NCT01340391

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 22, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

March 28, 2011

Last Update Submit

April 21, 2011

Conditions

Distal Radius Fracture

Keywords

cast, radius fracture

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

splinting method

EXPERIMENTAL

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

Device: Omnicast

Interventions

OmnicastDEVICE

dorsal splint 2-5 weeks

Also known as: Omnicast by Onbone Finland
splinting method

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • distal radius fracture not older than 14 days
  • age 17-90 years
  • mother tongue finnish or swedish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist FracturesRadius Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneForearm Injuries

Study Officials

  • Nina C Lindfors, MD, PhD, MSci

    Helsinki University Central Hospital- Helsinki University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2011

First Posted

April 22, 2011

Study Start

August 1, 2009

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

April 22, 2011

Record last verified: 2011-03