Back to resultsStudy on Wood-plastic Composite for Circumferential Casting (WOODCAST)
Primary Purpose
Bone Fracture, Radius Fracture, Ankle Fracture
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
limb casting/splinting
Sponsored by
About this trial
This is an interventional treatment trial for Bone Fracture focused on measuring cast, splint, circumferential casting, casting techniques, fracture in extremity
Eligibility 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.
Sites / Locations
- Helsinki University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
limb casting/splinting
Arm Description
Patient age 0-90 years. Patient treatment requires extremity immobilization
Outcomes
Primary Outcome Measures
Efficient Casting With Woodcast Circular System
Efficient casting conduc ted with Novel Woodcast material
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01493167
Brief Title
Study on Wood-plastic Composite for Circumferential Casting
Acronym
WOODCAST
Official Title
Study on Circumferential Casting Techniques With WOODCAST
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onbone Oy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture, Radius Fracture, Ankle Fracture
Keywords
cast, splint, circumferential casting, casting techniques, fracture in extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
limb casting/splinting
Arm Type
Other
Arm Description
Patient age 0-90 years. Patient treatment requires extremity immobilization
Intervention Type
Other
Intervention Name(s)
limb casting/splinting
Intervention Description
ankle and arm cast
Primary Outcome Measure Information:
Title
Efficient Casting With Woodcast Circular System
Description
Efficient casting conduc ted with Novel Woodcast material
Time Frame
1 - 6 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina C Lindfors, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on Wood-plastic Composite for Circumferential Casting
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