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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onbone Oy
ClinicalTrials.gov Identifier:
NCT01493167
First received: December 13, 2011
Last updated: December 3, 2014
Last verified: December 2014

December 13, 2011
December 3, 2014
December 2011
August 2014   (final data collection date for primary outcome measure)
Efficacy study for new design of scafoideum and ankle casts. [ Time Frame: 1 - 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01493167 on ClinicalTrials.gov Archive Site
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Study on Wood-plastic Composite for Circumferential Casting
Study on Circumferential Casting Techniques With WOODCAST
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Healthy patients with fracture in extremity Age range of patients 0-90 years
  • Bone Fracture
  • Radius Fracture
  • Ankle Fracture
Other: limb casting/splinting
ankle and arm cast
limb casting/splinting
Patient age 0-90 years. Patient treatment requires extremity immobilization
Intervention: Other: limb casting/splinting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
December 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
up to 90 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01493167
37/13/03/02/2011
No
Not Provided
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Onbone Oy
Onbone Oy
Not Provided
Principal Investigator: Nina C Lindfors, MD PhD Helsinki University Central Hospital
Onbone Oy
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP