Abstract
Background
Bioactive glass synthetic bone grafts are used to treat osseous defects in orthopaedic surgery. Characterization of the clinical scenarios associated with bioactive glass use in the context of orthopaedic trauma, are not well established. This study aims to characterize population demographics, operative variables, as well as postoperative variables, for patients who required bone grafting for treatment of traumatic orthopaedic injuries and received a bioactive glass bone substitute intraoperatively.
Methods
The electronic medical record at a large Level I trauma center was queried for fracture patients between January 1st, 2019, and April 30th, 2022. Our retrospective cohort included fracture patients who received Fibergraft Matrix or Fibergraft Putty intraoperatively, and their respective control groups. This study ascertained patient demographic variables, operative variables, and postoperative variables. Differences in categorical variables were tested with Fischer's Exact Tests, while differences in continuous variables were tested with ANOVA. Statistical significance was determined as P < 0.05. If the overall Group model was significant for a given variable, post-hoc Fischer's Exact or Tukey HSD tests were used to assess pairwise significance between individual Group pairs.
Results
A total of four categories across our analysis of demographic, operative, and postoperative variables displayed significant differences amongst subject Groups (P ≤ 0.03). Individual groups were compared such that significant differences between subject groups could be appreciated for a specific variable. FM subjects had greater length of surgery, billable costs, and vitamin D supplementation at the time of surgery compared to FM controls. Similarly, FP subjects had greater length of surgery, billable cost, and implants used intraoperatively compared to FP controls.
Conclusion
This analysis revealed Fibergraft patients to have greater length of surgery and billable cost, with respect to their matched controls. These data suggest that Fibergraft patients had more severe orthopaedic fractures compared to matched controls.
Keywords: Bone grafting, Bone loss, Bioactive glass, Orthopaedic trauma, Demographics
1. Introduction
An estimated 7.2 million fractures occurred in the United States (U.S.) between 2013 and 2014, with approximately 16 % of these fractures requiring emergency surgical intervention.1 Falls and transportation-related injuries account for over 80 % of emergency orthopaedic surgical interventions, with nearly 22 % of the 7.2 million fractures requiring inpatient hospitalization.1 Fractures requiring a greater magnitude of care—such as emergency surgical intervention or inpatient hospitalization—are associated with higher energy mechanisms of injury.2,3 Open fractures and complex orthopaedic injuries carry a greater risk of bone loss, especially after debridement of the surgical site and removal of unsalvageable bone fragments.3 The amount of bone loss as well as the anatomic site of injury are important factors influencing fracture union, with fracture severity and defect size correlating with complication and reoperation rates.3, 4, 5 To optimize fracture healing, fixation of fractures considered at risk for nonunion may be augmented with the addition of bone graft.3,6
Augmentation with bone graft is known to be effective at promoting bone growth and repair at the fracture site.6,7 Although autograft remains the gold standard, there is an increased risk of patient morbidity, as graft must often be collected from sites remote to the fracture. Additionally, the amount of graft that can be collected from one site is often limited. To address these issues, bone graft substitutes, such as bioactive glass, have been developed.6
Bioactive glass is an emerging technology that has found application within orthopaedics, including augmentation of bone defects, coating of metallic implants as well as uses in facial reconstruction, and lumbar fusion surgery.8, 9, 10, 11, 12, 13 Work in animal models demonstrates a superior ability to fill cancellous bone defects with bioactive glass when compared to autograft.14
While bioactive glass has been used clinically for many years, its use in fracture care as well as the patient characteristics of those receiving it remain unclear. Therefore, the objective of this study was to characterize population demographics, operative variables, as well as postoperative variables, for patients who required bone grafting for treatment of traumatic orthopaedic injuries and received a bioactive glass bone substitute intraoperatively.
2. Methods
After obtaining IRB approval, the electronic medical record (EMR) at a large Level I trauma center in the midwestern United States was queried for fracture patients between January 1st, 2019, and April 30th, 2022. Patients were selected for our retrospective cohort if their surgical management included the use of a Fibergraft bone graft. Fibergraft is a bone graft substitute made from 45S5 bioactive glass used to fill bony gaps and defects that are not essential for structural stability. This compound was utilized in both matrix and putty mediums in this study. Fibergraft Matrix delivers bioactive glass fibers to bony defects in a medium comprised of type 1 collagen, whereas Fibergraft Putty delivers bioactive glass granules in a bioactive polymer medium, OSSIGLIDE.
