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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]

Foot lenght

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

knee arthroplasty

tibial osteotomy

knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

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]

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]

tibia height

Timepoint [1]

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]

femur length using x-ray

Timepoint [1]

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?

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]

Poland

State/province [1]

Lódzkie

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Country [1]

Primary sponsor type

Individual

Name

Jan Poszepczynski

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

KOMISJA BIOETYCZNA PRZY UNIWERSYTECIE MEDYCZNYM W LODZI

Ethics committee address [1]

90-647 Lódz Plac Hallera 1B , Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

29/01/2021

Approval date [1]

09/02/2021

Ethics approval number [1]

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

Dr Jan Poszepczynski

Address

Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz Stefana Zeromskiego 113, 90-549 Lódz

Country

Poland

Phone

+4842 639 35 11

Fax

janek24061982@tlen.pl

Contact person for public queries

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

Phone

+4842 639 35 11

Fax

janek24061982@tlen.pl

Contact person for scientific queries

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

Phone

+4842 639 35 11

Fax

janek24061982@tlen.pl

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Available to any scientist who will need them for further analysis and possible comparison with another population.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Age, gender, height, shoe size, shin length, thigh length.

What types of analyses could be done with individual participant data?

• Available to perform comparative analyzes with other populations and possibly find global relationships.

When can requests for individual participant data be made (start and end dates)?

From:
1 year after the study is completed .

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Through the website of the magazine in which this work will be published.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically