Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis

J Neurosurg Spine 38:115–125, 2023

The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial.

METHODS The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory.

RESULTS A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°).

CONCLUSIONS This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Complications of degenerative lumbar spondylolisthesis and stenosis surgery in patients over 80 s

Acta Neurochirurgica (2022) 164:923–931

Degenerative spondylolisthesis (DS) is a debilitating condition that carries a high economic burden. As the global population ages, the number of patients over 80 years old demanding spinal fusion is constantly rising. Therefore, neurosurgeons often face the important decision as to whether to perform surgery or not in this age group, commonly perceived at high risk for complications.

Methods Six hundred seventy-eight elder patients, who underwent posterolateral lumbar fusion for DS (performed in three different centers) from 2012 to 2020, were screened for medical, early and late surgical complications and for the presence of potential preoperative risk factors. Patients were divided in three categories based on their age: (1) 60–69 years, (2) 70–79 years, (3) 80 and over. Multiple logistic regression was used to determine the predictive power of age and of other risk factors (i.e., ASA score; BMI; sex; presence or absence of insulin-dependent and -independent diabetes, use of anticoagulants, use of antiaggregants and osteoporosis) for the development of postoperative complications.

Results In univariate analysis, age was significantly and positively correlated with medical complications. However, when controls for other risk factors were added in the regressions, age never reached significance, with the only noticeable exception of cerebrovascular accidents. ASA score and BMI were the two risk factors that significantly correlated with the higher numbers of complication rates (especially medical).

Conclusion Patients of different age but with comparable preoperative risk factors share similar postoperative morbidity rates. When considering octogenarians for lumbar arthrodesis, the importance of biological age overrides that of chronological.

The Effect of Older Age on the Perioperative Outcomes of Spinal Fusion Surgery in Patients With Lumbar Degenerative Disc DiseaseWith Spondylolisthesis

Neurosurgery, Volume 87, Issue 4, 1 October 2020, Pages 672–678

Degenerative spondylolisthesis (DS) is often treated with lumbar spinal fusion (LSF). However, there is concern that the morbidity of LSF may be prohibitively high in older adults.

OBJECTIVE: To evaluate the impact of advanced age on the safety of LSF for DS.

METHODS: Patients who underwent LSF for DS were retrospectively identified from National Surgical Quality Improvement Program datasets for 2011 to 2015 using Current Procedural Terminology codes. Data on demographic characteristics, comorbidities, surgical factors, and 30-d morbidity and mortality were collected. Propensity score matching (nearest neighbor) was performed with age (<70 vs ≥70 yr) as the dependent variable and sex, type of fusion procedure, number of levels fused, diabetes, smoking, hypertension, and chronic steroid use as covariates. Outcomes were compared between age <70 and ≥70 groups.

RESULTS: The study cohort consisted of 2238 patients (n=1119, age<70; n=1119, age≥70). The 2 age groups were balanced for key covariates including sex, race, diabetes, hypertension, CHF, smoking, chronic steroid use, type of fusion, and number of levels. Rates of all complications were similar between younger and older age groups, except urinary tract infection, which was more frequent among the ≥70 age group (OR 2.32, P = .009). Further, patients in the older age group were more likely to be discharged to a rehabilitation (OR 2.94, P < .001) or skilled care (OR 3.66, P < .001) facility, rather than directly home (OR 0.25, P < .001).

CONCLUSION: LSF may be performed safely in older adults with DS. Our results suggest older age alone should not exclude a patient from undergoing lumbar fusion for DS.

The influence of spinopelvic parameters on adjacent-segment degeneration after short spinal fusion for degenerative spondylolisthesis

J Neurosurg Spine 29:407–413, 2018

Spinopelvic parameters, such as the pelvic incidence (PI) angle, sacral slope angle, and pelvic tilt angle, are important anatomical indices for determining the sagittal curvature of the spine and the individual variability of the lumbar lordosis (LL) curve. The aim of this study was to investigate the influence of spinopelvic parameters and LL on adjacent-segment degeneration (ASD) after short lumbar and lumbosacral fusion for single-level degenerative spondylolisthesis.

METHODS The authors retrospectively reviewed the records of all short lumbar and lumbosacral fusion surgeries performed between August 2003 and July 2010 for single-level degenerative spondylolisthesis in their orthopedic department.

RESULTS A total of 30 patients (21 women and 9 men, mean age 64 years) with ASD after lower lumbar or lumbosacral fusion surgery comprised the study group. Thirty matched patients (21 women and 9 men, mean age 63 years) without ASD comprised the control group, according to the following matching criteria: same diagnosis on admission, similar pathologic level (≤ 1 level difference), similar sex, and age. The average follow-up was 6.8 years (range 5–8 years). The spinopelvic parameters had no significant influence on ASD after short spinal fusion.

CONCLUSIONS Neither the spinopelvic parameters nor a mismatch of PI and LL were significant factors responsible for ASD after short spinal fusion due to single-level degenerative spondylolisthesis.

