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Comparison of the functional and radiological outcomes of arthroscopic-assisted (AA) and fluoroscopic-assisted (FA) reduction of Intra-articular fracture of distal radius

Protocol summary

Study aim
Evaluation of functional and radiological results of intra-articular distal radius fracture (DRF) treatment with arthroscopic and fluoroscopic aid and comparison of two methods with each other.
Design
Single center, two arm parallel groups, randomized trial with blinded postoperative functional evaluation, on 60 patients. R software was used to randomization.
Settings and conduct
This study is being performed at Taleghani Hospital. The patients are randomly divided into two equal groups. In the ORIF group, all fractures will be reduced through the Henry approach and fixed by VLP, fluoroscopically. In another group, based on the surgeon's decision, patients may have undergone ORIF with VLP and then additional arthroscopic-assisted reduction (AAR), or AAR using the multiple pins from the beginning. Functional outcomes are evaluated by another surgeon who is blinded to the patient assignment. The radiological results can not be blinded due to differences in surgical procedures.
Participants/Inclusion and exclusion criteria
Patients over 18 years with unilateral, type B3 and C, intra-articular DRF, who have the possibility of follow-up for evaluation of functional and radiological results for at least 1 year.
Intervention groups
Wrist arthroscopy will be performed to achieve the reduction of intra-articular DRF or correct that, and to assess and treat the accompanying soft tissue injuries.
Main outcome variables
Functional outcomes will be evaluated in the 3rd and 12th months postoperatively, and include VAS, DASH, PRWE, grip strength and ROM. The last two are expressed as a percentage of the opposite side. Radiological outcomes will be evaluated in the 12th months postoperatively, and include the radial inclination, ulnar variance, radiocarpal tilt, SL and CL angles which will be calculated on AP and LAT radiographs. Intra-articular gap and step will be assessed with a wrist CT-SCAN.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180306038971N1
Registration date: 2020-05-22, 1399/03/02
Registration timing: registered_while_recruiting

Last update: 2020-05-22, 1399/03/02
Update count: 0
Registration date
2020-05-22, 1399/03/02
Registrant information
Name
Mohammad Ali Okhovatpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2222
Email address
okhovatpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the functional and radiological outcomes of arthroscopic-assisted (AA) and fluoroscopic-assisted (FA) reduction of Intra-articular fracture of distal radius
Public title
Examination of arthroscopic and fluoroscopic assisted methods in the treatment of intra-articular fracture of distal radius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intra-articular fracture of distal radius (AO/OTA type B3,C) Age over 18 years
Exclusion criteria:
Open fractures: type 2 and above according to the Gustilo-Anderson classification Concomitant fracture of the ipsilateral upper extremity or the other wrist except the ulnar styloid process fracture Neurovascular alteration such as acute carpal tunnel syndrome Compartment syndrome Previous limitation of movement in the wrist due to neuromuscular diseases or untreated nonunion or malunion of the wrist bones, or other injuries which interfered with the next rehabilitation program The need to use a dorsal plate to fix the fracture
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 intervention groups. The randomization method will done using software, 30 random numbers for each intervention group. The researcher can not play a role in predicting treatment of the disease, and choosing the type of treatment. random sequence will generate by software. Group 1: 30 Cases and Group 2: 30 cases.
Blinding (investigator's opinion)
Single blinded
Blinding description
To compare the functional outcomes of two methods, patients are examined by an orthopedist who is unaware of their surgical procedure in the 3rd and 12th months after surgery, while wearing long gloves or stockinette
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti university of medical science
Street address
Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2019-05-31, 1398/03/10
Ethics committee reference number
IR.SBMU.MSP.REC.1398.310

Health conditions studied

1

Description of health condition studied
Intra-articular fracture of distal radius
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Comparison of the effect of surgical procedure on postoperative disability
Timepoint
3rd and 12th months in postoperative follow-up
Method of measurement
Patient-rated wrist/hand evaluation (PRWHE) questionnaire

Secondary outcomes

1

Description
Comparison of the effect of surgical procedure on extra-articular displacement, including radial inclination, radiocarpal tilt and ulnar variance
Timepoint
12th months in postoperative follow-up
Method of measurement
Anteroposterior (AP) and lateral (LAT) wrist radiographs

2

Description
Comparison of the effect of surgical procedure on scapholunate (SL) and capitolunate (CL) angle
Timepoint
12th months in postoperative follow-up
Method of measurement
LAT wrist radiography

3

Description
Comparison of the effect of surgical procedure on intra-articular displacement, including gap and step-off
Timepoint
12th months in postoperative follow-up
Method of measurement
Wrist CT-scan

4

Description
Comparison of the effect of surgical procedure on postoperative pain
Timepoint
3rd and 12th months in postoperative follow-up
Method of measurement
Visual analogue scale (VAS) questionnaire

5

Description
Comparison of the effect of surgical procedure on postoperative disability
Timepoint
3rd and 12th months in postoperative follow-up
Method of measurement
Disabilities of the arm, shoulder and hand (DASH) questionnaire

6

Description
Comparison of the effect of surgical procedure on postoperative hand grip strength
Timepoint
3rd and 12th months in postoperative follow-up
Method of measurement
Dynomometer

7

Description
Comparison of the effect of surgical procedure on postoperative wrist range of motion (ROM)
Timepoint
3rd and 12th months in postoperative follow-up
Method of measurement
Goniometer

Intervention groups

1

Description
Intervention group: Based on the surgeon's decision, patients may have undergone open reduction and internal fixation (ORIF) with volar locking plate (VLP) and then additional arthroscopic assisted reduction (AAR), or AAR using the multiple pinning.
Category
Treatment - Surgery

2

Description
Control group: Patients will be undergone surgery with ORIF using VLP under the fluoroscopic control
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Mohammad Ali Okhovat Pour
Street address
Next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Email
okhovatpour@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for research and technology, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for research and technology, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Okhovat Pour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
hand surgery
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Email
okhovatpour@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Okhovat Pour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
hand surgery
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Email
okhovatpour@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Okhovatpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No.5, central Oedibehesht Ave., South Makooeipoor
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2595
Fax
+98 21 2243 2595
Email
okhovatpour@gmail.com

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 data can be shared potentially after patients became unrecognizable.
When the data will become available and for how long
After completing the results and analyzing the data, access to them is allowed.
To whom data/document is available
This is only available for people working in academic institutions
Under which criteria data/document could be used
After obtaining written permission, the use of the data is permitted with reference to the source.
From where data/document is obtainable
Orthopaedic ward in Taleghani hosopital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway. Tell: 00982123031216 Mohammad Ali Okhovat Pour Tell:00982123031294 e-mail: okhovatpour@gmail.com Yaser Safaei Tell:00989155113937 e-mail: yasersafa@yahoo.com
What processes are involved for a request to access data/document
After completing the results and analyzing the data, the use of the data is allowed after the written request.
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