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STUDY DESIGN: A prospective, comparative study on clinical, radiographic, and health-related quality of life (HRQoL) outcomes in adolescents with acute spondylolysis treated with a rigid thoracolumbar orthosis (Boston brace) or with a placebo (elastic lumbar support) with a 2-year follow-up time. OBJECTIVE: To compare outcomes of acute adolescent spondylolysis treated with a rigid thoracolumbar orthosis or a placebo with a 2-year follow-up time. SUMMARY OF BACKGROUND DATA: The benefits of the use of rigid orthosis for treatment of spondylolysis and achieving bony union of spondylolysis remains unclear. METHODS: Sixty consecutive patients with acute spondylolysis were prospectively enrolled. Three patients were excluded from analysis as they did not fulfill inclusion criteria. First 14 patients were randomized and the remaining 46 chose treatment method themselves. Treatment time was four months and follow-up time was two years. HRQoL was measured using Scoliosis Research Society-24 (SRS-24) outcome questionnaire. The primary outcome was the HRQoL at 24 months and whether treatment type, bony union of the spondylolysis or development of spondylolisthesis affected it. RESULTS: Thirty (30/57) patients were treated with a Boston brace and twenty-seven (27/57) patients with a placebo. The bony union rate of spondylolysis did not differ between study groups (20/30 vs 17/27, respectively, P=0.789). The HRQoL did not differ between treatment groups in the SRS-24 domains through follow-up (P>0.05 for all). Five patients (5/57) developed spondylolisthesis (mean slip 4.2 mm) during two-year follow-up time. Non-union of the spondylolysis predicted development of spondylolisthesis (P=0.005), but treatment type did not affect it (P>0.05). Two years after treatment patients who had bony union had higher SRS-24 total (P=0.005) and satisfaction domain (P<0.001) compared to patients with non-union. CONCLUSION: A rigid brace is not necessary for treatment of acute spondylolysis. Achieving bony union of adolescent spondylolysis is desirable as their HRQoL is higher at two years. LEVEL OF EVIDENCE: II.

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STUDY DESIGN: A prospective study on clinical, radiographic, and health-related quality of life (HRQoL) outcomes in children with acute spondylolysis treated with a rigid thoracolumbar orthosis or with an elastic lumbar support. OBJECTIVE: To compare outcomes of pediatric spondylosysis treated with a hard brace or an elastic lumbar support. SUMMARY OF BACKGROUND DATA: The benefits of the use of a rigid orthosis in treatment of spondylolysis are not clear. MATERIALS AND METHODS: Fifty-seven consecutive children with acute spondylolysis (mean age: 14.1 yr, range: 9-17 yr) were prospectively enrolled. Patients were treated with a rigid thoracolumbar orthosis (Boston brace) or with a low-profile, elastic lumbar support. First 14 patients were randomized the remaining 43 chose brace type themselves. Treatment period was four months. Treatment outcomes included bony union of the spondylolysis assessed with a computed tomography at four months and HRQoL using the Scoliosis Research Society-24 outcome questionnaire filled out before and after the treatment. RESULTS: Of the 57 patients, 54 completed the treatment protocol. Twenty-nine patients were treated using the Boston brace and 25 patients the elastic lumbar support. Bony union was obtained in 69.0% (20/29) of the Boston brace and in 60.0% (15/25) of the elastic lumbar support group patients. Difference in union rates was not significant (relative risk=1.14, 95% confidence interval: 0.44-2.98, P =0.785). There was no difference in the Scoliosis Research Society-24 total or domain scores at the end of follow-up between the treatment groups ( P >0.159 for all comparisons). In the whole cohort, the bony union did not predict better HRQoL in the end of the treatment ( P =0.869), although the pain domain improved significantly in the whole cohort ( P <0.001). CONCLUSIONS: A rigid thoracolumbar orthosis did not provide any benefits over an elastic lumbar support in terms of bony union or HRQoL outcomes in children with acute spondylolysis. LEVEL OF EVIDEN: 2.

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INTRODUCTION: Medial epicondyle fracture of the humerus is a common injury in childhood. There is uniform agreement that minimally displaced fractures (dislocation ≤2 mm) can be treated nonoperatively with immobilisation. Open fractures, fractures with joint incarceration or ulnar nerve dysfunction require surgery. There is no common consensus in treatment of closed medial epicondyle fractures with >2 mm dislocation without joint incarceration or ulnar nerve dysfunction. We hypothesise that there is no difference in treatment outcomes between nonoperative and operative treatment. METHODS AND ANALYSIS: This is a multicentre, controlled, prospective, randomised noninferiority study comparing operative treatment to non-operative treatment of >2 mm dislocated paediatric medial epicondyle fractures without joint incarceration or ulnar nerve dysfunction. A total of 120 patients will be randomised in 1:1 ratio to either operative or nonoperative treatment. The study will have a parallel nonrandomised patient preference arm. Operative treatment will be open reduction and internal fixation. Nonoperative treatment will be upper limb immobilisation in long arm cast for 4 weeks. Data will be collected at baseline and at each follow-up up to 2 years. Quick-DASH is used as primary outcome measure. Secondary outcomes are patient-reported pain, differences in range of motion, Pediatric Quality of Life Inventory, cosmetic visual analogue scale and Mayo Elbow Performance Score. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Helsinki University Hospital (HUS) ethical board HUS/1443/2019. Each study centre has obtained their own permission for the study. A written authorisation from legal guardian will be acquired and the child will be informed about the trial. Results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov with registration number NCT04531085.

