Objectives: Kienbock's disease, is a rare, debilitating condition that can lead to chronic pain and dysfunction. It is caused by lack of blood supply for lunate bone. Desfroxamine is a drug with positive effects on angiogenesis and bone repair. Here we aim to evaluate the Deferoxamine effect on the vascularization of lunate bone in Kienbock's disease.
Design: Clinical trial.
Setting and conduct: A total of 10 Patients, referred to shafa orthopedic hospital, diagnosed with Kienbock's disease, will be assigned into intervention group.
Inclusion and exclusion criteria: Inclusion criteria: Radiologic Diagnosis of the Kienbock's disease by 3 hand surgeons; Age of 18 to 60 years. Lack of hematologic disorders and any disease with platelet Dysfunction; Lack of any comorbid disorders that might increase the risk of surgery including uncontrolled diabetes, cardiovascular disorders, rheumatic diseases such as rheumatoid arthritis, cancers, hepatic and renal failure and etc; Consumption of no drug which affect bone restoration such as corticosteroids. Exclusion Criteria: New severe trauma affecting the fracture dislocation and fixation status, Incidence of severe infection which can not be controlled with antibiotics and needs surgery; Incidence of disorders needing specific drugs such as corticosteroids and chemotherapy which affect the bone repair.
Intervention: Local Deferoxamine (500 mg) will be infused at days 0 and 14 along with the implication of external fixator.
Main outcome measures: The outcome will be assessed using clinical (range of motion) and paraclinical (X-ray and MRI) measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017073035382N1
Registration date:2017-08-11, 1396/05/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-11, 1396/05/20
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, Iran University of Medical Sciences
Expected recruitment start date
2017-12-20, 1396/09/29
Expected recruitment end date
2018-04-18, 1397/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of local Deferoxamine impact on revascularization and improvement of avascular necrosis of the lunate bone (Kienbock's disease)
Public title
implication of Deferoxamine in the treatment of kienbock’s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Radiologic Diagnosis of the Kienbock's disease by 3 hand surgeons; Age of 18 to 60 years. Lack of hematologic disorders and any disease with platelet Dysfunction; Lack of any comorbid disorders that might increase the risk of surgery including uncontrolled diabetes, cardiovascular disorders, rheumatic diseases such as rheumatoid arthritis, cancers, hepatic and renal failure and etc; Consumption of no drug which affect bone restoration such as corticosteroids.
Exclusion Criteria: New severe trauma affecting the fracture dislocation and fixation status, Incidence of severe infection which can not be controlled with antibiotics and needs surgery; Incidence of disorders needing specific drugs such as corticosteroids and chemotherapy which affect the bone repair.
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
-
Health conditions studied
1
Description of health condition studied
Kienböck disease of adults
ICD-10 code
M93.1
ICD-10 code description
Adult osteochondrosis of carpal lunate
Primary outcomes
1
Description
Clinical and radiologic symptoms
Timepoint
Months 3, 6 and 12 of intervention
Method of measurement
Range of Motion, Xray and MRI
Secondary outcomes
empty
Intervention groups
1
Description
Deferoxamine, 500mg, two sessions, once at the start of the study and once two weeks later.
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
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
Next to Milad tower, 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, Faculty Member
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Sq