Early results about efficacy of Allograft in comparison with autografts in treatment of long bone fractures that need bone graft are controversial. For evaluation of the efficacy of these two methods patients with comminuted fractures of long bones are divided in two groups. In one group patients treated by autogenous iliac bone graft and the other one treated by allograft. Rate and time of fracture healing in two groups evaluated by x-Rays in 1, 2 and 6 month intervals. Finally the efficacy of the allograft and autograft in the two groups evaluated. The morbidly of donor site in autograft is determined. SPSS 15 will be used for statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811283352N1
Registration date:2010-09-09, 1389/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-09, 1389/06/18
Registrant information
Name
Ali Sadighi
Name of organization / entity
Medical Since University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 7765
Email address
sadighi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of allograft and autograft on rate of union in comminuted fracture of long bones.
Public title
Comparison of the Effects of Allograft and Autograft on Rate of Union in Comminuted Fracture of Long Bones.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Comminuted fractures of long bones.
Exclusion criteria : Head trauma , systemic diseases such as diabetes mellitus , pathological fractures.
Age
To 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Tabriz Medical Univercity
Street address
Tabriz Medical Univercity
City
Tabriz
Postal code
5166877781
Approval date
empty
Ethics committee reference number
8813
Health conditions studied
1
Description of health condition studied
Long bone fracture
ICD-10 code
S82
ICD-10 code description
Fracture of lower leg, including ankle
2
Description of health condition studied
Long bone fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
3
Description of health condition studied
Long bone fracture
ICD-10 code
S52
ICD-10 code description
Fracture of forearm
4
Description of health condition studied
Long bone fracture
ICD-10 code
S42
ICD-10 code description
Fracture of shoulder and upper arm
Primary outcomes
1
Description
Rate of union
Timepoint
One- three- six month
Method of measurement
Serial radiography from fracture area
Secondary outcomes
1
Description
Infection
Timepoint
One month
Method of measurement
Clinical examination and testing ESR If necessary
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
Eaducation and medical center shohada
Full name of responsible person
Dr Ali Sadighi
Street address
Elgoli, Golshahr, Shohada hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shohada hospital
Full name of responsible person
Dr Ali Sadighi
Street address
Shohada hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shohada hospital
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical University of Tabriz
Full name of responsible person
Dr. Ali Sadighi
Position
Associate Professor
Other areas of specialty/work
Street address
Hospital Shohada
City
Tabriz
Postal code
5166877781
Phone
+98 41 1385 9314
Fax
+98 41 1385 7765
Email
sadighi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Tabriz
Full name of responsible person
Dr Hossen Aslani
Position
Assistant Professor
Other areas of specialty/work
Street address
Hospital Shohada
City
Tabriz
Postal code
Phone
+98 41 1385 9314
Fax
+98 41 1385 7765
Email
dr_Aslani73@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical University
Full name of responsible person
Dr Amin Moradi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shohada Hospital
City
Tabriz
Postal code
Phone
+98 41 1385 9315
Fax
+98 41 1385 7765
Email
Moradi85ortho@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)