SpineCor Treatment Procedure - Pediatric Scoliosis Brace

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TREATMENT PROCEDURE

Brace Fitting

In the first visit, some evaluations are required in order to fit the SpineCor® brace.

To help to perform these evaluations, some anatomical points can be mark on your back with a make-up pencil, which will be erased at the end of the visit.

For all the evaluations, you will be asked to place your feet in a foot template to avoid any influence of an eventual change of your position on the evaluations.

evaluation

Then, the following evaluations will be performed:

Clinical Evaluation - Evaluation will be conducted on your growth pattern and any postural abnormalities.

Radiological Evaluation - A radiological study is needed to evaluate the type of curve and its potential of progression. The x-rays required for this study are the following:

Frontal x-ray
Lateral x-ray
Supine x-ray (optional)

Note: All x-rays used for this study should have been done recently (a maximum of 1 month old) in order to have accurate information to evaluate the scoliosis curve.

The data resulting from the clinical and radiological exams are entered in the SpineCor Assistant Software, which will provide information to fit the brace correctly.

evaluation in brace

Once the brace is fitted, it is necessary to evaluate the effectiveness of the brace fitting performing the following exams:

Clinical Evaluation in Brace

Radiological Evaluation in Brace - 1 new frontal x-ray in brace is required to confirm the result.

At the end of the visit, all patients/parents will be shown how to perform their specific Corrective Movement and shown how to correctly fit the brace, maintaining an optimal corrective movement position, and how to take it off. Patients/parents should demonstrate by fitting the brace independently 2 – 3 times that they fully understand the correct fitting procedure. Each patient is provided with a Patient Manual with the instructions to fit the brace correctly and indications for its correct maintenance.

Follow-up Visits

Patients will be asked to visit regularly their bracing practitioner (doctor, orthotist or therapist) along the duration of the treatment for regular readjustments of the brace and to control the evolution of the curve. The frequency of the visits and the evaluations to be performed are as shown in the Standard SpineCor Protocol: The table below gives a summary of the basic evaluations and their frequency.

	1st Visit Brace Fitting	2nd Visit 1month after brace fitting	3rd Visit 3 months after brace fitting	Following visits every 3 months*
Verification of brace as worn by the patient		X	X	X
Clinical evaluation	X	X	X	X
Frontal x-ray without brace	X or x-rays < 1 month			Decision by MD but not normally necessary until brace weaning
Lateral x-ray without brace	X or x-rays < 1 month			Decision by MD according to evolution
Supine x-ray without brace	X Optional
Corrective Movement	X	X	X	X
Brace fitting / readjustment	X	X	X	X
P/A x-ray with brace (and shoe lift if prescribed)	X	X	X	Decision by MD but normally each 6 months
Lateral x-ray with brace (and shoe lift if prescribed)			X	Decision by MD but normally once per year

* Follow-up visits after the first 3 months of treatment are advised at 3 month intervals. This review period may be extended to 4 or 5 months only in cases where the prescribing doctor is confident that the progression risk is low. Extended review periods are not advised without great experience of SpineCor Treatment.

TREATMENT DURATION

The SpineCor® brace is worn for 20 hours per day. The 4-hour out of the brace period should be taken in two or more intervals during the least active part of the day. The brace MUST be worn while sleeping.

Average treatment duration for adolescent idiopathic scoliosis is 26 months. Bracing is not weaned before the following criteria are satisfied:

1. Risser 4+
2. 24 months post menarche
3. Minimum brace wearing duration of 18 months
4. With Brace and Without Brace x-rays show the same or very similar Cobb angles (5° or less difference)

Providing the above criteria are met, the patient should have developed a neuromuscular integration of the corrective movement strategy to maintain a stabile curve. Long term 5 year post treatment studies show 93% of cases do not increase their Cobb angles from the point of weaning.


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