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Safety Study on a Wood-plastic Composite Cast

Primary Purpose

Distal Radius Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omnicast
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring cast, radius fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    splinting method

    Arm Description

    A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures.

    Outcomes

    Primary Outcome Measures

    How well will the material fulfil the demands of a splinting material
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2011
    Last Updated
    April 21, 2011
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01340391
    Brief Title
    Safety Study on a Wood-plastic Composite Cast
    Official Title
    A Wood-plastic Composite Cast - a New Ecological Splinting Method
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    April 2011 (Anticipated)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture
    Keywords
    cast, radius fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    33 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    splinting method
    Arm Type
    Experimental
    Arm Description
    A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures.
    Intervention Type
    Device
    Intervention Name(s)
    Omnicast
    Other Intervention Name(s)
    Omnicast by Onbone Finland
    Intervention Description
    dorsal splint 2-5 weeks
    Primary Outcome Measure Information:
    Title
    How well will the material fulfil the demands of a splinting material
    Description
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nina C Lindfors, MD, PhD, MSci
    Organizational Affiliation
    Helsinki University Central Hospital- Helsinki University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety Study on a Wood-plastic Composite Cast

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