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A comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developed brace.

A comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developed brace. - comparison of two scoliosis bracing methods

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32933
Enrollment
6
Registered
2009-07-14
Start date
2009-12-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathische scoliose idiopathic scoliosis

Interventions

- spinal X-rays with each 0,135mSv - non-invasive pressure measurements with NOVEL pressure measurement device

Sponsors

Orthopaedie
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)