Patients who sustained an orthopaedic fracture requiring surgical management, regardless of complexity and severity, in which Fibergraft was used, were included in our retrospective cohort. Control patients were matched to Fibergraft patients at a 1:1 ratio primarily based on ICD-10 medical codes, identical sex assigned at birth (male or female), age (±10 years) and fracture location. These matched controls were confirmed to have orthopaedic fractures requiring surgical management; however, their operative treatment did not include the use of Fibergraft. If multiple matching controls were identified within our institutional records, secondary matching criteria included fracture location, BMI (±5 points), height (±5 cm), smoking status, cancer status, race, sex assigned at birth, and Vitamin D supplement status. Patients not receiving Fibergraft who had the greatest number of matching secondary criteria to those treated with it were selected as controls for this retrospective study. Patients who received Fibergraft matrix or putty, but lacked orthopaedic fractures were excluded from this study, as were patients whose primary treatment was for tumor resection, patients who received both Fibergraft matrix and putty simultaneously, and patients positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
Demographic characteristics were collected on patients who met inclusion criteria. This study ascertained patient demographic variables of sex assigned at birth, age (years), height (cm), mass (kg), Body Mass Index (BMI), race, smoking status, diabetic status, cancer status, Vitamin D supplementation status, bone growth medication usage and fracture location. Operative variables included length of surgery (minutes), number of implants, and billable cost (in US dollars). Postoperative variables measured were inpatient status, and time to last follow up (days). Patient BMI was calculated using height and weight measurements from the medical encounter closets to the date of surgery. Smoking status was categorized as “Never”, “Former”, “Current”, or “Unknown” based on the patient's chart summary. The diabetic status was evaluated based on the past medical history in the EMR. Patient cancer status was based on the chart summary and the most recent post-operative follow-up note. Details regarding the anatomic location of patient fractures were abstracted from the operative note. Data on the length of surgery, billable costs, and number of implants used intraoperatively were gathered from the surgical encounter report. Inpatient status was defined as any orthopaedic fracture requiring overnight hospitalization or continued hospitalization post-operatively. The time to last follow-up was determined by the number of days that elapsed between the surgical date and the last follow-up visit. For the purposes of this study, Fibergraft putty and matrix were not considered implants. Implants were defined as hardware placed to stabilize traumatic fractures. Diabetic status, cancer status, Vitamin D supplementation status, bone growth medication status, and inpatient status were measured as nominal values (yes or no), without accounting for HbA1C labs, cancer type, medication dosages, or hospital length of stay respectively.
Patients were subsequently divided into four different groups: Fibergraft Matrix patients (FM), Fibergraft Matrix matched control patients (FM controls), Fibergraft Putty patients (FP), and Fibergraft Putty matched control patients (FP controls). Differences in categorical variables were tested with Fischer's Exact Tests, while differences in continuous variables were tested with ANOVA using Group as the main factor. Statistical significance was determined as P < 0.05. If the overall Group model was significant for a given variable, post-hoc Fischer's Exact or Tukey HSD tests were used to assess pairwise significance between individual Group pairs (FM vs FM controls, FP vs FP controls, FM vs FP, FM controls vs FMP).
3. Results
Over the identified timeframe, 161 orthopaedic patients treated with Fibergraft were identified. Based on our inclusion/exclusion criteria, 113 patients were eligible for analysis (20 excluded for tumor, 13 excluded for non-fracture surgery, 12 excluded for >10-year age differential with eligible controls, and 3 excluded for simultaneous use of matrix and putty substrates). One control was matched to each patient, resulting in 226 total subjects in this analysis.
A total of four categories across our analysis of demographic, operative, and postoperative variables displayed significant differences amongst subject Groups (P ≤ 0.03). Individual groups were compared such that significant differences between subject groups could be appreciated for a specific variable. FM subjects had greater length of surgery, billable costs, and vitamin supplementation at the time of surgery compared to FM controls. Similarly, FP subjects had greater length of surgery, billable cost, and implants used intraoperatively compared to FP controls.
3.1. Demographic variables
Statistical analysis of demographics factors associated with our retrospective cohort revealed a lack of significant differences (P ≥ 0.06) (Table 1) with the exception of Vitamin D status (P = 0.04). Specifically, FM subjects were more likely to be taking supplemental vitamin D when compared to FM control subjects (P = 0.02). No other pairwise differences were observed relative to vitamin D supplementation (P > 0.23). Differences in sex assigned at birth amongst Groups approached significance (P = 0.06) but maintained a normal distribution. Between Group differences failed to reach statistical significance for all other variables considered (P ≥ 0.12).
Table 1.
