TY - JOUR
T1 - Operative treatment outcomes for adult cervical deformity
T2 - a prospective multicenter assessment with mean 3-year follow-up
AU - International Spine Study Group
AU - Elias, Elias
AU - Bess, Shay
AU - Line, Breton G.
AU - Lafage, Virginie
AU - Lafage, Renaud
AU - Klineberg, Eric
AU - Kim, Han Jo
AU - Passias, Peter
AU - Nasser, Zeina
AU - Gum, Jeffrey L.
AU - Kebaish, Khaled
AU - Eastlack, Robert
AU - Daniels, Alan H.
AU - Mundis, Gregory
AU - Hostin, Richard
AU - Protopsaltis, Themistocles S.
AU - Soroceanu, Alex
AU - Hamilton, D. Kojo
AU - Kelly, Michael P.
AU - Gupta, Munish
AU - Hart, Robert
AU - Schwab, Frank J.
AU - Burton, Douglas
AU - Ames, Christopher P.
AU - Shaffrey, Christopher I.
AU - Smith, Justin S.
N1 - Funding Information:
Dr. Bess is a consultant for Alphatec and Mirus. He is a patent holder with K2M Stryker, and NuVasive. He has received clinical or research support for the study described (includes equipment or material) from DePuy Synthes. He receives support of a non–study-related clinical or research effort that he oversees from Medtronic, Globus, SeaSpine, K2M Stryker, Carlsmed, Orthofix, NuVasive, and the ISSGF. He is in the speakers bureau for Alphatec and Stryker, and he receives royalties from K2M Stryker and NuVasive. Mr. Line is a consultant for the ISSG. Dr. Lafage receives honoraria from Stryker, Implanet, and DePuy Synthes Spine. She is a consultant for Alphatec and Globus Medical, and receives royalties from NuVasive. She owns VFT Solutions LLC. Dr. Klineberg is a consultant for DePuy Synthes, Stryker, and Medicrea/Medtronic. He receives honoraria from AO Spine, and is also the fellowship director chair at AO Spine. Dr. Kim receives royalties from Zimmer Biomet, Surgical Acuity, and K2M-Stryker. He is a consultant for NuVasive. He receives support for a non–study-related clinical or research effort that he oversees from the ISSGF and SI-Bone. Dr. Passias is a consultant and is on the advisory board for Medtronic; is a consultant and is involved with product development for Globus; and consults/ provides research support for Cerapedics. Dr. Gum is a consultant for Acuity, DePuy, Medtronic, NuVasive, and Stryker. He receives royalties from Acuity, Medtronic, and NuVasive. He is an employee of Norton Healthcare, Inc. He has a less than 1% ownership in Cingulate Therapeutics. He is a patent holder with Medtronic, and is in the speakers bureau for Medtronic and Stryker. He receives honoraria from Baxter, Broadwater, NASS, and Pacira Pharmaceuticals. He receives clinical or research support for the study described (includes equipment or material) from the following: Pfizer; Texas Scottish Rites Hospital; Alan L. & Jacqueline B. Stuart Spine Research Society; Cerapedics, Inc.; Scoliosis Research Society; Biom’Up; Empirical Spine, Inc.; National Spine Health Foundation; Stryker; and Medtronic. He is a reviewer for Global Spine Journal, Spine Deformity, and The Spine Journal. He is on the medical scientific board for the National Spine Health Foundation. Dr. Eastlack has direct stock ownership in SI Bone, SeaSpine, NuVasive, and Alphatec. He is a consultant for SI Bone, SeaSpine, NuVasive, Medtronic, J/J, Carevature, Spinal Elements, Biedermann Motech, and NEO Spine. He is a patent holder with SI Bone, Stryker, Globus, and SeaSpine. He receives support of a non–study-related clinical or research effort that he oversees from NuVasive, Medtronic, SeaSpine, and Spinal Elements. He is in the speakers bureau for Radius. He receives