Abstract
Background Literature supports the need for improved techniques to achieve spinopelvic alignment and reduce complication rates in patients with adult spinal deformity (ASD). Personalized interbody devices were developed to address this need and are under evaluation in the multicenter Clinical Outcome Measures in Personalized aprevo Spine Surgery (COMPASS) registry. This report presents interim COMPASS pre- and postoperative sagittal alignment results and complication rates for a subcohort of COMPASS patients diagnosed and surgically treated for spinal deformity.
Methods COMPASS is a postmarket observational registry of patients enrolled either before or after index surgery and then followed prospectively for 24 months. Sagittal alignment was assessed with SRS-Schwab modifiers for pelvic incidence minus lumbar lordosis, pelvic tilt, and T1 pelvic angle. Summed SRS-Schwab modifiers were utilized to assign overall deformity status as mild, moderate, or severe. Complications were extracted from patient medical records.
Results The study included 67 patients from 9 centers. Preoperative severe deformity was observed in 66% of patients. Index surgeries included implantation of a median of 2 personalized interbody devices by anterior, lateral, or transforaminal approaches and with a median of 8 posteriorly instrumented levels. Overall postoperative sagittal alignment improved with a significant decrease in the mean sum of SRS-Schwab modifiers that correlated strongly to improvements in pelvic incidence minus lumbar lordosis. Among 44 patients with preoperative severe overall deformity, 16 improved to moderate and 9 to mild deformity. Complications occurred for 13 patients (19.4%), including 1 mechanical complication requiring revision 9 months after surgery and none related to personalized interbody devices.
Conclusions This study demonstrates that ASD patients whose treatment included personalized interbody devices can obtain favorable postoperative alignment status comparable to published results and with no complications related to the personalized interbody devices.
Clinical Relevance This study contributes to growing evidence that personalized interbody devices contribute to improved sagittal alignment in ASD patients by directly adjusting the orientation of adjacent vertebra.
Level of Evidence 3.
Footnotes
Funding This work was supported by funding from Carlsmed.
Declaration of Conflicting Interests Roland S. Kent discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Christopher P. Ames discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Jahangir Asghar discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Donald J. Blaskiewicz discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Joseph A. Osorio discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Chun-Po Yen discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Jeffrey P. Mullin discloses that he is a clinical research investigator and receives consulting fees from Carlsmed. Justin S. Smith discloses that he is a shareholder and receives consulting fees from Carlsmed. John M. Small discloses that he is a clinical research investigator for Carlsmed. Michele Temple-Wong discloses that she is an employee of Carlsmed. Jeffrey D. Schwardt discloses that he is an employee of Carlsmed.
Disclosures In addition to the relationships listed in the Declaration of Conflicting Interests, Christopher Ames reports grants/contracts from SRS; royalties/licenses from DePuy Synthes, K2M, Next Orthosurgical, Stryker, Biomet Zimmer Spine, Medicrea, and NuVasive; consulting fees from DePuy Synthes, Medicrea, Agada Medical, Medtronic, and K2M; is the chair of the SRS Safety and Value Committee and serves on the executive committee of ISSG; serves on the editorial board fro Operative Neurosurgery and Neurospine; is the director of Global Spinal Analytics, and has research interests with Titan Spine, ISSG, and DePuy Synthes. Roland Kent reports consulting fees from SI Bone and Globus Medical; payment/honoraria from SI Bone, Globus Medical, and Premia Spine; and patents pending for SI Bone. Jeffrey Mullin reports consulting fees from Medtronic, Globus, and SI Bone, and serves on the CNS and AANS/CNS Joint Spine Section Executive Committees. Joseph Osorio reports grants/contracts from Medtronic; royalties/licenses from Alphatec; and consulting fees from Alphatec, Medtronic, and DePuy. John Small reports royalties/licenses from Astura Spine. Justin Smith reports grants/contracts from SeaSpine/Orthofix, NREF, AO Spine, and DePuy Synthes/ISSGF; royalties/licenses from Highridge and Globus/NuVasive; consulting fees from Highridge, SeaSpine/Orthofix, Medtronic, Cerapedics, and Globus/NuVasive; support for attending meetings/travel from AO Spine; serving on the SRS Board of Directors and ISSGF Executive Committee; and stock/stock options from Alphatec and Globus/NuVasive. Chun-Po Yen reports consulting fees from Life Spine and Medtronic and support for teaching a cadaveric course from Life Spine.
Ethics Statement Institutional Review Board approval was obtained prior to patient enrollment. All patients provided informed consent.
- 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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