Tripod-Fix, a novel titanium-based implant with a triangular pyramid-like design, expands three-dimensionally to enhance the stability of the cement against both vertical and horizontal forces. Our study demonstrated that Tripod-Fix effectively alleviated pain (VAS decreased from 8.6 ± 1.8 to 0.7 ± 0.9) and improved patient mobility (ODI decreased from 73.7 ± 16.3 to 2.7 ± 4.1). Post-treatment imaging revealed superior vertebral body height restoration at t he anterior (15.9 ± 5.1%) and middle (7.1 ± 2.3%) portions compared with SpineJack® [21]. Importantly, there were no device-related adverse events, such as cement leakage, vertebral body collapse, or adjacent vertebral fractures (AVFs).
Studies have highlighted that AVF recurrence rates at 1 year post-vertebral augmentation procedures (VP/BKP) range from 6.5–7.4%, with factors like bone mineral density and cement leakage being significant risk factors [22][23]. Tripod-Fix addresses these concerns by enabling precise cement delivery, minimizing the risk of excessive cement injection and subsequent complications [24] [25].
Comparing our results, the postoperative VAS score for pain in our patients (2.8±1.5) aligns well with previous reports by Lin et al. who compared the BKP and VP outcomes. Notably, our study demonstrated a greater reduction (-5.8) in VAS score compared to Lin et al. (-4.1), suggesting that Tripod-Fix may offer enhanced postoperative pain relief. Additionally, the ODI improvement (-41.8 ± 14.8%) with Tripod-Fix is comparable to the outcomes seen with SpineJack® (-48.6 ± 21.4) [26]. However, the recent use of intravertebral reduction devices has shown greater height restoration than BKP, which warrants consideration [27][28]. Nevertheless, the 3D expansion of Tripod-Fix, coupled with its ability to prevent cement leakage, may provide more long-term benefits to patients.
The precise control over cement deposition with Tripod-Fix (4.4 ± 0.8 cc) is noteworthy because it allows for tailored cement delivery compared with SpineJack® (4.1 ± 1.7 cc) [25, 29]. Notably, Noriega et al. highlighted the advantages of titanium-based vertebral augmentation devices over traditional methods for pain relief [26].
In this study, the operation time for the Tripod-Fix implantaiton and cement deposit (40.3±4.8 mins) were comparable to those reported for SpineJack® by Noriega et al. [15] [29][26]. We anticipate that future advancements in Tripod-Fix procedures will further reduce operation times without compromising safety or efficacy.
Our study had limitations, including the lack of long-term follow-ups beyond 1 year, given the reluctance of elderly patients to return for extended assessments. However, it remains imperative to evaluate the Tripod-Fix efficacy across short-term (3 months), mid-term (6 months), and long-term (1 year) follow-up periods. To monitor device performance and assess VCF recurrence. Furthermore, the small sample size and specific patient demographics (predominantly female and Asian) in this preliminary study represent additional limitations. Although 77% of nontraumatic fractures occur in women, conducting a preliminary evaluation with this patient cohort was essential. Moving forward, recruitment of a more diverse patient population with VCFs is crucial to validate the effectiveness and safety of Tripod-Fix across broader demographics.