Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000673640
Ethics application status
Approved
Date submitted
2/06/2014
Date registered
26/06/2014
Date last updated
26/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of early mobility in patients after Total Knee Replacement on hospital length of stay,pain and function: A randomised control trial
Scientific title
The effect of early mobility in patients after Total Knee Replacement on hospital length of stay, pain and function: A randomised control trial
Secondary ID [1] 284822 0
nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery from total knee replacement 292142 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292411 292411 0 0
Physiotherapy
Musculoskeletal 292640 292640 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients after Total Knee Replacement were mobilised within first 4-6hrs. This involves getting these patients out of bed and mobilising a short distance and then sitting them out in a chair for a short period of time, to see if their recovery is faster than our current protocol
Intervention code [1] 289504 0
Rehabilitation
Comparator / control treatment
The control is the current protocol of mobilising patients within the 24hrs
Control group
Active

Outcomes
Primary outcome [1] 292273 0
Lenght of hospital stay for these patients in number of days
Timepoint [1] 292273 0
at the time of discharge from the acute ward
Primary outcome [2] 292342 0
pain score measured in VAS
Timepoint [2] 292342 0
before surgery, on discharge from the ward and 6wks after the surgery
Primary outcome [3] 292343 0
knee range of motion measured in degrees using a goniometer
Timepoint [3] 292343 0
before surgery, on discharge from the ward and 6wks post surgery
Secondary outcome [1] 308735 0
Time taken in seconds for the patient to perform a Timed Up and Go test (getting up from a chair, walking 3m andsitting back down on the chair)
Timepoint [1] 308735 0
before surgery, on discharge from the ward and 6wks post surgery

Eligibility
Key inclusion criteria
patients under the age of 80 and over the age of 40, with no major cardiovascular or repiratory diseases and no diabetes, patients with OA who is having a primary Total Knee Replacement
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients aged over 80, with known cardiovascular, respiratory diseases and diabetes

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 were seen at the preadmission clinic prior tho the surgery, eligible patients were given detailed information about the study, writtern consent signed by them. Then they were asked a pick a number from the hat with numbers 1 and 2 . I allocated to the control group and 2 allocated to the experiment al group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
picking a number from the hat
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
Actual
23/10/2006
Date of last participant enrolment
Anticipated
Actual
12/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8220 0
2137 - Concord

Funding & Sponsors
Funding source category [1] 289338 0
Hospital
Name [1] 289338 0
concord hospital
Country [1] 289338 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital
Address
Hospital Road,
Conord Hospital,
Concord 2137
Australia NSW
Country
Australia
Secondary sponsor category [1] 288120 0
None
Name [1] 288120 0
Address [1] 288120 0
Country [1] 288120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291111 0
Concord Repatriation Hospital Ethics commitee
Ethics committee address [1] 291111 0
Hospital Rd,
Concord Hospital,
Concord 2137
Asutralia NSW
Ethics committee country [1] 291111 0
Australia
Date submitted for ethics approval [1] 291111 0
05/10/2006
Approval date [1] 291111 0
17/10/2006
Ethics approval number [1] 291111 0

Summary
Brief summary
Trial aimed at determining whether mobilising patients after Total Knee Replacement within the first 4-6hrs after surgery compared to mobilising within the 24 hrs after surgery changes the outcome for these patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48898 0
Mrs Sathiyapriya Gnanakumaran
Address 48898 0
Concord Hospital,
Hospital Road,
Concord 2137
Australia NSW
Country 48898 0
Australia
Phone 48898 0
+61434287792
Fax 48898 0
Email 48898 0
[email protected]
Contact person for public queries
Name 48899 0
Mrs Sathiyapriya Gnanakumaran
Address 48899 0
concord Hopsital,
Hopsital Road,
Concord 2137
australia NSW
Country 48899 0
Australia
Phone 48899 0
+61434287792
Fax 48899 0
Email 48899 0
[email protected]
Contact person for scientific queries
Name 48900 0
Mrs Sathiyapriya Gnanakumaran
Address 48900 0
Concord Hospital,
Hospital Road,
Concord 2137
Australia NSW
Country 48900 0
Australia
Phone 48900 0
+61434287792
Fax 48900 0
Email 48900 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.