Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000152224
Ethics application status
Approved
Date submitted
30/12/2008
Date registered
17/03/2009
Date last updated
16/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Early motion following metacarpal fractures
Scientific title
The effect of early mobilisation on functional outcomes following a stable, extra-articular metacarpal fracture.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metacarpal fracture 4163 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4372 4372 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Immobilisation (control group)
All 4 fingers immobilised in a forearm based, thermoplastic splint for 4 weeks post fracture. Range of motion exercises commenced at 4 weeks post fracture.

Group 2: Hand-based Regional Immobilisation
Injured digit and adjacent border digit immobilised in a hand based, ulnar or radial gutter thermoplastic splint, for 4 weeks post fracture. Digits that are not included in splint commence range of motion exercises on initial patient contact. Range of motion exercises of injured digits commenced at 4 weeks post fracture.

Group 3: Early Mobilisation (forearm resting splint)
All 4 fingers included in a removable forearm based thermoplastic resting splint. Injured digit taped to adjacent long finger. Splint to be worn full time, removing every 2 hours to complete exercises. Range of motion exercises commenced at initial patient contact (less than 2 weeks).

Group 4: Early Mobilisation (hand-based fracture brace)
Thermoplastic functional fracture brace is worn until 4 weeks post fracture. Injured and adjacent long finger buddy taped, and commence range of motion exercises from initial patient contact (less than 2 weeks). Exercises completed wearing fracture brace. Patient instructed not to remove brace and not to attempt heavy functional tasks.

All groups to receive oedema management, scar management and further treatment techniques as required. Strengthening exercises to be introduced to all groups at 6 weeks post fracture.
Intervention code [1] 3880 0
Rehabilitation
Comparator / control treatment
Group 1:Immobilisation (control group). All 4 fingers immobilised in a forearm based, thermoplastic splint for 4 weeks post fracture. Range of motion exercises commenced at 4 weeks post fracture.
Control group
Active

Outcomes
Primary outcome [1] 5246 0
Range of motion measured using a Rolyan finger Goniometer.
Timepoint [1] 5246 0
at 4, 6, 8, 10 and 12 weeks after fracture, or until full range of motion achieved.
Primary outcome [2] 5247 0
Return to functional use of injured hand Measured using the Disabilities of the Arm, Shoulder and Hand (DASH) self report questionaire.
Timepoint [2] 5247 0
at 6, 8, 10 and 12 weeks after fracture, or until score of less than 15 achieved.
Followup posted assessment 6 months post injury
Primary outcome [3] 5248 0
Strength
Measured using Jamar Dynomometer.
Timepoint [3] 5248 0
at 6, 8, 10 and 12 weeks after fracture, or until full return to function
Secondary outcome [1] 8847 0
Therapist time and resource cost
Measured by therapist report. Standardised costing developed for splint prices.
Timepoint [1] 8847 0
On patient being discharged from service.

Eligibility
Key inclusion criteria
Single, stable, extra-articular metacarpal fracture of digits 2-5.
Suitable for conservative management.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgical fixation.
Unstable fracture.
Angulation or rotation of an unacceptable level.
Associated soft tissue injury.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table used to generate randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4334 0
Hospital
Name [1] 4334 0
Austin Health
Country [1] 4334 0
Australia
Primary sponsor type
Hospital
Name
Hand Therapy Clinic
Address
Occupational Therapy Department
Austin Health
PO Box 5444
Heidelberg West
Victoria, 3081
Country
Australia
Secondary sponsor category [1] 3904 0
None
Name [1] 3904 0
Address [1] 3904 0
Country [1] 3904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6631 0
Austin Health
Ethics committee address [1] 6631 0
Ethics committee country [1] 6631 0
Australia
Date submitted for ethics approval [1] 6631 0
04/02/2009
Approval date [1] 6631 0
Ethics approval number [1] 6631 0
H2009/03482

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

Contacts
Principal investigator
Name 35065 0
Address 35065 0
Country 35065 0
Phone 35065 0
Fax 35065 0
Email 35065 0
Contact person for public queries
Name 12412 0
Tanya Cole
Address 12412 0
Austin Health
PO Box 5444
Heidelberg West
Victoria, 3081
Country 12412 0
Australia
Phone 12412 0
+61 3 9496 2197
Fax 12412 0
+61 3 9496 2974
Email 12412 0
[email protected]
Contact person for scientific queries
Name 3340 0
Tanya Cole
Address 3340 0
Austin Health
PO Box 5444
Heidelberg West
Victoria, 3081
Country 3340 0
Australia
Phone 3340 0
+61 3 9496 2197
Fax 3340 0
+61 3 9496 2974
Email 3340 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.