Objectives: Variety of surgical techniques have been introduced for the treatment of Kienbock's disease. However, there is no consensus regarding the best therapeutic approach. Here we aim to compare the results of radius osteotomy with capitates osteotomy in these patients.
Design: Clinical trial
Setting and conduct: A number of 20 patients with the confirmed diagnosis of Kienbock's disease, referred to the Shafa Orthopedic Journal, will be entered into the study.
Major inclusion and exclusion Criteria: Inclusion criteria: Radiologic Diagnosis of the Kienbock's disease by a hand surgeons; Exclusion criteria: Incidence of any comorbid disorders that might increase the risk of surgery including cardiovascular disorders, uncontrolled diabetes, rheumatic diseases such as rheumatoid arthritis, cancers, hepatic and renal failure and etc.
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:IRCT2017080335382N2
Registration date:2017-08-03, 1396/05/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-03, 1396/05/12
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 for research of Iran University of Medical Sciences
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Radius osteotomy and capitate osteotomy in the treatment of Kienbock's disease
Public title
Comparison of two therapeutic approach in Kienbock's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Radiologic Diagnosis of the Kienbock's disease by a hand surgeons; Exclusion criteria: Incidence of any comorbid disorders that might increase the risk of surgery including cardiovascular disorders, uncontrolled diabetes, rheumatic diseases such as rheumatoid arthritis, cancers, hepatic and renal failure and etc.
Age
No age limit
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
Next to Milad tower, Hammat 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
Range of motion of the wrist and radilogical sympptoms
Timepoint
Months 3, 6 of intervention
Method of measurement
Goniometer and X-ray and MRI
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Radius osteotomy
Category
Treatment - Surgery
2
Description
Group 2: Capitate osteotomy
Category
Treatment - Surgery
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
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/Science committee
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square