45S5 bioglass graft decreases surgical site infection after posterior transforaminal lumbar interbody fusion reconstruction compared to alternative graft materials

Introduction

Posterior lumbar fusion is a family of procedures, including posterior transforaminal lumbar interbody fusion (TLIF), that necessarily require bone graft to foster successful bone healing and optimized patient outcomes (1). While fusion rates continue to improve along with availability and understanding of increasingly sophisticated bone graft options, postoperative infection after posterior lumbar spine surgery remains a potentially devastating complication representing a significant clinical challenge and major economic burden to both the patient and healthcare system (2-4). Surgical site infection (SSI) remains a prevalent and consequential complication following spine surgery, exerting a profound impact on patient morbidity, overall outcomes, length of hospitalization, mortality, and financial expenditures (2,3,5). Therefore, proven clinical strategies to minimize the complication rate of SSI are of particular importance in improving patient outcomes as well as minimizing economic burden.

One component of these posterior lumbar TLIF procedures often overlooked from an infection standpoint is the bone graft composition. Bone graft materials are used during orthopaedic surgery and spine surgery to bridge areas of instability, fill osseous voids and gaps, all with a goal of optimizing bone healing to restore and maintain skeletal length, alignment, and to achieve and maintain structural stability (6-10). A broad range of bone graft types are used by orthopaedic surgeons, though with a recent increasing propensity for synthetic osteobiologic materials such as ceramics, polymers, molecular biologics, and bioactive glasses (including 45S5 bioglass) (11,12). Bioactive glasses are typically composed of four oxide materials—SiO₂, CaO, Na₂O, and P₂O₅. These materials have a well-established history of successful clinical use as bone graft in general orthopaedics and in spine (3,13-15); 45S5 graft materials have demonstrated effectiveness in spine surgery, with reported fusion rates of approximately 89% to 100% at 12- to 24-month follow-up across contemporary cervical and lumbar clinical series, and with equivalence to autologous iliac crest bone graft reported in a within-patient ALIF comparison (8,10,16-18). Uniquely among the entire commercially available spectrum of bone graft materials, synthetic bioactive glass bone graft (45S5 bioglass) is the only currently clinically available graft material that has established intrinsic antimicrobial material properties that have been studied and well documented through in-vitro and animal research (19-24). It is well established that 45S5 bioglass is a highly effective bone graft material, though 45S5 bioglass graft has not been previously evaluated clinically to determine if the antimicrobial properties observed in the basic science setting lead to a significantly decreased SSI rate in the operative setting when compared to non-bioglass graft materials. This study was conducted to determine whether the use of 3rd-generation 45S5 bioglass graft is associated with a lower risk of SSI in the setting of posterior TLIF compared to non-bioglass graft materials. We present this article in accordance with the STROBE reporting checklist (available at https://jss.amegroups.com/article/view/10.21037/jss-2025-1-205/rc).

Methods

Study design and setting

Upon IRB approval, we conducted a retrospective review of a consecutive series of patients at Hughston Clinic and Greater Pittsburgh Orthopedic Associates in the United States undergoing posterior open TLIF from November 2017–July 2022 in which the interbody graft material was 45S5 synthetic bioglass bone graft alone (Synergy BioSphere Putty, Synergy Biomedical, Wayne, PA, USA) and the posterolateral graft material was a 50/50 mix (by volume) of local autogenous corticocancellous laminectomy bone with 45S5 synthetic bioglass putty, and as compared to a generalized cohort of all other non-bioglass graft materials combined. Thirteen total surgeons performed the operations using similar standard posterior bilateral pedicle screw instrumentation and TLIF surgical implants through open operative approaches, necessarily including interbody and posterolateral bone grafting in all cases.

Participants/study subjects

Overall, 2,380 patients were identified using current procedural terminology (CPT) code 22633 with manual verification that they underwent primary posterior open TLIF procedure for the following indications: stenosis with radiculopathy and/or neurogenic claudication in the presence of segmental spinal instability. Patients were excluded only if they had missing data or less than 1-year postoperative follow up (n=1,004), except in the case of SSI occurring within 1-year. Patients undergoing fully percutaneous TLIF (without posterolateral graft) were excluded. The final included cohort consisted of 1,376 patients, 470 receiving 45S5 bioglass graft (Biosphere, Synergy Biomedical, Wayne, PA, USA) and 906 receiving alternative, non-bioglass grafts (non-bioglass group) comprised of local autogenous corticocancellous (laminectomy) graft, demineralized bone matrix graft, or infuse bone morphogenic protein osteobiologic graft.

Variable definitions and description of perioperative protocols

SSI was defined similar to the Centers for Disease Control and Prevention (CDC) criteria for deep/implant-associated infection only, with superficial infections not considered SSI for this study (25). Specifically, we employed the recently published criteria in which a spinal implant-associated infection/SSI was defined by: secondary wound dehiscence, visible implant or intraoperative visible purulence, culture growth of two or more peri-implant tissue samples or sonication fluid, or histopathological findings including presence of acute and/or chronic inflammation in peri-implant tissue (26). Fusion was defined as radiographically visible bridging osseous union and standing AP, lateral, and lateral flexion and extension dynamic radiographs, and without evident segmental motion across the fusion on the dynamic flexion and extension studies, as previously described (27). This was further evaluated by computed tomography (CT) scan at the six-month postoperative mark for patients with ongoing symptoms that could not be explained otherwise (28). Fusion was assessed by the managing surgeon, and also assessed at time of data collection by an independent researcher not involved in clinical management of the patient. Discordant cases were adjudicated by an independent expert 3rd party not associated with this study. The modified 5-factor frailty score was determined, as previously described, by the presence of diabetes mellitus, chronic obstructive pulmonary disease (COPD), heart failure, hypertension (HTN) requiring therapy, and/or non-independent activity of daily living (ADL) status (29). Standard perioperative procedures were adhered to according to institutional protocols, including initiation of standard IV antibiotics within 1 hour prior to surgical incision. Patients were released from follow up at the discretion of the operative surgeon upon achieving fusion and healing of surgical wound.

Ethical approval

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Ethical approval for this study was obtained from the Hughston Foundation Institutional Review Board (No. HIRB2022-23). Informed consent was waived given the retrospective study design.

Statistical analysis

Fisher’s exact and chi-square tests were performed for categorical variables, and linear regression analysis was performed for continuous variables to compare the bioglass and non-bioglass groups. We compared all patient-related variables, perioperative/surgical variables, and outcomes noted above between the two groups. Multivariable regression analysis was performed to compare outcomes of interest between the groups, controlling for preoperative and perioperative variables with P<0.05 on univariate analysis, including use of vancomycin powder. Statistical significance was considered P value <0.05.

Results

Study variables and baseline descriptive data

Patients in the bioglass group were less likely to be chronically on corticosteroids (2% vs. 8%, P<0.001) compared to those in the non-bioglass group. The groups also differed in modified 5-factor frailty score (P<0.001) while being similar in average age, sex, race, average body mass index (BMI), and tobacco use (Table 1). Based on comorbid conditions, the groups were similar in rates of HTN, vitamin D deficiency, heart failure, COPD, peripheral vascular disease (PVD), prior transient ischemic attack/cerebral vascular accident (TIA/CVA), and dyslipidemia (Table 2). Patients in the bioglass group were more likely to have renal insufficiency (3% vs. 1%, P=0.02), coronary artery disease (CAD) (33% vs. 8%, P<0.001), and diabetes mellitus (53% vs. 27%, P<0.001) while being less likely to have comorbid osteoporosis (2% vs. 5%, P=0.01), prior adjacent fusion procedure (5% vs. 17%, P<0.001), and prior gastric bypass surgery (1% vs. 3%, P=0.02) compared to those in the non-bioglass group (Table 2). Perioperatively, there was no difference between the groups in the average number of surgical fusion levels (1.5 vs. 1.6 levels, P=0.69), despite differing in the American Society of Anaesthesiologists (ASA) status (Table 3). However, the bioglass group had an increased average operative duration (184 vs. 174 minutes, P<0.001) while having decreased average blood loss (311 vs. 383 mL, P<0.001) compared to the non-bioglass group (Table 3). While beyond the scope of the study, there were 4 patients with intraoperative dural tear (1 bioglass group, 3 non-bioglass group). The only postoperative hospital-acquired conditions were—all in the non-bioglass group only—1 case each of ileus, altered mental status/delirium, and sepsis associated with SSI. The bioglass group also had a shorter average length of hospital stay (1.9 vs. 2.4 days, P<0.001) compared to the non-bioglass group (Table 4). The average follow-up duration was 21 months (standard deviation: 11 months).

Primary findings

The 1-year SSI rate overall was 1.9% (27/1376), with the bioglass group resulting in a decreased rate of SSI compared to the non-bioglass group (0.6% vs. 2.7%, P=0.01). When controlling for CAD, operative time, blood loss, DM, prior gastric bypass, renal insufficiency, corticosteroid use, osteoporosis, adjacent prior fusion, ASA status (1/2 vs. 3/4), the use of bioglass was associated with a decreased risk of 1-year SSI [odds ratio (OR) 0.19, 95% confidence interval (CI): 0.05–0.77, P=0.02] compared to other non-bioglass graft materials (Table 5).

Other findings

Of the 27 overall SSI, 10 (37%) were coagulase-negative staphylococci, 7 (26%) Staphylococcus aureus, 4 (15%) culture negative, 3 (11%) gram-negative bacilli, and 3 (11%) polymicrobial (Figure 1). Six of the twenty-seven total SSI events—2 bioglass and 4 non-bioglass—occurred beyond the first three postoperative months, with the remaining twenty-one SSI events identified in either group occuring within the first three postoperative months. The overall median time to SSI was 21 days (range, 4–360 days) post-TLIF surgery.

Figure 1 Pie chart demonstrating the breakdown of deep implant/hardware associated SSI type by pathogen for the bioglass and non-bioglass graft groups. SSI, surgical site infection.

The bioglass and non-bioglass groups achieved equal fusion rates while resulting in no difference in overall all-cause 1-year aseptic reoperation rates (Table 4).

Discussion

Background and rationale

Infection after posterior lumbar fusion surgery places patients at higher risk for pseudoarthrosis, chronic pain, return to surgery, further adverse outcomes, and death. Current methods of minimizing this risk include alcohol-based skin preparation, intrawound vancomycin powder, betadine irrigation of the surgical site prior to closure, silver-impregnated or vacuum dressings, extended intravenous antibiotics and supplemental oxygen therapy (30). Despite these measures, the incidence of SSI after spinal surgery remains as high as 12%, with consistently reported SSI rates of 2–7% for posterior spinal fusion surgeries including posterior TLIF (30-33). Graft materials have not yet been investigated for their implications in SSI risk after posterior TLIF. Our study is distinct in that it is, to our knowledge, the first clinical investigation of whether the established in-vitro antimicrobial properties of 45S5 bioactive glass translate into reduced incidence of SSI in the primary surgical setting—that is, SSI prevention rather than fusion assessment or infection treatment. In this same framework, bioglass is distinguished as an osteobiologic material class by its proven in vitro efficacy from an antimicrobial standpoint, and amongst the bioglass compositions, 45S5 has recently demonstrated the most powerful antimicrobial capacity in the laboratory setting (34). No other available autograft, allograft, or synthetic ostebiologic graft material has intrinsic antimicrobial properties. While bioglasses such as S53P4 have been studied clinically in the craniofacial setting, previous systematic reviews have cited the lack of clinical investigations into 45S5 bioglass effectiveness at inhibiting bacterial growth (35). We therefore aimed to investigate if these properties had clinical implications, and the results of our study demonstrated that the use of 45S5 bioglass graft material is independently associated with a decreased risk of SSI after posterior lumbar TLIF compared to alternative non-bioglass graft materials.

Does 45S5 bioglass graft decrease the probability of SSIs in posterior TLIF compared to other commonly used implants?

Our study indicates that the use of 45S5 bioglass is independently associated with 5 times reduced risk of 1-year SSI after posterior TLIF compared to other non-bioglass graft materials used in this setting. While previous studies have demonstrated obesity, diabetes smoking, malnutrition, antibiotic administration, advanced age and extended hospitalization to play a role in posterior TLIF SSI risk (36), we found bioglass use to be independently associated with decreased SSI risk (OR 0.19, 95% CI: 0.05–0.77, P=0.02) when controlling for these and other variables. Our results are similar to those in craniofacial surgery in which S53P4, another bioactive glass with antimicrobial properties and a noted faster degradation compared to the 45S5 composition, has demonstrated antimicrobial capacity (37-39) in the treatment of chronic osteomyelitis (40-42). This study represents the first to demonstrate clinical association between currently understood in-vitro antimicrobial properties of 45S5 bioglass specifically. The antimicrobial mechanism of 45S5 bioactive glass is multifactorial and operates at the nanoscale interface between the graft and the surrounding tissue. As the glass dissolves in physiologic fluid, rapid ion exchange releases sodium, calcium, and silica species, elevating local pH and osmotic pressure to levels that disrupt bacterial membrane homeostasis and inhibit replication (19,34,37-39). In parallel, the dissolving surface generates needle-like silica-rich debris and exposes reactive silanol (Si-OH) groups on its nanocrystalline surface; these have been shown to adhere to bacterial cell walls and directly disrupt the bacterial membrane, with additional contributions from reactive oxygen species generated by strained Si-O-Si surface chemistry (19,43,44). Critically, these effects do not appear to select for bacterial resistance, consistent with a physicochemical rather than receptor-mediated kill mechanism (45). These same nanoscale surface features, and the ionic products of dissolution, concurrently stimulate osteoblast proliferation, up-regulate IGF-II and cell-cycle gene expression, and favorably restructure adsorbed extracellular proteins to promote osteogenic cell attachment (22-24). 45S5 bioglass also exerts immunomodulatory effects on the local host response, including polarization of macrophages toward a pro-resolution phenotype (24). Together, these converging mechanisms create a local wound environment that is selectively hostile to bacterial colonization while supportive of osteogenic repair.

