Comparison of the results of two methods of autograft and allograft in trauma patients with long-bone fractures referred to orthopedic ward in the Shahid Beheshti hospital Babol
Choosing the right graft method for long bone fractures
Design
In this study, 100 patients have been assigned to two groups of intervention and control by using random numbers table.
Settings and conduct
In this clinical trial, all patients who undergon bone graft surgery in Shahid Beheshti Hospital with upper and lower extremity bone fractures diagnosis include the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient willingness, Having genetic disorders and other skeletal deformities in the organs that affect the outcome of the study, Having Systemic Disease Like: Metabolic Diabetes, Split fractures of diaphyseal bone with long bones without general or specific bone disease, Lack of brain trauma. Exclusion criteria: Systemic underlying disease, such as diabetes, bone underlying disease, such as bony cysts, Head injury, Lack of timely referral for follow-up therapy to the orthopedic clinic.
Intervention groups
One group was treated with conglomerate autograft and another group with allografts of cannell chips.
Main outcome variables
Rate of union; Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160508027797N3
Registration date:2018-05-26, 1397/03/05
Registration timing:retrospective
Last update:2018-05-26, 1397/03/05
Update count:0
Registration date
2018-05-26, 1397/03/05
Registrant information
Name
Masoud Bahrami Ferydoni
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.bahrami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-23, 1395/04/03
Expected recruitment end date
2017-06-24, 1396/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of two methods of autograft and allograft in trauma patients with long-bone fractures referred to orthopedic ward in the Shahid Beheshti hospital Babol
Public title
Comparison of the results of two methods of autograft and allograft in trauma patients with long-bone fractures referred to orthopedic ward in the Shahid Beheshti hospital Babol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient Satisfaction to Participate in this Study
Not having genetic disorders and other skeletal deformities in the organs that affect the outcome of the study.
Not having systemic illness like: diabetes mellitus
Split fractures of diaphyseal bone with long bones without general or specific bone disease
Lack of brain trauma
Exclusion criteria:
In cases of systemic underlying disease, such as diabetes, bone underlying disease such as bony cysts
Head injury
Lack of timely referral for follow-up therapy to the orthopedic clinic
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups of autograft and allograft using Permuted Block Randomization. Number will be selected for allocation concealment by one of the colleagues and by another, that assignment chain is chosen.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
MUBABOL.HRI.REC.1396.89
Health conditions studied
1
Description of health condition studied
Long bone fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Rate of union
Timepoint
Three and Six months after the end of the intervention
Method of measurement
Serial radiography from fracture area
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:open reduction, Allograft, this is ready made that will be purchased from the providing company and there is no need for iliac crest surgery
Category
Treatment - Surgery
2
Description
Control group: open redaction, iliac bone graft (Autograft)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Drbahrami865@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4
Phone
+98 11 3219 7667
Email
Hamid_va@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Valiollahpour Amiri
Position
Orthopedic Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Hamid_va@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Drbahrami865@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Valiollahpour Amiri
Position
Orthopedic Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Hamid_va@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD