Safety Study on a Wood-plastic Composite Cast

NCT ID: NCT01340391

Last Updated: 2011-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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splinting method

A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures.

Group Type EXPERIMENTAL

Omnicast

Intervention Type DEVICE

dorsal splint 2-5 weeks

Interventions

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Omnicast

dorsal splint 2-5 weeks

Intervention Type DEVICE

Other Intervention Names

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Omnicast by Onbone Finland

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Töölö Hospital

Principal Investigators

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Nina C Lindfors, MD, PhD, MSci

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital- Helsinki University

Other Identifiers

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HUCS

Identifier Type: -

Identifier Source: org_study_id

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