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Study on Wood-plastic Composite for Circumferential Casting (WOODCAST)

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ClinicalTrials.gov Identifier: NCT01493167
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : November 15, 2016
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Bone Fracture Radius Fracture Ankle Fracture Other: limb casting/splinting

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Circumferential Casting Techniques With WOODCAST
Study Start Date : December 2011
Primary Completion Date : August 2014
Study Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
limb casting/splinting
Patient age 0-90 years. Patient treatment requires extremity immobilization
Other: limb casting/splinting
ankle and arm cast

Outcome Measures

Primary Outcome Measures :
  1. Efficient Casting With Woodcast Circular System [ Time Frame: 1 - 6 weeks ]
    Efficient casting conduc ted with Novel Woodcast material

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493167

Helsinki University Hospital
Helsinki, Finland
Sponsors and Collaborators
Onbone Oy
Principal Investigator: Nina C Lindfors, MD PhD Helsinki University Central Hospital
More Information

Responsible Party: Onbone Oy
ClinicalTrials.gov Identifier: NCT01493167     History of Changes
Other Study ID Numbers: 37/13/03/02/2011
First Posted: December 15, 2011    Key Record Dates
Results First Posted: November 15, 2016
Last Update Posted: July 5, 2017
Last Verified: December 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Onbone Oy:
circumferential casting
casting techniques
fracture in extremity

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Ankle Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries