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A randomised controlled trial investigating the effect of duration of immobilisation on function and pain following open reduction and internal fixation (ORIF) for adult distal radius fractures managed with a locked volar plate.

A randomised controlled trial investigating the effect of duration of immobilisation on function and pain following open reduction and internal fixation (ORIF) for adult distal radius fractures managed with a locked volar plate.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000902897
Enrollment
135
Registered
2012-08-24
Start date
2012-09-09
Completion date
2016-04-24
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

Although distal radius fractures commonly occur, factors that affect treatment outcomes have not been well defined. There is a gap in our current knowledge regarding how long a wrist should be immobilised in a cast following surgical repair. The aim of this investigation is to compare participants following surgical repair of their distal radius fracture and immobilised in a cast for either one, three or six weeks. The hypothesis for this investigation is that three or six weeks of immobilisation is not superior to one week of immobilisation for participants following surgery for acute distal radius fracture for any of the recorded outcomes when measured over a six month period from the date of surgery. The information gained from this investigation will enable us to improve the management of distal radius fractures following surgical repair in the future. It is known from previous investigations that moving the fractured area as early as one to two days following surgical repair of a fracture is safe. Previous investigations also tell us that immobilisation periods ranging from less than one week up to six weeks have their advantages and disadvantages. This investigation aims to compare the immobilisation periods of one, three and six weeks so we can determine the best management for participants following a surgical repair for distal radius fracture.

Interventions

Immobilisation periods of one and three weeks for acute distal radius fracture following locked volar plate fixation. This investigation involves three separate treatment groups that differ in the periods of immobilisation for participants following surgery. The treatment groups are one, three and six weeks of immobilisation. All participants will receive the same treatment for the first week following surgery. Overlying the post-operative dressing, a below elbow volar splint will be appl

Immobilisation periods of one and three weeks for acute distal radius fracture following locked volar plate fixation. This investigation involves three separate treatment groups that differ in the periods of immobilisation for participants following surgery. The treatment groups are one, three and six weeks of immobilisation. All participants will receive the same treatment for the first week following surgery. Overlying the post-operative dressing, a below elbow volar splint will be applied immediately following ORIF. This will remain insitu for seven days following surgery during which time participants will be encouraged to perform light functional activities and active finger, thumb, elbow and shoulder range of motion exercises on the injured side. The first post-operative review with the orthopaedic surgeon and treating physiotherapist will be scheduled for all participants seven days following surgery. At this review, all participants will receive standard advice about wound care, swelling control, fracture protection and activity levels. Participants will have different treatment protocols depending on group allocation. The one week immobilisation group will have their splint removed while the three and six week immobilisation groups will have a full below elbow plaster applied which will remain in place for two and five weeks respectively. Following removal of the splint in one week immobilisation group and the plaster cast in the three and six weeks immobilisation groups, all participants will receive a standardised six week program of physiotherapy. Standardised physiotherapy treatment will be provided by physiotherapists working in the outpatient departments of Western Health. All treatments will be provided by one of four physiotherapists specifically trained on the treatment principles applied in this investigation. Training sessions will be given by the principal investigator to each of the four treating physiotherapists on the standardised assessment and support of participants enrolled in this investigation. Treatment will be commenced within three days of splint/cast removal. The nature of this investigation makes it impossible to blind the physiotherapists providing care to treatment group. After removal of the splint/cast, participants from each treatment group will follow a standardised exercise protocol weekly for a period of six weeks. Therefore, the exercise protocol will be given to participants in the one week immobilisation group from the beginning of week two to the end of week seven, participants in the three week immobilisation group from the beginning of week four to the end of week nine and the six week immobilisation group from the beginning of week seven to the end of week 12. All participants will attend an individual appointment with one of the four study physiotherapists. At this appointment, and the six subsequent weekly appointments, the following eight areas will be addressed: 1. Information on surgery, prognosis, expectations 2. Patient-Specific Functional Scale (PSFS) 3. Recording of wrist and forearm active range of motion, grip strength and pain on VAS 4. Discussion and therapist demonstration of weekly exercises from standardised exercise program 5. Participant demonstration of weekly exercises from standardised exercise program 6. Training diary 7. Complications following surgery 8. Participant questions

Sponsors

Western Health
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

1. Fracture involving the distal radius (within 3cm of the distal end of the radius) with or without an associated ulna fracture 2. Operative management involving a locked volar plate for distal radius fracture 3. 18 years or more

Exclusion criteria

1. Fracture is pathological 2. If the participant has a cognitive impairment/intellectual disability 3. If the participant mobilises with a gait aid using the injured upper limb and therefore would take weight through the injured upper limb following ORIF 4. Participants who are transferred from Western Health to another health service for their ongoing management following ORIF

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026