Safety Study on a Wood-plastic Composite Cast
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture||Device: Omnicast||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: splinting method
A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures.
dorsal splint 2-5 weeks
Other Name: Omnicast by Onbone Finland
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340391
|Principal Investigator:||Nina C Lindfors, MD, PhD, MSci||Helsinki University Central Hospital- Helsinki University|