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Safety Study on a Wood-plastic Composite Cast

A Wood-plastic Composite Cast - a New Ecological Splinting Method

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01340391
Enrollment
33
Registered
2011-04-22
Start date
2009-08-31
Completion date
2011-06-30
Last updated
2011-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

cast, radius fracture

Brief summary

An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.

Interventions

DEVICEOmnicast

dorsal splint 2-5 weeks

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* distal radius fracture not older than 14 days * age 17-90 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 upper extremity * a multiple injured hand * decreased co-operation of the patient * malignancy * an illness affecting the general health

Design outcomes

Primary

MeasureTime frameDescription
How well will the material fulfil the demands of a splinting material1 yearThe aim of the study was to evaluate how well the material fulfils the demands of a splinting material, the subjective satisfaction of the treatment and the orthopaedic technicians´opinion of the material.The following parameters will be detected: immobilisation-time, conservative / operative treatment, re-reposition, mechanical properties of the cast, skin appearance or irritation caused by the cast, allergic reactions and subjective opinion.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026