Safety Study on a Wood-plastic Composite Cast
Not Applicable
- Conditions
- Distal Radius Fracture
- Interventions
- Device: Omnicast
- Registration Number
- NCT01340391
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- distal radius fracture not older than 14 days
- age 17-90 years
- mother tongue finnish or swedish
Exclusion Criteria
- open fracture
- other fractures or a previous fracture
- a previous or simultaneous tendon-, nerve- or vascular injury to the upper extremity
- a multiple injured hand
- decreased co-operation of the patient
- malignancy
- an illness affecting the general health
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description splinting method Omnicast A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures.
- Primary Outcome Measures
Name Time Method How well will the material fulfil the demands of a splinting material 1 year The aim of the study was to evaluate how well the material fulfils the demands of a splinting material, the subjective satisfaction of the treatment and the orthopaedic technicians´opinion of the material.The following parameters will be detected: immobilisation-time, conservative / operative treatment, re-reposition, mechanical properties of the cast, skin appearance or irritation caused by the cast, allergic reactions and subjective opinion.
- Secondary Outcome Measures
Name Time Method