Study on Wood-plastic Composite for Circumferential Casting

NCT ID: NCT01493167

Last Updated: 2017-07-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

Detailed Description

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An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.

Conditions

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Bone Fracture Radius Fracture Ankle Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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limb casting/splinting

Patient age 0-90 years. Patient treatment requires extremity immobilization

Group Type OTHER

limb casting/splinting

Intervention Type OTHER

ankle and arm cast

Interventions

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limb casting/splinting

ankle and arm cast

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient treatment involves circular casting;
* age 0-90 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 extremity yo be treated;
* a multiple injured extremity;
* decreased co-operation of the patient;
* malignancy;
* an illness affecting the general health.
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onbone Oy

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina C Lindfors, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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37/13/03/02/2011

Identifier Type: -

Identifier Source: org_study_id

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