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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: May 31, 2013
Last verified: May 2013
History of Changes
  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: WOODCAST casting/splinting product

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Circumferential Casting Techniques With WOODCAST

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Onbone Oy:

Primary Outcome Measures:
  • Efficacy study for new design of scafoideum and ankle casts. [ Time Frame: 1 - 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
extremity immobilization
Patient age 0-90 years. Patient treatment requires extremity immobilization.
 Other: WOODCAST casting/splinting product

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

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Onbone Oy
ClinicalTrials.gov Identifier: NCT01493167     History of Changes
Other Study ID Numbers: 37/13/03/02/2011
Study First Received: December 13, 2011
Last Updated: May 31, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

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

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

ClinicalTrials.gov processed this record on June 18, 2013