A multicenter randomized controlled trial comparing gamification with remote monitoring against standard rehabilitation for patients after arthroscopic shoulder surgery.

BACKGROUND: Gamification has become increasingly popular in rehabilitation and is viewed as a tool to improve patient activation, motivation, and engagement. The aim of this study was to compare the efficacy of validated exergames played through a system using "depth sensor" and bespoke software against standard physiotherapy in patients treated with arthroscopic shoulder surgery. This included the following common conditions: subacromial impingement syndrome, calcific tendinopathy, and rotator cuff tear. METHODS: Following arthroscopic shoulder surgery, patients were randomized into 1 of 2 groups: In the standard rehabilitation group, patients were followed up for 12 weeks after surgery with standard postoperative physiotherapy and underwent electronic measurements of their active range of movement (ROM). In the exergame group, patients followed a postoperative regimen of exergames using the principles of gamification with physiotherapy support. Patients were given an exergame schedule prescribed by their therapist on Medical Interactive Recovery Assistant (MIRA) software (MIRA Rehab, London, UK) paired with a Microsoft Kinect sensor (Microsoft, Redmond, WA, USA). The primary outcome was active ROM objectively measured by MIRA and Kinect. Secondary outcome measures included the Oxford Shoulder Score, the Disabilities of the Arm, Shoulder and Hand score, and the EQ-VAS score at 12 weeks after surgery. RESULTS: A total of 71 patients were recruited to the study. We excluded 7 patients based on intraoperative findings. Thirty-three patients were treated with exergames, and 31 patients underwent conventional physiotherapy. There was no significant difference between the 2 groups in baseline ROM. Postoperatively, there was no significant difference in any of the cardinal planes of movement (forward flexion, P = .64; abduction, P = .33; and external rotation, P = .75). The mean Oxford Shoulder Score improved from 29.25 to 38.2 in the control group (P = .001) and from 27.1 to 35.1 in the trial group (P = .01); there was no significant difference between the groups at 12 weeks (P = .246). The mean Disabilities of the Arm, Shoulder and Hand score improved from 38.13 to 16.98 in the control group (P = .001) and from 42.3 to 22.54 in the trial group (P = .007); there was no significant difference between the 2 groups (P = .328). There was no significant difference in the EQ-VAS score in either group at any time point (P = .5866). CONCLUSION: This randomized controlled trial demonstrates that exergames can be used effectively in the rehabilitation of patients following arthroscopic shoulder surgery. Outcomes, judged by ROM and patient-reported outcome measures, are equivalent to conventional physiotherapy rehabilitation protocols. This health care innovation has the potential to relieve some of the heavy burden placed on physiotherapy departments for "routine" postoperative care in shoulder surgery.

Development of a model to predict the probability of incurring a complication during spine surgery.

PURPOSE: Predictive models in spine surgery are of use in shared decision-making. This study sought to develop multivariable models to predict the probability of general and surgical perioperative complications of spinal surgery for lumbar degenerative diseases. METHODS: Data came from EUROSPINE's Spine Tango Registry (1.2012-12.2017). Separate prediction models were built for surgical and general complications. Potential predictors included age, gender, previous spine surgery, additional pathology, BMI, smoking status, morbidity, prophylaxis, technology used, and the modified Mirza invasiveness index score. Complete case multiple logistic regression was used. Discrimination was assessed using area under the receiver operating characteristic curve (AUC) with 95% confidence intervals (CI). Plots were used to assess the calibration of the models. RESULTS: Overall, 23'714/68'111 patients (54.6%) were available for complete case analysis: 763 (3.2%) had a general complication, with ASA score being strongly predictive (ASA-2 OR 1.6, 95% CI 1.20-2.12; ASA-3 OR 2.98, 95% CI 2.19-4.07; ASA-4 OR 5.62, 95% CI 3.04-10.41), while 2534 (10.7%) had a surgical complication, with previous surgery at the same level being an important predictor (OR 1.9, 95%CI 1.71-2.12). Respectively, model AUCs were 0.74 (95% CI, 0.72-0.76) and 0.64 (95% CI, 0.62-0.65), and calibration was good up to predicted probabilities of 0.30 and 0.25, respectively. CONCLUSION: We developed two models to predict complications associated with spinal surgery. Surgical complications were predicted with less discriminative ability than general complications. Reoperation at the same level was strongly predictive of surgical complications and a higher ASA score, of general complications. A web-based prediction tool was developed at https://sst.webauthor.com/go/fx/run.cfm?fx=SSTCalculator .

