Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.

Continuous data capture of gait and mobility metrics using wearable devices for postoperative monitoring in common elective orthopaedic procedures of the hip, knee, and spine: a scoping review.

BACKGROUND: Surgical procedures involving the hip, knee, or spine represent a majority of orthopaedic procedures performed electively in the health care system. Postoperative care is a key aspect of surgery and mobilisation without injury is the primary objective. Recent advances in wearable technologies allow objective evaluation of walking metrics to inform and guide postoperative care following orthopaedic surgery. PURPOSE: The aim of this scoping review is to explore current applications of wearable devices, objective data capture and gait analysis in monitoring postoperative recovery following commonly performed elective orthopaedic procedures of the hip, knee and spine. METHODS: A search against pre-defined criteria was performed on the following scientific databases from date of inception to February 28th, 2021: Medline (via OvidSP), Embase (via OvidSP) and Cochrane Library (via CENTRAL). Data were collected according to a predetermined checklist including study participants, surgery, wearable device (model), sensor location, and monitoring parameters such as mobility metrics, monitoring timepoints and monitoring duration for each study included in our review. Quality was assessed independently using the Newcastle Ottawa Scale (NOS). CONCLUSIONS: To our knowledge, this is the first review of wearable monitoring (of postoperative recovery) following hip, knee and spine surgery. Patients undergoing elective orthopaedic procedures may benefit from wearable monitoring of their walking health and mobility metrics.

Proposed objective scoring algorithm for clinical evaluation of walking asymmetry in lumbar disc herniation, based on relevant gait metrics from wearable devices: The Gait Symmetry Index (GSiTM) - Observational study.

•The proposed GSi algorithm aims to objectively evaluate the walking impairment associated with lumbar disc herniation (LDH).•GSi is calculated as deviation from mean (age-matched) normative values for gait velocity, step time asymmetry and step length asymmetry.•Clinical performance was assessed in a prospective, single surgeon series of 33 lumbar disc herniation (LDH) patients.•GSi was lower in LDH participants with significant distribution between surgical and conservative management subgroups.

The concept of recovery kinetics: an observational study of continuous post-operative monitoring in spine surgery.

Background: The spine surgeon's understanding of an individual patient's burden of disease and functional disability in daily life is shaped by patient-reported outcome measures (PROMs). Although PROMs are useful in understanding the patient's perception of their disease, the use of PROMs constitutes a "snapshot" approach of single timepoint data capture, omitting day-to-day fluctuations in functional status. We introduce the concept of kinetics when considering continuous and objective postoperative patient monitoring with wearable sensors. Methods: A prospective single-centre series was performed using patients either undergoing lumbar decompression for lumbar spinal stenosis (LSS) (n=12), or posterior lumbar fusion for degenerative spondylolisthesis (n=12). The Oswestry Disability Index (PROM) was conducted preoperatively and 12-weeks postoperatively. During this timeframe, continuous measurements of step count and distance travelled were made using a wrist-based wearable accelerometer. Results: Over the 12-week study period, mean daily step count for all participants improved from 4,700 to 7,700 steps per day (P=0.013), following an initial dip in total steps taken. The mean daily distance travelled improved from 3,300 to 5,300 meters per day (P=0.003). Decompression group recovered at a faster rate than the fusion group. Conclusions: Although overall improvement was similar between the decompression and fusion groups, the recovery kinetics varied. The recovery kinetics approach of continuous postoperative monitoring provides additional insight to postoperative patient progress.

Rapid Personalised Virtual Planning and On-Demand Surgery for Acute Spinal Trauma Using 3D-Printing, Biomodelling and Patient-Specific Implant Manufacture.

Three-dimensional printing is a rapidly growing field, with extensive application to orthopaedics and spinal surgery. Three-dimensional-printed (3DP) patient-specific implants (PSIs) offer multiple potential benefits over generic alternatives, with their use increasingly being described in the spinal literature. This report details a unique, emergency case of a traumatic spinal injury in a 31-year-old male, acquired rurally and treated with a 3DP PSI in a tertiary unit. With increasing design automation and process improvements, rapid, on-demand virtual surgical planning (VSP) and 3DP PSIs may present the future of orthopaedics and trauma care, enabling faster, safer, and more cost-effective patient-specific procedures.

Analysing Gait Patterns in Degenerative Lumbar Spine Disease Using Inertial Wearable Sensors: An Observational Study.

OBJECTIVE: Using a chest-based inertial wearable sensor, we examined the quantitative gait patterns associated with lumbar disc herniation (LDH), lumbar spinal stenosis (LSS), and chronic mechanical low back pain (CMLBP). 'Pathological gait signatures' were reported as statistically significant group difference (%) from the 'normative' gait values of an age-matched control population. METHODS: A sample of patients presenting to the Prince of Wales Private Hospital (Sydney, Australia) with primary diagnoses of LDH, LSS, or CMLBP were recruited. Spatial, temporal, asymmetry, and variability metrics were compared with age-matched (±2 years) control participants recruited from the community. Participants were fitted at the sternal angle with an inertial measurement unit, MetaMotionC, and walked unobserved (at a self-selected pace) for 120 m along an obstacle-free, carpeted hospital corridor. RESULTS: LDH, CMLBP, and LSS groups had unique pathological signatures of gait impairment. The LDH group (n = 33) had marked asymmetry in terms of step length, step time, stance, and single-support asymmetry. The LDH group also involved gait variability with increased step length variation. However, distinguishing the CMLBP group (n = 33) was gait variability in terms increased single-support time variation. The gait of participants with LSS (n = 22) was both asymmetric and variable in step length. CONCLUSIONS: Wearable sensor-based accelerometry was found to be capable of detecting the gait abnormalities present in patients with LDH, LSS, and CMLBP, when compared to age-matched controls. Objective and quantitative patterns of gait deterioration uniquely varied between these subtypes of lumbar spine disease. With further testing and validation, gait signatures may aid clinical identification of gait-altering pathologies.

Walking orientation randomness metric (WORM) score: pilot study of a novel gait parameter to assess walking stability and discriminate fallers from non-fallers using wearable sensors.

BACKGROUND: Musculoskeletal disorders can contribute to injurious falls and incur significant societal and healthcare burdens. Identification of fallers from non-fallers through wearable-based gait analysis can facilitate timely intervention to assist mobility and prevent falls whilst improving care and attention for high fall-risk patients. In this study, we use wearable sensor-based gait analysis to introduce a novel variable to assess walking stability in fallers and non-fallers - the Walking Orientation Randomness Metric. The WORM score quantifies the stability, or 'figure-of-eight' motion of a subject's trunk during walking as an indicator of a falls-predictive (pathological) gait. METHODS: WORM is calculated as the 'figure-of-eight' oscillation mapped out in the transverse-plane by the upper body's centre-point during a walking bout. A sample of patients presenting to the Prince of Wales Hospital (Sydney, Australia) with a primary diagnosis of "falls for investigation" and age-matched healthy controls (non-fallers) from the community were recruited. Participants were fitted at the sternal angle with the wearable accelerometer, MetaMotionC (Mbientlab Inc., USA) and walked unobserved (at self-selected pace) for 5-50 m along an obstacle-free, carpeted hospital corridor. RESULTS: Participants comprised of 16 fallers (mean age: 70 + 17) and 16 non-fallers (mean age: 70 + 9) based on a recent fall(s) history. The (median) WORM score was 17-fold higher (p < 0.001) in fallers (3.64 cm) compared to non-fallers (0.21 cm). ROC curve analyses demonstrate WORM can discriminate fallers from non-fallers (AUC = 0.97). Diagnostic analyses (cut-off > 0.51 cm) show high sensitivity (88%) and specificity (94%). CONCLUSION: In this pilot study we have introduced the WORM score, demonstrating its discriminative performance in a preliminary sample size of 16 fallers. WORM is a novel gait metric assessing walking stability as measured by truncal way during ambulation and shows promise for objective and clinical evaluation of fallers.

Gait metrics analysis utilizing single-point inertial measurement units: a systematic review.

BACKGROUND: Wearable sensors, particularly accelerometers alone or combined with gyroscopes and magnetometers in an inertial measurement unit (IMU), are a logical alternative for gait analysis. While issues with intrusive and complex sensor placement limit practicality of multi-point IMU systems, single-point IMUs could potentially maximize patient compliance and allow inconspicuous monitoring in daily-living. Therefore, this review aimed to examine the validity of single-point IMUs for gait metrics analysis and identify studies employing them for clinical applications. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines (PRISMA) were followed utilizing the following databases: PubMed; MEDLINE; EMBASE and Cochrane. Four databases were systematically searched to obtain relevant journal articles focusing on the measurement of gait metrics using single-point IMU sensors. RESULTS: A total of 90 articles were selected for inclusion. Critical analysis of studies was conducted, and data collected included: sensor type(s); sensor placement; study aim(s); study conclusion(s); gait metrics and methods; and clinical application. Validation research primarily focuses on lower trunk sensors in healthy cohorts. Clinical applications focus on diagnosis and severity assessment, rehabilitation and intervention efficacy and delineating pathological subjects from healthy controls. DISCUSSION: This review has demonstrated the validity of single-point IMUs for gait metrics analysis and their ability to assist in clinical scenarios. Further validation for continuous monitoring in daily living scenarios and performance in pathological cohorts is required before commercial and clinical uptake can be expected.

Novel Technique for Sacral-Alar-Iliac Screw Placement Using Three-Dimensional Patient-Specific Template Guide.

INTRODUCTION: The sacral-alar-iliac (SAI) screw technique is becoming popular for sacropelvic fixation. However, appropriately placing SAI screws is technically demanding because of a narrow safe corridor and the risk of neurovascular/visceral injuries. Recently, a three-dimensional patient-specific template guiding technique for pedicle screw placement has been considered a promising method to improve accuracy and safety. The objective of the present study was to investigate the accuracy of SAI screw placement with a patient-specific template guide using cadaveric and prospective clinical pilot studies. METHODS: Three-dimensional planning of SAI screw placement, including entry point, screw trajectory, length, and diameter, was performed using a computer simulation software. Then, three-dimensional printed patient-specific template guides were created based on the plan. Firstly, a total of 12 SAI screws were placed for 6 cadaveric specimens using the guides. Next, in a prospective clinical trial, a total of 20 SAI screws were placed for 10 consecutively enrolled patients. The safety and accuracy of screw placement were analyzed using postoperative computed tomography by the evaluation of any cortical breach and measurement of screw deviations between the planned and actual screw positions. RESULTS: All the screws showed no perforation. In the cadaveric study, the mean horizontal and vertical deviations from the planned screw position at the entry point were 1.40±1.21 mm and 1.34±1.09 mm, respectively. The mean angular deviations in the sagittal and transverse planes were 1.68°±1.24° and 1.53°±1.06°, respectively. The results of the clinical study showed comparable accuracy with those of the cadaveric study, except for the vertical deviation at the entry point (p=0.048). CONCLUSIONS: This is the first study to evaluate the feasibility and accuracy of using a patient-specific template guide for SAI screw placement. This technique could become an effective solution to achieve accurate screw placement.

Proposed objective scoring algorithm for walking performance, based on relevant gait metrics: the Simplified Mobility Score (SMoS™)-observational study.

BACKGROUND: Walking is a fundamental part of living, and its importance is not limited by age or medical status. Reduced walking speed (WS), or gait velocity, is a sign of advancing age, various disease states, cognitive impairment, mental illness and early mortality. Activity levels, as defined in the literature as "daily step count" (DSC), is also a relevant measure of health status. A deterioration in our walking metrics, such as reduced WS and DSC, is associated with poor health outcomes. These objective measures are of such importance, that walking speed has been dubbed "the 6th vital sign". We report a new objective measure that scores walking using the relevant metrics of walking speed and daily step count, into an easy-to-understand score from 0 (nil mobility) to 100 (excellent mobility), termed the Simplified Mobility Score (SMoS™). We have provided equal weighting to walking speed and daily step count, using a simple algorithm to score each metric out of 50. METHODS: Gait data was collected from 182 patients presenting to a tertiary hospital spinal unit with complaints of pain and reduced mobility. Walking speed was measured from a timed walk along an unobstructed pathway. Daily step count information was obtained from patients who had enabled step count tracking on their devices. The SMoS of the sample group were compared to expected population values calculated from the literature using 2-tailed Z tests. RESULTS: There were significantly reduced SMoS in patients who presented to the spinal unit than those expected at each age group for both genders, except for the 50-59 age bracket where no statistically significant reduction was observed. Even lower scores were present in those that went on to have surgical management. There was a significant correlation of SMoS scores with subjective disability scores such as the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) in this cohort. CONCLUSIONS: The SMoS is a simple and effective scoring tool which is demonstrably altered in spinal patients across age and gender brackets and correlates well with subjective disability scores. The SMoS has the potential to be used as a screening tool in primary and specialised care settings.

