Distal Radius FractureNCT01340391
Safety Study on a Wood-plastic Composite Cast
A study testing Omnicast in people with Distal Radius Fracture, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Omnicast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- distal radius fracture not older than 14 days
- age 17-90 years
- mother tongue finnish or swedish
Who cannot join
- 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
About this study
Official title: A Wood-plastic Composite Cast - a New Ecological Splinting Method
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.
- Conditions
- Distal Radius Fracture
- Being tested
- Omnicast
- Keywords
- cast, radius fracture
- Medical subject headings
- Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnicastDevice
Also called Omnicast by Onbone Finland
dorsal splint 2-5 weeks
| Study group | Role | What they receive |
|---|---|---|
| splinting method | Experimental | A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures. Receives: Device: Omnicast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionApr 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nina C Lindfors, MD, PhD, MSci, Principal investigator, Helsinki University Central Hospital- Helsinki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340391
- Sponsor's protocol ID
- HUCS
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wood-plastic Composite Cast - a New Ecological Splinting Method
- ClinicalTrials.gov ID
- NCT01340391
- Acronym / sponsor ID
- HUCS
- Conditions
- Distal Radius Fracture
- Keywords
- cast, radius fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| splinting method | Experimental | Device: OmnicastA new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- distal radius fracture not older than 14 days
- age 17-90 years
- mother tongue finnish or swedish
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmnicastAlso: Omnicast by Onbone Finlanddorsal splint 2-5 weeks | Device | splinting method |
Primary outcome
How well will the material fulfil the demands of a splinting material
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina C Lindfors, MD, PhD, MSci principal investigator
Helsinki University Central Hospital- Helsinki University
Questions about this trial
What is this clinical trial studying?
A study testing Omnicast in people with Distal Radius Fracture, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How well will the material fulfil the demands of a splinting material (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2011.