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

This study has been completed.
Information provided by (Responsible Party):
Onbone Oy Identifier:
First received: December 13, 2011
Last updated: December 3, 2014
Last verified: December 2014
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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Circumferential Casting Techniques With WOODCAST

Resource links provided by NLM:

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 ]

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)
Groups/Cohorts 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.

Ages Eligible for Study:   up to 90 Years   (Child, Adult, Senior)
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01493167

Helsinki University Hospital
Helsinki, Finland
Sponsors and Collaborators
Onbone Oy
Principal Investigator: Nina C Lindfors, MD PhD Helsinki University Central Hospital
  More Information

Responsible Party: Onbone Oy Identifier: NCT01493167     History of Changes
Other Study ID Numbers: 37/13/03/02/2011 
Study First Received: December 13, 2011
Last Updated: December 3, 2014
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

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

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Ankle Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries processed this record on October 21, 2016