Aspects of bracing in adolescent idiopathic scoliosis

Rationale: Our rationale for the study is multi-layered. Brace treatment is only effective if the  patient is compliant; an optimally constructed brace is not effective if only worn for two hours  a week. The Maastricht brace was developed to increase compliance by optimizing  wearability and therefore more comfort, while obtaining the same pressure and therefore  effect as the current golden standard in the Netherlands, the Boston brace. Initial results are  promising and further effects need to be objectified. As thoracic parts of the Maastricht brace  are flexible, we expect pulmonary function to improve compared to previously reported  pulmonary function in a Boston brace. Motion analysis within a thoracolumbar brace is rarely  described. With adequate placement and optimal fitting we expect to obtain a gait analysis  close to the normal population. With this study we would like to develop an optimal treatment  plan for AIS and obtain more insight in the pathophysiology of AIS and the effects (or  effectiveness) of bracing. 

Objective: The primary objective of the study is determining the contributing factors in  bracing for AIS. The contributing factors are determined as factors of influence in the  corrective possibilities and therefore end term results of the M-brace, which are currently  unknown. The contributing factors are listed as secondary objectives together with patient  characteristics such as length and weight. The effect of contributing factors is quantified in  changes of Cobb’s angle over time. Secondary objectives are compliance of bracing using  thermal sensors (Orthotimer), pulmonary function and development of pulmonary restriction in brace, motion analysis of gait impairment (CAREN) before, during and after bracing and  pressure (Pressure Guardian) applied by the brace itself during bracing. 

prospective cohort

Maastricht brace 

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden associated with participation is as follows (Table 1,  Appendix 1):

1. An increase of time in every outpatient clinical visit to evaluate brace compliance with  use of the Orthotimer and Pressure Guardian (Appendix 2). 

a. Reading the sensors (both the Orthotimer and Pressure Guardian) will take  place at the outpatient clinic and lasts about five minutes.

2. After an adequate brace placement of the initial brace there is an additional  pulmonary test (+-2 hours) and an additional motion analysis (+-2 hours). These tests  are non-invasive, but they do however consume half a day in total. These tests are to  be repeated every year until endpoint of bracing at full bone maturity. 

a. In summary both the pulmonary tests and the motion analysis will be taken  every year and at start- and endpoint of brace treatment. 

3. There is only one group of patients subject for these tests, there is no control group.  There are no risks of attending. Treatment with the Maastricht brace and  outpatient clinical controls are identical to current clinical practice in  adolescent idiopathic scoliosis. 

4. Additional questionnaires (two) are filled in every three months at the outpatient clinic.  The average time investment is 15 minutes per visit.