TY - JOUR
T1 - Complication rate evolution across a 10-year enrollment period of a prospective multicenter database
AU - On behalf of The International Spine Study Group
AU - Lafage, Renaud
AU - Fong, Alex M.
AU - Klineberg, Eric
AU - Smith, Justin S.
AU - Bess, Shay
AU - Shaffrey, Christopher I.
AU - Burton, Douglas
AU - Kim, Han Jo
AU - Elysee, Jonathan
AU - Mundis, Gregory M.
AU - Passias, Peter
AU - Gupta, Munish
AU - Hostin, Richard
AU - Schwab, Frank
AU - Lafage, Virginie
N1 - Funding Information:
The International Spine Study Group (ISSG) is funded through research grants from DePuy Synthes (current), NuVasive (current), K2M (current), Innovasis (past), Biomet (past), and individual donations.
Funding Information:
Mr. Lafage has an ownership interest in Nemaris, Inc. Dr. Klineberg is a consultant for DePuy Synthes, Stryker, and Medicrea/Medtronic. He receives honoraria and has a fellowship grant from AO Spine. Dr. Smith is a consultant for Zimmer Biomet, NuVasive, Cerapedics, DePuy Synthes, and SeaSpine. He has direct stock ownership in Alphatec and NuVasive. He 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 DePuy Synthes and NuVasive. He receives royalties from Zimmer Biomet, NuVasive, and Thieme. Dr. Bess is a consultant for K2M Stryker, and Mirus. He is a patent holder with K2M Stryker, and NuVasive. He received clinical or research support for the study described (includes equipment or material) from K2M Stryker, NuVasive, the International Spine Study Group Foundation (ISSGF), and DePuy Synthes. He receives support of a non–study-related clinical or research effort that he oversees from K2M Stryker, NuVasive, the ISSGF, Globus, Medtronic, and SI Bone. He receives royalties from K2M, Stryker and NuVasive. Dr. Shaffrey is a consultant for Medtronic, NuVasive, and SI Bone. He has direct stock ownership in NuVasive, and is a patent holder with Medtronic, NuVasive, and Zimmer Biomet. He received clinical or research support for the study described (includes equipment or material) from DePuy Synthes, Globus, and Stryker. Dr. Burton has direct stock ownership in Progenerative Medical, and he is a patent holder with DePuy. He is a consultant for Globus. Dr. Mundis is a consultant for NuVasive, Stryker, Viseon, SeaSpine, and Carlsmed. He has direct stock ownership in Alphatec and SeaSpine, and he receives royalties from Stryker and NuVasive. Dr. Passias is a consultant for Globus, Royalbiologics, and Spinwave. Dr. Gupta is a consultant for DePuy, Globus, and Medtronic. He has direct stock ownership in P&G and J&J. He receives honoraria from AO Spine and royalties from DePuy and Innomed. He has received travel reimbursements from SRS, AO Spine, DePuy, Medtronic, and Globus. Dr. Schwab has direct stock ownership in VFT Solutions and SeaSpine. He is a consultant for Zimmer Biomet and Medtronic. He receives royalties from Zimmer Biomet, Medtronic, and Medicrea. He is on the executive committee of the ISSG. Dr. Lafage is a consultant for Globus Medical, and she receives royalties from NuVasive. She receives honoraria from DePuy Synthes and Implanet. She has an ownership interest in Nemaris, Inc.
