Skip to content

Wrist splint versus conventional casting for the management of wrist fractures.

A prospective randomised control trial evaluating the clincial efficacy and patient satisfaction scores of a novel adjustable wrist splint (Zero-Cast) for the treatment of distal wrist fractures.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001606370
Enrollment
42
Registered
2017-12-07
Start date
2018-02-01
Completion date
2018-07-01
Last updated
2017-12-16

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

Conditions

None listed

Brief summary

The unprecedented growth in populations globally has resulted in changing trends of health utilisation. Advancement in medical knowledge and other technologies has seen as increase in survival and prolongation of life in both the older persons and those with disabilities. Projected increases in both ageing and growing populations will lead to greater utilisation of health care service, particularly in the older population. Age has been identified to be a factor correlating to an increasing incidence in fractures. Amongst these, are fractures of the distalradius, which account for up to 17 per cent of all fractures diagnosed. Traditional management of non-displaced distal radius fractures involves immobilisation with external plaster cast. There are many issues associated with this approach including: -cumbersome and restrictive -itchy and smelly -heavy -inability to use the lim in daily activity -susceptiblity to water damage -compromised clothing choices -cast loosens as swelling subsides, leading to loss of fracture position -requires multiple changes We propose that the adaptable wrist splint can reduce these issues while achieving equivalent immobilisation of fracture that the plaster cast achieves. The randomised control trial will evaluated the patients experience of pain and function while using the adaptable wrist splint. An exploration of the expectations, perceptions and experience of the health professionals involved with the applicaton and maintenance of the adaptable wrist splint will also be captured in one to one interviews and questionnaires. The project will have the potential to inform the ongoing management of distal radius fractures and potentially imporve services at the fracture clinic.

Interventions

This is a RCT with two arms - intervention group and control. The intervention group will have their distal radius fracture managed with the adaptable wrist splint (low risk medical device) to immobilise the fracture. This will be applied by the fracture clinic staff who are qualified nurses and doctors. Their management of clinic attendance will follow the same protocol as the control group (traditional plaster cast) in terms of follow up appointment and X-rays. The researcher (registered

This is a RCT with two arms - intervention group and control. The intervention group will have their distal radius fracture managed with the adaptable wrist splint (low risk medical device) to immobilise the fracture. This will be applied by the fracture clinic staff who are qualified nurses and doctors. Their management of clinic attendance will follow the same protocol as the control group (traditional plaster cast) in terms of follow up appointment and X-rays. The researcher (registered physiotherapist) will moniter both groups weekly with telephone questionnaires and identify any risks as appropriate to refer onto the orthodpaedic consultant. The adaptable wrist splint is a custom fitted, prefabricated ride device which allows for adjustment and adaptation for fracture reduction and stabilisation. It consists of a volar plate, dorsal plate, proximal strap and ratchet-legs linking the volar and dorsal plates together. Once the plates are pressed together guided by the ratchet legs , it is then locked. The device is not able to be removed by participants at any time. The overall duration of splint wear is for 6 weeks.

Sponsors

Waikato District Health Board
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Non-displaced distal radius fracture. Able to give informed consent. Age 65 and over.

Exclusion criteria

Displaced distal radius fractures that require manipulation or surgery. Unable to give informed consent. Under the age of 65 years old.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026