Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000169246
Ethics application status
Approved
Date submitted
9/02/2009
Date registered
6/04/2009
Date last updated
12/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does balanced resection provide a better post-operative functional and radiological result than measured resection in primary total knee arthroplasty.
Scientific title
Does balanced resection provide a better post-operative functional and radiological result than measured resection in people undergoing a primary total knee arthroplasty.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 4292 0
Rheumatoid Arthritis 4293 0
Condition category
Condition code
Inflammatory and Immune System 4522 4522 0 0
Rheumatoid arthritis
Musculoskeletal 4523 4523 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Balanced resection: This is a method whereby the surgeon uses a tensor balancer device to distract the joint to be able to produce an equal and rectangular flexion/extension gap through ligament balancing before the femoral cuts are made. The duration is usually no longer than 15 minutes.
Intervention code [1] 4022 0
Treatment: Surgery
Comparator / control treatment
Measured resection: This is a method whereby the surgeon makes all his bony cuts then proceeds to produce an equal and rectangular flexion/extension gap through ligament balancing once trial components are in place. The duration is usually no longer than 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 5403 0
Functional - improvement in knee score using the International Knee Society Score (IKS), SF-12 survey and the Knee injury and Osteoarthritis Outcome Score (KOOS) short-form survey.
Timepoint [1] 5403 0
Prior to the procedure at pre-admissions then 6 weeks, 3, 6,12 and 24 months, 5 and 10 years after the procedure.
Primary outcome [2] 5404 0
Radiological:
Alignment measured using long-leg standing films using lines of the anatomical axis and the knee joint line.
Rotation through Perth Protocol CT-Scan
Timepoint [2] 5404 0
Alignment measured at baseline prior to procedure, and both alignment and rotation measured at 6 weeks post procedure.
Secondary outcome [1] 9083 0
Range of motion using a goniometer.
Timepoint [1] 9083 0
Baseline prior to procedure and 6 weeks, 3, 6,12 and 24 months, 5 and 10 years post procedure.
Secondary outcome [2] 9084 0
Infection rate: assessed by clinical presentation deemed to be an infected joint by the treating surgeon, requiring washout. Will be classified as deep if involving joint capsule and superficial if not involving joint capsule, as deemed by operative notes during washout.
Timepoint [2] 9084 0
6 weeks, 3, 6,12 and 24 months, 5 and 10 years post procedure the records will be checked for any notes regarding an infection.

Eligibility
Key inclusion criteria
Those undergoing a primary total knee arthroplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy.
Under 18

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
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/04/2009
Actual
27/10/2009
Date of last participant enrolment
Anticipated
Actual
18/02/2011
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
100
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4471 0
Hospital
Name [1] 4471 0
St. Vincent's Hospital public - Melbourne
Country [1] 4471 0
Australia
Funding source category [2] 4757 0
Charities/Societies/Foundations
Name [2] 4757 0
Research Endowment Fund
Country [2] 4757 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital public - Melbourne
Address
41 Victoria prd
Fitzroy
Vic 3065
Country
Australia
Secondary sponsor category [1] 4295 0
None
Name [1] 4295 0
Address [1] 4295 0
Country [1] 4295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6794 0
Human Research Ethics Committe (HREC-A) St. Vincent's Hospital (Melbourne)
Ethics committee address [1] 6794 0
Research Governance Unit
Level 5 Aikenhead Building
45 Victoria Prade
Fitzroy, Vic 3065
Ethics committee country [1] 6794 0
Australia
Date submitted for ethics approval [1] 6794 0
Approval date [1] 6794 0
02/04/2009
Ethics approval number [1] 6794 0
021/09

Summary
Brief summary
The aim of this project is to identify which of the two most commonly used techniques for ligament balancing results in better functional and radiological outcomes in total knee replacements. The difference between the two techniques is mainly regarding the order things are done. In one technique (balanced resection), the tibial bone cut is made and the joint is opened up using a distracter device and the ligaments balanced before the femoral bone cuts are made. In the other method (measured resection) all the bone cuts are made prior to ligament balancing. Ligament balancing is described simply as a way of obtaining a rectangular and even flexion/extension gap by modifying the ligaments around the knee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29262 0
Address 29262 0
Country 29262 0
Phone 29262 0
Fax 29262 0
Email 29262 0
Contact person for public queries
Name 12509 0
Michelle Dowsey
Address 12509 0
Department of orthopaedics
Level 3- Daly wing
St. vincent's hospital
41 victoria prade
Fitzroy, VIC 3065
Country 12509 0
Australia
Phone 12509 0
+61 3 92883955
Fax 12509 0
Email 12509 0
[email protected]
Contact person for scientific queries
Name 3437 0
Michelle Dowsey
Address 3437 0
Department of orthopaedics
Level 3- Daly wing
St. vincent's hospital
41 victoria prade
Fitzroy, VIC 3065
Country 3437 0
Australia
Phone 3437 0
+61 3 92883955
Fax 3437 0
Email 3437 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.