Comparison of two methods of parallel percutaneous pinning from metacarpal head and cross pinning from condyle of proximal phalanx in proximal phalanx fractures in referrals to Shahid Bahonar Hospital, Kerman
the purpose of the study is assessment and comparison of two common methods of treatment of proximal phalanges fractures of the hand. Patients with extra articular fractures of the proximal phalanges of hand, in case of not meeting exclusion criteria (such as multiple phalanges or pathological fractures) and and after informed consent will be divided randomly into two treatment groups until the sample size is reached (30 patients). In one of the groups the pins will be inserted into the phalangeal condyles and in the other from the metacarpal head to the proximal phalanx. The patients will be followed for at least 6 months for range of motion and work return and surgery complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405142115N3
Registration date:2016-02-23, 1394/12/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-23, 1394/12/04
Registrant information
Name
Ali Reza Saied
Name of organization / entity
Kerman Neurosceince research center, Kerman University of medical sciecnes
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 6432
Email address
arsaied@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-03-08, 1394/12/18
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of parallel percutaneous pinning from metacarpal head and cross pinning from condyle of proximal phalanx in proximal phalanx fractures in referrals to Shahid Bahonar Hospital, Kerman
Public title
Comparison of two methods of percutaneous pinning in treatment of proximal phalanges fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
informed consent؛ proximal phalanx extra-articular fracture, except thumb
Exclusion Criteria:
Multiple fingers fractures؛ pathological fractures؛3 pregnancy؛ Any underlying disease affecting bone healing
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
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
Kerman University of medical sciences
Street address
Kerman, Jomhoory Bolvd.
City
Kerman
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93/701/KA
Health conditions studied
1
Description of health condition studied
extraarticular fracture of proximal pahalanx
ICD-10 code
S62.6
ICD-10 code description
Fracture of other finger
Primary outcomes
1
Description
finger joint range of motion
Timepoint
two months
Method of measurement
Goniameter
Secondary outcomes
1
Description
infection
Timepoint
teo months
Method of measurement
lab nad examination
Intervention groups
1
Description
In the first group the pins will be inserted from skin to the phalangeal condyles.
Category
Treatment - Surgery
2
Description
In the second group the pins will be inserted to the metacarpal head and then to the phalanx via skin
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Bahonar Hospital, Kerman
Full name of responsible person
Alireza Saied
Street address
Dr Bahonar Hospital, Kerman, Iran
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of medical sciences
Full name of responsible person
Alireza Saied
Street address
Bahonar Hospital, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of medical Sceinces
Full name of responsible person
Alireza Saied
Position
Orthopedic Surgeon, Associate Professor
Other areas of specialty/work
Street address
Bahonar Hospital, Kerman
City
Kerman
Postal code
Phone
+98 34 3246 2229
Fax
Email
arsaiedmd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of medical Sceinces
Full name of responsible person
Alireza Saied
Position
Hand Surgery Fellowship
Other areas of specialty/work
Street address
Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3246 2229
Fax
Email
arsaiedmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical sciecnces
Full name of responsible person
Alireza Saied
Position
Associate Professor of orthopedics
Other areas of specialty/work
Street address
Orthopeidcs Dept, Dr. Bahonar Hospital, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3246 2229
Fax
Email
arsaiedmd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)