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Trial registered on ANZCTR


Registration number
ACTRN12612000902897
Ethics application status
Approved
Date submitted
15/08/2012
Date registered
24/08/2012
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 281048 0
None
Universal Trial Number (UTN)
U1111-1133-4359
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radius fracture managed with open reduction and internal fixation involving locked volar plate 287147 0
Condition category
Condition code
Injuries and Accidents 287468 287468 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 285472 0
Treatment: Other
Comparator / control treatment
Immobilisation period of six weeks for acute distal radius fracture following locked volar plate fixation.
Control group
Active

Outcomes
Primary outcome [1] 287737 0
Mean score on Patient Rated Wrist Evaluation
Timepoint [1] 287737 0
Measured by a blind assessor at six, 12 and 26 weeks following date of surgery.
Primary outcome [2] 287738 0
Mean score on Visual Analogue Scale (VAS) for 'worst' and 'usual' pain over past week.
Timepoint [2] 287738 0
Measured weekly for six weeks following removal of immobilisation by assessor not blinded to intervention group and measured at six, 12 and 26 weeks following surgery by blind assessor.
Secondary outcome [1] 298738 0
Mean wrist and forearm active range of motion measures
Timepoint [1] 298738 0
Measured weekly for six weeks following removal of immobilisation by assessor not blinded to intervention group and measured at six, 12 and 26 weeks following surgery by blind assessor.
Secondary outcome [2] 298762 0
Mean Disabilities of the Arm, Shoulder and Hand (DASH) score
Timepoint [2] 298762 0
Measured at six, 12 and 26 weeks following surgery by blind assessor.
Secondary outcome [3] 298763 0
Mean grip strength measure
Timepoint [3] 298763 0
Measured weekly for six weeks following removal of immobilisation by assessor not blinded to intervention group and measured at six, 12 and 26 weeks following surgery by blind assessor.
Secondary outcome [4] 298764 0
Number of 'adverse events'

Screening for adverse events/complications will occur during the clinical examination by the orthopaedic team at the review one week following surgery and during the six weeks of physiotherapy treatment following removal of the immobilisation. For this investigation, adverse events include any of the following:

-Neuropathy
-Carpal tunnel syndrome
-Tendinopathy or tendon rupture
-Wound infection
-Fixation position loss

Members of the orthopaedic team will be advised to discuss any adverse events/complications detected at the one week review appointment that could impact on appropriateness for the participant's allocation to immobilisation groups with the treating physiotherapist. Any adverse events/complications identified by a member of the orthopaedic team or treating physiotherapist will be documented by the treating physiotherapist. Discussions between an orthopaedic surgeon, the treating physiotherapist +/- the principal investigator will determine if the adverse event/complication is significant enough for the participant to be removed from the investigation. All attempts will be made for the immobilisation time and physiotherapy management to remain unchanged from the original allocation. Participants who experience or are at risk of experiencing an adverse event/complication will be closely monitored by the treating physiotherapist.
Timepoint [4] 298764 0
Measured by a member of the orthopaedic team one week following surgery and weekly for six weeks following removal of immobilisation by an assessor not blinded to intervention group and measured at six, 12 and 26 weeks following surgery by blind assessor.
Secondary outcome [5] 298875 0
Mean Patient Specific Functional Scale (PSFS) score
Timepoint [5] 298875 0
Measured weekly for six weeks following removal of immobilisation by assessor not blinded to intervention group.
Secondary outcome [6] 298876 0
Compliance with home exercise program. This measurement will be based on the participant's weekly entries in their training diary and by the assessor asking the following question at each assessment:

How would you describe your completion of your home exercises over the past week?
-Did not complete any exercises in the past week
-Completed exercises on some days in the past week
-Completed exercises on most days in the past week
-Completed exercises on all days in the past week
Timepoint [6] 298876 0
Measured weekly for six weeks following removal of immobilisation by assessor not blinded to intervention group and measured at six, 12 and 26 weeks following surgery by blind assessor.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A member of the research team will be responsible for reviewing the operating lists at Sunshine and
Footscray hospital daily to identify potential participants listed for an ORIF of their distal radius fracture. Within one
day either side of the surgery, a reseacher will make contact with the potential participant at either Sunshine or Footscray Hospitals. The researcher will explain the details of the investigaiton and review their medical history to determine if they meet the inclusion criteria. Participants who meet the inclusion criteria will be provided with further details of the investigation and taken through the consenting process.

Following the provision of informed consent, 135 participants that meet the inclusion/exclusion requirements will be enrolled in this investigation. All participants will be stratified by age (above or below 55 years). An off-site researcher (not aware of any participant details or involved with any of the participant assessments or treatments) will use a concealed computer generated mixed random allocation sequence to advise of participant allocation to either of the one, three or six week immobilisation group. To enable concealment, generation of randomised allocation will occur off site. Researchers will conduct the consenting and enrolment of all participants in this investigation.