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AIMS: It is uncertain whether instrumented spinal fixation in nonambulatory children with neuromuscular scoliosis should finish at L5 or be extended to the pelvis. Pelvic fixation has been shown to be associated with up to 30% complication rates, but is regarded by some as the standard for correction of deformity in these conditions. The incidence of failure when comparing the most caudal level of instrumentation, either L5 or the pelvis, using all-pedicle screw instrumentation has not previously been reported. In this retrospective study, we compared nonambulatory patients undergoing surgery at two centres: one that routinely instrumented to L5 and the other to the pelvis. METHODS: In all, 91 nonambulatory patients with neuromuscular scoliosis were included. All underwent surgery using bilateral, segmental, pedicle screw instrumentation. A total of 40 patients underwent fusion to L5 and 51 had their fixation extended to the pelvis. The two groups were assessed for differences in terms of clinical and radiological findings, as well as complications. RESULTS: The main curve (MC) was a mean of 90° (40° to 141°) preoperatively and 46° (15° to 82°) at two-year follow-up in the L5 group, and 82° (33° to 116°) and 19° (1° to 60°) in the pelvic group (p < 0.001 at follow-up). Correction of MC and pelvic obliquity (POB) were statistically greater in the pelvic group (p < 0.001). There was no statistically significant difference in the operating time, blood loss, or complications. Loss of MC correction (> 10°) was more common in patients fixated to the pelvis (23% vs 3%; p = 0.032), while loss of pelvic obliquity correction was more frequent in the L5 group (25% vs 0%; p = 0.007). Risk factors for loss of correction (either POB or MC) included preoperative coronal imbalance (> 50 mm, odds ratio (OR) 11.5, 95%confidence interval (CI) 2.0 to 65; p = 0.006) and postoperative sagittal imbalance (> 25 mm, OR 11.0, 95% CI1.9 to 65; p = 0.008). CONCLUSION: We found that patients undergoing pelvic fixation had a greater correction of MC and POB. The rate of complications was not different. Preoperative coronal and postoperative sagittal imbalance were associated with increased risks of loss of correction, regardless of extent of fixation. Therefore, we recommend pelvic fixation in all nonambulatory children with neuromuscular scoliosis where coronal or sagittal imbalance are present preoperatively. Cite this article: Bone Joint J 2020;102-B(2):261-267.

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BACKGROUND: Pregabalin as part of a multimodal pain-management regimen has been shown to reduce opioid consumption after spinal surgery in adults but it is unclear whether this is also true in adolescents. Pregabalin has been found to have neuroprotective effects and therefore could have a positive impact on pain after spinal deformity surgery. We conducted a randomized, double-blinded, placebo-controlled clinical trial of adolescent patients undergoing spinal fusion to evaluate the short-term effects of pregabalin on postoperative pain and opioid consumption. METHODS: Adolescents with adolescent idiopathic scoliosis, Scheuermann kyphosis, or spondylolisthesis who were scheduled for posterior spinal fusion with all-pedicle-screw instrumentation were randomized to receive either pregabalin (2 mg/kg twice daily) or placebo preoperatively and for 5 days after surgery. The patients ranged from 10 to 21 years of age. The primary outcome was total opioid consumption as measured with use of patient-controlled analgesia. Postoperative pain scores and opioid-related adverse effects were evaluated. RESULTS: Sixty-three of 77 eligible patients were included and analyzed. Cumulative oxycodone consumption per kilogram did not differ between the study groups during the first 48 hours postoperatively, with a median of 1.44 mg/kg (95% confidence interval [CI],1.32 to 1.67 mg/kg) in the pregabalin group and 1.50 mg/kg (95% CI, 1.39 to 1.79 mg/kg) in the placebo group (p = 0.433). A subgroup analysis of 51 patients with adolescent idiopathic scoliosis showed the same result, with a mean of 1.45 mg/kg (95% CI, 1.24 to 1.65 mg/kg) in the pregabalin group and 1.59 mg/kg (95% CI, 1.37 to 1.82 mg/kg) in the placebo group (p = 0.289). Total oxycodone consumption per hour (mg/kg/hr) was not different between the groups over the time points (p = 0.752). The postoperative pain scores did not differ significantly between the groups (p = 0.196). CONCLUSIONS: The use of perioperative pregabalin does not reduce the postoperative opioid consumption or pain scores in adolescents after posterior spinal fusion surgery. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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BACKGROUND: Posterior spinal fusion with pedicle screws is the gold-standard treatment for adolescent idiopathic scoliosis (AIS); however, it is unclear whether this procedure results in improved long-term back pain and health-related quality of life compared with patients not surgically treated for AIS. The aim of the present study was to evaluate back pain and quality of life in surgically managed patients with a minimum follow-up of 5 years compared with patients with untreated AIS and a healthy control group. METHODS: Fifty-five consecutive adolescent patients who underwent posterior pedicle screw instrumentation for AIS by a single orthopaedic surgeon were prospectively enrolled. At a minimum of 5 years postoperatively, 49 patients completed Scoliosis Research Society (SRS)-24 questionnaires, and data on reoperation were collected. Pain and quality-of-life parameters were compared with those of 49 age and sex-matched patients with untreated AIS and 49 healthy controls. RESULTS: The major curve averaged 53° preoperatively and 12° at 2 years postoperatively. One reoperation (pedicle screw removal) was needed because of a new neurological deficit (transient). The SRS-24 pain, function, and total scores improved significantly from preoperatively to 5 years postoperatively (all p ≤ 0.016), with pain scores improving from 4.0 to 4.3 (p = 0.003). There was no association between pain scores and the preoperative major curve, instrumentation below L1, or postoperative rib hump. The surgical treatment group had significantly better pain, activity, and self-image domain scores at 5 years postoperatively compared with the untreated AIS group (all p ≤ 0.014), and similar pain, self-image, and activity domain scores compared with the healthy control group; however, function scores were significantly lower among patients in the surgical treatment group (p < 0.001). CONCLUSIONS: Patients who underwent posterior spinal fusion with pedicle screws experienced improved back pain and health-related quality of life compared with patients with untreated AIS. Patients in the surgical treatment group had similar health-related quality of life to that of the healthy control group, except for function, which was significantly lower. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

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PURPOSE: To compare treatment efficacy between the Boston full-time brace and the Providence part-time brace in main thoracic adolescent idiopathic scoliosis (AIS). METHODS: Patients were treated with either the Boston brace (n = 37) or the Providence brace (n = 40). Inclusion criteria were Risser grade ≤2, major curve between 25° and 40° with the apex of the curve between T7 and T11 vertebrae. Two-year follow-up was available in all patients unless brace treatment had reached endpoint. The primary outcome measure was main curve progression to ≥45°. RESULTS: Median age was 12.6 years and median treatment length at follow-up was 25 months (interquartile range (IQR): 18-32)) with no difference between the groups (p ≥ 0.116). Initial median main Cobb angle was 29° (IQR: 27-33) and 36° (IQR: 33-38) in the Boston and Providence groups, respectively (p < 0.001). At follow-up, 13 patients (35%) had progressed to ≥45° in the Boston group versus 16 patients (40%) in the Providence group (p = 0.838). Twenty-three patients (62%) had progressed by more than 5° in the Boston group versus 22 patients (55%) in the Providence group (p = 0.685). The secondary thoracolumbar/lumbar curve progressed by more than 5° in 14 (38%) and 18 (45%) in the Boston and Providence groups, respectively (p = 0.548). CONCLUSIONS: Despite a larger initial curve size in the Providence group, progression of more than 5° or to surgical indication area was similar in the Boston group. Our results indicate that nighttime bracing is a viable alternative to full-time bracing also in main thoracic AIS.

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OBJECTIVE: Pedicle screw instrumentation is widely used for spinal deformity correction and fusion in adolescents for idiopathic scoliosis. The goal is to achieve and sustain good alignment in all 3 planes. We compared 2 different cobalt-chromium (CoCr) rod designs with different stiffnesses with regard to the restoration of coronal and sagittal balance in adolescents operated on for idiopathic scoliosis. MATERIAL AND METHODS: A prospective comparative study was made of 90 consecutive adolescents, mean age (standard deviation) 15.6 years (2.1 years), with idiopathic scoliosis who underwent posterior spinal fusion by the use of bilateral segmental pedicle screw instrumentation (PSI) with 6.0 Co-Cr rods. Fifty-four adolescents (43 girls) were operated on by the use of circular rods and 36 (27 girls) by the use of sagittal reinforced rods, with a 2-year follow-up. RESULTS: Preoperative major coronal curves were similar and at 2 years: 11° (5.0) and 17° (7.2) with correction percentages of 78% (10) and 69% (12) in the circular and reinforced rod groups (P < 0.01). Thoracic kyphosis at 2 years measured 16° (7) and 21° (6) in the circular and reinforced rod groups (P < 0.01). The number of patients with hypokyphosis was lower in the reinforced rod group at 2 years (P = 0.02). In the reinforced rod group, there was a negative correlation between coronal correction and thoracic kyphosis (r = -0.52, P < 0.01). CONCLUSIONS: Both circular and sagittal reinforced 6.0-mm CoCr rods provide adequate coronal correction for adolescents with idiopathic scoliosis. The use of sagittal reinforced rods provided better thoracic kyphosis restoration and a lower risk for postoperative hypokyphosis.

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