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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01340391
Other study ID # HUCS
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 28, 2011
Last updated April 21, 2011
Start date August 2009
Est. completion date June 2011

Study information

Verified date March 2011
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland:National Supervisory Authority for Welfare and Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Omnicast
dorsal splint 2-5 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Outcome

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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