Limitations

This study has limitations. First, the retrospective study design poses challenges to internal validity including another event other than the intervention influencing the outcome. The large number of variables collected sought to combat and reduce the implications of this limitation. Second, residual confounding from graft selection bias and individual surgeon preference cannot be excluded, as graft choice was not randomized. The large number of patient- and surgery-level covariates included in the multivariable model was intended to mitigate this limitation, but is not a substitute for prospective randomization. Third, the study utilized one commercially available preparation of 45S5 bioglass (Synergy Bioedical BioSphere Putty) in order to limit this as a variable and to power best possible statistical analysis in this setting. The selected synthetic graft preparation is over 90% 45S5 spherical particulate graft matrix by volume with a phospholipid carrier that is dispersed rapidly after graft implantation, leaving only 45S5 graft behind (yet without compaction or a decrease in total volume of the graft matrix by virtue of the stacked spacing of the spherical 45S5 graft particles). It is possible that the observed anti-infection effects would not translate to other commercially available bioglass graft preparations. However, as the effects are believed to be related to an intrinsic material property of 45S5 graft itself, it is suspected that the observed anti-infection benefits in this series may well extend to other commercially available 45S5 graft preparations. This would be an area for further study. Additionally, our inclusion criteria requiring one year of follow-up excludes a number of patients who did not have a recorded one-year follow-up. Therefore, this opens the possibility of transfer bias. While our sample size remains one of the largest to date for posterior TLIF procedures and our number of included variables accounted for was intentionally broad in attempt to best mitigate such potential concerns, we cannot completely exclude this as a limitation of our work. Lastly, these results are from two large institutions with large, diverse patient populations in the southern and mid-Atlantic regions of the United States but should be further validated at additional institutions to ensure they are definitively generalizable to the broader population.

Conclusions

In conclusion, this multi-center retrospective analysis supports that the established intrinsic antimicrobial properties of 45S5 bioglass graft are clinically associated with a significantly decreased SSI risk in the setting of posterior TLIF surgery. This expands the known clinical properties of 3rd-generation 45S5 bioglass bone graft; in this way 45S5 bioglass is distinguished among bone graft options as both a highly effective synthetic osteobiologic graft material with regards to bone healing, while concurrently and uniquely demonstrating antimicrobial properties that were found to be associated with a 5-fold decrease in SSI in the operative setting described. This retrospective work provides a compelling and objective guide to inform ongoing clinical use of 45S5 bioglass given the associated decrease in SSI risk compared to other bone graft materials, while also laying the groundwork for future multicenter prospective trials on this topic to further validate the potential causal relationship between 45S5 bioglass graft and decreased SSI.

Acknowledgments

We thank Zachary Hartman, Tristan Melton, Hamit Martinez, Jonathan Saviskas, Grace Hurley and Rachel Welch for their contributions to constructing the database required for our analysis.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jss.amegroups.com/article/view/10.21037/jss-2025-1-205/rc

Data Sharing Statement: Available at https://jss.amegroups.com/article/view/10.21037/jss-2025-1-205/dss

Peer Review File: Available at https://jss.amegroups.com/article/view/10.21037/jss-2025-1-205/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jss.amegroups.com/article/view/10.21037/jss-2025-1-205/coif). K.H.C. reports scientific advisory board membership for BD Biosciences and Symcel and consulting for Nanovis. D.J.T. reports consulting for Synergy Biomedical. L.E.W. reports consulting for Nuvasive and SeaSpine, and serves as a board/committee member for North American Spine Society (NASS). The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Ethical approval for this study was obtained from the Hughston Foundation Institutional Review Board (No. HIRB2022-23). Informed consent was waived given the retrospective study design.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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