PROPOSE. Development and validation of a prediction model for shared decision making for patients with lumbar spinal stenosis.

Background: Decompression for lumbar spinal stenosis (LSS) is the most frequently performed spine surgery in Denmark. According to the Danish spine registry DaneSpine, at 1 year after surgery, about 75% of patients experiences considerable pain relief and around 66% improvement in quality of life. However, 25% do not improve very much. We have developed a predictive decision support tool, PROPOSE. It is intended to be used in the clinical conversation between healthcare providers and LSS patients as a shared decision-making aid presenting pros and cons of surgical intervention. This study presents the development and evaluation of PROPOSE in a clinical setting. Methods: For model development, 6.357 LSS patients enrolled in DaneSpine were identified. For model validation, predictor response and predicted outcome was collected via PROPOSE from 228 patients. Observed outcome at 1 year was retrieved from DaneSpine. All participants were treated at 3 Danish spine centers. The outcome measures presented are improvement in walking distance, the Oswestry Disability Index, EQ-5D-3L and leg/back pain on the Visual Analog Scale. Outcome variables were dichotomized into success (1) and failure (0). With the exception of walking distance, a success was defined as reaching minimal clinically important difference at 1-year follow-up. Models were trained using Multivariate Adaptive Regression Splines. Performance was assessed by inspecting confusion matrix, ROC curves and comparing GCV (generalized cross-validation) errors. Final performance of the models was evaluated on independent test data. Results: The walking distance model demonstrated excellent performance with an AUC of 0.88 and a Brier score of 0.14. The VAS leg pain model had the lowest discriminatory performance with an AUC of 0.67 and a Brier score of 0.22. Conclusions: PROPOSE works in a real-world clinical setting as a proof of concept and demonstrates acceptable performance. It may have the potential of aiding shared decision making.

Usability and performance expectancy govern spine surgeons' use of a clinical decision support system for shared decision-making on the choice of treatment of common lumbar degenerative disorders.

Study design: Quantitative survey study is the study design. Objectives: The study aims to develop a model for the factors that drive or impede the use of an artificial intelligence clinical decision support system (CDSS) called PROPOSE, which supports shared decision-making on the choice of treatment of ordinary spinal disorders. Methods: A total of 62 spine surgeons were asked to complete a questionnaire regarding their behavioral intention to use the CDSS after being introduced to PROPOSE. The model behind the questionnaire was the Unified Theory of Acceptance and Use of Technology. Data were analyzed using partial least squares structural equation modeling. Results: The degree of ease of use associated with the new technology (effort expectancy/usability) and the degree to which an individual believes that using a new technology will help them attain gains in job performance (performance expectancy) were the most important factors. Social influence and trust in the CDSS were other factors in the path model. r2 for the model was 0.63, indicating that almost two-thirds of the variance in the model was explained. The only significant effect in the multigroup analyses of path differences between two subgroups was for PROPOSE use and social influence (p = 0.01). Conclusion: Shared decision-making is essential to meet patient expectations in spine surgery. A trustworthy CDSS with ease of use and satisfactory predictive ability promoted by the leadership will stand the best chance of acceptance and bridging the communication gap between the surgeon and the patient.

6.2 l of residual urine without recognized pathology in the urinary tract before knee arthroplasty.

This is a rare case report in an elective orthopaedic setting, in which a 72-year-old man without known urologic disorders presented with a 6.2 l post-void residual urine (PVR) before a planned knee arthroplasty surgery. The PVR was found because of a newly established local guideline in an orthopaedic department regarding examination and treatment for PVR. The guideline was made in collaboration with urologists to improve the quality of treatment. Early diagnosis and treatment may prevent chronic bladder injury, urinary tract infections, urosepsis and kidney damage.

New growth rod concept provides three dimensional correction, spinal growth, and preserved pulmonary function in early-onset scoliosis.

INTRODUCTION: This study aims to describe a novel minimal invasive early-onset scoliosis (EOS) growth rod concept, the Cody Bünger (CB) Concept, which combines concave interval distraction and contralateral-guided growth with apical control and to investigate the 3D deformity correction, the spinal growth, and the pulmonary development. METHOD: A series of 38 children with progressive EOS and growth potential, receiving a highly specialized surgical treatment, including primary and conversion cases. Mean age was 10.2 years (4.4-15.8) with a mean follow-up of 5.6 years, and they underwent 168/184 open/magnetic lengthening procedures. Outcomes were as follows: scoliosis, kyphosis, and lordosis angles; apical rotation; spinal length; apical translation; coronal and sagittal vertical alignment; complications; and pulmonary function in a subgroup. RESULTS: Scoliosis improved from mean 76° (46-129) to 35° (8-74) post-op and was 42° (13-83) at end of treatment. Apical rotation was reduced by 30% but was partially lost during treatment. Thoracic kyphosis initially decreased by mean 15° and was partially lost during treatment. Lordosis was largely unaltered during treatment. Mean T1-S1 height increased from 30.7 cm (22.7-39.2) to 34.6 cm (27.8-45.1) postop and further increased to 38.5 cm (30.1-48.1) during treatment. This corresponded to a T1-S1 growth rate of 12 mm/year, and positive growth rates were found in all height parameters evaluated. Frontal balance and apical translation improved, whereas sagittal balance was unaltered. Complications occurred in 22/38 patients, and 11/38 had an unintended reoperation. Pulmonary function (FVC and FEV) increased but the relative lung function was unchanged. CONCLUSION: The new growth rod concept provided 3D correction and spinal growth at complication rates comparable with other growth-friendly techniques for EOS, while pulmonary function was preserved. Single magnetic rod distraction was incorporated successfully, replacing surgical elongations.

