Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| limb casting/splinting | Other | Patient age 0-90 years. Patient treatment requires extremity immobilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| limb casting/splinting | Other | ankle and arm cast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficient Casting With Woodcast Circular System | Efficient casting conduc ted with Novel Woodcast material | 1 - 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nina C Lindfors, MD PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Limb Casting/Splinting | Patient age 0-90 years. Patient treatment requires extremity immobilization limb casting/splinting: ankle and arm cast |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Woodcast Circular System Casts | Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficient Casting With Woodcast Circular System | Efficient casting conduc ted with Novel Woodcast material | Posted | Number | participants | 1 - 6 weeks |
|
|
1-6 weeks (whole treatment period)
All Adverse Events were monitored/collected, but none observed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Limb Casting/Splinting | Patient age 0-90 years. Patient treatment requires extremity immobilization limb casting/splinting: ankle and arm cast |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nina Linfors | Helsinki University Hospital | 358 9 4711 | nina.c.lindfors@hus.fi |
Not provided
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D011885 | Radius Fractures |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D016512 | Ankle Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 97 |
| 0 |
| 97 |
Not provided
Not provided
| D007869 |
| Leg Injuries |