Study on Wood-plastic Composite for Circumferential Casting

NCT01493167 | Completed Results

• 1 other identifier: 37/13/03/02/2011
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

Conditions

Bone Fracture; Radius Fracture; Ankle Fracture

Keywords

cast; splint; circumferential casting; casting techniques; fracture in extremity

Outcome Measures

Primary Outcomes (1)

• Efficient Casting With Woodcast Circular System

  Efficient casting conduc ted with Novel Woodcast material

  1 - 6 weeks

Study Arms (1)

limb casting/splinting

OTHER

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

Other: limb casting/splinting

Interventions

limb casting/splinting OTHER

ankle and arm cast

limb casting/splinting

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onbone Oy: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Fractures, Bone; Radius Fractures; Ankle Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Forearm Injuries; Arm Injuries; Ankle Injuries; Leg Injuries

Results Point of Contact

• Title: Dr Nina Linfors
• Organization: Helsinki University Hospital

nina.c.lindfors@hus.fi

358 9 4711

Study Officials

• Nina C Lindfors, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 5, 2017
• Results First Posted: November 15, 2016

Record last verified: 2014-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)