Retrospective Cohort Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Oct 18, 2017; 8(10): 770-776
Published online Oct 18, 2017. doi: 10.5312/wjo.v8.i10.770
Soft tissue swelling incidence using demineralized bone matrix in the outpatient setting
Kingsley R Chin, Fabio J R Pencle, Jason A Seale, Juan M Valdivia
Kingsley R Chin, Charles E. Schmidt College of Medicine at Florida Atlantic University, Boca Raton, FL 33431, United States
Kingsley R Chin, Jason A Seale, Juan M Valdivia, Less Exposure Surgery Specialists Institute, Fort Lauderdale, FL 33311, United States
Kingsley R Chin, Herbert Wertheim College of Medicine at Florida International University, Miami, FL 33199, United States
Fabio J R Pencle, Jason A Seale, Juan M Valdivia, Less Exposure Surgery Society, Malden, MA 02148, United States
Author contributions: All authors contributed with drafting writing and final revision of manuscript; Pencle FJR performed statistical analysis; Valdivia JM provided independent assessment of pre and post op radiographs; Chin KR performed supervision and important critical revision.
Institutional review board statement: IRB approval was granted for patients involved in study from George Washington University as part of a cohort of patients who had anterior cervical surgery.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: We did not seek or receive any funding from the National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI), or others for this work. Chin KR is a shareholder in and receives other benefits from SpineFrontier Inc.; none of the other authors (Pencle FJR, Valdivia JM and Seale JA) have any potential conflicts of interest to declare for this work.
Data sharing statement: This dataset available from the corresponding author at Dryad repository, who will provide a permanent, citable and open-access home for the dataset.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Fabio JR Pencle, Research Fellow, Less Exposure Surgery Society, 350 Main Street, Malden, MA 02148, United States. fabiopencle@thelessinstitute.com
Telephone: +1-954-6406010 Fax: +1-855-4114647
Received: February 21, 2017
Peer-review started: February 26, 2017
First decision: July 10, 2017
Revised: July 28, 2017
Accepted: August 15, 2017
Article in press: August 16, 2017
Published online: October 18, 2017
Processing time: 238 Days and 9.1 Hours
Abstract
AIM

To assess use of demineralized bone matrix (DBM) use in anterior cervical discectomy and fusion (ACDF) in outpatient setting.

METHODS

One hundred and forty-five patients with prospectively collected data undergoing single and two level ACDF with DBM packed within and anterior to polyetheretherketone (PEEK) cages. Two groups created, Group 1 (75) outpatients and control Group 2 (70) hospital patients. Prevertebral soft tissue swelling (PVSTS) was measured anterior to C2 and C6 on plain lateral cervical radiographs preoperatively and one week postoperatively and fusion assessed at two years.

RESULTS

There was no intergroup significance between preoperative and postoperative visual analogue scales (VAS) and neck disability index (NDI) scores between Group 1 and 2. Mean preoperative PVSTS in Group 1 was 4.7 ± 0.2 mm at C2 level and 11.1 ± 0.5 at C6 level compared to Group 2 mean PVSTS of 4.5 ± 0.5 mm and 12.8 ± 0.5, P = 0.172 and 0.127 respectively. There was no radiographic or clinical evidence of adverse reaction noted. In Group 1 mean postoperative PVSTS was 5.5 ± 0.4 mm at C2 and 14.9 ± 0.6 mm at C6 compared Group 2 mean PVSTS was 4.9 ± 0.3 mm at C2 and 14.8 ± 0.5 mm at C6, P = 0.212 and 0.946 respectively. No significant increase in prevertebral soft tissue space at C2 and C6 level demonstrated.

CONCLUSION

ACDF with adjunct DBM packed PEEK cages showed a statistical significant intragroup improvement in VAS neck pain scores and NDI scores (P = 0.001). There were no reported serious patient complications; post-operative radiographs demonstrated no significant difference in prevertebral space. We conclude that ACDF with DBM-packed PEEK cages can be safely done in an ASC with satisfactory outcomes.

Keywords: Ambulatory surgery center; Anterior cervical discectomy and fusion; Demineralized bone matrix; Less Exposure Surgery; Packed polyetheretherketone cages

Core tip: This manuscript scientifically assesses prevertebral swelling with the use of demineralized bone matrix (DBM) anterior to cervical cage. The use of clinical and radiographic outcomes demonstrates the safety of DBM in the outpatient setting. There are no studies showing safety or outcomes of DBM anterior to the cage and directly exposed to the pre vertebral soft tissues therefore we wanted to document this study.