Research Protocols

Initial studies at Ste Justine Hospital, Montreal and six Beta sites in the USA and France looked at the efficacy of SpineCor treatment with different patient cohorts, 15º - 30º and 31º - 50º, comparing results to other treatments.

The later prospective randomised protocol studies were commenced at selected centres comparing SpineCor treated patients with an untreated control group.

The objective of the study was to quantify the difference that treatment made to the natural evolution of Idiopathic Scoliosis.

For ethical reasons, this study could only include patients from the 15º - 30º cohort.

Although protocols vary from site to site in terms of comparison basis, the general inclusion and exclusion criteria for all the studies were as follows:

Inclusion criteria

• Must have a confirmed idiopathic scoliosis diagnosis. There must be no significant pathological malformation of the spine under X-ray examination.
  
• Girl or boy.
  
• Initial Cobb angle equal or above 15° Cohort 1, 31º Cohort 2
  
• Initial Cobb angle equal or less than 30° Cohort 1, 50° Cohort 2
  
• Risser 0, 1 or 2.
  
• Scoliosis with suspected high risk of evolution (i.e. family history or other prognosis factors) or proven progressive (Cobb angle increase of 5° or more in the last six months).

Exclusion criteria

• Postural scoliosis: When an X-ray shows an almost complete reduction, the diagnosis must be reviewed because it could be a postural scoliosis and not a true idiopathic scoliosis [18].
  
• Patient who cannot accept all the protocol rules.
  
• Patient who has received a previous treatment such as rigid brace or other, except for physiotherapy.
  
• Patient with a congenital malformation of the spine such as Spina Bifida Aperta, Spondylolisthesis.