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IRCT20191104045328N55 IRCT 2026-05-12 Arak University of Medical Sciences Comparison of Two Surgical Methods for Intra‑Articular Distal Radius Fractures Comparison of the therapeutic outcomes of intra‑articular distal radius fractures treated with locking plate alone versus locking plate combined with external fixator. 2026-05-20 anticipated 64 Recruiting https://irct.ir/trial/89930 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A distal radius fracture. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: Access will commence from August 21, 2026, until August 21, 2029, for a duration of 3 years. To whom: University researchers Conditions: 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. Where to obtain: 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 How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Hesamuddin Modir
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 he_modir@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Mohsen Parsi Khameneh
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 parsimkh@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 60 years Both 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). S52.5 Fracture of lower end of radius Treatment - Surgery Treatment - Surgery 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. 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. Range of motion of the wrist joint. Timepoint: 2 weeks, 1, 2, and 6 months post-surgery. Method of measurement: Goniometer. Pain score. Timepoint: 2 weeks, 1, 2, and 6 months post-surgery. Method of measurement: Visual Analog Scale. 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. Mayo Wrist Score. Timepoint: 2 weeks, 1, 2, and 6 months post-surgery. Method of measurement: Mayo Wrist Score. Time to return to work. Timepoint: Within 6 months after surgery. Method of measurement: Medical history. Arak University of Medical Sciences Approved 2026-04-12 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran. Arak Markazi Iran (Islamic Republic of)