SOSORT BRACE STUDY

1. Aims
2. Participants
3. Confidentiality
4. Log-in
5. Timetable
6. Material
7. Management of scoliotic patients
8. Methods
9. Examination

STUDY DESIGN: multicenter, prospective, controlled, non-randomized.

1. creation of multicenter network for collaboration of medical professionals engaged in non-surgical management of idiopathic scoliosis (IS) in children and adolescents,
2. application of a unified protocol of evaluation of scoliotic patient by all participants of the study,
3. on-line real time collection of the data to a specially created internet database supervised by the SOSORT Board of the study,
4. collection of a relevant material containing an important number of scoliotic patients at risk of progression, presenting similar degree of deformity and similar risk of progression (Cobb angle 25 - 45 degrees and Risser test zero),
5. final evaluation of the outcome of braced patients versus unbraced patients as well as versus literature data on natural history of the disease,
6. assessment of evidence of therapeutic value of brace treatment and definition of the limits of rational indications for bracing in scoliotic patients
7. continuous education of participants and observers.

PARTICIPANTS OF THE STUDY (2):

Physicians concerned with non-surgical management of idiopathic scoliosis - specialists in rehabilitation or orthopaedics are invited to participate to the study. The initial group consists of members of the Study Group (Society) on Spinal Orthopaedic and Rehabilitation Treatment SOSORT - founded in 2004 in Barcelone. New participants accepting the conditions mentioned hereby are welcomed.

The participants engaged in the study are asked to carefully follow the criteria of inclusion of patients and the protocol of evaluation. All the participants having provided at least 10 patients with full documentation throughout the follow-up period will be considered the authors of the study. The participants assure storing of the patients data (medical records, photos, radiographs, surface topography images) till the end of the study and will render it accessible to the SOSORT Study Board on the request.

CONFIDENTIALITY (3):

The data collected in the on-line database are protected. The protection level is comparable to that assured by banks to protect financial transactions. However the participants are kindly asked to regularly check-up their computers with antivirus programs.

The patient's name is known exclusively by the Board of the study. Patient's records introduced into the system by one participant can be watched by all other participants with exception of patient's personal data. The initials and birth date appear as free-accessed information.

The photos cannot consider the patients face or any other element making possible the identification. Patients name should be covered on radiographs and surface topography records before introducing them into the database.

Names and e-mail addresses of physicians participating to the study are not confidential.

Log-in (4):

To provide any data each participant has to log-in to the system on the web page www.sosort.org

During the first log-in the participant is asked to fill the registration formula and to choose his personal login (user name). This login is a composition of letters or ciphers. It can be freely composed by the participant up to 8 characters with exclusion of special marks. The registration formula is sent to web page administrator. After having registered the participant will obtain his personal password by e-mail. This process will usually take a few minutes.

A registered participant is able to enter the database and to add new records or to watch the records already collected. Each participant can watch the records introduced by all other participants except patient's personal data. Each participant is able to modify records of his patient but not the others' records. The date and the nature of data modification are stored in the system and can be analyzed later. In this real-time longitudinal study the data have to be introduced simultaneously with patient's control, i.e during the treatment. The retrospective procedure is not admitted.

Timetable (5):

Protocol of the study was decided during Consensus SOSORT Meeting in Milan, January 2005. The preliminary study is being conducted for 6 months. Then the SOSORT Board decides on the definitive protocol.

Any suggestion concerning the protocol of the study as well as the functioning of the on-line database is welcomed.

Please send each message or question concerning the scientific aspect of the study to the following members of the Board of the SOSORT Brace Study:
grivastb@panafonet.gr - dr Theodoros B Grivas (Athens, Greece)
kotwicki@amp.edu.pl - dr Tomasz Kotwicki (Poznan, Poland)
stefano.negrini@isico.it - dr Stefano Negrini (Milano, Italy)
rigo.quera.rehab@eresmas.net - dr Manuel Rigo (Barcelone, Spain)
weiss.scolio.AKSK@t-online.de - dr Hans Rudolf Weiss (Bad Sobernheim, Germany)

Questions, messages or remarks concerning functioning of the web page and the on-line database should be sent to:
kotwicki@amp.edu.pl - dr Tomasz Kotwicki
witold.dudziński@plusnet.pl - dr Witold Dudziński
tomasz.stryczynski@e-surf.pl - Tomasz Stryczyński (web page administrator)

Material (6):

The study concerns exclusively girls suffering from idiopathic scoliosis (IS) and fulfilling the inclusion criteria.

