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Performance Evaluation of Adjustable External Splint for Wrist Fracture (Distal Radius Fracture)

Evaluation of clinical effectiveness and practicality of adjustable external splint(Zero-Cast) for distal radius fracture against conventional plaster cast

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001118695
Enrollment
300
Registered
2014-10-22
Start date
2014-11-10
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Distal radius fracture (wrist fracture) is a common an injury and accounts for approximately 1/3rd of wall wrist injuries. These type of fractures can managed in several ways and are determined by several factors. In fractures that have not displaced or are stable once they have been set they usually do not require an operation and are kept in position by the use of an external plaster. This current method of keeping the fracture well positioned often delivers acceptable results. However, plaster can be inconvenient to the patient. Patients find it cumbersome, they often report problems like, itching, difficult to maintain hygiene, inability to use the limb. It often needs regular changing of plaster during course of treatment. The adjustable external splint (Zero-Cast) was designed to have similar clinical functionality as traditional plaster cast, however aimed to reduce the problems reported by traditional plaster immobilization. This research has been designed to assess whether the splint can maintain adequate fracture position and be more comfortable and manageable both for the patient and the Doctor/Technician managing the fracture.

Interventions

Duration of Use: until fracture has healed Healthcare Professionals will be administering the splint and giving instructions on how to maintain the splint. Any adjustment of the splint position will be done by healthcare professional. Name of the Splint: Zero-cast (Adjustable External Splint for Distal Radius Fracture) Participants will be followed up by healthcare professional at week 1,2 and 6.

Sponsors

Surgisplint Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
4 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Extraarticular Distal radius fracture less than 6cm from joint surface Patient with distal radius fracture configuration who can be treated by below elbow plaster cast

Exclusion criteria

No patient under age of 4 or over 75 Patient unable to provide informed consent Patient who cannot complete the study protocol Patient who requires surgical intervention Patient with previous deformity Patient who does not belong to defined size range Patient with skin disease and allergic reactions Patient with open fractures. Patient with multiple fractures Patient with multiple injuries

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026