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IRCT20260423069141N1 IRCT 2026-07-19 Hamedan University of Medical Sciences Comparing scaphoid waist fracture fixation using screws and screws with pins Comparing the results of scaphoid waist fracture fixation using screws and screws with pins in acute scaphoid waist fractures 2026-04-21 anticipated 30 Recruiting https://irct.ir/trial/90316 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be used in this study. In this method, each patient will have an equal probability of being assigned to one of the two treatment groups, and patient allocation will be performed independently of the allocation of other participants. The unit of randomization in this study is individual randomization, meaning that each patient will be independently assigned to one of the two treatment groups. Stratified randomization will not be used in this study because the primary objective is to compare the overall outcomes of the two treatment methods, and no specific variable has been considered for stratification. The random allocation sequence will be generated using a random number table/statistical software. Initially, a random sequence for the entire sample size will be generated using statistical software (such as SPSS or Random Allocation Software), so that each patient will be randomly assigned to either the “screw fixation” group or the “screw plus pin fixation” group. The allocation result for each number will then be written on a separate sheet and placed inside an opaque envelope. The envelopes will be sequentially numbered. To prevent selection bias, the Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) method will be used for allocation concealment. The envelopes will be opaque and numbered in sequence. After patient enrollment and baseline data collection, the corresponding envelope will be opened by the researcher to determine the type of intervention. The individual responsible for generating the random allocation sequence will have no involvement in patient enrollment or outcome assessment, Blinding description: In this study, the patients and the data analyst will be blinded to the type of intervention; however, blinding of the surgeon will not be feasible due to the nature of the surgical procedure. Patients will be informed that they may randomly receive one of the treatment methods, but they will ultimately remain unaware of the specific procedure performed. In addition, the statistician/data analyst will be blinded to group allocation. The treatment groups will be identified using specific codes (such as Group A and Group B), and the analyst will not have access to the actual type of interventions until completion of the statistical analysis. N/A scaphoid waist fracture. Intervention 1: Intervention group: A 3–5 mm incision will be made on the volar or dorsal side. First, two pins will be inserted from distal to proximal and from volar to dorsal, or vice versa, toward the center of the scaphoid. Then, a screw will be inserted along the same axis, corresponding to the length of the inserted and measured pin, and fixation will be achieved. The postoperative cast will be removed after approximately one month. Intervention 2: Control group: A 3–5 mm incision will be made on the volar or dorsal side. First, two 1-mm pins will be inserted under C-arm guidance from the volar to dorsal direction or vice versa, and from distal to proximal. Then, one screw will be inserted from distal to proximal. After that, the pins will be removed and a cast will be applied. The cast will be removed one month after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information is available.
public Mohamad Amini
Shahid Beheshti Blvd, Hamadan
Hamadan Iran (Islamic Republic of) 6515737461 +98 81 3824 1515 M.AMINI@UMSHA.AC.IR Hamedan University of Medical Sciences scientific Mohamad Amini
Shahid Beheshti Blvd, Hamadan
Hamadan Iran (Islamic Republic of) 6515737461 +98 81 3264 0020 M.AMINI@UMSHA.AC.IR Hamedan University of Medical Sciences Iran (Islamic Republic of) Confirmed scaphoid waist fracture no limit no limit Both Presence of an associated wrist fracture Chronic fracture Fracture associated with ligament injury and perilunate injury Need for open surgery (open surgical procedure) Presence of SNAC signs Treatment - Surgery Treatment - Surgery Intervention group: A 3–5 mm incision will be made on the volar or dorsal side. First, two pins will be inserted from distal to proximal and from volar to dorsal, or vice versa, toward the center of the scaphoid. Then, a screw will be inserted along the same axis, corresponding to the length of the inserted and measured pin, and fixation will be achieved. The postoperative cast will be removed after approximately one month. Control group: A 3–5 mm incision will be made on the volar or dorsal side. First, two 1-mm pins will be inserted under C-arm guidance from the volar to dorsal direction or vice versa, and from distal to proximal. Then, one screw will be inserted from distal to proximal. After that, the pins will be removed and a cast will be applied. The cast will be removed one month after surgery. Improvement in wrist joint function. Timepoint: At the beginning of the study and at 1-, 3-, and 6-month follow-up periods after surgery. Method of measurement: MAYO questionnaire. Pain severity. Timepoint: At the beginning of the study and at 1-, 3-, and 6-month follow-up periods after surgery. Method of measurement: Visual Analogue Scale. Wrist range of motion in flexion and extension. Timepoint: At 3 and 6 months after surgery. Method of measurement: Joint range of motion in different directions using a goniometer. Fracture union rate. Timepoint: At 1, 3, and 6 months after surgery. Method of measurement: Based on the presence of tenderness in the anatomical snuffbox and the complete crossing of bony trabeculae on all three radiographic views (posteroanterior, lateral, and scaphoid views). Scapholunate angle on lateral radiographs. Timepoint: At 1, 3, and 6 months after surgery. Method of measurement: The angle between the scaphoid axis (a line drawn along its longitudinal poles) and the lunate axis (a line perpendicular to the line connecting its proximal and distal ends) is measured. The normal range is 30–60 degrees. Hamedan University of Medical Sciences Approved 2026-04-18 Ethics committee of Hamadan University of Medical Sciences Shahid Fahmideh Blvd, Hamadan Hamadan Hamadan Iran (Islamic Republic of)