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
  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:


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
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 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 July 20, 2014