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Trial registered on ANZCTR


Registration number
ACTRN12612001013853
Ethics application status
Approved
Date submitted
10/07/2012
Date registered
19/09/2012
Date last updated
2/08/2019
Date data sharing statement initially provided
2/08/2019
Date results information initially provided
2/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Assessment of the Clinical Outcome of High Tibial Osteotomy
Scientific title
Prospective Assessment of the Clinical Outcome of High Tibial Osteotomy
Secondary ID [1] 280812 0
Nil
Universal Trial Number (UTN)
U1111-1132-5490
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Tibial Osteotomy 286873 0
Condition category
Condition code
Musculoskeletal 287198 287198 0 0
Osteoarthritis
Surgery 287206 287206 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Clinical and radiological outcome of High Tibial Osteotomy observed at 5 and 10 years post surgery
Intervention code [1] 285240 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287488 0
Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 287488 0
5 and 10 years from surgery
Primary outcome [2] 288013 0
British Orthopaedic Association Patient Satisfaction Scale
Timepoint [2] 288013 0
10 years from surgery
Secondary outcome [1] 298277 0
Radiological Alignment
Timepoint [1] 298277 0
10 years from surgery

Eligibility
Key inclusion criteria
1. High Tibial Osteotomy performed during 2000-2002 with full preoperative assessment
2. Full articular cartilage in the opposite compartment
3. Correctable deformity
4. First 100 consecutive patients with pre-operative assessment
5. Australian resident at time of surgery
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patients seeking compensation for their injury

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 285607 0
Self funded/Unfunded
Name [1] 285607 0
Address [1] 285607 0
Country [1] 285607 0
Australia
Primary sponsor type
Individual
Name
Leo Pinczewski
Address
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, The Mater Clinic
3 Gillies St
Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 284848 0
None
Name [1] 284848 0
Address [1] 284848 0
Country [1] 284848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287607 0
University of Sydney
Ethics committee address [1] 287607 0
Human Research Ethics Comittee
University of Sydney
NSW 2006
Ethics committee country [1] 287607 0
Australia
Date submitted for ethics approval [1] 287607 0
09/07/2007
Approval date [1] 287607 0
20/07/2007
Ethics approval number [1] 287607 0
10192

Summary
Brief summary
This prospective single centre outcome study will document in a longitudinal manner the clinical outcome of high tibial osteotomy. Patients who undergo a High Tibial Osteotomy by Dr Leo Pinczewski between 2000 and 2002 will be invited to participate. At 5 and 10 years after their surgery patients will be contacted by the researchers and invited to return for clinical assessment.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 34418 0
A/Prof Leo PInczewski
Address 34418 0
The Mater Clinic, Suite 2
3 Gillies St Wollstonecraft NSW 2065
Country 34418 0
Australia
Phone 34418 0
+61 2 94375999
Fax 34418 0
Email 34418 0
lsalmon@nsosmc.com.au
Contact person for public queries
Name 17665 0
Dr Dr Lucy Salmon
Address 17665 0
NSOSMC
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country 17665 0
Australia
Phone 17665 0
+612 9437 5999
Fax 17665 0
+612 9437 9595
Email 17665 0
lsalmon@nsosmc.com.au
Contact person for scientific queries
Name 8593 0
A/Prof Associate Professor Leo Pinczewski
Address 8593 0
NSOSMC
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country 8593 0
Australia
Phone 8593 0
+612 9437 5999
Fax 8593 0
+612 9437 9595
Email 8593 0
lsalmon@nsosmc.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not planned
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 3465 0
The outcome at 10 years of lateral closing wedge high tibial osteotomy: Preoperative predictors of survivorship and determinants of functional outcome Nick Howells, John Scanelli, Lucy Salmon, Alison Waller, Leo Pinczewski. Bone Joint Journal November 2014 96-B (11): 1491-1497
Attachments [1] 3465 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary