Safety Study on a Wood-plastic Composite Cast

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340391
Recruitment Status : Unknown
Verified March 2011 by Helsinki University Central Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Information provided by:
Helsinki University Central Hospital

Brief Summary:
An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Device: Omnicast Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Wood-plastic Composite Cast - a New Ecological Splinting Method
Study Start Date : August 2009
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: splinting method
A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures.
Device: Omnicast
dorsal splint 2-5 weeks
Other Name: Omnicast by Onbone Finland

Primary Outcome Measures :
  1. How well will the material fulfil the demands of a splinting material [ Time Frame: 1 year ]
    The aim of the study was to evaluate how well the material fulfils the demands of a splinting material, the subjective satisfaction of the treatment and the orthopaedic technicians´opinion of the material.The following parameters will be detected: immobilisation-time, conservative / operative treatment, re-reposition, mechanical properties of the cast, skin appearance or irritation caused by the cast, allergic reactions and subjective opinion.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • distal radius fracture not older than 14 days
  • age 17-90 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 upper extremity
  • a multiple injured hand
  • decreased co-operation of the patient
  • malignancy
  • an illness affecting the general health

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340391

Sponsors and Collaborators
Helsinki University Central Hospital
Principal Investigator: Nina C Lindfors, MD, PhD, MSci Helsinki University Central Hospital- Helsinki University

Responsible Party: Nina Lindfors / Senior lecturer, Töölö Hospital Identifier: NCT01340391     History of Changes
Other Study ID Numbers: HUCS
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: March 2011

Keywords provided by Helsinki University Central Hospital:
cast, radius fracture

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