Primary lumbar decompression using ultrasonic bone curette compared to conventional technique.

PURPOSE: The ultrasonic bone curette (Bone Scalpel) is a novel technique in neurosurgery for bony dissection. This study aimed to evaluate its use against conventional techniques for primary lumbar decompression. MATERIALS AND METHODS: This study was a retrospective cohort comparison, using Spine Tango Registry data. All patients undergoing a primary procedure for lumbar decompression secondary to degenerative disease during a 2-year period (2014-2016) were identified, split into age and gender matched cohorts utilising either bone scalpel or conventional techniques intra-operatively. RESULTS: Ninety-three patients were identified within each cohort, which did not differ significantly in terms of age, gender, BMI, number of operative vertebral levels or seniority of the principal surgeon. The incidence of intra-operative blood loss >100 ml was significantly reduced within the bone scalpel cohort (16.1% bone scalpel, 34.4% conventional, p = 0.04). There was no difference in the incidence of iatrogenic dural breach (9.7% bone scalpel, 16.1% conventional, p = 0.27). There was no significant difference in pre-operative Core Outcomes Measures Index (COMI) between the cohorts (7.91 bone scalpel, 8.02 conventional, p = 0.67) and both cohorts demonstrated a significant reduction in mean COMI at 24 months (bone scalpel p = 0.004, conventional p = <0.001). No difference in mean COMI existed between either cohort at any point across the 24-month post-operative period (p = 0.18). CONCLUSIONS: The use of ultrasonic bone curette for primary lumbar decompression is associated with reduced intra-operative blood loss compared to conventional techniques, alongside a comparable safety profile and equivalent patient reported outcomes.

Validation of a surgical invasiveness index in patients with lumbar spinal disorders registered in the Spine Tango registry.

INTRODUCTION: Being able to quantify the invasiveness of a surgical procedure is important to weigh up its associated risks, since invasiveness governs the blood loss, operative time and likelihood of complications. Mirza et al. (Spine (Phila Pa 1976) 33:2651-2661, 2008) published an invasiveness index for spinal surgery. We evaluated the validity of a modified version of the Mirza invasiveness index (mMII), adapted for use with registry data. METHODS: A cross-sectional analysis was performed with data acquired from the Spine Tango registry including 21,634 patients. The mMII was calculated as the sum of six possible interventions on each vertebral level: decompression, fusion and stabilization either on anterior or posterior structures. The association between the mMII and blood loss, operative time and complications was evaluated using multiple regression, adjusting for possible confounders. RESULTS: The mean (± SD) mMII was 3.9 ± 5.0 (range 0-40). A 1-point increase in the mMII was associated with an additional blood loss of 12.8% (95% CI 12.6-13.0; p < 0.001) and an increase of operative time of 10.4 min (95% CI 10.20-10.53; p < 0.001). The R2 for the blood loss model was of 43% and for operative time, 47%. The mean mMII was significantly (p < 0.001) higher in patients with surgical complications (4.5 ± 5.6) and general medical complications (6.5 ± 7.0) compared to those without (3.8 ± 4.9). Our results were comparable to those reported in the original publication of Mirza et al. CONCLUSION: The mMII appeared to be a valid measure of surgical invasiveness in our study population. It can be used in predictor models and to adjust for surgical case-mix when comparing outcomes in different studies or different hospitals/surgeons in a registry.

Incidental durotomy in decompression for lumbar spinal stenosis: incidence, risk factors and effect on outcomes in the Spine Tango registry.

