Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000028808
Ethics application status
Approved
Date submitted
22/07/2008
Date registered
9/01/2012
Date last updated
23/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weight Bearing in the Treatment of Acute Achilles Tendon Ruptures: A Randomised Controlled Trial
Scientific title
Weight bearing versus non-weight bearing casts in the treatment of acute achilles tendon ruptures: effects on re-rupture rate and functional outcomes
Secondary ID [1] 279675 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendon ruptures 3439 0
Condition category
Condition code
Musculoskeletal 3593 3593 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weightbearing group - Gravity equinus cast applied over foot/lower leg for a total of 8 weeks. cast applied straight after allocation. These patients received a bohler iron attachement to their cast from day 1.
Intervention code [1] 3172 0
Treatment: Other
Intervention code [2] 283921 0
Treatment: Devices
Comparator / control treatment
Non-weightbearing group - Gravity equinus cast applied over foot/lower leg for a total of 8 weeks. cast applied straight after allocation. These patients did not receive a bohler iron at anytime.
Control group
Active

Outcomes
Primary outcome [1] 4495 0
Return to work via telephone follow-up call
Timepoint [1] 4495 0
3 months after the cast has been applied.
Secondary outcome [1] 7603 0
Rerupture Rate via hospital database search
Timepoint [1] 7603 0
one year after interventional commencement, ie time of casting

Eligibility
Key inclusion criteria
Unilateral acute rupture
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous 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)
All patients presenting to Northshore and Middlemore hospitals with in the study period with an acute achilles tendon rupture were offered enrolment, once enrolled, the patients were allocated to either group using a numbered, sealed and sequential envelope generated by a thrid party with no affiliations centrally
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated, no stratification was done or was felt to be neccessary
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
4/09/2007
Date of last participant enrolment
Anticipated
1/01/2009
Actual
24/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1049 0
New Zealand
State/province [1] 1049 0
Auckland, New Zealand

Funding & Sponsors
Funding source category [1] 3621 0
Charities/Societies/Foundations
Name [1] 3621 0
Wishbone Trust
Country [1] 3621 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospiital
Address
Middlemore Hospital
100 Hospital Road
Otahuhu 2025
Auckland
Country
New Zealand
Secondary sponsor category [1] 3256 0
None
Name [1] 3256 0
Address [1] 3256 0
Country [1] 3256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5673 0
Northern X ethics committee
Ethics committee address [1] 5673 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland 1061
Ethics committee country [1] 5673 0
New Zealand
Date submitted for ethics approval [1] 5673 0
Approval date [1] 5673 0
04/06/2007
Ethics approval number [1] 5673 0
NTX0705047

Summary
Brief summary
Acute achilles tendon ruptures are increasing in incidence, however there remains a lack of consensus on the optimum treatment for acute ruptures. Non surgical treatment is favoured in many parts of the world and it is unclear what is the best post operative protocol. we believe that early weight bearing may assist in the healing of the tendon resulting in better functional outcomes and faster return to work. This study aims investigate whether early weightbearing with a bohler iron is beneficial for conservatively treated patients with acute achilles tendon ruptures
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28769 0
Mr Simon Young
Address 28769 0
North Shore Hospital, Shakespeare Road, Takapuna, Auckland, New Zealand
Country 28769 0
New Zealand
Phone 28769 0
640273654986
Fax 28769 0
Email 28769 0
simonwyoung@gmail.com
Contact person for public queries
Name 11926 0
Mr Simon Young
Address 11926 0
Northshore hospital, 124 Shakespeare Road, Westlake 0622, Auckland
Country 11926 0
New Zealand
Phone 11926 0
+64 21616183
Fax 11926 0
Email 11926 0
simonwyoung@gmail.com
Contact person for scientific queries
Name 2854 0
Mr Matt Tomlinson
Address 2854 0
Middlemore hospital, 100 Hospital Road, Papatoetoe 2025, Auckland
Country 2854 0
New Zealand
Phone 2854 0
+64 9 2760000
Fax 2854 0
Email 2854 0
mtomlinson@cmdhb.govt.nz

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.