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Marc L. Schröder and Victor E. Staartjes

OBJECTIVE

The accuracy of robot-guided pedicle screw placement has been proven to be high, but little is known about the impact of such guidance on clinical outcomes such as the rate of revision surgeries for screw malposition. In addition, there are very few data about the impact of robot-guided fusion on patient-reported outcomes (PROs). Thus, the clinical benefit for the patient is unclear. In this study, the authors analyzed revision rates for screw malposition and changes in PROs following minimally invasive robot-guided pedicle screw fixation.

METHODS

A retrospective cohort study of patients who had undergone minimally invasive posterior lumbar interbody fusion (MI-PLIF) or minimally invasive transforaminal lumbar interbody fusion was performed. Patients were followed up clinically at 6 weeks, 12 months, and 24 months after treatment and by mailed questionnaire in March 2016 as a final follow-up. Visual analog scale (VAS) scores for back and leg pain severity, Oswestry Disability Index (ODI), screw revisions, and socio-demographic factors were analyzed. A literature review was performed, comparing the incidence of intraoperative screw revisions and revision surgery for screw malposition in robot-guided, navigated, and freehand fusion procedures.

RESULTS

Seventy-two patients fit the study inclusion criteria and had a mean follow up of 32 ± 17 months. No screws had to be revised intraoperatively, and no revision surgery for screw malposition was needed. In the literature review, the authors found a higher rate of intraoperative screw revisions in the navigated pool than in the robot-guided pool (p < 0.001, OR 9.7). Additionally, a higher incidence of revision surgery for screw malposition was observed for freehand procedures than for the robot-guided procedures (p < 0.001, OR 8.1). The VAS score for back pain improved significantly from 66.9 ± 25.0 preoperatively to 30.1 ± 26.8 at the final follow-up, as did the VAS score for leg pain (from 70.6 ± 22.8 to 24.3 ± 28.3) and ODI (from 43.4 ± 18.3 to 16.2 ± 16.7; all p < 0.001). Undergoing PLIF, a high body mass index, smoking status, and a preoperative ability to work were identified as predictors of a reduction in back pain. Length of hospital stay was 2.4 ± 1.1 days and operating time was 161 ± 50 minutes. Ability to work increased from 38.9% to 78.2% of patients (p < 0.001) at the final follow-up, and 89.1% of patients indicated they would choose to undergo the same treatment again.

CONCLUSIONS

In adults with low-grade spondylolisthesis, the data demonstrated a benefit in using robotic guidance to reduce the rate of revision surgery for screw malposition as compared with other techniques of pedicle screw insertion described in peer-reviewed publications. Larger comparative studies are required to assess differences in PROs following a minimally invasive approach in spinal fusion surgeries compared with other techniques.

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Victor E. Staartjes and Marc L. Schröder

OBJECTIVE

Recently, objective functional tests have generated interest since they can supplement an objective dimension to clinical assessment. The five-repetition sit-to-stand (5R-STS) test is a quick and objective tool that tests movements frequently used in everyday life. The aim of this prospective study was to evaluate the validity and reliability of the 5R-STS test in patients with degenerative pathologies of the lumbar spine.

METHODS

Patients and healthy volunteers completed the standardized 5R-STS, Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), visual analog scale (VAS) for back and leg pain, and EQ-5D for health-related quality of life (HRQOL). To assess convergent validity, the 5R-STS test times were correlated with these questionnaires.

RESULTS

Overall, 157 patients and 80 volunteers were enrolled. Direct correlation with RMDQ (r = 0.49), ODI (r = 0.44), and VAS for back pain (r = 0.31) and indirect correlation with the EQ-5D index (r = −0.41) were observed (p < 0.001). The 5R-STS test showed no correlation with VAS for leg pain and EQ-5D VAS (p > 0.05). In 119 individuals, the 5R-STS test demonstrated excellent test-retest reliability with an intraclass correlation coefficient of 0.98. The upper limit of normal, distinguishing patients with and without objective functional impairment, was identified as 10.35 seconds. A severity stratification classified patients with test times of 10.5–15.2, 15.3–22.0, or greater than 22.0 seconds as having mild, moderate, or severe functional impairment, respectively.

CONCLUSIONS

The 5R-STS test is a simple and effective tool to describe objective functional impairment. A patient able to perform the test in 10.4 seconds can be considered to have no relevant objective functional impairment.

Clinical trial registration no.: NCT03303300 (clinicaltrials.gov)

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Victor E. Staartjes, Marlies P. de Wispelaere and Marc L. Schröder

OBJECTIVE

Enhanced recovery after surgery (ERAS) has led to a paradigm shift in various surgical specialties. Its application can result in substantial benefits in perioperative healthcare utilization through preoperative physical and mental patient optimization and modulation of the recovery process. Still, ERAS remains relatively new to spine surgery. The authors report their 5-year experience, focusing on ERAS application to a broad population of patients with degenerative spine conditions undergoing elective surgical procedures, including anterior lumbar interbody fusion (ALIF).

METHODS

A multimodal ERAS protocol was applied between November 2013 and October 2018. The authors analyze hospital stay, perioperative outcomes, readmissions, and adverse events obtained from a prospective institutional registry. Elective tubular microdiscectomy and mini-open decompression as well as minimally invasive (MI) anterior or posterior fusion cases were included. Their institutional ERAS protocol contains 22 pre-, intra-, and postoperative elements, including preoperative patient counseling, MI techniques, early mobilization and oral intake, minimal postoperative restrictions, and regular audits.

RESULTS

A total of 2592 consecutive patients were included, with 199 (8%) undergoing fusion. The mean hospital stay was 1.1 ± 1.2 days, with 20 (0.8%) 30-day and 36 (1.4%) 60-day readmissions. Ninety-four percent of patients were discharged after a maximum 1-night hospital stay. Over the 5-year period, a clear trend toward a higher proportion of patients discharged home after a 1-night stay was observed (p < 0.001), with a concomitant decrease in adverse events in the overall cohort (p = 0.025) and without increase in readmissions. For fusion procedures, the rate of 1-night hospital stays increased from 26% to 85% (p < 0.001). Similarly, the average length of hospital stay decreased steadily from 2.4 ± 1.2 days to 1.5 ± 0.3 days (p < 0.001), with a notable concomitant decrease in variance, resulting in an estimated reduction in nursing costs of 46.8%.

CONCLUSIONS

Application of an ERAS protocol over 5 years to a diverse population of patients undergoing surgical procedures, including ALIF, for treatment of degenerative spine conditions was safe and effective, without increase in readmissions. The data from this large case series stress the importance of the multidisciplinary, iterative improvement process to overcome the learning curve associated with ERAS implementation, and the importance of a dedicated perioperative care team. Prospective trials are needed to evaluate spinal ERAS on a higher level of evidence.

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Carlo Serra, Lelio Guida, Victor E. Staartjes, Niklaus Krayenbühl and Uğur Türe

The authors report on and discuss the historical evolution of the 3 intellectual and scientific domains essential for the current understanding of the function of the human thalamus: 1) the identification of the thalamus as a distinct anatomical and functional entity, 2) the subdivision of thalamic gray matter into functionally homogeneous units (the thalamic nuclei) and relative disputes about nuclei nomenclature, and 3) experimental physiology and its limitations.

Galen was allegedly the first to identify the thalamus. The etymology of the term remains unknown although it is hypothesized that Galen may have wanted to recall the thalamus of Odysseus. Burdach was the first to clearly and systematically define the thalamus and its macroscopic anatomy, which paved the way to understanding its internal microarchitecture. This structure in turn was studied in both nonhuman primates (Friedemann) and humans (Vogt and Vogt), leading to several discrepancies in the findings because of interspecies differences. As a consequence, two main nomenclatures developed, generating sometimes inconsistent (or nonreproducible) anatomo-functional correlations. Recently, considerable effort has been aimed at producing a unified nomenclature, based mainly on functional data, which is indispensable for future developments. The development of knowledge about macro- and microscopic anatomy has allowed a shift from the first galenic speculations about thalamic function (the “thalamus opticorum nervorum”) to more detailed insights into the sensory and motor function of the thalamus in the 19th and 20th centuries. This progress is mostly the result of lesion and tracing studies. Direct evidence of the in vivo function of the human thalamus, however, originates from awake stereotactic procedures only.

Our current knowledge about the function of the human thalamus is the result of a long process that occurred over several centuries and has been inextricably intermingled with the increasing accumulation of data about thalamic macro- and microscopic anatomy. Although the thalamic anatomy can currently be considered well understood, further studies are still needed to gain a deeper insight into the function of the human thalamus in vivo.

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Alessandro Siccoli, Marlies P. de Wispelaere, Marc L. Schröder and Victor E. Staartjes

OBJECTIVE

Patient-reported outcome measures (PROMs) following decompression surgery for lumbar spinal stenosis (LSS) demonstrate considerable heterogeneity. Individualized prediction tools can provide valuable insights for shared decision-making. The authors aim to evaluate the feasibility of predicting short- and long-term PROMs, reoperations, and perioperative parameters by machine learning (ML) methods.

METHODS

Data were derived from a prospective registry. All patients had undergone single- or multilevel mini-open facet-sparing decompression for LSS. The prediction models were trained using various ML-based algorithms to predict the endpoints of interest. Models were selected by area under the receiver operating characteristic curve (AUC). The endpoints were dichotomized by minimum clinically important difference (MCID) and included 6-week and 12-month numeric rating scales for back pain (NRS-BP) and leg pain (NRS-LP) severity and the Oswestry Disability Index (ODI), as well as prolonged surgery (> 45 minutes), extended length of hospital stay (> 28 hours), and reoperations.

