WOODCAST: Study on Wood-plastic Composite for Circumferential Casting

• Sponsor: Onbone Oy (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01493167
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

Condition or Disease	Intervention/Treatment	Phase
Bone Fracture; Radius Fracture; Ankle Fracture	Other: limb casting/splinting	N/A

Detailed Description

An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on Circumferential Casting Techniques With WOODCAST
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: limb casting/splinting Patient age 0-90 years. Patient treatment requires extremity immobilization	Other: limb casting/splinting; ankle and arm cast

Outcome Measures

Primary Outcome Measures

1. Efficient Casting With Woodcast Circular System [1 - 6 weeks]

   Efficient casting conduc ted with Novel Woodcast material

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient treatment involves circular casting;

• age 0-90 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 extremity yo be treated;

• a multiple injured extremity;

• decreased co-operation of the patient;

• malignancy;

• an illness affecting the general health.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki		Finland

Sponsors and Collaborators

• Onbone Oy

Investigators

• Principal Investigator: Nina C Lindfors, MD PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Onbone Oy
• ClinicalTrials.gov Identifier: NCT01493167
• Other Study ID Numbers: 37/13/03/02/2011
• First Posted: Dec 15, 2011
• Last Update Posted: Jul 5, 2017
• Last Verified: Dec 1, 2014

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Onbone Oy: cast; splint; circumferential casting; casting techniques; fracture in extremity
• Additional relevant MeSH terms: Fractures, Bone; Radius Fractures; Ankle Fractures

Study Results

Participant Flow

Arm/Group Title	Limb Casting/Splinting
Arm/Group Description	Patient age 0-90 years. Patient treatment requires extremity immobilization limb casting/splinting: ankle and arm cast
Period Title: Overall Study
STARTED	97
COMPLETED	97
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Woodcast Circular System Casts
Arm/Group Description	Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast
Overall Participants	97
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	85 87.6%
>=65 years	12 12.4%
Sex: Female, Male (Count of Participants)
Female	59 60.8%
Male	38 39.2%
Region of Enrollment (participants) [Number]
Finland	97 100%

Outcome Measures

1. Primary Outcome

Title	Efficient Casting With Woodcast Circular System
Description	Efficient casting conduc ted with Novel Woodcast material
Time Frame	1 - 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Limb Casting/Splinting
Arm/Group Description	Patient age 0-90 years. Patient treatment requires extremity immobilization limb casting/splinting: ankle and arm cast
Measure Participants	97
Number [participants]	90 92.8%

Adverse Events

Time Frame	1-6 weeks (whole treatment period)
Adverse Event Reporting Description	All Adverse Events were monitored/collected, but none observed.
Arm/Group Title	Limb Casting/Splinting
Arm/Group Description	Patient age 0-90 years. Patient treatment requires extremity immobilization limb casting/splinting: ankle and arm cast
All Cause Mortality
	Limb Casting/Splinting
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Limb Casting/Splinting
	Affected / at Risk (%)	# Events
Total	0/97 (0%)
Other (Not Including Serious) Adverse Events
	Limb Casting/Splinting
	Affected / at Risk (%)	# Events
Total	0/97 (0%)

Limitations/Caveats

[Not Specified]

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.