royalties from Globus, SI Bone, SeaSpine, and NuVasive. Dr. Mundis is a consultant for NuVasive, SeaSpine, SI Bone, Carlsmed, and Viseon. He has direct stock ownership in SeaSpine and Alphatec. He receives royalties from NuVasive and Stryker, and he is a patent holder with Stryker. Dr. Protopsaltis is a consultant for Globus, NuVasive, Medtronic, and K2M Stryker. He receives royalties from Altus, and has stock options from Spine Align and Torus Medical. Dr. Kelly has received honoraria from Spine. He is on the board of directors for the Setting Scoliosis Straight Foundation, and also receives research support unrelated to this study from them. Dr. Gupta receives royalties from DePuy, Innomed, and Globus. He is a consultant for DePuy, Medtronic, and Globus, Alphatec—began and ended in 2019. He has direct stock ownership in J&J. He has received honoraria from AO Spine, Wright State, LSU, and the Malaysian Spine Society. He is also on the Scoliosis Research Society’s board of directors (nonfinancial—his travel is paid for being course chair), and he is on the National Spine Health Foundation’s scientific advisory board (nonfinancial—voluntary) Dr. Hart is a consultant for DePuy, Globus, Medtronic, Allosource, SeaSpine, ProprioVision, and Orthofix. He receives clinical or research support for the study described (includes equipment or material) from Misonix and DePuy. He is a member of the ISSG board. He receives royalties from DePuy, Globus, and SeaSpine. Dr. Schwab has direct stock ownership in VFT Solutions and SeaSpine. He is a consultant for Zimmer Biomet, Medtronic, and Mainstay Medical. He receives royalties from Zimmer Biomet, Medtronic, and Medicrea. He receives support of a non–study-related clinical or research effort that he oversees from DePuy, K2M, NuVasive, Medtronic, Globus, Allosource, Orthofix, and SI Bone (paid through the ISSG Foundation). He is on the executive committee for the ISSG. Dr. Burton has direct stock ownership in Progenerative Medical. He is a consultant for Globus, and receives royalties from Globus and Blue Ocean Spine. He receives support of a non–study-related clinical or research effort that he oversees from DePuy. Dr. Ames receives royalties from Stryker, Biomet Zimmer Spine, DePuy Synthes, NuVasive, Next Orthosurgical, K2M, and Medicrea. He is a consultant for DePuy Synthes, Medtronic, Medicrea, K2M, Agada Medical, and Carlsmed. He performs research for Titan Spine, DePuy Synthes, and the ISSG. He is on the editorial board for Operative Neurosurgery. He receives grant funding from SRS. He is on the executive committee of the ISSG. He is the director of Global Spine Analytics. He is the committee chair for SRS Safety and Value Committee. Dr. Shaffrey is a consultant for Medtronic, NuVasive, SI Bone, and Proprio. He receives royalties from and is a patent holder with Medtronic, NuVasive, and SI Bone. The has direct stock ownership in NuVasive. Dr. Smith is a consultant for Zimmer Biomet, Carlsmed, DePuy Synthes, NuVasive, Stryker, SeaSpine, and Cerapedics. He receives royalties from Zimmer Biomet, NuVasive, and Thieme. He receives clinical or research support for the study described (includes equipment or material) from DePuy Synthes/ISSGF, and he also receives support of a non–study-related clinical or research effort that he oversees from DePuy Synthes/ISSGF, NuVasive, and AO Spine. He owns stock in Alphatec and NuVasive.
Funding Information:
The ISSG is funded through research grants from DePuy Synthes.
Publisher Copyright:
© AANS 2022.