RESULTS

A total of 635 patients were included. The average age was 62 ± 10 years, and 333 patients (52%) were male. At 6 weeks, MCID was seen in 63%, 76%, and 61% of patients for ODI, NRS-LP, and NRS-BP, respectively. At internal validation, the models predicted MCID in these variables with accuracies of 69%, 76%, and 85%, and with AUCs of 0.75, 0.79, and 0.92. At 12 months, 66%, 63%, and 51% of patients reported MCID; the observed accuracies were 62%, 74%, and 66%, with AUCs of 0.68, 0.72, and 0.79. Reoperations occurred in 60 patients (9.5%), of which 27 (4.3%) occurred at the index level. Overall and index-level reoperations were predicted with 69% and 63% accuracy, respectively, and with AUCs of 0.66 and 0.61. In 15%, a length of surgery greater than 45 minutes was observed and predicted with 78% accuracy and AUC of 0.54. Only 15% of patients were admitted to the hospital for longer than 28 hours. The developed ML-based model enabled prediction of extended hospital stay with an accuracy of 77% and AUC of 0.58.

CONCLUSIONS

Preoperative prediction of a range of clinically relevant endpoints in decompression surgery for LSS using ML is feasible, and may enable enhanced informed patient consent and personalized shared decision-making. Access to individualized preoperative predictive analytics for outcome and treatment risks may represent a further step in the evolution of surgical care for patients with LSS.

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Alessandro Siccoli, Victor E. Staartjes, Marlies P. de Wispelaere and Marc L. Schröder

OBJECTIVE

While it has been established that lumbar discectomy should only be performed after a certain waiting period unless neurological deficits are present, little is known about the association of late surgery with outcome. Using data from a prospective registry, the authors aimed to quantify the association of time to surgery (TTS) with leg pain outcome after lumbar discectomy and to identify a maximum TTS cutoff anchored to the minimum clinically important difference (MCID).

METHODS

TTS was defined as the time from the onset of leg pain caused by radiculopathy to the time of surgery in weeks. MCID was defined as a minimum 30% reduction in the numeric rating scale score for leg pain from baseline to 12 months. A Cox proportional hazards model was utilized to quantify the association of TTS with MCID. Maximum TTS cutoffs were derived both quantitatively, anchored to the area under the curve (AUC), and qualitatively, based on cutoff-specific MCID rates.

RESULTS

From a prospective registry, 372 patients who had undergone first-time tubular microdiscectomy were identified; 308 of these patients (83%) obtained an MCID. Attaining an MCID was associated with a shorter TTS (HR 0.718, 95% CI 0.546–0.945, p = 0.018). Effect size was preserved after adjustment for potential confounders. The optimal maximum TTS was estimated at 23.5 weeks based on the AUC, while the cutoff-specific method suggested 24 weeks. Discectomy after this cutoff starts to yield MCID rates under 80%. The 24-week cutoff also coincided with the time point after which the specificity for MCID first drops below 50% and after which the negative predictive value for nonattainment of MCID first surpasses ≥ 20%.

CONCLUSIONS

The study findings suggest that late lumbar discectomy is linked with poorer patient-reported outcomes and that—in accordance with the literature—a maximum TTS of 6 months should be aimed for.

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Anita M. Klukowska, Marc L. Schröder, Martin N. Stienen and Victor E. Staartjes

OBJECTIVE

The five-repetition sit-to-stand (5R-STS) test provides a new dimension of clinical assessment by capturing objective functional impairment (OFI). Through the utilization of data from two prospective studies, the authors sought to evaluate the concurrent validity of the proposed 5R-STS baseline severity stratification (BSS) for OFI with the following levels based on time to completion in seconds: none, ≤ 10.4; mild, 10.5–15.2; moderate, 15.3–22.0; and severe, > 22.0 seconds.

METHODS

Patients with degenerative diseases of the spine performed the 5R-STS test and completed visual analog scales (VASs) for back and leg pain, the Oswestry Disability Index (ODI), the Roland-Morris Disability Questionnaire (RMDQ), and EQ-5D questionnaires. The degree of OFI severity was assessed based on the previously proposed BSS, and its association with patient-reported scales was evaluated using ANOVA as well as crude and adjusted linear regression models.

RESULTS

Our sample included 240 patients, of whom 101 exhibited no OFI, whereas 80, 34, and 25 were judged to have mild, moderate, and severe OFI, respectively. A higher baseline severity was strongly associated with loss of working ability (p < 0.001), as well as results of all patient-reported scales (p ≤ 0.001), with the exception of the VAS for leg pain (p = 0.556). Crude and adjusted regression analyses corroborated these findings, although only patients with moderate and severe OFI as judged by using the 5R-STS BSS demonstrated clinically relevant differences compared with patients without OFI.

CONCLUSIONS

The degree of OFI—based on the 5R-STS BSS—is strongly associated with measures of back pain, subjective functional impairment, and health-related quality of life. However, leg pain severity is not reflected within the dimension of OFI measured by the 5R-STS. The proposed BSS appears to be a concurrently valid and clinically relevant measure of OFI in patients with degenerative spinal pathologies.