The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis. A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity.
A prospective study on the comparison of the clinical efficacy and patient's acceptance of the 2 orthotic management methods.
                To compare the treatment effectiveness and patients' acceptance of the flexible spinal orthosis, SpineCor with that of the rigid spinal orthosis for the patients with moderate adolescent idiopathic scoliosis.
                The patients' acceptance to the rigid spinal orthoses is always a concern as it could greatly affect the clinical outcome. SpineCor is a relatively new design for tackling those inevitable drawbacks found in rigid orthosis. However, there was no study to compare this design with the conventional method regarding their treatment efficacy and the patient's acceptance.
                Forty-three subjects with moderate adolescent idiopathic scoliosis were randomly assigned to the SpineCor group (S group, n = 22) and rigid orthosis group (R group, n = 21). Their survival rate in the first 45 months of intervention was studied. The subjects' acceptance to the orthoses was evaluated by a purpose-designed questionnaire, which was administered in the 3rd, 9th, and 18th months of intervention.
                In the study period, there were 68% of the subjects in the S group and 95% of the subjects in the R group did not show curve progression. Significant difference (P = 0.046, by Fisher exact test) in failure rate between the 2 subject groups was found although the 2 groups had similar responses to the questionnaire.
                The current study showed that the failure rate of the SpineCor was significantly higher than that of the rigid spinal orthosis, and the patients' acceptance to the SpineCor was comparable to the conventional rigid spinal orthosis. The Swedish patients included in the previous SRS brace study were invited to take part in a long-term follow-up.
                To investigate the rate of scoliosis surgery and progression of curves from baseline as well as after maturity.
                Brace treatment was shown to be superior to electrical muscle stimulation, as well as observation alone, in the original SRS brace study. Few other studies have shown that brace treatment is effective in the treatment of scoliosis.
                Of 106 patients, 41 in Malmö (all Boston brace treatment) and 65 in Göteborg (observation alone as the intention to treat), 87% attended the follow-up, including radiography and chart review. All radiographs were (re)measured for curve size (Cobb method) by an unbiased examiner. Searching in the mandatory national database for performed surgery identified patients who had undergone surgery after maturity.
                The mean follow-up time was 16 years and the mean age at follow-up was 32 years The 2 treatment groups had equal curve size at inclusion. The curve size of patients who were treated with a brace from the start was reduced by 6 degrees during treatment, but the curve size returned to the same level during the follow-up period. No patients who were primarily braced went on to undergo surgery. In patients with observation alone as the intention to treat, 20% were braced during adolescence due to progression and another 10% underwent surgery. Seventy percent were only observed and increased by 6 degrees from inclusion until now. No patients underwent surgery after maturity. Progression was related to premenarchal status.
                The curves of patients with adolescent idiopathic scoliosis with a moderate or smaller size at maturity did not deteriorate beyond their original curve size at the 16-year follow-up. No patients treated primarily with a brace went on to undergo surgery, whereas 6 patients (10%) in the observation group required surgery during adolescence compared with none after maturity. Curve progression was related to immaturity.
There is very low quality evidence in favour of using braces, making generalization very difficult. Further research could change the actual results and our confidence in them; in the meantime, patients' choices should be informed by multidisciplinary discussion. Future research should focus on short and long-term patient-centred outcomes, in addition to measures such as Cobb angles. RCTs and prospective cohort studies should follow both the Scoliosis Resarch Society (SRS) and Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) criteria for bracing studies.