PY - 2022/12
Y1 - 2022/12
N2 - OBJECTIVE Adult cervical deformity (ACD) has high complication rates due to surgical complexity and patient frailty. Very few studies have focused on longer-term outcomes of operative ACD treatment. The objective of this study was to assess minimum 2-year outcomes and complications of ACD surgery. METHODS A multicenter, prospective observational study was performed at 13 centers across the United States to evaluate surgical outcomes for ACD. Demographics, complications, radiographic parameters, and patient-reported outcome measures (PROMs; Neck Disability Index, modified Japanese Orthopaedic Association, EuroQol-5D [EQ-5D], and numeric rating scale [NRS] for neck and back pain) were evaluated, and analyses focused on patients with ≥ 2-year follow-up. RESULTS Of 169 patients with ACD who were eligible for the study, 102 (60.4%) had a minimum 2-year follow-up (mean 3.4 years, range 2-8.1 years). The mean age at surgery was 62 years (SD 11 years). Surgical approaches included anterior-only (22.8%), posterior-only (39.6%), and combined (37.6%). PROMs significantly improved from baseline to last follow-up, including Neck Disability Index (from 47.3 to 33.0) and modified Japanese Orthopaedic Association score (from 12.0 to 12.8; for patients with baseline score ≤ 14), neck pain NRS (from 6.8 to 3.8), back pain NRS (from 5.5 to 4.8), EQ-5D score (from 0.74 to 0.78), and EQ-5D visual analog scale score (from 59.5 to 66.6) (all p ≤ 0.04). More than half of the patients (n = 58, 56.9%) had at least one complication, with the most common complications including dysphagia, distal junctional kyphosis, instrumentation failure, and cardiopulmonary events. The patients who did not achieve 2-year follow-up (n = 67) were similar to study patients based on baseline demographics, comorbidities, and PROMs. Over the course of follow-up, 23 of the total 169 enrolled patients were reported to have died. Notably, these represent all-cause mortalities during the course of follow-up. CONCLUSIONS This multicenter, prospective analysis demonstrates that operative treatment for ACD provides significant improvement of health-related quality of life at a mean 3.4-year follow-up, despite high complication rates and a high rate of all-cause mortality that is reflective of the overall frailty of this patient population. To the authors' knowledge, this study represents the largest and most comprehensive prospective effort to date designed to assess the intermediate-term outcomes and complications of operative treatment for ACD.
AB - OBJECTIVE Adult cervical deformity (ACD) has high complication rates due to surgical complexity and patient frailty. Very few studies have focused on longer-term outcomes of operative ACD treatment. The objective of this study was to assess minimum 2-year outcomes and complications of ACD surgery. METHODS A multicenter, prospective observational study was performed at 13 centers across the United States to evaluate surgical outcomes for ACD. Demographics, complications, radiographic parameters, and patient-reported outcome measures (PROMs; Neck Disability Index, modified Japanese Orthopaedic Association, EuroQol-5D [EQ-5D], and numeric rating scale [NRS] for neck and back pain) were evaluated, and analyses focused on patients with ≥ 2-year follow-up. RESULTS Of 169 patients with ACD who were eligible for the study, 102 (60.4%) had a minimum 2-year follow-up (mean 3.4 years, range 2-8.1 years). The mean age at surgery was 62 years (SD 11 years). Surgical approaches included anterior-only (22.8%), posterior-only (39.6%), and combined (37.6%). PROMs significantly improved from baseline to last follow-up, including Neck Disability Index (from 47.3 to 33.0) and modified Japanese Orthopaedic Association score (from 12.0 to 12.8; for patients with baseline score ≤ 14), neck pain NRS (from 6.8 to 3.8), back pain NRS (from 5.5 to 4.8), EQ-5D score (from 0.74 to 0.78), and EQ-5D visual analog scale score (from 59.5 to 66.6) (all p ≤ 0.04). More than half of the patients (n = 58, 56.9%) had at least one complication, with the most common complications including dysphagia, distal junctional kyphosis, instrumentation failure, and cardiopulmonary events. The patients who did not achieve 2-year follow-up (n = 67) were similar to study patients based on baseline demographics, comorbidities, and PROMs. Over the course of follow-up, 23 of the total 169 enrolled patients were reported to have died. Notably, these represent all-cause mortalities during the course of follow-up. CONCLUSIONS This multicenter, prospective analysis demonstrates that operative treatment for ACD provides significant improvement of health-related quality of life at a mean 3.4-year follow-up, despite high complication rates and a high rate of all-cause mortality that is reflective of the overall frailty of this patient population. To the authors' knowledge, this study represents the largest and most comprehensive prospective effort to date designed to assess the intermediate-term outcomes and complications of operative treatment for ACD.
KW - adult
KW - cervical deformity
KW - complications
KW - outcomes
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85143195946&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85143195946&partnerID=8YFLogxK
U2 - 10.3171/2022.6.SPINE22422
DO - 10.3171/2022.6.SPINE22422
M3 - Article
C2 - 35901674
AN - SCOPUS:85143195946
SN - 1547-5654
VL - 37
SP - 855
EP - 864
JO - Journal of Neurosurgery: Spine
JF - Journal of Neurosurgery: Spine
IS - 6
ER -