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Bone & Joint Open
Vol. 4, Issue 8 | Pages 573 - 579
8 Aug 2023
Beresford-Cleary NJA Silman A Thakar C Gardner A Harding I Cooper C Cook J Rothenfluh DA

Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1359 - 1367
3 Oct 2020
Hasegawa K Okamoto M Hatsushikano S Watanabe K Ohashi M Vital J Dubousset J

Aims

The aim of this study is to test the hypothesis that three grades of sagittal compensation for standing posture (normal, compensated, and decompensated) correlate with health-related quality of life measurements (HRQOL).

Methods

A total of 50 healthy volunteers (normal), 100 patients with single-level lumbar degenerative spondylolisthesis (LDS), and 70 patients with adult to elderly spinal deformity (deformity) were enrolled. Following collection of demographic data and HRQOL measured by the Scoliosis Research Society-22r (SRS-22r), radiological measurement by the biplanar slot-scanning full body stereoradiography (EOS) system was performed simultaneously with force-plate measurements to obtain whole body sagittal alignment parameters. These parameters included the offset between the centre of the acoustic meatus and the gravity line (CAM-GL), saggital vertical axis (SVA), T1 pelvic angle (TPA), McGregor slope, C2-7 lordosis, thoracic kyphosis (TK), lumbar lordosis (LL), pelvic incidence (PI), PI-LL, sacral slope (SS), pelvic tilt (PT), and knee flexion. Whole spine MRI examination was also performed. Cluster analysis of the SRS-22r scores in the pooled data was performed to classify the subjects into three groups according to the HRQOL, and alignment parameters were then compared among the three cluster groups.