Comparison of clinical and radiographic outcomes of two fixation methods: percutaneous pinning and external fixator insertion and percutaneous pinning and dorsal bridge plate insertion in distal radius fracture
Determining the clinical and radiographic outcomes of two fixation methods: percutaneous pinning and external fixator insertion and percutaneous pinning and dorsal bridge plate insertion in distal radius fractures.
Design
patients are randomly divided into two groups, the patients in these two groups are matched in terms of age and gender, and one group is placed under external fixator and the other group is placed under dorsal bridge plate. Randomization of individuals is done using simple randomization method based on registration number. The blinding method in this study is single blinded.
Settings and conduct
performing surgery in the operation room of Imam Khomeini, Shariati and Sina hospital
Participants/Inclusion and exclusion criteria
The subjects included in the study were those who had a distal radius fracture and were candidates for surgical treatment with an external fixator or dorsal bridge plate due to articular surface involvement.
Inclusion criteria:
1 - Distal radius fracture
2 - Articular surface comminution (type C2 and C3 according to AO classification)
3 - Closed physis
Exclusion criteria:
1 - Previous fracture in the same upper limb
2 - Simultaneous fracture in the same upper limb
3 - Evidence of distal radioulnar joint instability (DRUJ)
4 - Neuropathy and vascular involvement of the limb
5 - Uncontrolled rheumatological diseases
6 - Open fracture and wound contamination
7 - Pathological fracture
8 - Active wrist joint infection
Intervention groups
One group of patients underwent pin and external fixator placement, and the other group underwent pin and dorsal bridge plate placement.
Main outcome variables
CRPS symptoms; Tendon complications; Neurological complications; Wound infection; Quick DASH score; Wrist range of motion (ROM); Grip strength; Radiological parameters including volar tilt; ulnar variance; radial height; radial inclination
General information
Reason for update
Acronym
DRUJ (distal radioulnar joint)
IRCT registration information
IRCT registration number:IRCT20241112063690N2
Registration date:2026-06-09, 1405/03/19
Registration timing:retrospective
Last update:2026-06-09, 1405/03/19
Update count:0
Registration date
2026-06-09, 1405/03/19
Registrant information
Name
Mohamad Ehsan Shapourgan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7705 9279
Email address
shapoorgan.ehsan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
2023-09-23, 1402/07/01
Actual recruitment end date
2026-02-20, 1404/12/01
Trial completion date
2026-04-07, 1405/01/18
Scientific title
Comparison of clinical and radiographic outcomes of two fixation methods: percutaneous pinning and external fixator insertion and percutaneous pinning and dorsal bridge plate insertion in distal radius fracture
Public title
Comparison of clinical and radiographic outcomes of two fixation methods: percutaneous pinning and external fixator insertion and percutaneous pinning and dorsal bridge plate insertion in distal radius fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
distal radius fracture
articular surface comminution (c2-c3 according to AO classification)
physical closure
Exclusion criteria:
previous fracture of the same limb
ipsilateral fracture of the same limb
DRUJ instability
neuropathy and vascular disease
uncontrolled reumatologia disease
open fracture
pathologic fracture
active infection of wrist
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
92
Actual sample size reached:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher and analyst are unaware of the type of surgery performed. The patient and surgeon are aware of the type of surgery performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences sina hospital
Street address
No. 604, 6th floor, central building of TUMS , Keshavarz blvd
City
tehran
Province
Tehran
Postal code
1461884513
Approval date
2024-10-07, 1403/07/16
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1403.088
Health conditions studied
1
Description of health condition studied
distal radius fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
Device removal time; , incidence of CTS, incidence of CRPS, tendon injury, infection, incidence of device failure, radiological parameters volar tilt, ulnar variance, radial height, radial inclination
Timepoint
after performing surgery and before device removal
Method of measurement
physical examination and radiography
2
Description
grip strength, range of wrist motion, quick dash score
Timepoint
after device removal
Method of measurement
physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: distal radius fracture that underwent external fixator insertion, It is a well-known surgical treatment for distal radius articular surface fractures. Two distal and two proximal pin screws are placed at the fracture site and connected to each other with the help of two rods.
Category
Treatment - Surgery
2
Description
Intervention group: distal radius fracture that underwent dorsal bridge plate insertion, A method introduced for comminuted fractures of the distal radius that uses a long plate posterior to the fracture site, which bridges the fracture site and is fixed on both sides with screws.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohamad's Ehsan Shapourgan
Street address
Shariati hospital, Jalal al Ahmad St, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shapoorgan.ehsan@gmail.com
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohamad's Ehsan Shapourgan
Street address
Imam Khomeini St. Hasan abad sq.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8587
Email
hosp_sina@sina.tums
3
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Mohamad Ehsan Shapourgan
Street address
Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Central University Organization, Qods Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ehsan Shapourgan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shariati hospital, Jalal al Ahmad st, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۳۵
Phone
+98 21 8490 1000
Email
Shapoorgan.ehsan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Shahriar Kamrani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shariati hospital, Jalal al Ahmad st. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۳۵
Phone
+98 21 8490 1000
Email
rz_kamrani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Shahriar Kamrani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shariati hospital, Jalal al Ahmad st. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۳۵
Phone
+98 21 8490 1000
Email
rz_kamrani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available