Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis
Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis
The purpose of this study is to study the effectiveness of in-brace 3D scoliosis correction
 by comparing Rigo Chêneau orthoses (RCO) with conventional Traditional Boston-style
 thoracolumbosacral orthoses (TLSO) in Adolescent Idiopathic Scoliosis (AIS) patients,
 following Scoliosis Research Society (SRS) and The International Scientific Society on
 Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) recommendations for non-operative
 AIS management and research studies. This group of patients that reach the threshold for
 bracing have an intrinsic higher risk for curve progression. Hence, the proposed study will
 provide novel and high quality evidence to improve the efficacy of bracing in the
 non-operative treatment of AIS. This will contribute significantly to the betterment of
 public health by reducing the number of patients requiring surgical intervention. Ultimately,
 new evidence-based clinical practice guidelines on the most effective type of scoliosis
 braces will benefit children diagnosed with AIS worldwide.
Adolescent idiopathic scoliosis (AIS), a three-dimensional (3D) deformity of the spinal
 column characterized by lateral deviation and vertebral rotation, affects 3.5% of children
 during puberty in Hong Kong. Untreated scoliosis continues to deteriorate beyond adolescence,
 and curves that progress beyond 50 degrees can lead to chronic back pain, cardiopulmonary
 compromise, poor cosmesis and negative psychological impact. Hence, surgical correction of
 the deformity by instrumented spinal fusion is recommended when curves reach 50 degrees.
 Although surgical risks have decreased with improved techniques, surgeries for scoliosis
 correction still carry significant medical co-morbidities, psychological stress to the
 children and their families, and substantial financial burden on healthcare. Effective
 non-operative strategies to prevent curve progression during adolescence are needed.
 Currently, the most effective non-operative treatment supported by high quality randomised
 controlled trial to prevent curve progression is by spinal bracing. In the Bracing in
 Adolescent Idiopathic Scoliosis Trial (BrAIST) study, bracing was effective in preventing
 curve progression to threshold for surgery in 72% of cases. The failure rate, therefore,
 remains substantially high despite the best available non-operative treatment. Previous
 studies have identified factors affecting brace success, including skeletal age, curve type,
 curve magnitude, and flexibility, but none of these is modifiable. Brace treatment requires a
 wholistic approach, and brace design and fabrication are important determinants of brace
 effectiveness. Traditional Boston-style thoracolumbosacral orthoses (TLSO), such as those
 used in the BrAIST study, can achieve in-brace coronal curve correction reliably but their
 effects on the 3D curve correction are highly variable. Since AIS is a 3D deformity, it is
 reasonable to postulate that braces which can achieve correction in all three planes have a
 higher chance of success.

 Rigo Chêneau orthoses (RCO) were developed approximately two decades ago by Dr. Manuel Rigo
 of Barcelona who made improvements to the Chêneau brace that French doctor Jacques Chêneau
 invented in 1978. RCO was designed with the intent to combine biomechanical forces in three
 dimensions, including curve derotation. They use an open pelvis design with anterior opening.
 Instead of focusing on one-dimensional correction, RCO treats scoliosis in all three
 dimensions and follows a unique curve Rigo classification protocol to guide brace design. RCO
 not only keeps the curves from getting worse as seen on an X-ray, but also corrects as much
 as possible the way the body looks. Every attempt is made to decrease the noticeable effects
 of scoliosis such as rib humps, uneven shoulders, hips which are translated or rotated, and
 centering the head over the pelvis. To achieve successful 3D scoliosis correction, in-brace
 Cobb angle correction must be 50% to be considered acceptable. This is often true and it is
 also true that the Cobb angle, which is easily assessed, has been the gold standard of
 measurement for brace quality. However, not all patients can and/or should be corrected to
 50% in-brace correction. In some cases, a 25% in-brace correction coupled with good 3D
 correction is acceptable and sufficient to prevent scoliosis progression, when greater Cobb
 angle correction would cause negative compensations. Overall, some patients are best served
 by targeting a low in-brace correction, whereas for others an 80% in-brace correction is both
 achievable and desirable.
Inclusion Criteria:

 -  Diagnosis of AIS

 -  Male or female from 10 to 15 year-old, inclusive, at the time of consent provided

 -  Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual
 fusion of the iliac apophysis) of 0, 1, or 2

 -  Cobb angle of 25-40

 -  No prior conservative or surgical treatment for AIS

 Exclusion Criteria:

 -  An underlying cause or association that may cause scoliosis

 -  Leg length discrepancies or lower limb deformities that may interfere with spinal
 posture

 -  Previous spinal surgery

 -  Cognitive impairment

 -  Those receiving any other forms of treatment including alternative medicine for the
 treatment of their scoliosis

 -  Those who are unable to return for follow-up to complete the trial