3-Year follow-up of a single magnetically controlled growing rod with contralateral gliding system and apical control for early onset scoliosis.

STUDY DESIGN: Two-center retrospective cohort study. OBJECTIVE: The aim of this study is to investigate the clinical effectiveness and safety of the MCGR hybrid in terms of spinal growth, 3D correction, balance, and complications. The magnetic-controlled growing-rod (MCGR) growth instrumentation method has gained popularity for early onset scoliosis (EOS) treatment in the past years due to the non-invasiveness of the subsequent interval elongation procedures. To improve 3D correction and reduce the costs, we combined a single concave MCGR with a sliding rod on the convex side to control the apex. METHODS: A retrospective cohort study of 18 EOS children with an average 3-year follow-up (range 2.0-3.7) from two European spine centers treated with the single MCGR hybrid concept; 14 primary and 4 conversion cases. The primary and conversion cases were both evaluated preoperatively, postoperatively, 1 year, 2 years, and last follow-up. RESULTS: Mean age was 9.9 (SD ± 2.9 years). The average frontal Cobb angle was reduced from mean 65° to 30° postoperatively, and had increased to 37° at latest follow-up. Rotation of the apical vertebra improved from mean 27° to 20° postoperatively which was partially lost to 23°. Kyphosis and lordosis both increased by an average of 5° during the time of follow-up. Spinal balance was improved. The post-implantation T1-S1 spine growth rate averaged 10 mm/year at last follow-up. There were 13 implant-related complications in 6 out of 18 patients. No screw pull-outs and nor surgical site infections were registered. CONCLUSIONS: This is the first medium-term results of a single MCGR hybrid construct. Maintenance of correction and growth are reasonable, and the complication rate is relatively low as compared to bilateral MCGR application. LEVEL OF EVIDENCE: III.

Lengthening of magnetically controlled growing rods caused minimal pain in 25 children: pain assessment with FPS-R, NRS, and r-FLACC.

STUDY DESIGN: Descriptive case series. OBJECTIVE: The aim of the study is to investigate the pain associated with magnetically controlled growing rod (MCGR) lengthening procedures. MCGRs have gained popularity because they offer non-surgical lengthening procedures in early-onset scoliosis (EOS) instead of semi-annual open surgery elongations with traditional growing rods. Many aspects of MCGR treatment have been investigated, but pain in conjunction with distraction is only sparsely described in the literature. METHODS: Pain intensity was assessed in 25 EOS patients before, during and after MCGR lengthening procedures in an outpatient setup. They underwent at least two (range 2-16) lengthening procedures prior to this study. The pain intensity was estimated using patient-reported Faces Pain Scale (FPS-R), caregiver-reported pain numeric rating scale (NRS), and NRS and revised Face, Legs, Activity, Cry, Consolability scale (r-FLACC) by two medically trained observers. The inter-rater reliability and correlation between instruments were analyzed. RESULTS: 23 of 25 EOS patients (8- to 16-year old) with mixed etiology were able to self-report pain. The average pain intensity was mild: median 1 (range 0-6) on all four instruments on a 0-to-10 scale. Afterward, 22/25 patients (88%) were completely pain free and the remaining 3 patients had a pain score of 1. MCGR stalling (i.e. clunking) was encountered in 14/25 (56%) of the patients without impact on the pain intensity. CONCLUSIONS: The average maximum pain intensities during the lengthening procedures were mild and pain ceased within few minutes. The inter-rater reliability was good to excellent for NRS and r-FLACC, and there were high correlations between all the four pain instruments, indicating high criterion validity. LEVEL OF EVIDENCE: Level IV, case series.

Percutaneous needle fasciotomy in Dupuytren contracture: a register-based, observational cohort study on complications in 3,331 treated fingers in 2,257 patients.

Background and purpose - Percutaneous needle fasciotomy (PNF) is a minimally invasive treatment option for Dupuytren contracture, which has gained momentum worldwide in recent years. However, evidence regarding safety and severe complications associated with PNF is sparse. Thus, we evaluated safety of a specific PNF method in the largest cohort reported in literature.Patients and methods - This is a single-center, register-based, observational study on PNF treatments between 2007 and 2015. The study cohort was identified by the Danish National Patient Registry, and diagnosis codes and procedure codes were used to identify potential severe postoperative complications such as: tendon rupture, nerve damage, infection, amputation, and reflex dystrophy for all index treatments. The Danish National Prescription Registry was used to identify non-hospital-treated infections. All index treatments and postoperative complications were verified by review of medical records.Results - 2,257 patients received PNF treatment of 3,331 treated finger rays. Median follow-up was 7.2 years (interquartile range: 4.9-9.5 years, range 1-12 years). 4 patients sustained flexor tendon rupture. 1 patient had digital nerve damage. 2 patients had an infection treated in hospital, while 31 patients received antibiotics in the primary sector for an infection or based on suspicion of an infection after PNF. None of the infections required surgical intervention. No finger amputations or ipsilateral upper limb reflex dystrophy cases were registered in relation to the procedure.Interpretation - Percutaneous needle fasciotomy for Dupuytren contracture is a safe procedure with a low rate of severe postoperative complications when a specific PNF method is applied.

Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial.

PURPOSE: Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use. METHOD: In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. RESULTS: Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. CONCLUSIONS: This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.