Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000404224
Ethics application status
Approved
Date submitted
14/05/2009
Date registered
2/06/2009
Date last updated
22/01/2020
Date data sharing statement initially provided
9/01/2019
Date results information initially provided
9/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Three Techniques for Establishing Component Alignment in Total Knee Reconstruction: A Randomised Clinical Trial
Scientific title
A comparison of extramedullary, intramedullary and computer-assisted surgery alignment techniques for establishing component alignment in total knee reconstruction: a randomised clinical trial
Secondary ID [1] 288989 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 4788 0
Osteoarthritis 4789 0
Condition category
Condition code
Musculoskeletal 237131 237131 0 0
Osteoarthritis
Surgery 237132 237132 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will undergo total knee replacement (TKR) using one of three methods:
1. extramedullary alignment (surgery uses a jig placed on the outside of the leg to determine cut placement)
2. intramedullary alignment surgery uses a jig placed on a rod sitting in the medullary canal of the tibia to determine cut placement)

3. Computer assisted surgery (CAS) alignment, surgery uses a jig, placement of which is determined by computer reconstruction of the leg to determine cut placement)
The surgery takes 1-2 hours for all the procedures.
Intervention code [1] 4562 0
Treatment: Surgery
Comparator / control treatment
intramedullary alignment
Control group
Active

Outcomes
Primary outcome [1] 237954 0
mechanical axis measured from computed tomography (CT) scan using computer software
Timepoint [1] 237954 0
3 months following surgery
Secondary outcome [1] 242052 0
measures of alignment, measured from computed tomography (CT) scan using computer software
Timepoint [1] 242052 0
3 months following surgery
Secondary outcome [2] 322824 0
knee function (oxford knee score)
Timepoint [2] 322824 0
prop, 10 years postop
Secondary outcome [3] 322825 0
knee end range flexion, end range extension (Drgoni smartphone app)
Timepoint [3] 322825 0
preop, 10 years postop
Secondary outcome [4] 322826 0
pain (NRS 0-10)
Timepoint [4] 322826 0
preop, 10 years postop
Secondary outcome [5] 322827 0
satisfaction (5pt likert)
Timepoint [5] 322827 0
10 years postop

Eligibility
Key inclusion criteria
Primary total knee replacement for varus osteoarthritis
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the trial for tibial deformity (including past fracture or high tibial osteotomy) or valgus 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)
Methods used to generate the sequence in which subjects will be randomised (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
Completed
Date of first participant enrolment
Anticipated
15/05/2009
Actual
24/03/2009
Date of last participant enrolment
Anticipated
Actual
11/11/2009
Date of last data collection
Anticipated
11/11/2019
Actual
11/11/2019
Sample size
Target
150
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 4962 0
Self funded/Unfunded
Name [1] 4962 0
Country [1] 4962 0
Australia
Primary sponsor type
Individual
Name
Riaz Khan
Address
1/ 85 Maonash Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 4488 0
None
Name [1] 4488 0
Address [1] 4488 0
Country [1] 4488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7062 0
Sir Charles Gairdner Hospital Research Ethics Committee
Ethics committee address [1] 7062 0
Ethics committee country [1] 7062 0
Date submitted for ethics approval [1] 7062 0
Approval date [1] 7062 0
01/01/2008
Ethics approval number [1] 7062 0

Summary
Brief summary
The purpose of the study is to determine which surgical technique provides the best alignment for total knee replacements The null hypothesis is that all techniques are equally good.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29609 0
Prof Riaz Khan
Address 29609 0
1/ 85 Monash Ave, Nedlands WA 6009
Country 29609 0
Australia
Phone 29609 0
+61 08 93863933
Fax 29609 0
Email 29609 0
[email protected]
Contact person for public queries
Name 12856 0
Prof Riaz Khan
Address 12856 0
Suite 1, Hollywood Medical Centre
85 Monash Ave, Nedlands WA 6009
Country 12856 0
Australia
Phone 12856 0
+61 8 93463333
Fax 12856 0
Email 12856 0
[email protected]
Contact person for scientific queries
Name 3784 0
Prof Riaz Khan
Address 3784 0
Suite 8, Hollywood Specialist Centre
95 Monash Avenue,
Nedlands
WA 6009
Country 3784 0
Australia
Phone 3784 0
+61 8 93463333
Fax 3784 0
Email 3784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.