The comparison of function, range of motion, and pain intensity in the two-year follow-up of patients with distal radius fracture with coronal shift undergoing surgical management versus conservative management
Design
Randomized control trial , parallel and RAND function in 50 patient.
Settings and conduct
50 patients with distal radial fracture referred to the Kashani Hospital affiliated at Isfahan University of Medical Sciences from March 2014 to April 2017. Randomized with excell software in two groups surgery with plate and close reduction and casting. without blindness
Participants/Inclusion and exclusion criteria
distal radius fracture with coronal shift in 18 to 55 without previous wrist surgery
Intervention groups
"Intervention group": Surgery and fixation with plate. "Control group": Close reduction and Casting
Main outcome variables
functional score on the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; pain score based on Visual Analogue Scale (VAS), and handgrip strength (HGS) measured via a dynamometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200604047653N1
Registration date:2020-09-07, 1399/06/17
Registration timing:retrospective
Last update:2020-09-07, 1399/06/17
Update count:0
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Meghdad Rahmani Doulatabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3779 0201
Email address
meghdad_rahmani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-01, 1395/12/11
Expected recruitment end date
2019-04-01, 1398/01/12
Actual recruitment start date
2017-03-01, 1395/12/11
Actual recruitment end date
2019-04-01, 1398/01/12
Trial completion date
2019-04-01, 1398/01/12
Scientific title
Surgical versus conservative management of distal radius fracture with coronal shift (18 to 55 old); a randomized controlled trial for the first time
Public title
Surgical versus conservative management of distal radius fracture with coronal shift; a randomized controlled trial for the first time
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Distal radius fracture type 1 Fernandez with coronal shift
Exclusion criteria:
previous surgery in wrist
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
50
Randomization (investigator's opinion)
Not 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
Ethics committee of Isfahan university of medical science
Street address
Isfahan University of Medical Science,Hezar Jarib Ave,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8177787755
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.MUI.MED.REC.1398.054
Health conditions studied
1
Description of health condition studied
Distal radius fracture type 1 Fernandez with coronal shift
ICD-10 code
S52.50
ICD-10 code description
Unspecified fracture of the lower end of radius
Primary outcomes
1
Description
function scoring DASH,
Timepoint
24 month after treatment
Method of measurement
Clinical evaluation and dynamometer
2
Description
pain scoring VAS,
Timepoint
24 month after treatment
Method of measurement
Clinical evaluation and dynamometer
3
Description
handgrip strength scorin HGS
Timepoint
24 month after treatment
Method of measurement
Clinical evaluation and dynamometer
Secondary outcomes
1
Description
-pain score based on Visual Analogue Scale (VAS) after 24 month
Timepoint
handgrip strength (HGS) measured via a dynamometer 24 month after treatment
Method of measurement
Medical Dynanometer
Intervention groups
1
Description
"Control group": Close reduction and Casting.
Category
Treatment - Surgery
2
Description
Intervention group: Open reduction and instrumentation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital in Isfahan
Full name of responsible person
Meghdad Rahmani
Street address
Kashani Hospital,Kashani Ave,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8177787755
Phone
+98 31 3235 0004
Email
Meghdad_rahmani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjoojavanmard
Street address
Isfahan university of medical science,hezar jarib ave,isfahan
City
Isfahan
Province
Isfehan
Postal code
8177787755
Phone
+98 31 3779 0201
Email
Meghdad_rahmani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?