Surgery for adult spondylolisthesis: a systematic review of the evidence

spondylolistesis

Eur Spine J (2016) 25:2359–2367

Surgery for isthmic and degenerative spondylolisthesis (SL) in adults is carried out very frequently in everyday practice. However, it is still unclear whether the results of surgery are better than those of conservative treatment and whether decompression alone or instrumented fusion with decompression should be recommended. In addition, the role of reduction is unclear.

Four clinically relevant key questions were addressed in this study: (1) Is surgery more successful than conservative treatment in relation to pain and function in adult patients with isthmic SL? (2) Is surgery more successful than conservative treatment in relation to pain and function in adult patients with degenerative SL? (3) Is instrumented fusion with decompression more successful in relation to pain and function than decompression alone in adult patients with degenerative SL and spinal canal stenosis? (4) Is instrumented fusion with reduction more successful in relation to pain and function than instrumented fusion without reduction in adult patients with isthmic or degenerative SL?

A systematic PubMed search was carried out to identify randomized and nonrandomized controlled trials on these topics. Papers were analyzed systematically in a search for the best evidence.A total of 18 studies was identified and analyzed: two for question 1, eight for question 2, four for question 3, and four for question 4.

Surgery appears to be better than conservative treatment in adults with isthmic SL (poor evidence) and also in adults with degenerative SL (good evidence). Instrumented fusion with decompression appears to be more successful than decompression alone in adults with degenerative SL and spinal stenosis (poor evidence). Reduction and instrumented fusion does not appear to be more successful than instrumented fusion without reduction in adults with isthmic or degenerative SL (moderate evidence).

Who Should Undergo Surgery for Degenerative Spondylolisthesis?

Spondylolisthesis

Spine 2013;38:1799–1811

Combined prospective randomized controlled trial and observational cohort study of degenerative spondylolisthesis (DS) with an as-treated analysis.

Objective. To determine modifi ers of the treatment effect (TE) of surgery (the difference between surgical and nonoperative outcomes) for DS using subgroup analysis. Summary of Background Data. Spine Patient Outcomes Research Trial demonstrated a positive surgical TE for DS at the group level. However, individual characteristics may affect TE.

Methods. Patients with DS were treated with either surgery (n = 395) or nonoperative care (n = 210) and were analyzed according to treatment received. Fifty-fi ve baseline variables were used to defi ne subgroups for calculating the time-weighted average TE for the Oswestry Disability Index during 4 years (TE = Δ Oswestry Disability Index surgery − Δ Oswestry Disability Index nonoperative ). Variables with signifi cant subgroup-by-treatment interactions ( P < 0.05) were simultaneously entered into a multivariate model to select independent TE predictors.

Results. All analyzed subgroups that included at least 50 patients improved signifi cantly more with surgery than with nonoperative treatment ( P < 0.05). Multivariate analyses demonstrated that age 67 years or less (TE − 15.7 vs. − 11.8 for age > 67, P = 0.014); female sex (TE − 15.6 vs. − 11.2 for males, P = 0.01); the absence of stomach problems (TE − 15.2 vs. − 11.3 for those with stomach problems, P = 0.035); neurogenic claudication (TE − 15.3 vs. − 9.0 for those without claudication, P = 0.004); refl ex asymmetry (TE − 17.3 vs. − 13.0 for those without asymmetry, P = 0.016); opioid use (TE − 18.4 vs. − 11.7 for those not using opioids, P < 0.001); not taking antidepressants (TE − 14.5 vs. − 5.4 for those on antidepressants, P = 0.014); dissatisfaction with symptoms (TE − 14.5 vs. − 8.3 for those satisfi ed or neutral, P = 0.039); and anticipating a high likelihood of improvement with surgery (TE − 14.8 vs. − 5.1 for anticipating a low likelihood of improvement with surgery, P = 0.019) were independently associated with greater TE.

Conclusion. Patients who met strict inclusion criteria improved more with surgery than with nonoperative treatment, regardless of other specific characteristics. However, TE varied signifi cantly across certain subgroups.

Level of Evidence: 3

Motion characteristics of the vertebral segments with lumbar degenerative spondylolisthesis in elderly patients

Motion characteristics of the vertebral segments with lumbar degenerative spondylolisthesis in elderly patients

Eur Spine J (2013) 22:425–431

Although some studies have reported on the kinematics of the lumbar segments with degenerative spondylolisthesis (DS), few data have been reported on the in vivo 6 degree-of-freedom kinematics of different anatomical structures of the diseased levels under physiological loading conditions. This research is to study the in vivo motion characteristics of the lumbar vertebral segments with L4 DS during weight-bearing activities.

Methods Nine asymptomatic volunteers (mean age 54.4) and 9 patients with L4 DS (mean age 73.4) were included. Vertebral kinematics was obtained using a combined MRI/ CT and dual fluoroscopic imaging technique. During functional postures (supine, standing upright, flexion, and extension), disc heights, vertebral motion patterns and instability were compared between the two groups.

Results Although anterior disc heights were smaller in the DS group than in the normal group, the differences were only significant at standing upright. Posterior disc heights were significantly smaller in DS group than in the normal group under all postures. Different vertebral motion patterns were observed in the DS group, especially in the left–right and cranial–caudal directions during flexion and extension of the body. However, the range of motions of the both groups were much less than the reported criteria of lumbar spinal instability.

Conclusion The study showed that lumbar vertebra with DS has disordered motion patterns. DS did not necessary result in vertebral instability. A restabilization process may have occurred and surgical treatment should be planned accordingly.

Midterm outcome after a microsurgical unilateral approach for bilateral decompression of lumbar degenerative spondylolisthesis

J Neurosurg Spine 16:68–76, 2012. DOI: 10.3171/2011.7.SPINE11222

The aim of this study was to evaluate the results and effectiveness of bilateral decompression via a unilateral approach in the treatment of lumbar degenerative spondylolisthesis (DS).

Methods. Operations were performed in 84 selected patients (mean age 62.1 ± 10 years) with lumbar DS between the years 2001 and 2008. The selection criteria included lower back pain with or without sciatica, neurogenic claudication that had not improved after at least 6 months of conservative treatment, and a radiological diagnosis of Grade I DS and lumbar stenosis. Decompression was performed at 3 levels in 15.5%, 2 levels in 54.8%, and 1 level in 29.7% of the patients with 1 level of spondylolisthesis. All patients were followed up for at least 24 months. For clinical evaluations, a visual analog scale, Oswestry Disability Index (ODI), and Neurogenic Claudication Outcome Score (NCOS) were used. Spinal canal size and (neutral and dynamic) slip percentages were measured both pre- and postoperatively.

Results. Neutral and dynamic slip percentages did not significantly change after surgery (p = 0.67 and p = 0.63, respectively). Spinal canal size increased from 50.6 ± 5.9 to 102.8 ± 9.5 mm2 (p < 0.001). The ODI decreased significantly in both the early and late follow-up evaluations, and good or excellent results were obtained in 64 cases (80%). The NCOS demonstrated significant improvement in the late follow-up results (p < 0.001). One patient (1.2%) required secondary fusion during the follow-up period.

Conclusions. Postoperative clinical improvement and radiological findings clearly demonstrated that the unilateral approach for treating 1-level and multilevel lumbar spinal stenosis with DS is a safe, effective, and minimally invasive method in terms of reducing the need for stabilization.

Imaging correlation of the degree of degenerative L4–5 spondylolisthesis with the corresponding amount of facet fluid

J Neurosurg Spine 11:614–619, 2009. DOI: 10.3171/2009.6.SPINE08413

The aim of this study was to correlate the degree of L4–5 spondylolisthesis on plain flexion-extension radiographs with the corresponding amount of L4–5 facet fluid visible on MR images.

Methods. Patients underwent evaluation at the Neurosurgical Spine Clinics of Stanford University Medical Center and National Health Insurance Medical Center (Goyang, South Korea) between January 2006 and December 2007. Only patients who were diagnosed with L4–5 degenerative spondylolisthesis (DS) and who had both lumbosacral flexion-extension radiographs and MR images available for review were eligible for this study. Each patient’s dynamic motion index (DMI) was measured using the lateral lumbosacral plain radiograph and was the percentage of the degree of anterior slippage seen on flexion versus that seen on extension. Axial T2-weighted MR images of the L4–5 facet joints obtained in each patient was analyzed for the amount of facet fluid, using the image showing the widest portion of the facets. The facet fluid index was calculated from the ratio of the sum of the amounts of facet fluid found in the right plus left facets over the sum of the average widths of the right plus left facet joints.

Results. Fifty-four patients with L4–5 DS were included in this study. Of these 54 patients, facet fluid was noted on MR images in 29 patients (53.7%), and their mean DMI was 6.349 ± 2.726. Patients who did not have facet fluid on MR imaging had a mean DMI of 1.542 ± 0.820; this difference was statistically significant (p < 0.001). There was a positive linear association between the facet fluid index and the DMI in the group of patients who exhibited facet fluid on MR images (Pearson correlation coefficient 0.560, p < 0.01). In the subgroup of 29 patients with L4–5 DS who showed facet fluid on MR images, flexion-extension plain radiographs in 10 (34.5%) showed marked anterolisthesis, while the corresponding MR images did not.

Conclusions. There is a linear correlation between the degree of segmental motion seen on flexion-extension plain radiography in patients with DS at L4–5 and the amount of L4–5 facet fluid on MR images. If L4–5 facet fluid in patients with DS is seen on MR images, a corresponding anterolisthesis on weight-bearing flexion-extension lateral radiographs should be anticipated. Obtaining plain radiographs will aid in the diagnosis of anterolisthesis caused by an L4–5 hypermobile segment, which may not always be evident on MR images obtained in supine patients.