Bone FractureWOODCASTNCT01493167
Study on Wood-plastic Composite for Circumferential Casting
A study testing limb casting/splinting in people with Bone Fracture and Radius Fracture, run by Onbone Oy at 1 site in Finland.
Trial summary
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Bone Fracture, Radius Fracture, Ankle Fracture
- What is being tested?
- limb casting/splinting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient treatment involves circular casting;
- age 0-90 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 extremity yo be treated;
- a multiple injured extremity;
- decreased co-operation of the patient;
- malignancy;
- an illness affecting the general health.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Circumferential Casting Techniques With WOODCAST
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
Read the 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.
- Conditions
- Bone Fracture, Radius Fracture, Ankle Fracture
- Being tested
- limb casting/splinting
- Keywords
- cast, splint, circumferential casting, casting techniques, fracture in extremity
- Medical subject headings
- Fractures, Bone, Radius Fractures, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limb casting/splintingOther
ankle and arm cast
| Study group | Role | What they receive |
|---|---|---|
| limb casting/splinting | Other | Patient age 0-90 years. Patient treatment requires extremity immobilization Receives: Other: limb casting/splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficient Casting With Woodcast Circular System
Efficient casting conduc ted with Novel Woodcast material
Measured: 1 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onbone Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nina C Lindfors, MD PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493167
- Sponsor's protocol ID
- 37/13/03/02/2011
- Acronym
- WOODCAST
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2011
- Last updated
- 5 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Circumferential Casting Techniques With WOODCAST
- ClinicalTrials.gov ID
- NCT01493167
- Acronym / sponsor ID
- WOODCAST / 37/13/03/02/2011
- Conditions
- Bone Fracture, Radius Fracture, Ankle Fracture
- Keywords
- cast, splint, circumferential casting, casting techniques, fracture in extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Onbone OyIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| limb casting/splinting | Other | Other: limb casting/splintingPatient age 0-90 years. Patient treatment requires extremity immobilization |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patient treatment involves circular casting;
- age 0-90 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 extremity yo be treated;
- a multiple injured extremity;
- 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 |
|---|---|---|
| limb casting/splintingankle and arm cast | Other | limb casting/splinting |
Primary outcome
Efficient Casting With Woodcast Circular System
Time frame: 1 - 6 weeks
Efficient casting conduc ted with Novel Woodcast material
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing limb casting/splinting in people with Bone Fracture and Radius Fracture, run by Onbone Oy at 1 site in Finland.
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: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficient Casting With Woodcast Circular System (time frame: 1 - 6 weeks). 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 5 Jul 2017.