Ankle Fracture, Bone Fracture, Radius Fracture
Conditions
Keywords
cast, splint, circumferential casting, casting techniques, fracture in extremity
Brief summary
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
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.
Interventions
OTHERlimb casting/splinting
ankle and arm cast
Sponsors
Onbone Oy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficient Casting With Woodcast Circular System | 1 - 6 weeks | Efficient casting conduc ted with Novel Woodcast material |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Woodcast Circular System Casts Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast | 97 |
| Total | 97 |
Baseline characteristics
| Characteristic | Woodcast Circular System Casts |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants |
| Region of Enrollment Finland | 97 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 97 |
| serious Total, serious adverse events | 0 / 97 |
Outcome results
Primary
Efficient Casting With Woodcast Circular System
Efficient casting conduc ted with Novel Woodcast material
Time frame: 1 - 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Limb Casting/Splinting | Efficient Casting With Woodcast Circular System | 90 participants |