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Safety Study on a Wood-plastic Composite Cast

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01340391
First received: March 28, 2011
Last updated: April 21, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Distal Radius Fracture
 Device: Omnicast

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Wood-plastic Composite Cast - a New Ecological Splinting Method

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • How well will the material fulfil the demands of a splinting material [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 33
Study Start Date: August 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340391

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

No publications provided

Responsible Party: Nina Lindfors / Senior lecturer, Töölö Hospital
ClinicalTrials.gov Identifier: NCT01340391     History of Changes
Other Study ID Numbers: HUCS
Study First Received: March 28, 2011
Last Updated: April 21, 2011
Health Authority: Finland:National Supervisory Authority for Welfare and Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013