Multicenter assessment of surgical outcomes in adult spinal deformity patients with severe global coronal malalignment: determination of target coronal realignment threshold

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  • 1 Department of Neurological Surgery, University of Virginia Health System, Charlottesville, Virginia;
  • 2 Departments of Neurological Surgery and Orthopaedic Surgery, Duke University, Durham, North Carolina;
  • 3 Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York;
  • 4 Department of Orthopaedic Surgery, University of California, Davis, California;
  • 5 Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, New York;
  • 6 Department of Orthopaedic Surgery, Scripps Clinic and San Diego Spine Foundation, La Jolla, California;
  • 7 Department of Orthopaedic Surgery, University of California, San Francisco, California;
  • 8 Department of Orthopaedic Surgery, Washington University, St. Louis, Missouri;
  • 9 Department of Orthopaedic Surgery, Brown University, Providence, Rhode Island;
  • 10 Department of Orthopaedic Surgery, Norton Leatherman Spine Center, Louisville, Kentucky;
  • 11 Department of Orthopaedic Surgery, University of Calgary, Alberta, Canada;
  • 12 Department of Neurological Surgery, University of Pittsburgh, Pennsylvania;
  • 13 Department of Orthopaedic Surgery, University of Kansas Medical Center, Kansas City, Kansas;
  • 14 Department of Orthopaedic Surgery, Southwest Scoliosis Institute, Baylor Scott and White Medical Center, Plano, Texas;
  • 15 Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, Maryland;
  • 16 Department of Orthopaedic Surgery, Swedish Neuroscience Institute, Seattle, Washington;
  • 17 Denver International Spine Center, Presbyterian/St. Luke’s Medical Center and Rocky Mountain Hospital for Children, Denver, Colorado; and
  • 18 Department of Neurological Surgery, University of California, San Francisco, California
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OBJECTIVE

The impact of global coronal malalignment (GCM; C7 plumb line–midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors’ primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes.

METHODS

This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed.

RESULTS

Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD–Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7–S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence–lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%–83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK).

CONCLUSIONS

Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.

ABBREVIATIONS ASD = adult spinal deformity; ASD-FI = Adult Spinal Deformity–Frailty Index; EBL = estimated blood loss; GCM = global coronal malalignment; HRQOL = health-related quality of life; IBF = interbody fusion; LL = lumbar lordosis; MCID = minimal clinically important difference; MCS = mental component summary of SF-36; NRS = numeric rating scale; ODI = Oswestry Disability Index; PCS = physical component summary of SF-36; PI = pelvic incidence; PI-LL = mismatch between PI and LL; PJK = proximal junctional kyphosis; PT = pelvic tilt; SCB = substantial clinical benefit; SRS = Scoliosis Research Society; SRS-22r = 22-Item SRS Patient Questionnaire; SVA = sagittal vertical axis; TK = thoracic kyphosis; UIV = uppermost instrumented vertebra; 3CO = 3-column osteotomy.

Supplementary Materials

    • Supplemental Tables and Figures (PDF 878 KB)

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Contributor Notes

Correspondence Thomas J. Buell: Duke University Medical Center, Durham, NC. thomas.buell@duke.edu.

INCLUDE WHEN CITING Published online December 4, 2020; DOI: 10.3171/2020.7.SPINE20606.

Disclosures The International Spine Study Group (ISSG) is funded through research grants from DePuy Synthes. Dr. Smith is a consultant for Zimmer Biomet, NuVasive, Stryker, DePuy Synthes, Cerapedics, and Carlsmed; receives royalties from Zimmer Biomet, NuVasive, and Thieme; has direct stock ownership in Alphatec; has received support from DePuy Synthes, ISSG, AO Spine, and NuVasive for non–study-related clinical or research effort; received clinical or research support from DePuy Synthes/ISSG Foundation (ISSGF) for the study described; has received fellowship funding from NREF and AO Spine; serves on the editorials boards of Neurosurgery, Operative Neurosurgery, and JNS: Spine; and serves on the board of directors of the Scoliosis Research Society. Dr. Shaffrey is a consultant for Medtronic, NuVasive, and SI Bone; has direct stock ownership in NuVasive; holds patents with Medtronic, NuVasive, and Zimmer Biomet; and received clinical or research support from ISSGF for the study described. Dr. Kim receives royalties from Zimmer Biomet and Stryker K2M and is a consultant for Alphatec. Dr. Klineberg is a consultant for DePuy Synthes, Stryker, and Medicrea and has received honoraria and a fellowship grant from AO Spine. Dr. V. Lafage is a consultant for Globus Medical, receives royalties from NuVasive, and has received honoraria from the Permanente Medical Group, DePuy Synthes, and Implanet. Mr. R. Lafage has direct stock ownership in Nemaris. Dr. Protopsaltis is a consultant for Globus, Stryker K2M, Medtronic, NuVasive, and Medicrea and receives royalties from Altus. Dr. Passias is a consultant for Medicrea, SpineWave, and Terumo; is part of the speakers bureau of Zimmer Biomet and Globus Medical; has received financial or material support from AlloSource; and has received clinical or research support from the Cervical Scoliosis Research Society for the study described. Dr. Mundis is a consultant for NuVasive, Stryker, Viseon, SeaSpine, and Carlsmed; has direct stock ownership in NuVasive, SeaSpine, and Alphatec; and receives royalties from NuVasive and Stryker. Dr. Deviren is a consultant for Zimmer Biomet, SeaSpine, Alphatec, Medicrea, and NuVasive and receives royalties from NuVasive. Dr. Kelly received clinical or research support from DePuy Synthes Spine for the study described. Dr. Daniels is a consultant for Medicrea, Spineart, Stryker, Orthofix, Medtronic, EOS, and Southern Spine. Dr. Gum is an employee of Norton Healthcare; is a consultant for Medtronic, Acuity, Stryker K2M, NuVasive, and Mazor; is part of the speakers bureau of DePuy; receives royalties from Acuity and NuVasive; has received honoraria from Pacira Pharmaceuticals, Baxter, Broadwater, and NASS; has direct stock ownership in Cingulate Therapeutica; holds patents with Medtronic; has received clinical or research support from Integra, Intellirod Spine Inc., Pfizer, ISSG, NuVasive, and Norton Healthcare for the study described; and is on the advisory/editorial board for Stryker K2M, Medtronic, and National Spine Health Foundation. Dr. Gupta is a consultant for Alphatec, Medtronic, and DePuy; receives royalties from Innomed and DePuy; has received funds from Medicrea, Globus, Mizhuo, and Scoliosis Society for travel; has received an institutional grant from Omega Fellowship; and has received honoraria from AO Spine. Dr. Burton has ownership of Progenerative Medical, receives royalties from DePuy, and is a consultant for DePuy and Bioventus. Dr. Hart is a consultant for Globus, DePuy Synthes, SeaSpine, Orthofix, and Medtronic and has received a grant from ISSLS for a lumbar spine book. Dr. Schwab is a consultant for Globus Medical, K2M, and Zimmer Biomet; receives royalties from Medicrea, Medtronic, and Zimmer Biomet; has received honoraria from Zimmer Biomet; and serves on the board of directors for ISSG. Dr. Bess is a consultant for Stryker and Mirus; has direct stock ownership in Progenerative Medical and Carlsmed; receives royalties from Stryker and NuVasive; received clinical or research support from Stryker, DePuy Synthes, and NuVasive for the study described; and has received support from Medtronic, Globus, SI Bone, and ISSFG for non–study-related clinical or research effort. Dr. Ames receives royalties from Stryker, Zimmer Biomet Spine, DePuy Synthes, NuVasive, Next Orthosurgical, K2M, and Medicrea; is a consultant for DePuy Synthes, Medtronic, Medicrea, and K2M; conducts research for Titan Spine, DePuy Synthes, and ISSG; serves on the editorial board of Operative Neurosurgery; has received grant funding from SRS; serves on the executive committee of ISSG; and is the director of Global Spinal Analytics.

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