Comparing the results of scaphoid waist fracture fixation using screws and screws with pins in acute scaphoid waist fractures

1. Comparison of scaphoid waist fracture fixation using a screw alone versus screw combined with pin fixation in acute scaphoid waist fractures based on the degree of functional improvement according to the MAYO questionnaire. 2. Comparison of the two groups in terms of pain severity. 3. Comparison of the two groups in terms of wrist range of motion in flexion and extension. 4. Comparison of the two groups in terms of fracture union rate. 5. Comparison of the two groups in terms of the scapholunate angle on lateral radiographs.

randomized, single-blind, controlled clinical trial with parallel group conducted on 30 patients. Randomization was performed using SPSS software.

The study will be conducted at Besat Hospital in Hamadan. radiographs will be obtained at 1, 3, and 6 months after surgery, and the patients will be evaluated based on the study variables.

Inclusion criteria: provision of informed consent Exclusion criteria: Refusal to participate in the study, Loss to follow-up

In the screw group (control), 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. In the screw-and-pin group (case), first, two pins will be inserted from distal to proximal and from volar to dorsal or vice versa toward the center of the scaphoid. Afterward, a screw will be inserted along the same axis, based on the size of the inserted and measured pin, and fixation will be achieved. The postoperative cast will be removed after approximately one month.

Functional improvement, pain severity, wrist range of motion, fracture union rate, and the scapholunate angle on lateral radiographs.

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.

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.