Objective To explore effectiveness of TiRobot-assisted screw implantation in the treatment of coracoid process fractures of the scapula. Methods A retrospective analysis was conducted on the clinical data from 24 patients with coracoid process fractures of the scapula admitted between September 2019 and January 2024 and met selection criteria. Among them, 12 patients underwent TiRobot-assisted screw implantation (robot group) and 12 underwent manual screw implantation (control group) during internal fixation. There was no significant difference (P>0.05) in baseline data such as gender, age, body mass index, disease duration, cause of injury, coracoid process fracture classification, and proportion of patients with associated injuries between the two groups. The incision length, operation time, intraoperative blood loss, hospital stay, accuracy of screw placement, coracoid process fracture healing time, and complications were recorded and compared, as well as pain visual analogue scale (VAS) score, and Constant-Murley score at last follow-up. ResultsThe intraoperative blood loss and incision length in the robot group were significantly lower than those in the control group (P<0.05); however, there was no significant difference in operation time and hospital stay between the two groups (P>0.05). All patients were followed up 8-27 months (mean, 17.5 months), and the difference in follow-up time between the two groups was not significant (P>0.05). At last follow-up, the VAS score for shoulder pain in the robot group was signifncatly lower compared to the control group, and the Constant-Murley score was significantly higher (P<0.05). In the robot group, 16 screws were implanted intraoperatively, while 13 screws were implanted in the control group. Radiographic re-evaluation showed that the excellent and good rate of screw implantation was higher in the robot group (93.8%, 15/16) than in the control group (61.5%, 8/13), but the difference in the precision of screw implantation between the two groups was not significant (P>0.05). Four patients in the robot group and 1 in the control group achieved double screws fixation; however, the difference in achieving double screws fixation between the two groups was not significant (P>0.05). All fractures healed in both groups with 1 case of malunion in the control group. There was no significant difference in healing time between the two groups (P>0.05). During follow-up, 1 patient in the control group experienced screw loosening and displacement. There was no significant difference in the incidence of screw loosening and fracture malunion between the two groups (P>0.05). Conclusion Compared with manual screw implantation, TiRobot-assisted minimally invasive treatment of coracoid process fractures of the scapula can reduce intraoperative blood loss, shorten incision length, alleviate pain, and obtain better promote shoulder joint functional recovery.
Compared to non-absorbable medical devices, the design and evaluation of repeated exposure systemic toxicity tests for absorbable medical devices present unique challenges. This article discusses the special considerations for conducting such tests on absorbable medical devices. Based on regulatory documentation, scientific literature and practical experience, and focusing on the degradation and metabolic characteristics of absorbable medical devices, the analysis summarizes personalized test design strategies from key aspects such as test duration and data collection points, exposure routes, dose design, sample preparation, and pathological examination. This article proposes the following points: ① the test duration should cover the in vivo degradation and absorption process of the medical device material, with multiple data collection points established according to the product’s degradation kinetics to reveal the time-effect relationship of toxic responses; ② the exposure route must closely simulate clinical use, as it directly affects the metabolic pathways and toxicological manifestations of degradation products; ③ dose group design should move beyond the traditional “limit test” approach by employing multiple dose groups to uncover potential dose-response relationships; and ④ result evaluation requires appropriate statistical methods to integrate pathological data from different dose groups, determine the relationship between toxic responses and the test samples, and analyze the relevance of toxic responses to clinical applications to guide clinical practice. This article provides a specific and practical reference for the accurate and objective assessment of repeated exposure systemic toxicity risks associated with absorbable medical devices.