Risk factors for neurophysiological events related to intraoperative halo-femoral traction in spinal deformity surgery.

PURPOSE: This study identifies risk factors for neurophysiological events caused by intraoperative halo-femoral traction (IOHFT) in patients with adolescent idiopathic scoliosis (AIS), and neuromuscular scoliosis (NMS). METHODS: Neurophysiological integrity was monitored using motor evoked potentials (MEPs). IONM event was defined as a decreased MEP amplitude of more than 80% of baseline in, at least, one muscle. Time between application of IOHFT and event, affected muscles, surgical stage, and time between removal of IOHFT and recovery of MEPs were described. Characteristics (age, height, weight, diagnosis, Cobb angle, and flexibility of the curve) of patients with and without IOHFT-events were compared using analysis of variance. Binary logistic regression analyses were performed to identify predictors. RESULTS: The study included 81 patients (age 15.6 ± 2.4 years, 53 females, AIS: n = 47, NMS n = 34). IOHFT-events occurred in 11 patients (13%; AIS n = 4, NMS n = 7). IOHFTevents affecting all limbs occurred pre-incision in NMS. Events affecting only the legs occurred during all stages of surgery. Patients with IOHFT-events were smaller (p = 0.009) and had stiffer curves (p = 0.046). Height was a predictor (odds ratio, 0.941; 95% confidence interval = 0.896-0.988). All MEPs recovered after removing IOHFT. CONCLUSION: Neurophysiologic events due to IOHFT were common, with the majority in patients with NMS. A shorter stature was a risk factor, and larger Cobb angle and stiffer curve were associated with IOHFT-events. Events occurred at any stage of surgery and involved upper and lower limbs. With an adequate response on IOHFT events, none of the patients had postoperative neurological impairments due to IOHFT.

Fracture rate after conventional external beam radiation therapy to the spine in multiple myeloma patients.

BACKGROUND CONTEXT: Conventional external beam radiation therapy (cEBRT) is used in multiple myeloma (MM) to treat severe pain, spinal cord compression, and disease-related bone disease. However, radiation may be associated with an increased risk of vertebral compression fractures (VCFs), which could substantially impair survival and quality of life. Additionally, the use of the Spinal Instability Neoplastic Score (SINS) in MM is debated in MM. PURPOSE: To determine the incidence of VCFs after cEBRT in patients with MM and to assess the applicability of the SINS score in the prediction of VCFs in MM. STUDY DESIGN: Retrospective multicenter cohort study. PATIENT SAMPLE: MM patients with spinal myeloma lesions who underwent cEBRT between January 2010 and December 2021. OUTCOME MEASURES: Frequency of new or progressed VCFs and subdistribution hazard ratios for potentially associated factors. METHODS: Patient and treatment characteristics were manually collected from the patients' electronic medical records. Computed tomography (CT) scans from before and up to 3 years after the start of radiation were used to score radiographic variables at baseline and at follow-up. Multivariable Fine and Gray competing risk analyses were performed to evaluate the diagnostic value of the SINS score to predict the postradiation VCF rate. RESULTS: A total of 127 patients with 427 eligible radiated vertebrae were included in this study. The mean age at radiation was 64 years, and 66.1% of them were male. At the start of radiation, 57 patients (44.9%) had at least one VCF. There were 89 preexisting VCFs (18.4% of 483 vertebrae). Overall, 39 of 127 patients (30.7%) reported new fractures (number of vertebrae (n)=12) or showed progression of existing fractures (n=36). This number represented 11.2% of all radiated vertebrae. Five of the 39 (12.8%) patients with new or worsened VCFs received an unplanned secondary treatment (augmentation [n=2] or open surgery [n=3]) within 3 years. Both the total SINS score (SHR 1.77; 95% confidence interval (CI) 1.54-2.03; p<.001) and categorical SINS score (SHR 10.83; 95% CI 4.20-27.94; p<.001) showed an independent association with higher rates of new or progressed VCFs in adjusted analyses. The use of bisphosphonates was independently associated with a lower rate of new or progressed VCFs (SHR 0.47 [95% CI 0.24-0.92; p=.027]). CONCLUSIONS: This study demonstrated that new or progressed VCFs occurred in 30.7% of patients within 3 years, in a total of 11.2% of vertebrae. The SINS score was found to be independently associated with the development or progression of VCFs and could thus be applied in MM for fracture prediction and possibly prevention.

Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System: Protocol for a Single-Center Clinical Cohort Study.

BACKGROUND: The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS. OBJECTIVE: This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS. METHODS: In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications. RESULTS: Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024. CONCLUSIONS: Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04441411; https://clinicaltrials.gov/study/NCT04441411. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47222.

Clinical significance of concomitant pectus deformity and adolescent idiopathic scoliosis: systematic review with best evidence synthesis.

Background: A misbalance in forces is proposed for causing adolescent idiopathic scoliosis (AIS). AIS is therefore correlated to adjacent musculoskeletal pathologies. Its concomitance with idiopathic pectus deformities (PD) is underexposed. This systematic review analyzes the clinical significance and predictive factors of PD-associated AIS. Methods: A search was performed in PubMed, UpToDate, Embase, and Cochrane. A study was included if it: assessed the association between PD and scoliosis (category I), reported a prevalence of scoliosis in PD patients (category II), or addressed other topics about PD-associated AIS (category III). Studies in category I discussing predictive factors were appraised using the Quality in Prognosis Studies tool. Because of heterogeneity among the studies, predictive factors were analyzed according to a best evidence synthesis. A mean prevalence of scoliosis in PD patients was calculated using category I and II. Category III was narratively reviewed. Results: Forty-eight studies were included (I:19, II:21, III:8). Category I comprised 512 patients with PD-concomitant scoliosis. Thirteen studies reported predictive factors, of which 15 concerned the prevalence of scoliosis in PD patients and 12 Cobb Angle (CA) change after PD correction. Compared with AIS, PD seems to develop earlier in adolescence, and PD with concomitant AIS was more frequently reported in older patients. Evidence remained conflicting regarding the association between the severity of PD and that of scoliosis. As opposed to at a younger age, late PD correction is not associated with a postoperative increase of CA. Limited evidence showed that patients with a high CA undergoing PD correction do not experience an increase in CA, though, strong evidence indicated that it would not lead to a decrease in CA. The mean probable prevalence of AIS in PD patients was 13.1%. Conclusion: Current literature confirms the association between PD and AIS in patients with an indication for PD correction.Level of evidence: III.

High Failure Rates of a Unilateral Posterior Peri-Apical Distraction Device (ApiFix) for Fusionless Treatment of Adolescent Idiopathic Scoliosis.

BACKGROUND: Conventional surgical treatment for adolescent idiopathic scoliosis (AIS) consists of correction of the spinal deformity with rigid spinal instrumentation and fusion. Less-invasive and fusionless surgery could potentially improve patient outcomes. The purpose of the present study was to evaluate the efficacy of a recently U.S. Food and Drug Administration (FDA)-approved posterior peri-apical self-distracting device (ApiFix) that is designed to gradually correct the deformity without spinal fusion. METHODS: In a prospective cohort study of 20 patients with AIS (Risser stage 1-4; Lenke 1 or 5; major curve Cobb angle, 40° to 55°; and Bunnell scoliometer rotation, <15°) were managed with the ApiFix device. Clinical and radiographic performance was assessed. RESULTS: Twenty patients with a mean age (and standard deviation) of 14.8 ± 1.4 years were followed for a mean of 3.4 ± 1.0 years. The average major curve was reduced from 45.4° preoperatively to 31.4° at 2 weeks postoperatively and 31.0° at the time of the latest follow-up. The average minor curve measured 31.3° preoperatively, 26.1° at 2 weeks postoperatively, and 24.2° at the time of the latest follow-up. Ten patients had serious complications that required revision surgery, including osteolysis (n = 6), screw and/or rod breakage (n = 2), failure of the ratchet mechanism (n = 1), and pain without explainable cause (n = 1). During revision surgery, metallosis was observed in all patients and cultures showed growth of Cutibacterium acnes in 6 patients. Because of the high failure rate, the study was terminated early. CONCLUSIONS: The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The Impact of Minimally Invasive Treatment for Rotator Cuff Calcific Tendinitis on Self-Reported Work Ability and Sick Leave.

PURPOSE: To examine the impact of rotator cuff calcific tendinitis on patients' self-reported work ability and sick leave, to compare work ability and sick leave with shoulder function after minimally invasive treatment, and to assess which prognostic factors influence the change in work ability. METHODS: A prospective cohort was analyzed in this study. The primary outcome measure was the single-question work ability score (0-10 points). Secondary outcome measures were quality and quantity of work, sick leave, functional outcome, and radiographic resorption. Potential predictive factors (treatment method, age, sex, resorption of the calcific deposit, physical work load, and work status) were tested in a statistical model. Follow-up was at 6 months and 1 year. RESULTS: The study cohort consisted of 67 patients. The mean age was 49.6 ± 6.4 years and 45 (67%) were female. Physical workload was categorized as light (58%), medium (24%), and heavy (18%). Work ability score improved from a mean of 6.1 ± 2.8 to 8.5 ± 2.0 points after 1 year. Treatment with minimally invasive treatment techniques was associated with a reduction in partial or full-time sick leave from 28% to 6%. The mean days of sick leave a month declined from 3.3 to 0.8 days. Functional disability was greater in patients with partial or full-time sick leave. The physical workload turned out to be the most important patient associated factor predicting change in work ability. CONCLUSIONS: This study supports the hypothesis that rotator cuff calcific tendinitis has a significant impact on work ability and sick leave. Minimally invasive treatment resulted in a clinically relevant improvement in work ability score and decline in sick leave. In particular, patients with medium and high physically demanding work for the shoulder benefit from minimally invasive treatment to improve their work ability. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Preoperative Planning and the Use of Free Available Software for Sagittal Plane Corrective Osteotomies of the Lumbar Spine in Ankylosing Spondylitis.

BACKGROUND: Ankylosing spondylitis (AS) may cause a severe rigid thoracolumbar kyphotic deformity (TLKD) that leads to considerable disturbances of posture and spinal balance. In few patients, a corrective osteotomy of the lumbar spine may be considered. Preoperative planning of a lumbar osteotomy for correction of a severe TLKD due to AS is important to correct patient's sagittal balance and view angle. There is a need for accurate preoperative planning that can be used easily in daily practice. METHODS: The basic biomechanical and mathematical principles of preoperative planning for correction of a TLKD due to AS are described. A search was performed for free available computer programs that can be used for pre-operative planning of spinal osteotomies in AS. Finally, the use of these computer programs is illustrated and described. RESULTS: Sagittal balance is measured on a standing lateral full-length radiograph of the spine. The assessment of the pelvic parameters (PI, PT, SS) in conjunction with sagittal vertical axis (SVA) and chin-brow-to-vertical angle (CBVA) provides a comprehensive picture of the sagittal spinal alignment and compensatory mechanisms of the patient. The relation between the level of lumbar osteotomy and the amount of correction needed can be calculated with different elementary trigonometric equations. Two free available computer programs, ASKyphoplan and Surgimap, are illustrated and described that can be used for pre-operative planning of spinal osteotomies in AS. CONCLUSION: Preoperative planning of the lumbar osteotomy in AS involves assessment of the combined effect of location of the osteotomy, amount of bone resection, SVA, CBVA, and pelvic parameters. Two free available computer programs, ASKyphoplan and Surgimap, are easy to use in clinical practice to predict postoperative sagittal balance of lumbar osteotomies in patients with severe TLKD due to AS.

Quantifying the minimal and substantial clinical benefit of the Constant-Murley score and the Disabilities of the Arm, Shoulder and Hand score in patients with calcific tendinitis of the rotator cuff.

BACKGROUND: To aid the interpretation of clinical outcome scores, it is important to determine the measurement properties. The aim of this study was to establish the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for the Constant-Murley score and Disabilities of the Arm, Shoulder and Hand score in patients with long-lasting rotator cuff calcific tendinitis treated with high-energy extracorporeal shockwave therapy and ultrasound guided needling. The secondary purpose was to assess the responsiveness of both questionnaires and to identify variables associated with achieving the MCID and SCB. METHODS: A prospective cohort of 80 patients with rotator cuff calcific tendinitis was analyzed. Two anchor-based methods were used to calculate the MCID and SCB. Effect sizes and standardized response means were calculated to assess the responsiveness. Additional univariate logistic regression analyses were performed to identify factors associated with the achievement of the MCID and SCB. RESULTS: For the Constant-Murley score, we found an MCID and SCB of 9.8 and 19.9, respectively, based on the mean change method and 5.5 and 10.5, respectively, based on receiver operating characteristic analysis. For the Disabilities of the Arm, Shoulder and Hand score, we found an MCID and SCB of -8.2 and -19.6, respectively, with the former and -11.7 and -12.5, respectively, with the latter. The responsiveness of both outcome measures was good, with large effect sizes and standardized response means. The radiographic resorption after 6 weeks and after 6 months appeared to be the most important positive predictor for achieving the MCID and SCB after 6 months. CONCLUSION: This study established the MCID, SCB, and responsiveness for patients with long-lasting rotator cuff calcific tendinitis who were treated with minimally invasive treatment options. With this information, physicians can distinguish between a statistically significant difference and a clinically relevant benefit. Successful radiographic resorption after 6 weeks and after 6 months was associated with achieving clinically significant improvement after treatment.

Comparing Ultrasound-Guided Needling Combined With a Subacromial Corticosteroid Injection Versus High-Energy Extracorporeal Shockwave Therapy for Calcific Tendinitis of the Rotator Cuff: A Randomized Controlled Trial.

PURPOSE: To compare clinical and radiographic outcomes after treatment with standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound-guided needling (UGN) in patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment. METHODS: The study was designed as a randomized controlled trial. The ESWT group received ESWT (2000 pulses, energy flux density 0.35 mJ/mm2) in 4 sessions with 1-week intervals. UGN was combined with a corticosteroid ultrasound-guided subacromial bursa injection. Shoulder function was assessed at standardized follow-up intervals (6 weeks and 3, 6, and 12 months) using the Constant Murley Score (CMS), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and visual analog scale for pain and satisfaction. The size, location, and morphology of the deposits were evaluated on radiographs. The a priori sample size calculation computed that 44 participants randomized in each treatment group was required to achieve a power of 80%. RESULTS: Eighty-two patients were treated (56 female, 65%; mean age 52.1 ± 9 years) with a mean baseline CMS of 66.8 ± 12 and mean calcification size of 15.1 ± 4.7 mm. One patient was lost to follow-up. At 1-year follow-up, the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 vs 15.7; P = .23), Disabilities of the Arm, Shoulder, and Hand questionnaire (-20.1 vs -20.7; P = .78), and visual analog scale for pain (-3.9 and -2.6; P = .12). The mean calcification size decreased by 13 ± 3.9 mm in the UGN group and 6.7 ± 8.2 mm in the ESWT group (

Outcomes of Nonsurgical Treatments for Symptomatic Adult Degenerative Scoliosis: A Systematic Review.

OBJECTIVE: To evaluate the effectiveness of nonsurgical treatments in symptomatic adult degenerative scoliosis (ADS). DESIGN: A systematic literature review. METHODS: PubMed, Web of Science, and The Cochrane Library were searched to identify research published since 1988. Randomized controlled trials (RCTs) and observational cohort studies were eligible if they featured symptomatic ADS patients aged ≥50 who received nonsurgical treatment. Minimum follow-up was six weeks, and outcomes of interest were pain, disability, quality of life, and Cobb angle. Evidence quality per intervention was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Six studies were included. Of these, four focused specifically on injections, bracing, or yoga; two involved multiple treatments. One RCT provided evidence for greater effectiveness of transforaminal epidural steroid injection over anesthetic alone in reducing radiating pain and disability. Two single-group retrospective cohort studies lent support for bracing to slow curve progression. One retrospective single-group cohort study suggested an association between yoga and reduced curve progression. Evidence for injections to reduce ADS symptoms was rated as low quality; evidence for bracing and yoga was rated as very low quality. No specific evidence was identified regarding other treatments, including physical therapy and analgesics. CONCLUSIONS: Literature describing the effectiveness of nonoperative treatments in symptomatic ADS is scarce. The quantity and quality of the evidence regarding injections, bracing, and yoga are insufficient to advise for or against the use of these methods to improve outcomes in symptomatic ADS. For these and other nonoperative treatment forms, further research is needed.