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Comparison of the therapeutic outcomes of intra‑articular distal radius fractures treated with locking plate alone versus locking plate combined with external fixator.

Protocol summary

Study aim
Comparison of the therapeutic outcomes of intra‑articular distal radius fractures treated with locking plate alone versus locking plate combined with external fixator.
Design
The present study is an open‑label, parallel‑group randomized clinical trial (using block randomization) conducted on 64 patients.
Settings and conduct
In this open‑label randomized clinical trial, patients who are candidates for distal radius surgery at Vali‑Asr Hospital in Arak will be randomly assigned to two groups (A and B) using block randomization. Blinding will not be performed due to the nature of the study, and the study outcomes will ultimately be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18–60 years with intra‑articular distal radius fractures; surgical intervention performed within a maximum of 10 days after injury; and provision of written informed consent to participate in the study and attend follow‑up visits at 2 weeks and at 1, 2, and 6 months. Exclusion criteria: Open fractures or contamination of the surgical site; Presence of uncontrolled diabetes, renal failure, or long‑term corticosteroid use.
Intervention groups
Group I (Volar Locking Plate, VLP): Patients undergo open reduction and internal fixation (ORIF) via the volar Henry approach. After anatomical reduction of fracture fragments, a volar locking plate is applied to the distal radius and fixation is confirmed with fluoroscopy. Group II (VLP + External Fixator): After ORIF with a volar locking plate as described above, a dynamic bridging external fixator is additionally applied based on the principle of ligamentotaxis to enhance stability and maintain reduction.
Main outcome variables
Range of motion of the wrist joint, pain score, Disabilities of the Arm, Shoulder and Hand (DASH) score, Mayo Wrist Score, and time to return to work.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N55
Registration date: 2026-05-12, 1405/02/22
Registration timing: prospective

Last update: 2026-05-12, 1405/02/22
Update count: 0
Registration date
2026-05-12, 1405/02/22
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-20, 1405/02/30
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic outcomes of intra‑articular distal radius fractures treated with locking plate alone versus locking plate combined with external fixator.
Public title
Comparison of Two Surgical Methods for Intra‑Articular Distal Radius Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18–60 years with intra‑articular distal radius fractures (AO classification types C2 and C3), based on radiographic imaging. Surgery performed within a maximum of 10 days after injury. Written informed consent from the patient for participation and follow-up at 2 weeks, and 1, 2, and 6 months.
Exclusion criteria:
Open fracture or contamination of the surgical site. Presence of a systemic disease affecting bone healing (such as uncontrolled diabetes, renal failure, or long‑term corticosteroid use).
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the two intervention groups in the order of enrollment and according to a pre-generated randomization sequence. This sequence will be unpredictable, and its arrangement will be completely random. Block randomization with blocks of four will be used for sample allocation. Accordingly, using random number generation software with a block randomization method, a randomization sequence appropriate to the required sample size for the three groups will be generated. Initially, all possible arrangements of the two labels, A and B, within blocks of four will be created. Then, one block will be randomly selected with replacement from among all blocks, and the arrangement pattern within that block will be used for participant allocation. The selected block will then be returned to the main pool, and another block will be randomly selected again. All these procedures will be performed using software called Sealed Envelope. Using this method, allocation concealment will also be maintained. Allocation concealment refers to preventing prediction of participants’ assignment to groups. In fact, the researcher will not be able to predict which group the next participant will be assigned to.
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 Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2026-04-12, 1405/01/23
Ethics committee reference number
IR.ARAKMU.REC.1405.028

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
Range of motion of the wrist joint
Timepoint
2 weeks, 1, 2, and 6 months post-surgery
Method of measurement
Goniometer

2

Description
Pain score
Timepoint
2 weeks, 1, 2, and 6 months post-surgery
Method of measurement
Visual Analog Scale

3

Description
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Timepoint
2 weeks, 1, 2, and 6 months post-surgery
Method of measurement
The standardized Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

4

Description
Mayo Wrist Score
Timepoint
2 weeks, 1, 2, and 6 months post-surgery
Method of measurement
Mayo Wrist Score

5

Description
Time to return to work
Timepoint
Within 6 months after surgery
Method of measurement
Medical history

Secondary outcomes

empty

Intervention groups

1

Description
Group I – Volar Locking Plate (VLP): In this group, patients are treated using Open Reduction and Internal Fixation (ORIF) via the anterior volar (Henry) approach. Following regional or general anesthesia, a skin incision is made along the Flexor Carpi Radialis (FCR) tendon. Initially, the fracture fragments are reduced to their anatomical position through direct manipulation and, if necessary, with the use of pins. The interval between the radial artery and the FCR tendon is then dissected, and the tendon is retracted ulnarly. The Pronator Quadratus (PQ) muscle is detached from the volar surface of the radius, providing full visualization of the sigmoid notch to assess the fracture site and the position of the plate. Subsequently, the VLP is placed on the volar surface of the radius, and locking screws are inserted to ensure axial stability and prevent secondary displacement. Fluoroscopic control in anteroposterior (AP) and lateral views is performed to confirm precise reduction and proper plate positioning. Finally, the wound is closed in layers, a sterile dressing is applied, and the limb is immobilized with a short arm splint for a short period to allow for early passive motion.
Category
Treatment - Surgery

2

Description
Group II – Volar Locking Plate with External Fixator:In this group, all of the aforementioned steps for internal fixation are first performed, and the plate is fixed in place using the Volar Locking Plate technique. Subsequently, to enhance stability and maintain longitudinal forces, a dynamic external fixator is applied based on the principle of ligamentotaxis.For this purpose, in bridging external fixation of the distal radius, a longitudinal incision is initially made over the radial aspect of the distal radial diaphysis. Through blunt dissection down to the bone, the superficial radial nerve and the lateral antebrachial cutaneous branch are carefully protected. Thereafter, two bicortical pins are inserted into the middle–lateral aspect of the radius, proximal to the fracture site.Next, a small incision is created over the second metacarpal between the first dorsal interosseous muscle and the extensor tendons of the index finger. Two pins are then inserted from the second metacarpal toward the third metacarpal, engaging one cortex of the latter, in order to create a three-point fixation construct. After connecting the pins using clamps and bars, the external fixation frame is assembled.Finally, the fracture is reduced, and the adequacy of reduction is confirmed under fluoroscopic guidance. The connections are then tightened, and complete stability with maintenance of reduction is verified. The fixator remains in place for one month and is removed upon observation of early signs of bony callus formation.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Valiasr Hospital
Full name of responsible person
Dr. Mohsen Parsi Khameneh
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 912 194 3813
Email
parsimkh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Behzad Khansari Nejad
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3383 8319
Email
behzad.khansarinejad@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Hesamuddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
he_modir@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohsen Parsi Khameneh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
parsimkh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Reza Soleimani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
Rezasoleimani1373@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
No - There is not 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
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will commence from August 21, 2026, until August 21, 2029, for a duration of 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
University researchers and university professors can request Dr. Ahmadreza Behrouzi to use the data after contacting the relevant professor via message or email. Dr. Hesamuddin Modiri: Phone: 09183615107 Email: modir.he@gmail.com, Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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