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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Onbone Oy
ClinicalTrials.gov Identifier:
NCT01493167
First received: December 13, 2011
Last updated: November 25, 2013
Last verified: May 2013

December 13, 2011
November 25, 2013
December 2011
May 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
Not Provided
Non-Probability Sample

Healthy patients with fracture in extremity Age range of patients 0-90 years

  • Bone Fracture
  • Radius Fracture
  • Ankle Fracture
Other: WOODCAST casting/splinting product
extremity immobilization
Patient age 0-90 years. Patient treatment requires extremity immobilization.
Intervention: Other: WOODCAST casting/splinting product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
May 2014
May 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
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01493167
37/13/03/02/2011
No
Onbone Oy
Onbone Oy
Not Provided
Principal Investigator: Nina C Lindfors, MD PhD Helsinki University Central Hospital
Onbone Oy
May 2013

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