The inclusion criteria are established to provide a homogenous study group. They are as follows:

1. sex - female,
2. age - minimum 10 years of chronological age,
3. presence of clinical signs of puberty - minimum S2 or P2 in Tanner?s scale of maturation,
4. diagnosis of idiopathic scoliosis (see the definition below),
5. Cobb angle minimum 25 degrees, maximum 40 degrees,
6. Risser test zero or one.

Study group and control group

As some participants to this study may be convinced of the necessity of treatment with a brace while the others may be convinced of uselessness of such a treatment, the distribution of patients into the study and control groups cannot be made in a randomized way.

MANAGEMENT OF SCOLIOTIC PATIENTS (7):

The participants of the study are free in choosing the therapy they believe the most proper for their patients (bracing, physiotherapy, observation). The participants only are responsible for final results in front of the patients and their families. Especially the participants are free in ordering the kind of brace they believe to be the most effective. Brace modifications and changing according to patients' growth are not considered as the change of treatment. The participants are asked to provide photos of brace (front and back view) in order to objectively classify the type of brace. Both "rigid" and "soft" braces are possible.

Physiotherapy is usually ordered for braced patients. Type of physiotherapy depends on the participant's decision. Both the type of ordered physiotherapy and the estimated realization of orders (compliance) should be mentioned in the protocol. In this study from the methodological point of view the physiotherapy is considered of having no influence on natural history of idiopathic scoliosis. This is supposed to be truth until the opposite is proven by an evidence based study. Such a study will be simultaneously carrying out by Sosort (Sosort Physiotherapy Study), Dr Stefano Negrini as the Chairman (stefano.negrini@isico.it). In case of conclusive results making into evidence influence of a specific type of physiotherapy on natural history of IS - the patients managed with this physiotherapy will be considered as "brace and physiotherapy treated group". Patients from control group may practice sport and exercises improving their general physical status. These patients will be considered as pure controls however the Sosort will analyze the activity of the patients in order to estimate the eventual impact on scoliosis.

METHODS (8):

The documentation of the patient is stored by the participant of the study. It should be accessible to be presented to the Board of Sosort Brace Study at any moment of the research program. Data are introduced to the protocol by the participant and he is the only to be responsible for providing reliable data.

It is vital to follow the precise protocol of evaluation of the patient. The data considered are: history, clinical examination, scoliometer value, radiographic parameters, surface topography parameters, respiratory assessment. The full protocol may be difficult to follow for lack of special equipment or time. This is why two options are proposed: a simple rapid protocol (BMG - basic method group) or more complex protocol (AMG - advanced method group). The participant is free to choose the protocol however he should maintain the same protocol for each evaluation of the same patient during the whole study.

EXAMINATION (9):

History
Age of onset of scoliosis.
This study will concern exclusively patients being adolescent (after the start of puberty) - by the definition of inclusion criteria. However it does not mean that they present adolescent idiopathic scoliosis (4). According to the age of onset, the patients can present early onset IS (juvenile) or adolescent IS. The nomenclature committee!
The age of onset of scoliosis is often difficult to find out. The participants are asked to indicate the source of the information on the onset: 1/ radiograph, 2/ medical record, 3/ paramedical professional's opinion (school nurse, gymnast teacher etc.), 4/ parents' opinion. If reasonable answer is difficult, the interrogation point (?) is given. Only radiograph or medical records are considered reliable in determination of the age of onset - to discuss in Milan.

The family history
Existence of scoliosis within family is identified on: 1/ clinical examination of parents by the participant of the study (Adams' forward bending test) or 2/ radiographs of family members provided.

Clinical examination
Puberty has to be assessed according to Tanner scale (Figures...). Size and weight are noted. Other parameters to discuss in Milan.
Scoliometer examination
Angle of Trunk Rotation (ATR) value is measured with scoliometer. The Bunnell scoliometer is recommended, alternatively the Pruijs scoliometer is accepted. The participant is asked to indicate the type of scoliometer he uses.
The scoliometer is used in forward bending test separately for thoracic and lumbar levels. (Figures ...).

Radiographic examination
Radiological data (BMG parameters: Cobb angle, Risser test, Perdriolle apical vertebra axial rotation; AMG additional parameters: kyphosis and lordosis angle) are produced by one or more Board Members delegated as experts by the Board of Sosort Brace Study. The measurements are made on the digital photos of radiographs provided by participants. The photos of high resolution (3 megapixels minimum) should be sent as "jpeg" or "pdf" or "tiff" files. Systematic storing of the images on hard discs will be assured in order to prevent blockage of the on-line database, nevertheless the participant is asked to store his copies of all images introduced into the database till the end of the study.
The progression factor, according to Lonstein and Carlson (2) will be automatically calculated by the system on the base of the formula:

                                    Cobb angle - 3 x Risser sign
Progression factor = -------------------------------------
                                    chronological age

Surface topography examination
Surface topography measurements are provided by the participant. The participant should indicate the system he uses: Moire, raster stereography, Isis, Quantec, digital photo. The parameters studied are: 1/ Suzuki and Asher POTSI (6) 2/ Suzuki HUMP SUM (5). The detailed procedure for getting these parameters is present in the references and will be published on Sosort web page by authors' permission. In some surface topography equipment a small software modification can be helpful to obtain semiautomatically POTSI and Hump Sum. Otherwise they can be measured manually. The originals of images that underwent analysis should be stored by the participant till the end of the study.

Respiratory examination
Respiratory evaluation is made by the participant. The parameters are ...............
To be discussed in Milano

PROTOCOLS FOR BASIC AND ADVANCED GROUP
are accessible on-line on web page www.sosort.org

History
      - birth date (yyyy-mm-dd)
      - age of onset of scoliosis (known and documented/unknown or not documented, in years)
      - scoliosis in relatives (yes/no, which relatives)
      - age of menarche (months and years of age)

Birth date will constitute the part of patient's personal number: yyyy-mm-dd-00 (for example 1994-11-27-04)

Clinical parameters:	size weight Tanner scale
Scoliometer ATR in degrees:	thoracic lumbar
Radiographic evaluation:	frontal thoracic Cobb angle frontal lumbar Cobb angle Perdriolle thoracic Perdriolle lumbar Risser value

ADDITIONAL PARAMETERS IN ADVANCED METHOD GROUP

Radiographic evaluation: (lateral radiograph)	- thoracic kyphosis - sagittal Cobb angle - lumbar lordosis - sagittal Cobb angle
Surface topography:	POTSI index Hump Sum
Respiratory evaluation:

GLOSSARY OF USEFULL DEFINITIONS AND TERMS

Idiopathic scoliosis

The definition of a lateral curvature of the spine of at least 10 degrees on a frontal radiograph is supported by Scoliosis Research Society.
Descriptive definition was discussed during last SOSORT Meeting in Milan 2005. The following conditions should be fulfilled:

1. developmental deformity of spine and trunk
2. unknown etiology
3. three-dimensional deformity including: a/ lateral deviation in frontal plane, b/ disturbance of sagittal physiological curvatures of the spine, c/ vertebral axial rotation in the transverse plane
4. frontal Cobb angle minimum 10 degrees
5. progression related to rapid spinal growth

REFERENCES

1. Kotwicki T, Dudziński W, Szulc A: Protocol for the prospective study on the effectiveness of bracing for scoliosis. Ped. Rehab. 2004; 7: 58.
2. Lonstein JE, Carlson JM: The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg 1984; 66-A: 1061-1071.
3. McCarthy RE: Evaluation of the patient with deformity [in:] The Pediatric Spine, Weinstein SL ed., Raven Press 1994: 185-224.
4. Stagnara P: Spinal deformity. Butterworths, 1988: 3-28 (Patient evaluation).
5. Suzuki N et al.: Application of Moire topography to spinal deformity. Moire Fringe Topography and Spinal Deformity, Pergamon Press, 1988: 225-240.
6. Suzuki N, Inami T, Ono T, Kohno K, Asher MA: Analysis of posterior trunk symmetry index (POTSI) in scoliosis. [in:] Research into Spinal Deformities 2, Stokes IAF ed., IOS Press 1999; 59: 81-84.