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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493167
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : November 15, 2016
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):
Onbone Oy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bone Fracture
Radius Fracture
Ankle Fracture
Intervention: Other: limb casting/splinting

  Participant Flow

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
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

  Baseline Characteristics

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
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]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      85  87.6% 
>=65 years      12  12.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      59  60.8% 
Male      38  39.2% 
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

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

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

Responsible Party: Onbone Oy Identifier: NCT01493167     History of Changes
Other Study ID Numbers: 37/13/03/02/2011
First Submitted: December 13, 2011
First Posted: December 15, 2011
Results First Submitted: March 30, 2016
Results First Posted: November 15, 2016
Last Update Posted: July 5, 2017