ROMANOFF - Rotational Malalignment in Nailing of Femur Fractures – A Study Protocol on Comparative Randomized Study between Supine and Lateral Position

Background Intramedullary (IM) nailing has become the preferred method for treating femur fractures in adults. It requires a small incision and minimal dissection, promotes excellent fracture healing, and allows for rapid recovery. The supine position on the fracture table is the preferred surgical position for most surgeons. However, studies have shown that the entry point and fracture reduction are much easier in the lateral decubitus position compared to the supine position. Whatever position may be used, a proportion of patients develop rotational malalignment of varying severity. CT has become the standard modality for assessing the rotational profile in patients post-femoral nailing. To the best of our knowledge, no study has compared the advantages of rotational alignment between these two positions in nailing for femoral shaft fractures. This study aims to assess the prevalence of rotational malalignment in patients and to evaluate whether the intraoperative position has any impact on the same. Methods and Design: Patients aged above 18 years presenting to the department of Trauma Orthopaedic Unit at Christian Medical College, Vellore with femur shaft fractures will be invited to participate in this study. A total of 90 patients are required to provide 80% statistical power at a 5% alpha level to detect a difference in postoperative rotational alignment between the two positions. The primary outcome measure will be the measurement of rotational alignment while the secondary outcome measures will include operative time, Radiation exposure, number of open reductions, intraoperative complications VAS pain score, LEFS score, clinical range of movements and time to union. These will be measured at 6 weeks, 3 months and 6 months. Based on the degree of malrotation, we divided patients into three groups: insignificant (< 15°), significant (15°- 25°), and excessive (> 25°). Complications will be recorded up to 12 months. The T test or Mann whitney test will be used to compare the two groups on the rotational alignment and operative time. All analysis will be done using SPSS software version 21.0. Differences will be considered significant at p < 0.05. Discussion Femoral shaft fractures are being treated by IM nails in both supine and lateral position. However, there is no study till date comparing rotational malalignment in terms of position. This study could provide more information about the best way to treat these injuries surgically. Trial registration The trial is registered with the Clinical Trials Registry – India (CTRI). Trial registration date – 07/07/2025. Trial registration number – CTRI/2025/07/090344