Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000911998
Ethics application status
Approved
Date submitted
23/08/2011
Date registered
25/08/2011
Date last updated
25/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of dedicated interpreter services for post-operative care following total knee replacement: A pilot randomised controlled trial.
Scientific title
The effectiveness of additional interpreter sessions post total knee surgery on impairment, self management and quality of life in Greek speaking patients versus usual care: A pilot randomised controlled trial.
Secondary ID [1] 262707 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post total knee replacement surgery 270412 0
Condition category
Condition code
Musculoskeletal 270556 270556 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 270811 270811 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the intervention group, four additional interpreter sessions of up to 90 minutes will be available in the post operative period; inclusive of the acute inpatient stay and sub-acute care (Hospital in the Home (HITH) visits or inpatient rehabilitation or post-acute/community care). Interpreter sessions will be available to be used up to 1 month post-operatively. All members of the multidisciplinary team will be notified of the interpreter’s attendance, to maximize utilization of the interpreter by each member of the team.
Intervention code [1] 267058 0
Rehabilitation
Comparator / control treatment
Usual care. Usual care in orthopaedics for non-English speaking patients involves access to interpreters whenever required, however due to limited resources interpreter services often need to be prioritized. In orthopaedics priority use of interpreters is often for consent to surgery and review appointments, more so than post-operative care.
Control group
Active

Outcomes
Primary outcome [1] 269308 0
International Knee Scores (IKS), inclusive of joint function and pain
Timepoint [1] 269308 0
3 months post-op
Secondary outcome [1] 279340 0
Partners in Health (PIH) scale
Timepoint [1] 279340 0
3 months post-op
Secondary outcome [2] 279341 0
Short Form 12 Item Health Survey
Timepoint [2] 279341 0
3 months post-op
Secondary outcome [3] 279342 0
Knee range of movement, assessed by goniometry
Timepoint [3] 279342 0
At recruitment and 3 months post-op
Secondary outcome [4] 279343 0
10 metre walk test
Timepoint [4] 279343 0
At recruitment and 3 months post-op

Eligibility
Key inclusion criteria
Greek speaking and undergoing total knee replacement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Complications during surgery that require increased length of stay (eg fractures), previous joint replacement surgery and inability to give informed consent.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267535 0
Hospital
Name [1] 267535 0
St Vincent's Health Melbourne
Country [1] 267535 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Health Melbourne
Address
PO Box 2900
Fitzroy 3065
Victoria
Country
Australia
Secondary sponsor category [1] 266573 0
None
Name [1] 266573 0
Address [1] 266573 0
Country [1] 266573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269491 0
Low Risk Research Sub-Committe of Human Research Ethics Committee-A (HREC-A) St Vincent's Hospital (Melbourne)
Ethics committee address [1] 269491 0
Ethics committee country [1] 269491 0
Australia
Date submitted for ethics approval [1] 269491 0
Approval date [1] 269491 0
09/06/2011
Ethics approval number [1] 269491 0
HREC-A- LRR 063/11

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

Contacts
Principal investigator
Name 32928 0
Address 32928 0
Country 32928 0
Phone 32928 0
Fax 32928 0
Email 32928 0
Contact person for public queries
Name 16175 0
Jane Higgs
Address 16175 0
Physiotherapy Department
St.Vincent's Health Melbourne
PO Box 2900
Fitzroy 3065
Victoria
Country 16175 0
Australia
Phone 16175 0
+61 3 9288 3813
Fax 16175 0
Email 16175 0
[email protected]
Contact person for scientific queries
Name 7103 0
Jane Higgs
Address 7103 0
Physiotherapy Department
St.Vincent's Health Melbourne
PO Box 2900
Fitzroy 3065
Victoria
Country 7103 0
Australia
Phone 7103 0
+61 3 9288 3813
Fax 7103 0
Email 7103 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.