PURPOSE: The three aims of this Spine Tango registry study of patients undergoing decompression for spinal stenosis were to: report the rate of dural tear (DT) stratified by treatment centre; find factors associated with an increased likelihood of incurring a DT; and compare treatment outcomes in relation to DT (none vs. repaired vs. unrepaired DT). METHODS: Multivariate logistic regression was used to assess the association between DT and patient and treatment characteristics. Patient-rated and surgical outcomes were compared in patients with no DT, repaired DT, and unrepaired DT, while adjusting for case-mix. RESULTS: DT occurred in 328/3254 (10.1%) of included patients. The rate for all 29 contributing hospitals was within 95% confidence intervals of the average. The likelihood of DT increased by 2% per year of age, 1.78 times with previous spine surgery, 1.67 for a minimally/less invasive surgery, 1.58 times with laminectomy, and 1.40, and 2.12 times for BMI 31-35, and >35 in comparison with BMI 26-30, respectively. The majority of DTs (272/328; 82.9%) were repaired. Repairing the DT was associated with a longer duration of surgery (p < 0.001). More patients with repaired than with unrepaired DTs were satisfied with treatment, but the difference was not statistically significant. There was no association between DT and patient-reported outcomes. CONCLUSION: The unadjusted rate of incidental DT during decompression for LSS was homogeneous across the participating centres and was associated with age, BMI, previous surgery at the same spinal level, minimally/less invasive surgery, and laminectomy. Non-repair of DTs had no negative association with treatment outcome; however, the unrepaired DTs may have been those that were smaller in size.

Influence of previous surgery on patient-rated outcome after surgery for degenerative disorders of the lumbar spine.

PURPOSE: Few studies have used multivariate models to quantify the effect of multiple previous spine surgeries on patient-oriented outcome after spine surgery. This study sought to quantify the effect of prior spine surgery on 12-month postoperative outcomes in patients undergoing surgery for different degenerative disorders of the lumbar spine. METHODS: The study included 4940 patients with lumbar degenerative disease documented in the Spine Tango Registry of EUROSPINE, the Spine Society of Europe, from 2004 to 2015. Preoperatively and 12 months postoperatively, patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10 scale). Patients' medical history and surgical details were recorded using the Spine Tango Surgery 2006 and 2011 forms. Multiple linear regression models were used to investigate the relationship between the number of previous surgeries and the 12-month postoperative COMI score, controlling for the baseline COMI score and other potential confounders. RESULTS: In the adjusted model including all cases, the 12-month COMI score showed a 0.37-point worse value [95 % confidence intervals (95 % CI) 0.29-0.45; p < 0.001] for each additional prior spine surgery. In the subgroup of patients with lumbar disc herniation, the corresponding effect was 0.52 points (95 % CI 0.27-0.77; p < 0.001) and in lumbar degenerative spondylolisthesis, 0.40 points (95 % CI 0.17-0.64; p = 0.001). CONCLUSIONS: We were able to demonstrate a clear "dose-response" effect for previous surgery: the greater the number of prior spine surgeries, the systematically worse the outcome at 12 months' follow-up. The results of this study can be used when considering or consenting a patient for further surgery, to better inform the patient of the likely outcome and to set realistic expectations.

Conservative management of type II and III odontoid fractures in the elderly at a regional spine centre: A prospective and retrospective cohort study.

BACKGROUND: The optimal management of odontoid fractures in the elderly population is unclear and management of this group of patients is complicated by multiple co-morbidities. This study aimed to determine the outcomes after conservative management strategies were applied in this patient group. METHODS: We carried out retrospective and prospective analyses of all patients with axial cervical spine injuries, at a single centre. We included patients aged over 60 years with type II and III odontoid fractures. Information was gathered on demographics, ASA grading-associated injuries and complications. The outcome measures were rates and type of union, pain and neurological functions, specifically ambulation. RESULTS: Fifty-seven adult patients with a median age of 78 years (range 60-92 years) were included. There were 42 type II and 15 type III odontoid fractures. Three patients required surgical fixation due to displaced fractures, which could not be reduced with manual traction. Twenty-four (41%) patients were managed with a rigid pinned halo orthosis to obtain adequate reduction and immobilisation. The remaining 30 (53%) were managed in a hard cervical collar. Patients managed with a halo were significantly younger and had more associated injuries than patients managed in a collar (age: t-test=4.05, p<0.01, associated injuries: Chi-square=4.38, p<0.05). At a mean follow-up of 25 weeks, 87% of type II and 100% of type III fractures had achieved bony union or stable, fibrous non-union. There were no statistical differences in fracture type, follow-up or neurological outcomes between the halo and collar groups. However, overall more patients managed in a collar developed stable fibrous non-union than bony fusion (Fisher's exact test, p<0.05), although this was not significant when analysed by each fracture type individually. A regression model was constructed and identified fracture type as the only independent predictor of time to union, with type III fractures healing faster than type II. CONCLUSIONS: High rates of bony union and stable fibrous non-union with a good functional outcome can be achieved in the elderly population sustaining type II or III odontoid fractures, when managed non-surgically. Halo orthosis may not offer any clear advantage over hard collar in this group. Close follow-up is needed for late complications and there must be a willingness to perform surgery if conservative measures fail.

Applications of the ultrasonic bone cutter in spinal surgery--our preliminary experience.

OBJECTIVE: To present our experience with the Misonix Ultrasonic Bone scalpel in spinal surgery, highlighting its potential applications and advantages. METHODS: Between March and December 2011, a total of 937 spinal cases were performed at a single centre. The Misonix Bone Scalpel (MBS) was used in 62 of these cases. Data were collected prospectively using the Spine Tango registry. Patient demographics, disease type, surgery performed and complications were all recorded along with pre- and post-operative core measures outcome index (COMI). RESULTS: The majority of cases were for spinal degenerative disorders, in particular, revision cases. The bone cutter was also used to achieve laminotomies for access to intradural tumours, corpectomies and a mixture of other pathologies. Of the 62 patients only 1 (1.6%) experienced a blood loss greater than 500 ml, and there was only 1 dural tear (1.6%) as a direct result of the MBS. Four illustrative cases are discussed. CONCLUSIONS: The MBS is a useful adjunct in spinal surgery with particular value in revision cases where scar tissue distorts the normal anatomy. There was a low complication rate with a trend to reduced blood loss. This was most apparent to the senior authors during cervical and thoracic corpectomies.

Raised intracranial pressure and hydrocephalus following hindbrain decompression for Chiari I malformation: a case series and review of the literature.

OBJECT: Chiari-syringomyelia is a heterogeneous condition that may be treated by decompression of the foramen magnum. Raised intracranial pressure (ICP) and/or hydrocephalus is a rare complication of this treatment. We aim to describe the incidence, clinical presentation, radiographic findings, management and outcome of patients developing raised ICP and/or hydrocephalus after hindbrain decompression for Chiari I malformation. METHODS: Retrospective analysis of 138 consecutive adult and paediatric patients with Chiari I malformation who underwent foramen magnum decompression. RESULTS: The incidence of post-operative symptomatic raised ICP and/or hydrocephalus in this series was 8.7%. Overall, 9 of 12 patients developing raised ICP or hydrocephalus required a VP shunt, an overall incidence of 6.5%. However, 3 of 12 patients were successfully managed with external ventricular drainage or conservatively. Presentation was with headache or CSF wound leak at a median of 13 days post-operatively. Subdural hygromata were observed in five cases in association with hydrocephalus and urgent drainage to relieve mass effect was required in two cases. At a mean follow up of 36 months, 9 of 12 patients were asymptomatic. CONCLUSIONS: There is a risk of requiring a permanent VP shunt associated with decompression for Chiari I even in the absence of ventriculomegaly or signs of raised ICP pre-operatively. Patients presenting with new symptoms or CSF wound leak following FMD mandate investigation to exclude hydrocephalus, raised ICP or subdural hygroma.