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Article History

Received: 19 March 2020

Accepted: 29 May 2020

First Online: 9 June 2020

Ethics approval and consent to participate

: The study protocol, informed consent forms, subject recruitment materials, and study protocol amendments were approved by an institutional review board (Sterling IRB, Protocol No. 105–17-0001, IRB ID: 6114-*MASTER) All subjects were appropriately consented prior to initiating screening activities. Written consent was obtained from all subjects.

: Not applicable.

: Dr. Badiola reports personal fees to the University of Pennsylvania from Avanos during the conduct of the study.Dr. Beall reports grants from Medtronic, Spineology, Merit Medical, Lilly, Johnson & Johnson, SpinTech, Imaging3, IZI, Medlantis, Techlamed, Consultant, Peterson Enterprises, Medical Metrics, Radius Pharmaceuticals, Avanos, Vertiflex, Sollis Pharmaceuticals, Simplify Medical, Stryker, Lenoss Medical, Spine BioPharma, Piramal, ReGelTec, grants from Medtronic, SpinTech, Medical Metrics, Avanos, Relievant, Vertiflex, Stryker, Sollis Pharmaceuticals, Simplify Medical, Lenoss Medical, Spine BioPharma, other from Medtronic, Imaging3, ReGelTec, Nanofuse, SpinTech, Nocimed, other from Artio, Sophiris, Eleven Biotherapeutics, Radius Pharmaceuticals, Flow Forward, Lenoss Medical, Spine BioPharma, other from Thieme, Springer, Humana other from Eli Lilly, Radius Pharmaceuticals, Stryker, Medtronic, Vivex, Vertiflex, Merit, Medlantis, Avanos, Piramal during the conduct of the study.Dr. Chen reports personal fees from Avanos, during the conduct of the study; personal fees from SLACK publishing, other from Joint Purification Systems, personal fees from ACI, personal fees from Stryker, personal fees from bOne, other from Sonoran Biosciences, other from Graftworx, grants from OREF, personal fees from Pfizer, personal fees from Irrisept, personal fees from Convatec, personal fees from 3 M, personal fees from Recro, personal fees from Zimmer, personal fees from Heraeus, personal fees from American Medical Foundation, personal fees from Zimmer, other from Hyalex, personal fees from DePuy, outside the submitted work.Dr. DePalma reports other from Avanos during the conduct of the study and has served on the clinical advisory board to Avanos and am also a co-investigator on this clinical trial .Dr. Guirguis reports personal fees from Avanos outside the submitted work.Dr. Khalouf has nothing to disclose.Dr. Kohan reports personal fees from Avanos during the conduct of the study.Dr. Loudermilk has nothing to disclose.Dr. Lyman reports grants, personal fees and non-financial support from Avanos, during the conduct of the study; grants and personal fees from Stryker Orthopedics outside the submitted work.Dr. Pingree reports other from Avanos during the conduct of the study; other from Avanos outside the submitted work.Dr. Zora has nothing to disclose.