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SOSORT BRACE STUDY



Multicenter, multinational, prospective, controlled, non randomized study organized under the auspices of the SOSORT

The aim of the study is to improve care of children and adolescents suffering from progressive  trunk deformity of an unknown cause: idiopathic scoliosis.
The purpose of undertaking the SOSORT BRACE STUDY is to increase the evidence for or against the non-surgical treatment of progressive idiopathic scoliosis during adolescence. As stated in the recent Cochrane Review [ ] there is a weak evidence in favour of bracing but the level of evidence of the existing studies is low. A randomized controlled trial (RCT) named BRAIST, organized in the USA, is being done, however there is no such a study in Europe since the last Dutch attempt has failed due to refusal of most parents to randomize their children between bracing and observation [ ].
The first aim of the SOSORT BRACE STUDY study is to prospectively collect the clinical and radiological data of the patients who meet the inclusion criteria and are being treated with a brace or are under observation. 
 

You will find here the description of the study as well as the instruction how to participate in it.

If you are a professional of conservative scoliosis care, if you are ready to provide your results and you agree to follow the common protocol of evaluation, you are welcome to become a participant of the SOSORT BRACE STUDY as well as a possible co-author of the future publication.

If you are taking care of scoliotic children but you do not practise the non-surgical management, you are also welcome to participate to this study. Your contribution may be important in verification of the effectiveness of various therapeutic methods as the children being under your care will form a control group.

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Aims

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

 

AIMS OF THE STUDY (1):

Steps of the study (1)

1. creation of multicenter network for collaboration of medical professionals engaged in non-surgical management of idiopathic scoliosis (IS) in children and adolescents,

  1. 2. application of a unified protocol of evaluation of scoliotic patient by all participants of the study,
  2. 3. on-line real time collection of the data to a specially created internet database supervised by the SOSORT Board of the study,
  3. 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),
  4. 5. final evaluation of the outcome of braced patients versus unbraced patients as well as versus literature data on natural history of the disease,
  5. 6. assessment of evidence of therapeutic value of brace treatment and definition of the limits of rational indications for bracing in scoliotic patients
  6. 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 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. They are not entered in the database. They remain the property of the author but may be used for publication.

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.editgrid.com

Each participant will receive a username and password.

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)

Questions, messages or remarks concerning functioning of the web page and the on-line database should be sent to the This email address is being protected from spambots. You need JavaScript enabled to view it.:

 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

Study group:
The number of patients in study group will result from recruitment and will be established during the study. Considering sex, age, growth period, scoliosis angle and skeletal immaturity - it is supposed that all patients from the study group present a progressive scoliosis.

Control group:
Patients managed with observation.
The control group is supposed to come from orthopaedic surgeons not using bracing for scoliosis; patients refusing bracing are also concerned.

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 (This email address is being protected from spambots. You need JavaScript enabled to view 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

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 can 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

Frontal thoracic Cobb angle; frontal lumbar or thoraco-lumbar Cobb angle:

the angle of scoliosis measured on frontal standing radiograph between superior vertebral end plate of superior limit vertebra and inferior vertebral end plate of inferior limit vertebra. Superior and inferior limit vertebrae are defined as most tilted vertebrae of the curve. They have usually neutral or minimal axial rotation and are situated closely to central sacral line.

To minimize intra and interobserver error all the radiological measurements will be done by SOSORT experts. The participant is not charged to make them himself.

Various vertebral levels may be chosen to measure angle of thoracic kyphosis or lumbar lordosis on the lateral radiograph. For this protocol it was decided as follows:

Sagittal thoracic Cobb angle: angle measured on lateral standing radiograph between superior vertebral plate of Th5 and inferior vertebral plate of Th12.

Sagittal lumbar Cobb angle: angle measured on lateral standing radiograph between superior vertebral plate of L1 and superior plate of sacrum.

A lot of additional radiological parameters are accessible on lateral radiograph. The digital images of radiographs will be stocked. The SOSORT Board will discuss on enlarging this study or making further research concerning more profound radiological evaluation. In case that an enlarged protocol is proposed, each participant will be consulted in order to ask his acceptance to use the provided data for other studies. As previously mentioned, each participant having provided at least ten cases will be taken into consideration for authorship of any eventual future publication.

 


REFERENCES

  1. Kotwicki T, Dudzi?Ö‚Äûski 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.