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Study on Wood-plastic Composite for Circumferential Casting (WOODCAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onbone Oy
ClinicalTrials.gov Identifier:
NCT01493167
First received: December 13, 2011
Last updated: September 26, 2016
Last verified: December 2014
Results First Received: March 30, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bone Fracture
Radius Fracture
Ankle Fracture
Intervention: Other: limb casting/splinting

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Limb Casting/Splinting

Patient age 0-90 years. Patient treatment requires extremity immobilization

limb casting/splinting: ankle and arm cast


Participant Flow:   Overall Study
    Limb Casting/Splinting
STARTED   97 
COMPLETED   97 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Woodcast Circular System Casts Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast

Baseline Measures
   Woodcast Circular System Casts 
Overall Participants Analyzed 
[Units: Participants]
 97 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   85 
>=65 years   12 
Gender 
[Units: Participants]
 
Female   59 
Male   38 
Region of Enrollment 
[Units: Participants]
 
Finland   97 


  Outcome Measures

1.  Primary:   Efficient Casting With Woodcast Circular System   [ Time Frame: 1 - 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Nina Linfors
Organization: Helsinki University Hospital
phone: 358 9 4711
e-mail: nina.c.lindfors@hus.fi



Responsible Party: Onbone Oy
ClinicalTrials.gov Identifier: NCT01493167     History of Changes
Other Study ID Numbers: 37/13/03/02/2011
Study First Received: December 13, 2011
Results First Received: March 30, 2016
Last Updated: September 26, 2016
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health