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Clinical outcomes research in spine surgery: what are appropriate follow-up times?

Presented at the 2018 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Oliver G. S. Ayling, Tamir Ailon, Greg McIntosh, Alex Soroceanu, Hamilton Hall, Andrew Nataraj, Christopher S. Bailey, Sean Christie, Alexandra Stratton, Henry Ahn, Michael Johnson, Jerome Paquet, Kenneth Thomas, Neil Manson, Y. Raja Rampersaud, and Charles G. Fisher

OBJECTIVE

There has been a generic dictum in spine and musculoskeletal clinical research that a minimum 2-year follow-up is necessary for patient-reported outcomes (PROs) to adequately assess the therapeutic effect of surgery; however, the rationale for this duration is not evidence based. The purpose of this study was to determine the follow-up time necessary to ensure that the effectiveness of a lumbar surgical intervention is adequately captured for three lumbar pathologies and three common PROs.

METHODS

Using the different PROs of pain, physical function, and mental quality of life from the Canadian Spine Outcomes and Research Network (CSORN) prospective database, the authors assessed the time course to the recovery plateau following lumbar spine surgery for lumbar disc herniation, degenerative spondylolisthesis, and spinal stenosis. One-way ANOVA with post hoc testing was used to compare scores on the following standardized PRO measures at baseline and 3, 12, and 24 months postoperatively: Disability Scale (DS), visual analog scale (VAS) for leg and back pain, and SF-12 Mental Component Summary (MCS) and Physical Component Summary (PCS).

RESULTS

Significant differences for all spine pathologies and specific PROs were found with one-way ANOVA (p < 0.0001). The time to plateaued recovery after surgery for lumbar disc herniation (661 patients), lumbar stenosis (913 patients), and lumbar spondylolisthesis (563 patients) followed the same course for the following PRO measures: VAS for back and leg pain, 3 months; DS, 12 months; PCS, 12 months; and MCS, 3 months. Beyond these time points, no further significant improvements in PROs were seen. Patients with degenerative spondylolisthesis or spinal stenosis who had undergone fusion surgery plateaued at 12 months on the DS and PCS, compared to 3 months in those who had not undergone fusion.

CONCLUSIONS

Specific health dimensions follow distinctly different recovery plateaus, indicating that a 2-year postoperative follow-up is not required for all PROs to accurately assess the treatment effect of lumbar spinal surgery. Ultimately, the clinical research question should dictate the follow-up time and the outcome measure utilized; however, there is now evidence to guide the specific duration of follow-up for pain, physical function, and mental quality of life dimensions.

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Themistocles S. Protopsaltis, Nicholas Stekas, Justin S. Smith, Alexandra Soroceanu, Renaud Lafage, Alan H. Daniels, Han Jo Kim, Peter G. Passias, Gregory M. Mundis Jr., Eric O. Klineberg, D. Kojo Hamilton, Munish Gupta, Virginie Lafage, Robert A. Hart, Frank Schwab, Douglas C. Burton, Shay Bess, Christopher I. Shaffrey, and Christopher P. Ames

OBJECTIVE

Cervical deformity (CD) patients have severe disability and poor health status. However, little is known about how patients with rigid CD compare with those with flexible CD. The main objectives of this study were to 1) assess whether patients with rigid CD have worse baseline alignment and therefore require more aggressive surgical corrections and 2) determine whether patients with rigid CD have similar postoperative outcomes as those with flexible CD.

METHODS

This is a retrospective review of a prospective, multicenter CD database. Rigid CD was defined as cervical lordosis (CL) change < 10° between flexion and extension radiographs, and flexible CD was defined as a CL change ≥ 10°. Patients with rigid CD were compared with those with flexible CD in terms of cervical alignment and health-related quality of life (HRQOL) at baseline and at multiple postoperative time points. The patients were also compared in terms of surgical and intraoperative factors such as operative time, blood loss, and number of levels fused.

RESULTS

A total of 127 patients met inclusion criteria (32 with rigid and 95 with flexible CD, 63.4% of whom were females; mean age 60.8 years; mean BMI 27.4); 47.2% of cases were revisions. Rigid CD was associated with worse preoperative alignment in terms of T1 slope minus CL, T1 slope, C2–7 sagittal vertical axis (cSVA), and C2 slope (C2S; all p < 0.05). Postoperatively, patients with rigid CD had an increased mean C2S (29.1° vs 22.2°) at 3 months and increased cSVA (47.1 mm vs 37.5 mm) at 1 year (p < 0.05) compared with those with flexible CD. Patients with rigid CD had more posterior levels fused (9.5 vs 6.3), fewer anterior levels fused (1 vs 2.0), greater blood loss (1036.7 mL vs 698.5 mL), more 3-column osteotomies (40.6% vs 12.6%), greater total osteotomy grade (6.5 vs 4.5), and mean osteotomy grade per level (3.3 vs 2.1) (p < 0.05 for all). There were no significant differences in baseline HRQOL scores, the rate of distal junctional kyphosis, or major/minor complications between patients with rigid and flexible CD. Both rigid and flexible CD patients reported significant improvements from baseline to 1 year according to the numeric rating scale for the neck (−2.4 and −2.7, respectively), Neck Disability Index (−8.4 and −13.3, respectively), modified Japanese Orthopaedic Association score (0.1 and 0.6), and EQ-5D (0.01 and 0.05) (p < 0.05). However, HRQOL changes from baseline to 1 year did not differ between rigid and flexible CD patients.

CONCLUSIONS

Patients with rigid CD have worse baseline cervical malalignment compared with those with flexible CD but do not significantly differ in terms of baseline disability. Rigid CD was associated with more invasive surgery and more aggressive corrections, resulting in increased operative time and blood loss. Despite more extensive surgeries, rigid CD patients had equivalent improvements in HRQOL compared with flexible CD patients. This study quantifies the importance of analyzing flexion-extension images, creating a prognostic tool for surgeons planning CD correction, and counseling patients who are considering CD surgery.