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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493167
First Posted: December 15, 2011
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Onbone Oy
  Purpose
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Circumferential Casting Techniques With WOODCAST

Further study details as provided by Onbone Oy:

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


Enrollment: 97
Study Start Date: December 2011
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
limb casting/splinting
Patient age 0-90 years. Patient treatment requires extremity immobilization
Other: limb casting/splinting
ankle and arm cast

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Sponsors and Collaborators
Onbone Oy
Investigators
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 Submitted: December 13, 2011
First Posted: December 15, 2011
Results First Submitted: March 30, 2016
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:
cast
splint
circumferential casting
casting techniques
fracture in extremity

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


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