Cervical Total Disc Replacement and Heterotopic Ossification: A Review of Literature Outcomes and Biomechanics.

Anterior cervical discectomy and fusion (ACDF) immobilizes surgical segments and can lead to the development of adjacent segment degeneration and adjacent segment disease. Thus, cervical total disc replacement (CTDR) has been developed with the aim to preserve the biomechanics of spine. However, heterotopic ossification (HO), a complication following CTDR, can reduce the segmental range of motion (ROM) and defects the motion-preservation benefit of CTDR. The pathological process of HO in CTDR remains unknown. HO has been suggested to be a self-defense mechanism in response to the non-physiological biomechanics of the cervical spine following CTDR. The current literature review is concerned with the association between the biomechanical factors and HO formation and the clinical significance of HO in CTDR. Endplate coverage, disc height, segmental angle, and center of rotation may be associated with the development of HO. The longer the follow-up, the higher the rate of ROM-limiting HO. Regardless of the loss of motion-preservation benefit of CTDR in patients with HO, CTDR confers patients with a motion-preservation period before the development of ROM-limiting HO. This may delay the development of adjacent segment degeneration compared with ACDF. Future clinical studies should explore the association between HO and changes in biomechanical factors of the cervical spine.

The use of radiolucent (carbon fibre-reinforced polymer) pedicle screw fixation for serial monitoring of clear cell meningioma: a case report.

Clear cell meningioma is an uncommon variant of meningioma associated with high rates of local recurrence and metastasis. However, monitoring for local recurrence may be complicated by metal-related artefacts generated by spinal instrumentation. We present a patient with recurrent lumbar atypical clear cell meningioma, which had been resected multiple times throughout her adolescence. Due to extensive bone and ligament resection, posterior stabilization of the lumbar spine with pedicle screws was required. To ensure clear postoperative visualization of the spinal cord for local recurrence, a carbon fibre/polyetheretherketone (CF/PEEK) pedicle screw and rod construct was used. CF/PEEK has non-inferior biomechanical and biocompatible properties to titanium, with a clear advantage of radiolucency to assist in detecting the local recurrence early and facilitating accurate radiotherapy planning.

Three-Dimensional Morphometric Analysis of Lumbar Vertebral End Plate Anatomy.

BACKGROUND: Information on the three-dimensional (3D) shape of vertebral end plates is lacking. Previous studies have analyzed two-dimensional shape; however, 3D data are important because they may help improve our understanding of how differences in shape are related to age, gender, race, size, and other parameters, which may subsequently help improve device design for interbody prosthesis. OBJECTIVE: To study the 3D shape of lumbar vertebral end plates from normal adult lumbar spines and correlate them with age, gender, spinal/end plate level, end plate surface area, concave depth, and size. METHODS: An in vivo analysis was undertaken of lumbar vertebral end plate 3D shape. A total of 136 patients' computed tomography scans were used to create 3D models of the lumbar spine for each patient, which were subsequently analyzed. RESULTS: The shape of the superior end plates is different compared with inferior end plates. Across the lumbar spine (L1-S1), the shape of inferior end plates is similar; however, the shape of the superior end plate varies between spinal levels significantly. There was no clear relationship between age and principal component (PC) shapes but there was a strong correlation between end plate concave depth and end plate PC shape scores. CONCLUSIONS: Future interbody (disc replacement and fusion) device designs could use the findings that inferior end plate shape is similar throughout the length of the lumbar spine, whereas superior end plate shape changes. Further, future implants could be level-specific because the present study shows that end plate shape varies through the length of the lumbar spine.

Commercial Postural Devices: A Review.

Wearables are devices worn on the human body and are able to measure various health parameters, such as physical activity, energy expenditure and gait. With the advancement of technology, the general population are now spending more hours craning our necks and slouching over smartphones, tablets and computers, et cetera. Bodily posture is representative of physical and mental health. Poor posture can lead to spinal complications and the same can be said vice versa. As the standard of living increases, there is an increase in consumerism and the expectation to maintain such a lifestyle even in the aging population. Therefore, many are able to afford small luxuries in life, such as a piece of technology that could potentially improve their health in the long run. Wearable technology is a promising alternative to laboratory systems for movement and posture analysis. This article reviews commercial wearable devices with a focus on postural analysis. The clinical applicability of posture wearables, particularly in preventing, monitoring and treating spinal and musculoskeletal conditions, along with other purposes in healthcare, will be discussed.

Combination Ti/PEEK ALIF cage for anterior lumbar interbody fusion: Early clinical and radiological results.

Anterior lumbar interbody fusion (ALIF) is a common procedure for patients with degenerative pathologies of the lumbar spine. In this study, the clinical and radiological outcomes of a combination titanium/polyetheretherketone (Ti/PEEK) ALIF cages in one, two and three-level surgery were evaluated. Over an 18-month time period, a prospective single surgeon series of 20 implants (15 patients) were included in the study, with minimum 10-months follow-up. From these 15 patients, two were supplemented with posterior percutaneous pedicle screw fixation for additional stability. Radiological follow-up with fine cut CT scan at 9-12months was performed to evaluate early fusion rates, and integration of the Titanium/PEEK cage at the endplate junction. 20 implants were followed for a minimum of 10months, and a mean of 15months. A 95% (19/20 implants) fusion rate with no implant related complications was achieved at the mean 15-month postoperative mark. Patients experienced statistically significant improvement in pain and functional outcomes (SF12 and ODI) compared to their pre-operative status. A single patient with a non-union at L5/S1 (smoker) did not experience any improvement in symptoms. A Ti-PEEK cage, with allograft and BMP-2 to achieve interbody fusion is an effective implant for use in anterior lumbar surgery with high fusion rates, no lucency around the titanium endplates at follow-up, and with promising early results.

Outcomes after decompressive laminectomy for lumbar spinal stenosis: comparison between minimally invasive unilateral laminectomy for bilateral decompression and open laminectomy: clinical article.

OBJECT: The development of minimally invasive surgical techniques is driven by the quest for better patient outcomes. There is some evidence for the use of minimally invasive surgery for degenerative lumbar spine stenosis (LSS), but there are currently no studies comparing outcomes with matched controls. The object of this study was to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS. METHODS: The authors conducted a prospective, 1:1 randomized trial comparing ULBD to open laminectomy for degenerative LSS. The study enrolled 79 patients between 2007 and 2009, and adequate data for analysis were available in 54 patients (27 in each arm of the study). Patient demographic characteristics and clinical characteristics were recorded and clinical outcomes were obtained using pre- and postoperative Oswestry Disability Index (ODI) scores, visual analog scale (VAS) scores for leg pain, patient satisfaction index scores, and postoperative 12-Item Short Form Health Survey (SF-12) scores. RESULTS: Significant improvements were observed in ODI and VAS scores for both open and ULBD interventions (p < 0.001 for both groups using either score). In addition, the ULBD-treated patients had a significantly better mean improvement in the VAS scores (p = 0.013) but not the ODI scores (p = 0.055) compared with patients in the open-surgery group. ULBD-treated patients had a significantly shorter length of postoperative hospital stay (55.1 vs. 100.8 hours, p = 0.0041) and time to mobilization (15.6 vs. 33.3 hours, p < 0.001) and were more likely to not use opioids for postoperative pain (51.9% vs. 15.4%, p = 0.046). CONCLUSIONS: Based on short-term follow-up, microscopic ULBD is as effective as open decompression in improving function (ODI score), with the additional benefits of a significantly greater decrease in pain (VAS score), postoperative recovery time, time to mobilization, and opioid use.

Current status of bone graft options for anterior interbody fusion of the cervical and lumbar spine.

Anterior cervical discectomy and fusion (ACDF) and anterior lumbar interbody fusion (ALIF) are common surgical procedures for degenerative disc disease of the cervical and lumbar spine. Over the years, many bone graft options have been developed and investigated aimed at complimenting or substituting autograft bone, the traditional fusion substrate. Here, we summarise the historical context, biological basis and current best evidence for these bone graft options in ACDF and ALIF.