The purpose of this study is to compare two different braces in idiopatic scoliosis, by means of body brace interface pressure measurements and conventional spinal x-rays (anterior-posterior).
ID
Source
Brief title
Condition
- Other condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Health condition
idiopathische scoliose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary objective is to compare the two braces, the classic Boston brace
and new developed brace, by means of comparing body brace interface pressure
and measured Cobbs angles on the control X-rays.
Secondary outcome
Our secondary objective is optimize the scoliosis brace treatment to the
individual situation of each scoliosis patient by applying body brace interface
pressure measurements as well as the Cobbs angles correction in patients with
idiopathic scoliosis.
Background summary
Idiopathic scoliosis is a relatively common deformation starting with or just
before the growth spurt. Brace treatment is used to prevent progression and if
possible correction of the scoliosis. In order to achieve a good result the
brace should be worn for 23 hours, and during the whole growth period. Patients
are predominantly girls in the age between 8 to 16 year old. The long treatment
in combination with the difficult age of the patients makes sufficient
compliance and therefore effectiveness a challenge. Therefor our group, TNO
(organisation for science projects), Welldesign (industrial designer), IDEE
(Instrument Development Engineering & Evaluation), Orthopaedie 2000
(orthopaedic instrumentmaker)and department Orthopaedic Surgery of the Academic
Hospital Maastricht, developed a brace to get an higher compliance with the
same or better correction of the scoliosis.
Study objective
The purpose of this study is to compare two different braces in idiopatic
scoliosis, by means of body brace interface pressure measurements and
conventional spinal x-rays (anterior-posterior).
Study design
Single centre, single measurement, non-randomised observational study
Intervention
- spinal X-rays with each 0,135mSv
- non-invasive pressure measurements with NOVEL pressure measurement device
Study burden and risks
One non invasive, risk less interface pressure measurement session in each
brace lasting for 30 minutes, subsequently after or during the regular
scoliosis outpatient clinic visit. During this session, the patient has to
assume fifteen different postures, mimicking daily activity. The correction of
the scoliosis is measured on the spinal X-rays, which will be planned before
the pressure measurements. The total extra time is about 60 minutes.
P. Debyelaan 25
6229 HX Maastricht
Nederland
P. Debyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
- Patients with idiopathic scoliosis, who are treated with a scoliosis brace.
- Male and female patients
- Cobbs angle between 20o-40o at start of treatment.
- Patients who read and understand the METC approved patient information
- Patients who are willing to participate and have written permission from their parents / guardians.
- Patients in the age of 12-16 yrs
Exclusion criteria
- Patients requiring surgical treatment. (Cobbs angle >40o and progression)
- Patients with other back problems
- Patients with spine operations in the past.
- Patients with neurological signs
- Patients willing, but without parental / guardian permission.
- Patients without a working knowledge of Dutch
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26949.068.09 |
| Other | TC1815 |