Publisher Copyright:
©AANS 2022
PY - 2022/6
Y1 - 2022/6
N2 - OBJECTIVE Adult spinal deformity is a complex pathology that benefits greatly from surgical treatment. Despite continuous innovation, little is known regarding continuous changes in surgical techniques and the complications rate. The objective of the current study was to investigate the evolution of the patient profiles and surgical complications across a single prospective multicenter database. METHODS This study is a retrospective review of a prospective, multicenter database of surgically treated patients with adult spinal deformity (thoracic kyphosis > 60°, sagittal vertical axis > 5 cm, pelvic tilt > 25°, or Cobb angle > 20°) with a minimum 2-year follow-up. Patients were stratified into 3 equal groups by date of surgery. The three groups’ demographic data, preoperative data, surgical information, and complications were then compared. A moving average of 320 patients was used to visualize and investigate the evolution of the complication across the enrollment period. RESULTS A total of 928/1260 (73.7%) patients completed their 2-year follow-up, with an enrollment rate of 7.7 ± 4.1 patients per month. Across the enrollment period (2008–2018) patients became older (mean age increased from 56.7 to 64.3 years) and sicker (median Charlson Comorbidity Index rose from 1.46 to 2.08), with more pure sagittal deformity (type N). Changes in surgical treatment included an increased use of interbody fusion, more anterior column release, and a decrease in the 3-column osteotomy rate, shorter fusion, and more supplemental rods and bone morphogenetic protein use. There was a significant decrease in major complications associated with a reoperation (from 27.4% to 17.1%) driven by a decrease in radiographic failures (from 12.3% to 5.2%), despite a small increase in neurological complications. The overall complication rate has decreased over time, with the lowest rate of any complication (51.8%) during the period from August 2014 to March 2017. Major complications associated with reoperation decreased rapidly in the 2014–2015. Major complications not associated with reoperation had the lowest level (21.0%) between February 2014 and October 2016. CONCLUSIONS Despite an increase in complexity of cases, complication rates did not increase and the rate of complications leading to reoperation decreased. These improvements reflect the changes in practice (supplemental rod, proximal junctional kyphosis prophylaxis, bone morphogenetic protein use, anterior correction) to ensure maintenance of status or improved outcomes.
AB - OBJECTIVE Adult spinal deformity is a complex pathology that benefits greatly from surgical treatment. Despite continuous innovation, little is known regarding continuous changes in surgical techniques and the complications rate. The objective of the current study was to investigate the evolution of the patient profiles and surgical complications across a single prospective multicenter database. METHODS This study is a retrospective review of a prospective, multicenter database of surgically treated patients with adult spinal deformity (thoracic kyphosis > 60°, sagittal vertical axis > 5 cm, pelvic tilt > 25°, or Cobb angle > 20°) with a minimum 2-year follow-up. Patients were stratified into 3 equal groups by date of surgery. The three groups’ demographic data, preoperative data, surgical information, and complications were then compared. A moving average of 320 patients was used to visualize and investigate the evolution of the complication across the enrollment period. RESULTS A total of 928/1260 (73.7%) patients completed their 2-year follow-up, with an enrollment rate of 7.7 ± 4.1 patients per month. Across the enrollment period (2008–2018) patients became older (mean age increased from 56.7 to 64.3 years) and sicker (median Charlson Comorbidity Index rose from 1.46 to 2.08), with more pure sagittal deformity (type N). Changes in surgical treatment included an increased use of interbody fusion, more anterior column release, and a decrease in the 3-column osteotomy rate, shorter fusion, and more supplemental rods and bone morphogenetic protein use. There was a significant decrease in major complications associated with a reoperation (from 27.4% to 17.1%) driven by a decrease in radiographic failures (from 12.3% to 5.2%), despite a small increase in neurological complications. The overall complication rate has decreased over time, with the lowest rate of any complication (51.8%) during the period from August 2014 to March 2017. Major complications associated with reoperation decreased rapidly in the 2014–2015. Major complications not associated with reoperation had the lowest level (21.0%) between February 2014 and October 2016. CONCLUSIONS Despite an increase in complexity of cases, complication rates did not increase and the rate of complications leading to reoperation decreased. These improvements reflect the changes in practice (supplemental rod, proximal junctional kyphosis prophylaxis, bone morphogenetic protein use, anterior correction) to ensure maintenance of status or improved outcomes.
KW - adult spinal deformity
KW - complications
KW - deformity surgery
KW - thoracolumbar surgery
UR - http://www.scopus.com/inward/record.url?scp=85131731681&partnerID=8YFLogxK
U2 - 10.3171/2021.10.SPINE21795
DO - 10.3171/2021.10.SPINE21795
M3 - Article
C2 - 35349975
AN - SCOPUS:85131731681
SN - 1547-5654
VL - 36
SP - 1012
EP - 1022
JO - Journal of Neurosurgery: Spine
JF - Journal of Neurosurgery: Spine
IS - 6
ER -