Objectives: Scaphoid fractures present unique therapeutic challenges due to the particular geometry of the fractures and the tenuous vascular pattern of the scaphoid, giving rise to a nonunion fracture in a considerable number of patients. Optimization of the existing methods, such as using nonvascularized bone grafting, might improve the outcome of these treatments. This study aims to evaluate the effects of graft pretreatment with Deferoxamine on the outcome of nonunion scaphoid fracture surgery.
Design: Clinical trial
Setting and conduct: A total of 20 patients will be divided into 2 groups, 10 patients each.
Inclusion criteria: Age of 18 to 60 years; No Comorbid disorders that might increase the risk of surgery; No hematologic disorders and any disease with platelet Dysfunction; Patients not receiving drugs which affect bone restoration such as corticosteroids; Fractures showing no improvement at least 3 months after occurrence; Exclusion criteria: New trauma leading to fixation disturbance; Severe infection untreatable with antibiotics; Incidence of diseases needing corticosteroids or chemotherapy.
Intervention: In group A, autologous cancellous allograft was pretreated with Deferoxamine (500 mg) right before implanting the graft into the position. In group B, autologous cancellous allograft was implanted into the position without pretreatment with Defroxamine.
Main outcome measures: Clinical evalution (range of motion) and radiologic evaluation of union.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091035382N5
Registration date:2017-09-19, 1396/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Farid Najd Mazhar
Name of organization / entity
Shafa orthopedic hospital, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2000
Email address
najdmazhar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research for Iran University of Medical Sciences
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of graft pretreatment with Deferoxamine on the outcome of nonunion scaphoid fracture
Public title
Pretreatment of graft with Deferoxamine and its effect on the outcome of nonunion scaphoid fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 60 years; No hematologic disorders and any disease with platelet Dysfunction; No Comorbid disorders that might increase the risk of surgery; Patients not receiving drugs which affect bone restoration such as corticosteroids; Fractures showing no improvement at least 3 months after occurrence. Exclusion criteria: New trauma leading to fixation disturbance; Severe infection untreatable with antibiotics; Incidence of diseases needing corticosteroids or chemotherapy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Hammat Highway, next to Milad tower
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
-
Health conditions studied
1
Description of health condition studied
Nonunion scaphoid fracture
ICD-10 code
M84.1
ICD-10 code description
pseudarthrosis after fusion or arthrodesis
Primary outcomes
1
Description
Wrist range of motion
Timepoint
3 months after the surgery
Method of measurement
Goniometer
2
Description
Radiologic outcome
Timepoint
3 months after the surgery
Method of measurement
X-ray and MRI
Secondary outcomes
empty
Intervention groups
1
Description
Group A: pretreatment of graft with Defroxamine, right before implanting the graft into the position
Category
Treatment - Surgery
2
Description
Group B: Implanting the graft into the position whiouth its pretreatment with deforxamine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Orthopedic Hospital
Full name of responsible person
Farid Najd Mazhar
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, Shahi Hemmat Highway,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
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
Shafa Orthopedic Hospital
Full name of responsible person
Farid Najd Mazhar
Position
Orthopedic surgeon
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square