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Trial registered on ANZCTR
Registration number
ACTRN12622000214730
Ethics application status
Approved
Date submitted
8/03/2021
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessment of tibia and femur length in patients undergoing elective surgery for knee osteoarthritis in Poland
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Scientific title
Assessment of tibia and femur length in patients undergoing elective surgery for knee osteoarthritis in Poland based on a scaled radiological image.
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Secondary ID [1]
305282
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Foot lenght
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
knee arthroplasty
321002
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tibial osteotomy
321003
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knee osteoarthritis
324719
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Condition category
Condition code
Musculoskeletal
318809
318809
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0
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Osteoarthritis
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Surgery
322166
322166
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants already scheduled fo r knee arthroplasty or tibial osteotomy . Attendance at a 10-minute session involving capture of standardized x-ray , measurement of height and weight, and completion of a questionnaire regarding shoe size, with each component taking approximately 2 minutes to complete.
1 day prior to knee arthroplasty or tibial osteotomy, etc.
Once only examination.
The assessment wil be perfomed by study researcher - orthopaedic surgeon.
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Intervention code [1]
319917
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Diagnosis / Prognosis
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Comparator / control treatment
Participants are tested only once because the aim of the study is to try to find a correlation between the height and length of the foot and the length of the tibia and femur. The control group will be volunteer employees of the ward of similar age who will give their consent to the study.
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Control group
Active
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Outcomes
Primary outcome [1]
326756
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tibia height
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Assessment method [1]
326756
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Timepoint [1]
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The only timepoint is the day 1 day prior to surgery - on which, as part of the standard scheduling, an X-ray, height and weight measurement and a survey is performed prior to a knee or tibial osteotomy.
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Secondary outcome [1]
392587
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femur length using x-ray
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Assessment method [1]
392587
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Timepoint [1]
392587
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Once only on the day prior to surgery,
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Eligibility
Key inclusion criteria
Adult participants will be those scheduled for elective knee arthroplasty or tibial osteotomy for osteoarthritis of the knee.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Presence of dwarfism, Marfan syndrome, or any other disease that significantly affects the length of the limbs.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
The length range of individual parts of the limb will be determined in relation to the height and size of the shoes, along with the standard deviation of the above parameters. We operate on about 400 people a year due to osteoarthritis of the knee, so we should easily gather a group of 200 patients.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/02/2022
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Actual
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Date of last participant enrolment
Anticipated
4/04/2023
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Actual
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Date of last data collection
Anticipated
5/04/2023
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
23515
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Poland
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State/province [1]
23515
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Lódzkie
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Funding & Sponsors
Funding source category [1]
307930
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Self funded/Unfunded
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Name [1]
307930
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Address [1]
307930
0
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Country [1]
307930
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Primary sponsor type
Individual
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Name
Jan Poszepczynski
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Address
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
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Country
Poland
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Secondary sponsor category [1]
308656
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None
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Name [1]
308656
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no
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Address [1]
308656
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no
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Country [1]
308656
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307931
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KOMISJA BIOETYCZNA PRZY UNIWERSYTECIE MEDYCZNYM W LODZI
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Ethics committee address [1]
307931
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90-647 Lódz Plac Hallera 1B , Poland
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Ethics committee country [1]
307931
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Poland
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Date submitted for ethics approval [1]
307931
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29/01/2021
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Approval date [1]
307931
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09/02/2021
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Ethics approval number [1]
307931
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RNN/41/21/KE
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Summary
Brief summary
The aim of the study is to measure the length of the tibia and femur and to try to find the correlation of these parameters with height, weight and shoe size. The examination will be performed in connection with the unresolved problem of selecting the appropriate length of the implant that fixes the fracture of the femur or tibia. The possible positive results may contribute to the establishment of new guidelines for preoperative planning in the treatment of long bone fractures with the use of an intramedullary nail.
Therefore, a group of researchers led by prof. dr hab. Dr. Marcin Domzalski, MD, decided to use a radiological examination, which is usually performed before elective surgeries, to trace the length of the tibia and femur, and to find their correlation with the height, weight and shoe size using statistical analysis. The study will cover adults aged 22-90 who agree to participate in the study. It is assumed that the study is to last at least a year, with the possibility of extending the duration of the study.
The study will include patients who have been planned for knee arthroplasty or corrective osteotomy of the femur or tibia and have a standard centimeter-graduated photo.
Patients who do not consent to the study will be excluded from the study.
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Trial website
no
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Trial related presentations / publications
no
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Public notes
no
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Contacts
Principal investigator
Name
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Dr Jan Poszepczynski
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Address
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Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
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Country
108966
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Poland
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Phone
108966
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+4842 639 35 11
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Fax
108966
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no
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Email
108966
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[email protected]
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Contact person for public queries
Name
108967
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Dr Jan Poszepczynski
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Address
108967
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Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
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Country
108967
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Poland
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Phone
108967
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+4842 639 35 11
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Fax
108967
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no
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Email
108967
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[email protected]
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Contact person for scientific queries
Name
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Dr Jan Poszepczynski
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Address
108968
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Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
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Country
108968
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Poland
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Phone
108968
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+4842 639 35 11
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Fax
108968
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no
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Email
108968
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Age, gender, height, shoe size, shin length, thigh length.
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When will data be available (start and end dates)?
1 year after the study is completed .
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Available to whom?
Available to any scientist who will need them for further analysis and possible comparison with another population.
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Available for what types of analyses?
Available to perform comparative analyzes with other populations and possibly find global relationships.
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How or where can data be obtained?
Through the website of the magazine in which this work will be published.
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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.
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