TY - JOUR
T1 - Rod fractures in thoracolumbar fusions to the sacrum/pelvis for adult symptomatic lumbar scoliosis
T2 - long-term follow-up of a prospective, multicenter cohort of 160 patients
AU - Sardi, Juan Pablo
AU - Lazaro, Bruno
AU - Smith, Justin S.
AU - Kelly, Michael P.
AU - Dial, Brian
AU - Hills, Jeffrey
AU - Yanik, Elizabeth L.
AU - Gupta, Munish
AU - Baldus, Christine R.
AU - Yen, Chun Po
AU - Lafage, Virginie
AU - Ames, Christopher P.
AU - Bess, Shay
AU - Schwab, Frank
AU - Shaffrey, Christopher I.
AU - Bridwell, Keith H.
N1 - Funding Information:
This trial was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases division of the NIH (5RO1-ARO55176) from 2010 to 2017, and since 2017 it has received funding through the Scoliosis Research Society.
Funding Information:
Dr. Smith reports receiving consultancy fees from Zimmer Biomet, NuVasive, DePuy Synthes, SeaSpine, Stryker, Carlsmed, and Cerapedics; receiving royalties from Zimmer Biomet, NuVasive, and Thieme; holding stock options in Alphatec and NuVasive; receiving research funding to his institution from DePuy Synthes, the International Spine Study Group Foundation (ISSGF), AO Spine, NuVasive, NIH, and the Scoliosis Research Society (SRS); receiving fellowship grant funding to his institution from AO Spine; serving on the editorial boards of Journal of Neurosurgery: Spine, Neurosurgery, Operative Neurosurgery, and Spine Deformity; and serving on the Executive Committee of ISSGF and on the Board of Directors of SRS. Dr. Kelly reports receiving grants from NIH and SRS while conducting the present study and grants outside the submitted work from the Setting Scoliosis Straight Foundation, ISSGF, and AO Spine; receiving compensation for travel and being a member of the Board of Directors for SRS; and receiving honoraria from Spine. Dr. Gupta reports receiving consultancy fees from DePuy Synthes, Medtronic, Globus, and Alphatec Spine (began and ended in 2019); receiving royalties from DePuy Synthes, Medtronic, Alphatec Spine, Innomed, and Globus; receiving fellowship grant funding from OmeGA and AO Spine; serving on an advisory board/panel for DePuy Synthes and Medtronic; holding stock in Johnson & Johnson; receiving travel funding/honoraria from Globus, AO Spine, Louisiana State University, SRS, Wright State, and the Malaysia Spine Society; being on the SRS Board of Directors; receiving faculty travel reimbursement for chairing courses from DePuy, Globus, Medtronic, Zimmer, and AO Spine; and volunteering for the National Spine Health Foundation. Dr. Ames reports being an employee for University of California, San Francisco; receiving royalties from Stryker, Biomet, Zimmer Spine, DePuy Synthes, NuVasive, Next Orthosurgical, K2M, and Medicrea; being a consultant for DePuy Synthes, Medtronic, Medicrea, K2M, Agada Medical, and Carlsmed; participating in research for Titan Spine, DePuy Synthes, and International Spine Study Group (ISSG); being an editorial board member for Operative Neurosurgery and Neurospine; receiving grant funding from SRS; and serving on the Executive Committee of ISSG, as the director of Global Spinal Analytics, and as the Safety and Value Committee Chair for SRS. Dr. Yanik reports receiving grants from SRS during the conduct of the study. Dr. Yen reports receiving consultancy fees from NuVasive. Dr. Lafage reports receiving grants from NIH during the conduct of the study; receiving personal fees outside the submitted work from Globus Medical, NuVasive, Nemaris Inc., DePuy Synthes Spine, Implanet, the Permanente Medical Group, and K2M Medical; receiving honoraria from Stryker, Implanet, and DePuy Synthes Spine; being a consultant for Alphatec and Globus Medical; receiving royalties from NuVasive; and ownership of VFT Solutions, LLC. Dr. Bess reports receiving grants from DePuy Synthes, Globus, Medtronic, SI Bone, and Mirus; receiving grants and other support from K2, Stryker, and NuVasive; receiving other support from Carlsmed and Progenerative Medicine; receiving grants outside the submitted work from ISSGF; being a consultant for Mirus, Stryker, and ATEC Spine; being a patent holder for Stryker and NuVasive; receiving clinical or research support for study described (includes equipment or material) from ISSGF; receiving support of non–study-related clinical or research effort overseen by author from DePuy Synthes, Globus, Medtronic, Stryker, SeaSpine, Carlsmed, SI Bone, and ISSGF; serving on the speakers bureau for Stryker and ATEC Spine, and receiving royalties from Stryker and NuVasive. Dr. Schwab reports receiving personal fees outside the submitted work from Globus Medical Inc., K2 Medical LLC, Medicrea USA Corp., Medtronic Sofamor Danek USA Inc., and Zimmer Biomet; personal fees from Synthes GmbH and NuVasive Inc.; direct stock ownership in VFT Solutions and SeaSpine; being a consultant for Zimmer Biomet, Medtronic, and Mainstay Medical; receiving royalties from Zimmer Biomet, Medtronic, and Medicrea; receiving support of non–study-related clinical or research effort overseen by author from DePuy, K2M, NuVasive, Medtronic, Globus, AlloSource, Orthofix, and SI Bone—paid through ISSGF; and being on the Executive Committee of ISSG. Dr. Shaffrey reports receiving grants during the conduct of the study from NIH; receiving personal fees outside the submitted work from NuVasive, Medtronic, Zimmer Biomet, and SI Bone; being a consultant for NuVasive, Medtronic, SI Bone, and Proprio; having direct stock ownership in NuVasive; being a patent holder in NuVasive and Medtronic; and receiving royalties from NuVasive, Medtronic, and SI Bone. Dr. Bridwell reports receiving grants during the conduct of the study from SRS.
Publisher Copyright:
©AANS 2023, except where prohibited by US copyright law.
PY - 2023/2
Y1 - 2023/2
N2 - OBJECTIVE Previous reports of rod fracture (RF) in adult spinal deformity are limited by heterogeneous cohorts, low follow-up rates, and relatively short follow-up durations. Since the majority of RFs present > 2 years after surgery, true occurrence and revision rates remain unclear. The objectives of this study were to better understand the risk factors for RF and assess its occurrence and revision rates following primary thoracolumbar fusions to the sacrum/pelvis for adult symptomatic lumbar scoliosis (ASLS) in a prospective series with long-term follow-up. METHODS Patient records were obtained from the Adult Symptomatic Lumbar Scoliosis–1 (ASLS-1) database, an NIH-sponsored multicenter, prospective study. Inclusion criteria were as follows: patients aged 40–80 years undergoing primary surgeries for ASLS (Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20 or Scoliosis Research Society-22r ≤ 4.0 in pain, function, and/or self-image) with instrumented fusion of ≥ 7 levels that included the sacrum/pelvis. Patients with and without RF were compared to assess risk factors for RF and revision surgery. RESULTS Inclusion criteria were met by 160 patients (median age 62 years, IQR 55.7–67.9 years). At a median followup of 5.1 years (IQR 3.8–6.6 years), there were 92 RFs in 62 patients (38.8%). The median time to RF was 3.0 years (IQR 1.9–4.54 years), and 73% occurred > 2 years following surgery. Based on Kaplan-Meier analyses, estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Baseline radiographic, clinical, and demographic characteristics were similar between patients with and without RF. In Cox regression models, greater postoperative pelvic tilt (HR 1.895, 95% CI 1.196–3.002, p = 0.0065) and greater estimated blood loss (HR 1.02, 95% CI 1.005–1.036, p = 0.0088) were associated with increased risk of RF. Thirty-eight patients (61% of all RFs) underwent revision surgery. Bilateral RF was predictive of revision surgery (HR 3.52, 95% CI 1.8–6.9, p = 0.0002), while patients with unilateral nondisplaced RFs were less likely to require revision (HR 0.39, 95% CI 0.18–0.84, p = 0.016). CONCLUSIONS This study provides what is to the authors’ knowledge the highest-quality data to date on RF rates following ASLS surgery. At a median follow-up of 5.1 years, 38.8% of patients had at least one RF. Estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Greater estimated blood loss and postoperative pelvic tilt were significant risk factors for RF. These findings emphasize the importance of long-term follow-up to realize the true prevalence and cumulative incidence of RF.
AB - OBJECTIVE Previous reports of rod fracture (RF) in adult spinal deformity are limited by heterogeneous cohorts, low follow-up rates, and relatively short follow-up durations. Since the majority of RFs present > 2 years after surgery, true occurrence and revision rates remain unclear. The objectives of this study were to better understand the risk factors for RF and assess its occurrence and revision rates following primary thoracolumbar fusions to the sacrum/pelvis for adult symptomatic lumbar scoliosis (ASLS) in a prospective series with long-term follow-up. METHODS Patient records were obtained from the Adult Symptomatic Lumbar Scoliosis–1 (ASLS-1) database, an NIH-sponsored multicenter, prospective study. Inclusion criteria were as follows: patients aged 40–80 years undergoing primary surgeries for ASLS (Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20 or Scoliosis Research Society-22r ≤ 4.0 in pain, function, and/or self-image) with instrumented fusion of ≥ 7 levels that included the sacrum/pelvis. Patients with and without RF were compared to assess risk factors for RF and revision surgery. RESULTS Inclusion criteria were met by 160 patients (median age 62 years, IQR 55.7–67.9 years). At a median followup of 5.1 years (IQR 3.8–6.6 years), there were 92 RFs in 62 patients (38.8%). The median time to RF was 3.0 years (IQR 1.9–4.54 years), and 73% occurred > 2 years following surgery. Based on Kaplan-Meier analyses, estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Baseline radiographic, clinical, and demographic characteristics were similar between patients with and without RF. In Cox regression models, greater postoperative pelvic tilt (HR 1.895, 95% CI 1.196–3.002, p = 0.0065) and greater estimated blood loss (HR 1.02, 95% CI 1.005–1.036, p = 0.0088) were associated with increased risk of RF. Thirty-eight patients (61% of all RFs) underwent revision surgery. Bilateral RF was predictive of revision surgery (HR 3.52, 95% CI 1.8–6.9, p = 0.0002), while patients with unilateral nondisplaced RFs were less likely to require revision (HR 0.39, 95% CI 0.18–0.84, p = 0.016). CONCLUSIONS This study provides what is to the authors’ knowledge the highest-quality data to date on RF rates following ASLS surgery. At a median follow-up of 5.1 years, 38.8% of patients had at least one RF. Estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Greater estimated blood loss and postoperative pelvic tilt were significant risk factors for RF. These findings emphasize the importance of long-term follow-up to realize the true prevalence and cumulative incidence of RF.
KW - adult scoliosis
KW - lumbar
KW - rod fracture
KW - spinal alignment
KW - spinal instrumentation
KW - spine deformity
KW - spine surgery
KW - thoracic
UR - http://www.scopus.com/inward/record.url?scp=85147309335&partnerID=8YFLogxK
U2 - 10.3171/2022.8.SPINE22423
DO - 10.3171/2022.8.SPINE22423
M3 - Article
C2 - 36461845
AN - SCOPUS:85147309335
SN - 1547-5654
VL - 38
SP - 217
EP - 229
JO - Journal of Neurosurgery: Spine
JF - Journal of Neurosurgery: Spine
IS - 2
ER -