Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000648022
Ethics application status
Not yet submitted
Date submitted
6/07/2010
Date registered
10/08/2010
Date last updated
10/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Dorsal versus volar surgical approaches for plate fixation of midshaft radius fractures: a randomised controlled trial
Scientific title
A randomised controlled trial comparing post-operative pain, return to work and pronation strength in patients with midshaft radius fractures randomly assigned to fixation via a dorsal (Thompson) approach or a volar (Henry) approach.
Secondary ID [1] 252166 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
THRUST
Thompson or Henry approach for radius (+/- ulna) shaft fracture triallists
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radial shaft fracture 257708 0
Optimal surgical approach for radial shaft fracture fixation 257709 0
Condition category
Condition code
Surgery 257878 257878 0 0
Surgical techniques
Injuries and Accidents 258086 258086 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dorsal (Thompson) approach involves an incision on the dorsal aspect of the forearm and splitting between extensor muscles with some stripping of the insertion of the supinator muscle to permit plate positioning for stabilisation of a fracture. The surgical approach will take approximately 10 minutes.
Intervention code [1] 256762 0
Treatment: Surgery
Comparator / control treatment
The volar (Henry) approach involves an incision on the volar aspect of the forearm with splitting between the flexor muscles, radial artery and superficial radial nerve, followed by division of the tendon of pronator teres and adjacent supinator to permit plate positioning for stabilisation of a fracture. The surgical approach will take approximately 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 258742 0
Pronation strength with physiotherapist supervised dynamometry.
Timepoint [1] 258742 0
6 weeks, 3 months, 6 months, 1 year following surgery.
Secondary outcome [1] 264790 0
Disability of Arm, Shoulder and Hand scores at 6 weeks, 3 months, 6 months and 12 months post surgery.
Timepoint [1] 264790 0
6 weeks, 3 months, 6 months, 12 months

Eligibility
Key inclusion criteria
Patients with a fracture of the middle 20% of the radial shaft.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe head injury
Neurological compromise of the upper limb (including stroke, brachial plexus injury, ipsilateral upper limb peripheral motor nerve injury and pre-existing complex regional pain syndrome)
Associated fractures of the upper limb (other than ulnar fractures)

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)
Patients will be offered study participation and consented if they agree. Allocation to treatment will be in theatre by means of sealed envelope. As the approach differs, patients and surgeons cannot be blinded to their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Slips of paper with "dorsal" or "volar" will be placed in sealed opaque envelopes. The envelopes will be shuffled and then drawn from a box by the operating surgeon or circulating nurse.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 2747 0
New Zealand
State/province [1] 2747 0

Funding & Sponsors
Funding source category [1] 257258 0
Hospital
Name [1] 257258 0
Whangarei Hospital
Country [1] 257258 0
New Zealand
Primary sponsor type
Hospital
Name
Whangarei Hospital
Address
PO Box 9742
Maunu Rd 0140
Whangarei
Country
New Zealand
Secondary sponsor category [1] 256501 0
None
Name [1] 256501 0
Address [1] 256501 0
Country [1] 256501 0
Other collaborator category [1] 251370 0
Individual
Name [1] 251370 0
Justin Chou
Address [1] 251370 0
Whangarei Hospital
PO Box 9742
Whangarei 0140
New Zealand
Country [1] 251370 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259274 0
Ethics committee address [1] 259274 0
Ethics committee country [1] 259274 0
Date submitted for ethics approval [1] 259274 0
01/09/2010
Approval date [1] 259274 0
Ethics approval number [1] 259274 0

Summary
Brief summary
Our study is designed to see whether patients recover after forearm fracture surgery more quickly with a dorsal or volar surgical approach. Our hypothesis is that there is no difference.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31369 0
Address 31369 0
Country 31369 0
Phone 31369 0
Fax 31369 0
Email 31369 0
Contact person for public queries
Name 14616 0
Jonathan Manson
Address 14616 0
Whangarei Hospital
PO Box 9742
Maunu Rd 0140
Whangarei
Country 14616 0
New Zealand
Phone 14616 0
+64 9 430 4100 +64 21 441 962
Fax 14616 0
Email 14616 0
[email protected]
Contact person for scientific queries
Name 5544 0
Jonathan Manson
Address 5544 0
Whangarei Hospital
PO Box 9742
Maunu Rd 0140
Whangarei
Country 5544 0
New Zealand
Phone 5544 0
+64 9 430 4100
Fax 5544 0
Email 5544 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.