Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000925741
Ethics application status
Approved
Date submitted
28/01/2022
Date registered
29/06/2022
Date last updated
29/06/2022
Date data sharing statement initially provided
29/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Minimally invasive method of obtaining autogenous spongy bone transplants from the proximal part of the tibia in patients requiring this type of transplant for reconstructive surgery.
Scientific title
Scar aesthetics and pain following a minimally invasive method of obtaining autogenous spongy bone transplants from the proximal part of the tibia in patients requiring this type of transplant for reconstructive surgery.
Secondary ID [1] 303827 0
no
Universal Trial Number (UTN)
Trial acronym
MIMOASG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autogenous spongy bone graft 321351 0
Condition category
Condition code
Injuries and Accidents 319128 319128 0 0
Fractures
Emergency medicine 322987 322987 0 0
Other emergency care
Anaesthesiology 322988 322988 0 0
Pain management
Injuries and Accidents 323370 323370 0 0
Other injuries and accidents
Surgery 323371 323371 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the initial stage of the reconstructive surgery, the orthopedic surgeon, using a crown drill and a guide with an olive, takes cylindrical fragments of the spongy bone from the side of the proximal part. The collection of the graft takes about 5 minutes and is made of a skin cut with a length of 15 millimeters. During follow-up visits (2 weeks, 6 weeks, 12 weeks and a year and 2 years after the surgery) at the orthopedic clinic, the aesthetics of the scar and symptoms from the graft collection site will be assessed. As the control group will have their transplants collected from another place, the study cannot be randomized.
Intervention code [1] 320134 0
Treatment: Surgery
Comparator / control treatment
In the initial stage of the reconstructive surgery, the orthopedic surgeon, using a crown drill and a guide with an olive, takes cylindrical fragments of the spongy bone from the side of the iliac region. The collection of the graft takes about 5 minutes and is made of a skin cut with a length of 50 millimeters. During follow-up visits (2 weeks, 6 weeks, 12 weeks and a year and 2 years after the surgery) at the orthopedic clinic, the aesthetics of the scar and symptoms from the graft collection site will be assessed.
Control group
Active

Outcomes
Primary outcome [1] 327014 0
Assessment of the volume of the harvested graft. It will be made by using a milliliter-graduated vessel into which 10 ml of saline will be poured, and then bone material will be placed and the level of liquid in the vessel will be re-evaluated.
Timepoint [1] 327014 0
At the completion of surgery
Secondary outcome [1] 393471 0
Pain assessed using a numeric rating scale,
Timepoint [1] 393471 0
2,6,12, weeks post-surgery , 1,2 year post-surgery.
Secondary outcome [2] 407443 0
Scar aesthetics using a numeric scale.
Timepoint [2] 407443 0
2 weeks, 6 weeks, 12 weeks, 1 year, and 2 years post-surgery'.

Eligibility
Key inclusion criteria
Adults who gave informed consent to conduct the study in which the use of spongy bone transplants was necessary to ensure the success of the entire surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
2/07/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 23570 0
Poland
State/province [1] 23570 0
Lódzkie

Funding & Sponsors
Funding source category [1] 308223 0
Self funded/Unfunded
Name [1] 308223 0
jan poszepczynski
Country [1] 308223 0
Poland
Primary sponsor type
Hospital
Name
Orthopedics Clinic of the University of Medical Sciences in Lódz,
Address
Orthopedics Clinic of the University of Medical Sciences in Lódz, Lódz, Zeromskiego 113, 90-549
Country
Poland
Secondary sponsor category [1] 311561 0
None
Name [1] 311561 0
Address [1] 311561 0
Country [1] 311561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308205 0
Komisja Bioetyczna Uniwersytetu Medycznego w Lodzi
Ethics committee address [1] 308205 0
90-647 Lódz, ul. Pl. Hallera 1B
Ethics committee country [1] 308205 0
Poland
Date submitted for ethics approval [1] 308205 0
Approval date [1] 308205 0
07/07/2021
Ethics approval number [1] 308205 0

Summary
Brief summary
Purpose of the study is to prove that minimally invasive method of obtaining autgenic spongy bone grafts from the proximal part of the tibia is a safe method that allows for good cosmetic results and does not cause pain from the site of the graft collection. This procedure is efficent an safe and doesn't cause any artifical pain .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109922 0
Dr Jan Poszepczynski
Address 109922 0
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz, Poland; 90-949 Lódz, ul. Zeromskiego 113
Country 109922 0
Poland
Phone 109922 0
+4842 639 35 11
Fax 109922 0
Email 109922 0
[email protected]
Contact person for public queries
Name 109923 0
Dr jan poszepczynski
Address 109923 0
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz, Poland; 90-949 Lódz, ul. Zeromskiego 113
Country 109923 0
Poland
Phone 109923 0
+4842 639 35 11
Fax 109923 0
Email 109923 0
[email protected]
Contact person for scientific queries
Name 109924 0
Dr jan poszepczynski
Address 109924 0
Department of Orthopedics and Traumatology, Military Medical Academy Memorial Teaching Hospital in Lodz, Poland; 90-949 Lódz, ul. Zeromskiego 113
Country 109924 0
Poland
Phone 109924 0
+4842 639 35 11
Fax 109924 0
Email 109924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.