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

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

doi:10.3171/2018.8.spine18715

Cited by 30 publications

(18 citation statements)

References 19 publications

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“…Ayling et al investigated on the appropriate follow up time for clinical outcome research in spine surgery and found that the time to plateaued recovery after surgery for VAS back and leg pain was 3 months; and 12 months for disability indices (ODI) for patients with degenerative spondylolisthesis who were treated with fusion. 14 In our study the minimum and the mean duration of follow up were 5 and 13.5 months respectively.…”

Section: Discussionmentioning

confidence: 46%

Patient Reported Outcome Analysis after Posterior Decompression and Posterolateral Fusion Surgery in Lumbar Degenerative Spondylolisthesis

et al. 2020

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Introduction: Lumbar degenerative spondylolisthesis is an acquired slippage of a vertebra due to degenerative arthritis of the facet joints without any defect in the vertebral ring. Degenerative spondylolisthesis is commonly treated with posterior decompression and posterolateral fusion. This study aims to evaluate the clinical outcome of posterior decompression and instrumented posterolateral fusion surgery by analysing patient reported outcome measures. Materials and Methods: A retrospective study in which patients who had posterior decompression and instrumented posterolateral fusion for lumbar degenerative spondylolisthesis between September 2017 and August 2019 at Nepal Mediciti Hospital were included in the study. Other types of spondylolisthesis managed with similar technique and patients who had follow up period of less than three months were excluded. Functional outcome was assessed by comparing pre and post-operative patient reported outcome measures: VAS leg pain, VAS back pain and Oswestry Disability Index (ODI). The paired t-test was used for statistical analysis. Results: Of the 16 patients, 81.25% were female. Mean age and mean follow up period were 58.81± 10.47 years and 13.56±7.15 months respectively. Seventy five percent had grade I spondylolisthesis. Most common level of spondylolisthesis was L4/5 (62.5%). Fourteen patients reported improvement in their symptoms after surgery. The changes in functional outcome scores between baseline and at follow up evaluation were as follows: 32.70 ± 17.44 points for ODI, 3 ±1.89 for VAS leg pain, and 5.37 ± 2.36 for VAS back pain (P<0.001). Superficial wound infection was the most common complication observed in 18.3%. Conclusion: In our case series, 87.5% had improvement in their symptoms after surgery. The change in mean score of patients’ reported outcome measures before and after surgery was statistically significant. We recommend a prospective comparative study between decompression alone and the fusion technique for the evaluation of long term functional outcome.

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Section: Discussionmentioning

confidence: 46%

Patient Reported Outcome Analysis after Posterior Decompression and Posterolateral Fusion Surgery in Lumbar Degenerative Spondylolisthesis

et al. 2020

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“…Additionally, fusion and complication rates may differ between various commercial preparations of DBM. 18 While 24-month follow-up has been shown to be adequate for assessing long-term patient improvement following lumbar spine surgery, 19 our 24-month follow-up may have missed cases of pseudarthrosis that presented with longer-term follow-up, as the average reported time to detection of lumbar pseudarthrosis is 3.5 years. 20 It is also known that postoperative patients with pseudarthrosis may initially have good relief of symptoms, which subsequently deteriorates over longer-term follow-up.…”

Section: Discussionmentioning

confidence: 95%

Efficacy, Cost, and Complications of Demineralized Bone Matrix in Instrumented Lumbar Fusion: Comparison With rhBMP-2

Eleswarapu

Rowan

et al. 2020

Global Spine Journal

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Study Design: Retrospective cohort study. Objectives: To evaluate demineralized bone matrix as an adjunct for instrumented lumbar spine fusion compared with recombinant human bone morphogenetic protein–2 (rhBMP-2). Methods: Clinical and radiographic review was performed of 43 patients with degenerative spine disease treated with posterolateral spinal fusion with or without posterior or transforaminal lumbar interbody fusion. Final analysis included sixteen patients treated with demineralized bone matrix (DBM; Accell Evo3, SeaSpine) compared with a retrospective matched group of 21 patients treated with rhBMP-2 (rhBMP-2, Infuse, Medtronic). All patients were followed for 24 months. Fusion was evaluated by computed tomography and/or x-ray. Clinical outcomes included visual analogue scale (VAS), Oswestry Disability Index (ODI), and Short Form 12 (SF-12). Results: Overall fusion rate, including posterolateral and/or interbody fusion, was 100% for both groups, though the fusion rates in the posterolateral space alone were 93.5% and 100% for the DBM and rhBMP-2 groups, respectively. Clinical outcomes were similar between groups, with the DBM group showing greater improvement in ODI. The rhBMP-2 group showed higher rates of radiographic complications with 7 of 21 patients (33.3%) demonstrating either adjacent level fusion or ectopic bone formation, compared with zero in the DBM group. Average biologic cost per level was $1522 for DBM and $3505 for rhBMP-2. Conclusions: DBM and rhBMP-2 demonstrated similar radiographic and clinical outcomes in instrumented lumbar fusions. rhBMP-2 was associated with higher rates of radiographic complications and significantly higher costs.

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“…This is a multicenter prospective study involving seven academic centers participating in the Canadian Spine Outcomes and Research Network (CSORN). 16 To evaluate the outcomes of surgical treatment of DLS, these seven CSORN sites have been prospectively enrolling consecutive eligible patients since 2015. This is a specific prospective study, with a priori questions and is separate from the broader CSORN registry.…”

Section: Methodsmentioning

confidence: 99%

Preoperative Patient-reported Outcomes are not Associated With Sagittal and Spinopelvic Alignment in Degenerative Lumbar Spondylolisthesis

Karim

Fisher

Glennie³

et al. 2022

Spine

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Study Design. Prospective cohort study. Objective. The aim of this study was to evaluate whether sagittal and spinopelvic alignment correlate with preoperative patient-reported outcomes (PROs) in degenerative lumbar spondylolisthesis (DLS) with spinal stenosis. Summary of Background Data. Positive global sagittal balance and spinopelvic malalignment are strongly correlated with symptom severity in adult spinal deformity, but this correlation has not been evaluated in DLS. Methods. Patients were enrolled in the Canadian Spine Outcomes Research Network (CSORN) prospective DLS study at seven centers between January 2015 and May 2018. Correlation was assessed between the following preoperative PROs: Oswestry Disability Index (ODI), numeric rating scale (NRS) leg pain, and NRS back pain and the following preoperative sagittal radiographic parameters SS, PT, PI, SVA, LL, TK, T1SPI, T9SPI, and PI-LL. Patients were further divided into groups based on spinopelvic alignment: Group 1 PI-LL<10°; Group 2 PI-LL ≥10° with PT <30°; and Group 3 PI-LL ≥10° with PT ≥30°. Preoperative PROs were compared among these three groups and were further stratified by those with SVA <50 mm and SVA ≥50 mm. Results. A total of 320 patients (61% female) with mean age of 66.1 years were included. Mean (SD) preoperative PROs were: NRS leg pain 7.4 (2.1), NRS back pain 7.1 (2.0), and ODI 45.5 (14.5). Preoperative radiographic parameters included: SVA 27.1 (33.4) mm, LL 45.7 (13.4°), PI 57.6 (11.9), and PI-LL 11.8 (14.0°). Weak but statistically significant correlations were observed between leg pain and PT (r = −0.114) and PI (ρ = −0.130), and T9SPI with back pain (r = 0.130). No significant differences were observed among the three groups stratified by PI-LL and PT. No significant differences in PROs were observed between patients with SVA <50 mm compared to those with SVA ≥50 mm. Conclusion. Sagittal and spinopelvic malalignment do not appear to significantly influence baseline PROs in patients with DLS. Level of Evidence. Prognostic level II.

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

Cited by 30 publications

References 19 publications

Patient Reported Outcome Analysis after Posterior Decompression and Posterolateral Fusion Surgery in Lumbar Degenerative Spondylolisthesis

Patient Reported Outcome Analysis after Posterior Decompression and Posterolateral Fusion Surgery in Lumbar Degenerative Spondylolisthesis

Efficacy, Cost, and Complications of Demineralized Bone Matrix in Instrumented Lumbar Fusion: Comparison With rhBMP-2

Preoperative Patient-reported Outcomes are not Associated With Sagittal and Spinopelvic Alignment in Degenerative Lumbar Spondylolisthesis

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