Safety Study on a Wood-plastic Composite Cast

Helsinki University Central Hospital33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Distal Radius Fracture

Interventions

OmnicastDEVICE

dorsal splint 2-5 weeks

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

How well will the material fulfil the demands of a splinting material

The 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.

Time frame: 1 year

Data from ClinicalTrials.gov

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