Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000433000
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
28/05/2010
Date last updated
28/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patella Eversion During Total Knee Replacement: a Prospective, Randomised Trial.
Scientific title
Patients undergoing primary total knee replacement prospectively randomized to patella eversion or retraction during the procedure and then assessed for significant difference in knee scores, range of motion and pain.
Secondary ID [1] 251886 0
none
Universal Trial Number (UTN)
U1111-1115-0618
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patella eversion during total knee replacement. 257415 0
Condition category
Condition code
Surgery 257563 257563 0 0
Surgical techniques
Musculoskeletal 257577 257577 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomized to patella eversion or retraction during total knee replacement. The standard handling of the patella during knee replacement is to evert or flip the patella over to expose the knee joint. In the retraction technique the patella is pulled to the side to expose the knee joint.
Intervention code [1] 256518 0
Treatment: Surgery
Comparator / control treatment
The standard handling of the patella during knee replacement is to evert or flip the patella over to expose the knee joint. In the retraction technique the patella is pulled to the side to expose the knee joint. The average time for a knee replacement is one hour.
Control group
Active

Outcomes
Primary outcome [1] 258479 0
SF12 general health score
Timepoint [1] 258479 0
Data collection was conducted pre-operatively, at three months and at one year
post-operatively.
Primary outcome [2] 258480 0
Oxford knee score
Timepoint [2] 258480 0
Data collection was conducted pre-operatively, at three months and at one year
post-operatively.
Primary outcome [3] 258481 0
Range of motion was measured by goniometer. Active flexion and extension is measured.
Timepoint [3] 258481 0
Data collection was conducted pre-operatively, at three months and at one year
post-operatively.
Secondary outcome [1] 264270 0
Length of hospital stay
Timepoint [1] 264270 0
Calculated at end of Hospital stay from hospital discharge summary data.
Secondary outcome [2] 264271 0
Complications related to the approach such as damage to the patella tendon or problems with wound healing or infection.
This data is obtained from the operative report and follow up clinic visits.
Timepoint [2] 264271 0
Data collection was conducted pre-operatively, at three months and at one year post-operatively.

Eligibility
Key inclusion criteria
Male or female patients of any age requiring primary total knee arthroplasty under the care of the
participating surgeons were included
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were body mass index over 40, nondislocatable
patellae (eg secondary to patella baja or obesity), domiciled outside of Western
Australia, and prior high tibial osteotomy or patella realignment procedures.

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)
Male or female patients of any age requiring primary total knee arthroplasty under the care of the
participating surgeons were included. The sequence was concealed until the interventions were assigned by opening a sealed envelope in the operating theater.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerized random sequence generator was used to assign the order of randomization.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
10/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257003 0
Hospital
Name [1] 257003 0
Sir Charles Gairdner Hospital
Country [1] 257003 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave.
Nedlands
6009
WA
Country
Australia
Secondary sponsor category [1] 256266 0
None
Name [1] 256266 0
Address [1] 256266 0
Country [1] 256266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259023 0
sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 259023 0
Ethics committee country [1] 259023 0
Australia
Date submitted for ethics approval [1] 259023 0
11/06/2006
Approval date [1] 259023 0
10/11/2006
Ethics approval number [1] 259023 0
2006-009

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

Contacts
Principal investigator
Name 31191 0
Address 31191 0
Country 31191 0
Phone 31191 0
Fax 31191 0
Email 31191 0
Contact person for public queries
Name 14438 0
grant booth
Address 14438 0
15A Barsden Street
Cottesloe
6011
WA
Country 14438 0
Australia
Phone 14438 0
(+61) 0421335420
Fax 14438 0
Email 14438 0
[email protected]
Contact person for scientific queries
Name 5366 0
grant booth
Address 5366 0
15A Barsden Street
Cottesloe
6011
WA
Country 5366 0
Australia
Phone 5366 0
(+61) 0421335420
Fax 5366 0
Email 5366 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.