CClinicalTrials.gg
CompletedNCT01493167WOODCASTUpdated Jul 5, 2017Results posted

Study on Wood-plastic Composite for Circumferential Casting

An interventional study of limb casting/splinting in Bone Fracture, Radius Fracture and Ankle Fracture, sponsored by Onbone Oy. Completed at 1 site in Finland. Open to participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by Onbone Oy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Not applicable
Ages
Up to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bone Fracture
  • Radius Fracture
  • Ankle Fracture

Keywords

  • cast
  • splint
  • circumferential casting
  • casting techniques
  • fracture in extremity
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 97 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Onbone Oy is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient treatment involves circular casting;
  • age 0-90 years;
  • mother tongue finnish or swedish

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Other
    limb casting/splinting

    Patient age 0-90 years. Patient treatment requires extremity immobilization

    Other: limb casting/splinting

Interventions

  • Otherlimb casting/splinting

    ankle and arm cast

06

What researchers measure

Primary outcomes

  1. Efficient Casting With Woodcast Circular System

    Efficient casting conduc ted with Novel Woodcast material

    Time frame: 1 - 6 weeks

07

Results

Posted Nov 15, 2016

Participant flow

Participant flow — Overall Study
MilestoneLimb Casting/Splinting
Started97
Completed97
Not completed0

Outcome measures

PrimaryEfficient Casting With Woodcast Circular System

Efficient casting conduc ted with Novel Woodcast material

Time frame:
1 - 6 weeks
Reported as:
Number · participants
Efficient Casting With Woodcast Circular System
participantsLimb Casting/Splinting
Efficient Casting With Woodcast Circular System90

Adverse events

Collected over 1-6 weeks (whole treatment period). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Limb Casting/Splinting—0/97 (0%)0/97 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Woodcast Circular System Casts
<=18 years0
Between 18 and 65 years85
>=65 years12
Sex: Female, Male
Sex: Female, Male(Participants)Woodcast Circular System Casts
Female59
Male38
Region of Enrollment
Region of Enrollment(participants)Woodcast Circular System Casts
Finland97
08

Study locations

1 site
  • Helsinki University Hospital
    Helsinki, Finland
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01493167
Lead sponsor
Onbone Oy
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Dec 2011
Primary completion
Aug 2014
Completion
Dec 2014
Results posted
Nov 15, 2016
Last update
Jul 5, 2017

Study contacts

Nina C Lindfors, MD PhD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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