infused PEEK cages demonstrates promising radiographic and clinical outcomes, supporting the potential benefits of incorporating HA into PEEK cages to enhance fusion rates and improve patient outcomes.

Clinical Relevance This study demonstrates a >90% fusion rate by level with reliable improvements in patient reported outcomes, along with a high rate of patient satisfaction, in a large patient cohort undergoing ACDF with HA-infused PEEK cages.

Level of Evidence 2 .

Footnotes

Funding The authors received no funding for the work. However, Innovasis supported the registry and performed the data analysis.
Disclosures Kris Radcliff discloses royalties or licenses from Corelink and Globus (both unrelated to the current topic; consulting fees from Innovasis, Corelink, Stryker, and Orthofix (all unrelated to the current topic; and payment for expert testimony for various law firms in New Jersey; and stock or stock options from 4 web medical and Orthofix (both unrelated to the current topic). Fred Mo discloses consulting fees from Spinewave, Stryker, and Innovasis and participation on a Scientific Monitoring Board—Ossdsgn. S. Babak Kalantar discloses payments from Innovasis made to their institution for registration of registry patients; royalties or licenses from Nuvasive and Royal Biologics; and consulting fees from Stryker, Nuvasive, Innovasis, and Royal Biologics. The remaining authors have no disclosures or conflicting interests.
IRB Approval Innovasis works with local IRB and WIRB to complete requirements to conduct the BioBase Registry at participating sites.

This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2024 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.

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