Comparing of clinical outcomes of radial shortening and radial shortening combined with vascularized bone graft in patients with early stage of Kienböck’s disease
The aim of this study is to compare tow surgery methods including radial shortening and radial shortening combined with vascularized bone graft for treatment of early stages of Kienböck’s disease. Inclusion criteria include patients 18-65 years whom diagnosed with stages II or IIIa of Kienböck’s disease according to the Lichtman criteria and exclusion criteria include any serious medical condition that may interfere with safe study participation. Subjects will be selected from patients who referred to Kashani Hospital (Isfahan, Iran) on years 2013-2014. The target sample size are 24 subjects who assign to radial shortening group or radial shortening combined with vascularized bone graft group one by one. In radial shortening group, an average of 3-mm radial shortening will be done and in radial shortening combined with vascularized bone graft group, concurrent radial shortening and anterior vascularized bone grafts from the dorsal distal radius based on the carpal branch of radial artery will be done. Postoperative immobilization will be applied with a short arm cast for 4 weeks. Pain intensity and range of motion will be assessed by the Mayo Wrist Score before the surgery and 9 months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404127841N5
Registration date:2014-04-18, 1393/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-18, 1393/01/29
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Psychiatric group, Isfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2457
Email address
sharbafchi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-05-01, 1393/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of clinical outcomes of radial shortening and radial shortening combined with vascularized bone graft in patients with early stage of Kienböck’s disease
Public title
Comparing of two surgical method, radial shortening and vascularized bone graft, in Kienböck’s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18-65 years aged;diagnosed with stages II or IIIa of Kienböck’s disease according to the Lichtman criteria;written informed consent. Exclusion criteria: any contraindication for receiving general anesthesia; any serious medical condition that may interfere with safe study participation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Isfahan University of Medical Sciences
Street address
Hezar jerib Street
City
Isfahan
Postal code
Approval date
2012-10-05, 1391/07/14
Ethics committee reference number
9/3144/د
Health conditions studied
1
Description of health condition studied
Kienböck’s disease
ICD-10 code
M92.2
ICD-10 code description
Juvenile osteochondrosis of hand
Primary outcomes
1
Description
Pain intensity
Timepoint
Before surgery and 9 months after surgery
Method of measurement
Mayo Wrist Score
2
Description
Range of motion of wrist
Timepoint
Before surgery and 9 months after surgery
Method of measurement
Mayo Wrist Score
Secondary outcomes
1
Description
Postoperative infection
Timepoint
1 week after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
In first group we use radial shortening up to 3 mm. The level of the osteotomy is at the diaphyseal area, nearly 7 cm proximal to the distal articular surface of the radius bone.
Category
Treatment - Surgery
2
Description
In second group we use radial shortening combined with Vascularized bone graft. We use radial shortening up to 3 mm and the level of the osteotomy is at the diaphyseal area, nearly 7 cm proximal to the distal articular surface of the radius bone.The graft and its pedicle are dissected to the transverse volar carpal artery origin.The bone graft is then placed in an about 4 mm deep hole which is made in middle of lunate bone and was stabilized with a fine 5 mm pin.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic ward of Kashani Hospital
Full name of responsible person
Ali Moshgelani
Street address
Hezar jerib Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Peyman Adibi
Street address
Hezar jerib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences, Department of Orthopedy
Full name of responsible person
Ali Moshgelani
Position
Resident of Orthopedy
Other areas of specialty/work
Street address
Hezar jerib Street
City
Isfahan
Postal code
Phone
+98 31 1668 9195
Fax
Email
dr_moshgelani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Department of Orthopedy
Full name of responsible person
Ali Moshgelani
Position
Resident of Orthopedy
Other areas of specialty/work
Street address
Hezar jerib Street
City
Isfahan
Postal code
Phone
+98 31 1668 9195
Fax
Email
dr_moshgelani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi Zadeh
Position
Medical Doctor
Other areas of specialty/work
Street address
Hezar jerib Street
City
Isfahan
Postal code
Phone
+98 31 1668 9195
Fax
Email
sharbafchi@res.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)