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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29387
Enrollment
6
Registered
2009-06-08
Start date
2009-06-09
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

None listed

Interventions

1. Conventional spinal x-rays
2. Pressure measurements.

Sponsors

Pieken in de Delta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with adolescent idiopathic scoliosis (age 12-16 yrs), who are treated with a scoliosis brace; 2. Male and female patients; 3. Cobbs angle between 20o-40o at start of treatment; 4. Patients who read and understand the METC approved patient information; 5. Patients who are willing to participate and have written permission from their parents / guardians.

Exclusion criteria

Exclusion criteria: 1. Patients requiring surgical treatment (Cobbs angle >40o and progression); 2. Patients with other back problems; 3. Patients with spine operations in the past; 4. Patients with neurological signs; 5. Patients with allergy of components of the brace or pressure measurement device; 6. Patients willing, but without parental / guardian permission; 7. 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.

Contacts

Public ContactL.W. Rhijn, van

Orthopaedic department Maastricht Academic Hospital Postbus 5800

lvr@sort.azm.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)