Trial Review

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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
Scientific title
Assessment of tibia and femur length in patients undergoing elective surgery for knee osteoarthritis in Poland based on a scaled radiological image.
Secondary ID [1] 305282 0
Foot lenght
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee arthroplasty 321002 0
tibial osteotomy 321003 0
knee osteoarthritis 324719 0
Condition category
Condition code
Musculoskeletal 318809 318809 0 0
Osteoarthritis
Surgery 322166 322166 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 319917 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 326756 0
tibia height
Timepoint [1] 326756 0
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.
Secondary outcome [1] 392587 0
femur length using x-ray
Timepoint [1] 392587 0
Once only on the day prior to surgery,

Eligibility
Key inclusion criteria
Adult participants will be those scheduled for elective knee arthroplasty or tibial osteotomy for osteoarthritis of the knee.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of dwarfism, Marfan syndrome, or any other disease that significantly affects the length of the limbs.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
4/04/2023
Actual
Date of last data collection
Anticipated
5/04/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 23515 0
Poland
State/province [1] 23515 0
Lódzkie

Funding & Sponsors
Funding source category [1] 307930 0
Self funded/Unfunded
Name [1] 307930 0
Country [1] 307930 0
Primary sponsor type
Individual
Name
Jan Poszepczynski
Address
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
Country
Poland
Secondary sponsor category [1] 308656 0
None
Name [1] 308656 0
no
Address [1] 308656 0
no
Country [1] 308656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307931 0
KOMISJA BIOETYCZNA PRZY UNIWERSYTECIE MEDYCZNYM W LODZI
Ethics committee address [1] 307931 0
90-647 Lódz Plac Hallera 1B , Poland
Ethics committee country [1] 307931 0
Poland
Date submitted for ethics approval [1] 307931 0
29/01/2021
Approval date [1] 307931 0
09/02/2021
Ethics approval number [1] 307931 0
RNN/41/21/KE

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.
Trial website
no
Trial related presentations / publications
no
Public notes
no

Contacts
Principal investigator
Name 108966 0
Dr Jan Poszepczynski
Address 108966 0
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
Country 108966 0
Poland
Phone 108966 0
+4842 639 35 11
Fax 108966 0
no
Email 108966 0
janek24061982@tlen.pl
Contact person for public queries
Name 108967 0
Dr Jan Poszepczynski
Address 108967 0
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
Country 108967 0
Poland
Phone 108967 0
+4842 639 35 11
Fax 108967 0
no
Email 108967 0
janek24061982@tlen.pl
Contact person for scientific queries
Name 108968 0
Dr Jan Poszepczynski
Address 108968 0
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz
Country 108968 0
Poland
Phone 108968 0
+4842 639 35 11
Fax 108968 0
no
Email 108968 0
janek24061982@tlen.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, gender, height, shoe size, shin length, thigh length.
When will data be available (start and end dates)?
1 year after the study is completed .
Available to whom?
Available to any scientist who will need them for further analysis and possible comparison with another population.
Available for what types of analyses?
Available to perform comparative analyzes with other populations and possibly find global relationships.
How or where can data be obtained?
Through the website of the magazine in which this work will be published.


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.