Comparison of the Treatment of the Distal Radius Fracture with Closed Reduction and Percutaneous Pinning with and without Superficial Radial Nerve Exploration
Comparison of the outcome and complications of the treatment of distal radius fracture with closed reduction and percutaneous pinning with and without radial nerve exploration
Design
A two-arm parallel-group single-blind randomized controlled trial
Settings and conduct
Patients with a distal radius fracture who refers to the emergency department of Shafa Orthopedic Hospital will be identified and in case of providing written consent will be randomly allocated into one of the two study groups (surgery without radial nerve exploration and surgery with radial nerve exploration). Twelve weeks after treatment with closed reduction and percutaneous pinning, the complications and outcome of the surgery will be compared between the two study groups. The patients will be blinded from the type of surgery.
Participants/Inclusion and exclusion criteria
Patients with distal radius fracture and age of more than 18 years will be included in the study after providing the written consent. Patients with a history of distal radius fracture and patients having associated injuries affecting the outcome of treatment will be excluded from the study.
Intervention groups
Group 1: Treatment of distal radius fracture with closed reduction and percutaneous pinning without radial nerve exploration
Group 2: Treatment of distal radius fracture with closed reduction and percutaneous pinning with radial nerve exploration
Main outcome variables
Wrist range of motion; wrist function; pinch strength; pain; first dorsal web sensation; paresthesia; hyperesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190903044677N1
Registration date:2019-11-09, 1398/08/18
Registration timing:prospective
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Pouria Tabrizian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2041
Email address
tabrizian.pouria@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Treatment of the Distal Radius Fracture with Closed Reduction and Percutaneous Pinning with and without Superficial Radial Nerve Exploration
Public title
Treatment of the Distal Radius Fracture with Closed Reduction and Percutaneous Pinning without Superficial Radial Nerve Exploration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of more than 18 years
Providing written consent to participate in the study
Exclusion criteria:
A history of distal radius fracture
Concomitant injury affecting the outcome of treatment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a computer-generated random number list. For this purpose, the patients will be numbered from 1 to 100. Within this range, 50 random numbers will be generated by Excel software. These random numbers will be matched with the patients' numbers, and corresponding patients will be allocated into the case group. The remaining 50 patients will be allocated to the control group. Accordingly, participants will randomly be assigned in a 1:1 ratio into the two study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients will be blinded from the group assignment.
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 the Milad tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.IUMS.REC.1398.118
Health conditions studied
1
Description of health condition studied
Distal radius fracture
ICD-10 code
M84.333A
ICD-10 code description
Stress fracture, right radius, initial encounter for fracture
Primary outcomes
1
Description
First dorsal web sensation
Timepoint
Before the intervention and two days after the end of intervention
Method of measurement
Patients' clinical examination
2
Description
Paresthesia
Timepoint
Before the intervention and two days after the end of intervention
Method of measurement
Patients' clinical examination
3
Description
Hyperesthesia
Timepoint
Before the intervention and two days after the end of intervention
Method of measurement
Patients' clinical examination
Secondary outcomes
1
Description
Wrist range of motion
Timepoint
Before the intervention and 12 months after the end of intervention
Method of measurement
Goniometer
2
Description
Wrist function
Timepoint
Before the intervention and 12 months after the end of intervention
Method of measurement
DASH questionaire
3
Description
Pinch strength
Timepoint
Before the intervention and 12 months after the end of intervention
Method of measurement
Dinamometer
4
Description
Pain
Timepoint
Before the intervention and 12 months after the end of intervention
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group: Treatment of distal radius fracture with closed reduction and percutaneous pinning without superficial radial nerve exploration
Category
Treatment - Surgery
2
Description
Control group: Treatment of distal radius fracture with closed reduction and percutaneous pinning with superficial radial nerve exploration
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Orthopedic Hospital
Full name of responsible person
Pouria Tabrizian
Street address
Mojahedine-eslam Ave.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
tabrizian.p@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Next to the Milad tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
ivco@iums.ac.ir
Web page address
http://iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shafa Orthopedic Hospital
Full name of responsible person
Pouria Tabrizian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojaheine-eslam Ave.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
tabrizian.p@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shafa Orthopedic Hospital
Full name of responsible person
Pouria Tabrizian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojahedine-eslam Ave.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
tabrizian.p@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shafa Orthopedic Hospital
Full name of responsible person
Pouria Tabrizian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojahedine-eslam Ave.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
tabrizian.p@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data associated with this study are sharable upon request, after anonymizing the participants.
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Academic investigators
Under which criteria data/document could be used
The applicant should provide sufficient documents to prove his/her academic identity. Allowed use of the data is dependent on the confirmation of the performers of this study.
What processes are involved for a request to access data/document
Email application for the data request, Evaluation of the request, identification of the applicant, the reason for requesting data, evaluation of the provided reasons, sending data through email in case of confirming the provided reasons.