Following completion of the consent process, the principal researcher will be advised of the participant enrolment. The principal researcher will use a text messaging system to advise the off-site researcher of the enrolment of a participant and the age grouping of above or below 55 years. The off-site researcher will use a concealed computer generated mixed random allocation sequence to advise of participant allocation to either of the one, three or six week immobilisation group. The principal researcher will be responsible for ensuring that the treating physiotherapists are aware of the group allocation for participants at the one week review following surgery. The treating physiotherapist will advise the plaster technicians of group allocation for participants at the review one week following surgery. The treating physiotherapist will also ensure that appointments are scheduled for each participant based on allocation to either one, three or six weeks immobilisation group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation stratified by age (above or below 55 years) will use the mixed randomisation model described by Schulz & Grimes (2002). The mixed randomisation model will involve blocking and a computer random number generator (EXCEL, 2010).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis of data from this investigation will not be commenced until the trial is completed. All data for this trial will be collected on site.

The data from this investigation will be analysed using intention-to-treat principles. Stratification for age will occur prior to randomisation and will facilitate sub-grouping participants based on age for data analysis.

The first aim of this investigation is to compare the primary outcomes of function (PRWE) and pain (VAS) following immobilisation periods of one, three and six weeks. The data collected to address this question will be PRWE and VAS pain scores [VAS for worst (VAS-W) and usual (VAS-U) pain in the past week] at six, 12 and 26 weeks following surgery. Paired t-tests will be used to determine if differences exist between the immobilisation periods of one and three weeks in addition to one and six weeks for each of these outcomes.
Analysis of the data will also occur once it has been stratified for participant age below or above 55 years. Paired t-tests will be used to determine if differences exist between the primary outcome measures of PRWE and VAS [VAS for worst (VAS-W) and usual (VAS-U) pain in the past week] for the two age groups within the one, three and six week immobilisation groups at the time periods of six, 12 and 26 weeks following surgery. Data will be pooled for analysis if no significant differences are established for the PRWE and VAS outcome measures when the data is stratified for age above or below 55 years.

The second aim of this investigation is to compare the secondary outcome measures of wrist and forearm range of movement, DASH scores, grip strength and adverse events following immobilisation periods of one, three and six weeks. The secondary outcome data will be collected at six, 12 and 26 weeks following surgery. An analysis of covariance (ANCOVA) will be used to test for differences between the immobilisation periods of one, three and six weeks for each of the secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2012
Actual
9/09/2012
Date of last participant enrolment
Anticipated
Actual
24/04/2016
Date of last data collection
Anticipated
Actual
3/11/2016
Sample size
Target
135
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285816 0
Hospital
Name [1] 285816 0
Western Health
Country [1] 285816 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Gordon Street
Footscray 3011
Victoria
Country
Australia
Secondary sponsor category [1] 284641 0
University
Name [1] 284641 0
Monash University
Address [1] 284641 0
P.O. Box 527
Frankston 3199
Victoria
Country [1] 284641 0
Australia
Other collaborator category [1] 277019 0
Individual
Name [1] 277019 0
Professor Jennifer Keating
Address [1] 277019 0
Monash University
P.O. Box 527
Frankston 3199
Victoria
Country [1] 277019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287830 0
Melbourne Health HREC
Ethics committee address [1] 287830 0
Ethics committee country [1] 287830 0
Australia
Date submitted for ethics approval [1] 287830 0
Approval date [1] 287830 0
03/04/2012
Ethics approval number [1] 287830 0
2011.255
Ethics committee name [2] 287831 0
Monash University HREC
Ethics committee address [2] 287831 0
Ethics committee country [2] 287831 0
Australia
Date submitted for ethics approval [2] 287831 0
Approval date [2] 287831 0
20/04/2012
Ethics approval number [2] 287831 0
2012000502

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34567 0
Mrs Narelle Watson
Address 34567 0
Western Health Physiotherapy Department Footscray Hospital Gordon Street Footscray 3011 Victoria
Country 34567 0
Australia
Phone 34567 0
+61 435 960 488
Fax 34567 0
+61 3 8345 6064
Email 34567 0
Narelle.Watson@wh.org.au
Contact person for public queries
Name 17814 0
Narelle Watson
Address 17814 0
Western Health Physiotherapy Department
Footscray Hospital
Gordon Street
Footscray 3011
Victoria
Country 17814 0
Australia
Phone 17814 0
+61 435 960 488
Fax 17814 0
+61 3 8345 6064
Email 17814 0
Narelle.Watson@wh.org.au
Contact person for scientific queries
Name 8742 0
Narelle Watson
Address 8742 0
Western Health Physiotherapy Department
Footscray Hospital
Gordon Street
Footscray 3011
Victoria
Country 8742 0
Australia
Phone 8742 0
+61 435 960 488
Fax 8742 0
+61 3 8345 6064
Email 8742 0
Narelle.Watson@wh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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