Distal Radius Fracture Clinical Trial
Official title:
A Wood-plastic Composite Cast - a New Ecological Splinting Method
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.
Status | Enrolling by invitation |
Enrollment | 33 |
Est. completion date | June 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | How well will the material fulfil the demands of a splinting material | 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. | 1 year | Yes |
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