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Trial registered on ANZCTR


Registration number
ACTRN12606000376549
Ethics application status
Approved
Date submitted
13/10/2005
Date registered
28/08/2006
Date last updated
8/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the clinical outcomes of the subvastus versus the medial parapatella approach to total knee replacement
Scientific title
An evaluation of the clinical outcomes (American Knee Society Score, Knee Range of Motion, Quadriceps Function, Functional Mobility, Pain, Patella Vascularity) of the subvastus versus the medial parapatella approach to total knee replacement
Secondary ID [1] 259749 0
1111111111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 1343 0
Condition category
Condition code
Musculoskeletal 1432 1432 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medial Parapatella approach to Total Knee Replacement involves dissection through the quadriceps. The Subvastus approach does not.
Assessments will be performed at PreOperative Period, Days 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively
Intervention code [1] 715 0
Treatment: Surgery
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1957 0
1. American Knee Society Score
Timepoint [1] 1957 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [2] 1958 0
2. Quadriceps Function
Timepoint [2] 1958 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [3] 1959 0
3. Knee Range of motion
Timepoint [3] 1959 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [4] 1960 0
4. Pain
Timepoint [4] 1960 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [5] 1961 0
5. Functional Mobility
Timepoint [5] 1961 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [6] 1962 0
6. Timed Up and Go Test
Timepoint [6] 1962 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [7] 1963 0
7. Knee girth
Timepoint [7] 1963 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Primary outcome [8] 1964 0
Intra-operative data being collected includes knee range of motion, knee stability, incision length, torniquet time, operation time (knife to skin - wound closure).
Timepoint [8] 1964 0
All primary outcome measures in this study will be measured at PreOperative Period, Day 1,2,3; 6 Weeks, 6 months, 12 months and 18 months post operatively.
Secondary outcome [1] 3430 0
Economic benefits
Timepoint [1] 3430 0
Assessed upon study completion.
Secondary outcome [2] 3431 0
Patella vascularity
Timepoint [2] 3431 0
Assessed at 18 months post operatively.

Eligibility
Key inclusion criteria
Adult participants. The expected age range of subjects undergoing total knee replacement surgery is between 50 and 65 years. Patients undergoing primary unilateral total knee replacement. Diagnosis of osteoarthritis. Healthy and no comorbidities that would prevent participating in the required rehabilitation programme. Normal mentation with the ability to accurately follow commands. Ability to attend supervised outpatient physiotherapy rehabilitation session(s) after being discharged from hospital. Ability to participate voluntarily and provide signed informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with concomitant medical conditions such as malignant tumours or severe Chronic Obstructive Pulmonary Disease that would prevent participation in the required rehabilitation programme. Lateral surgical approach required. Inability to follow commands. Persons not able to mobilise in a bipedal manner with or without a walking aid. Conditions preventing full weight bearing post-operatively. The inability to provide signed informed consent. Revision TKR or any previous major arthrotomy or previous High Tibial Osteotomy on the knee to be operated onLess than 70 degrees of flexion. Persons undergoing bi-lateral total knee replacements. Persons identified as being unlikely to follow Queensland Health's TKR Clinical Pathway (e.g. requiring admission to the rehabilitation unit preoperatively) Greater than 15 degree FFD (Fixed flexion deformity).

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)
1. sealed opaque envelopes. 3. central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Ratio 1:1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Physiotherapist blinded to intervention collects all measures at each assessment point. Participants blinded to intervention. Surgeon who is unblided to the intervention collects Intraoperative data.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1564 0
Government body
Name [1] 1564 0
Queensland Health
Country [1] 1564 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Queensland Health - QEII Jubile Hospital
Kessels Rd
Nathan Brisbane QLD
Country
Australia
Secondary sponsor category [1] 1376 0
University
Name [1] 1376 0
University of Queensland, Brisbane
Address [1] 1376 0
St Lucia, Brisbane
Country [1] 1376 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2996 0
Princess Alexandra Hospital HREC-QEII Jubilee Hospital
Ethics committee address [1] 2996 0
St Lucia Brisbane
Ethics committee country [1] 2996 0
Australia
Date submitted for ethics approval [1] 2996 0
Approval date [1] 2996 0
31/01/2006
Ethics approval number [1] 2996 0
2005/191
Ethics committee name [2] 2997 0
University of QLD Medical Research Ethics Committee
Ethics committee address [2] 2997 0
Ethics committee country [2] 2997 0
Australia
Date submitted for ethics approval [2] 2997 0
Approval date [2] 2997 0
08/03/2006
Ethics approval number [2] 2997 0
2006000154

Summary
Brief summary
Study Hypothesis: We hypothesise that participants receiving the subvastus approach will enjoy better medium term funtional outcomes than those receiving the medial parapatell approach.
Physiotherapists are blinded to the intervention and will collect all outcome measures at each assessment point. Participants are blinded to the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35993 0
Address 35993 0
Country 35993 0
Phone 35993 0
Fax 35993 0
Email 35993 0
Contact person for public queries
Name 9904 0
Mr Michael Bourke
Address 9904 0
Queen Elizabeth II Jubilee Hospital
Private Bag 2
Acacia Ridge
Brisbane QLD 4110
Country 9904 0
Australia
Phone 9904 0
+61 7 32756173
Fax 9904 0
+61 7 3275 6579
Email 9904 0
michael.bourke@uqconnect.edu.au
Contact person for scientific queries
Name 832 0
Mr Michael Bourke
Address 832 0
Queen Elizabeth II Jubilee Hospital
Private Bag 2
Acacia Ridge
Brisbane QLD 4110
Country 832 0
Australia
Phone 832 0
+61 7 32756173
Fax 832 0
+61 7 3275 6579
Email 832 0
michael_bourke@health.qld.gov.au

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

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