Demographic Characteristics of the study population by Cohort Group. The last column displays significance of ANOVA or Fishers Exact testing for each demographic variable.
| Variable | Fibergraft Matrix (n = 62) | Fibergraft Matrix Controls (n = 62) | Fibergraft Putty (n = 51) | Fibergraft Putty Controls (n = 51) | ANOVA/Fischer's Exact |
|---|---|---|---|---|---|
| Sex (%) | 0.06 | ||||
| Male | 52 | 53 | 33 | 35 | |
| Female | 48 | 47 | 67 | 65 | |
| Age (years) | 52.5 (17.0) | 51.1 (15.8) | 50.2 (15.7) | 49.6 (15.5) | 0.79 |
| Height (cm) | 171 (12) | 171 (14) | 170 (18) | 167 (9) | 0.42 |
| Mass (kg) | 89.4 (27.8) | 95.8 (37.4) | 91.8 (32.5) | 83.0 (23.5) | 0.18 |
| BMI | 30.4 (8.8) | 32.8 (12.7) | 32.1 (11.4) | 29.8 (7.6) | 0.38 |
| Race (%) | 0.93 | ||||
| Caucasian | 79 | 76 | 78 | 84 | |
| African American | 19 | 21 | 18 | 14 | |
| Asian | 0 | 2 | 0 | 2 | |
| Hispanic | 2 | 2 | 2 | 0 | |
| Native American | 0 | 0 | 0 | 0 | |
| Other | 0 | 0 | 2 | 0 | |
| Smoking Status (%) | 0.52 | ||||
| Current | 24 | 31 | 29 | 33 | |
| Former | 37 | 26 | 27 | 18 | |
| Never | 37 | 42 | 39 | 49 | |
| Unknown | 2 | 2 | 4 | 0 | |
| Diabetic Status (%) | 0.15 | ||||
| Yes | 10 | 19 | 16 | 6 | |
| No | 90 | 81 | 84 | 94 | |
| Cancer Status (%) | 0.31 | ||||
| Yes | 5 | 2 | 10 | 6 | |
| No | 92 | 98 | 88 | 90 | |
| Survivor | 3 | 0 | 2 | 4 | |
| Vitamin D Status (%) | 0.04* | ||||
| Yes | 71 | 48 | 65 | 51 | |
| No | 29 | 50 | 35 | 49 | |
| Bone Growth Medication (%) | 0.49 | ||||
| Yes | 15 | 10 | 6 | 8 | |
| No | 85 | 90 | 94 | 92 |
3.2. Operative and postoperative variables
The length of surgery, number of implants, and billable cost amongst all Groups varied significantly (P ≤ 0.03; Table 2). Length of surgery was found to be significantly different between FM vs FP, FM vs FM controls, FP vs FP controls, and FM controls vs FP controls (P < 0.01; Table 3). FM and FP patients both demonstrated greater mean length of surgery relative to their control groups (P < 0.01) and FM patients had a greater average length of surgery relative to FP patients (P < 0.01). Furthermore, sub-cohort analysis indicated that FP subjects utilized more implants than FP control subjects (P < 0.01) (Table 3). Similarly, FM subjects had greater billable cost than FM controls (P < 0.01), FP had greater billable cost than FP controls (P < 0.01), and FM controls had greater billable cost than FP controls (P < 0.01) (Table 3). Postoperative variables of inpatient status (P = 0.12) and time to last follow-up (P = 0.68) did not vary significantly across group, nor did they have significant between-group differences (Table 4).
Table 2.
Surgical Variables of the study population by Group. The last column displays significance of ANOVA or Fishers Exact testing for each surgical variable. Significant ANOVA tests are highlighted red.
| Variable | Fibergraft Matrix (n = 62) | Fibergraft Matrix Controls (n = 62) | Fibergraft Putty (n = 51) | Fibergraft Putty Controls (n = 51) | ANOVA |
|---|---|---|---|---|---|
| Length of Surgery (min) | 232 (98) | 144 (75) | 194 (70) | 107 (55) | < 0.001* |
| Number of Implants | 1.4 (1.0) | 1.2 (1.1) | 1.5 (0.8) | 0.9 (0.8) | 0.03* |
| Billable Cost ($) | 88,285 (47,805) | 65,710 (27,661) | 77,316 (31,539) | 52,526 (23,807) | < 0.001* |
Table 3.
Sub-cohort comparisons for Surgical Variables. Each column displays significance of post-hoc testing for between-group comparisons. Significant pair-wise tests are highlighted red.
| Variable | Matrix vs Putty | Matrix vs Control | Putty vs Control | Control vs Control |
|---|---|---|---|---|
| Length of Surgery (min) | <0.001* | <0.001* | <0.001* | <0.01* |
| Number of Implants | 0.5 | 0.54 | < 0.01* | 0.1 |
| Billable Cost ($) | 0.16 | < 0.01* | < 0.01* | 0.01* |
Table 4.
Postoperative variables of the study population by Group. The last column displays significance of ANOVA or Fishers Exact testing for each post-operative variable. No significant variance was observed across group for either inpatient status or Time to Last Follow-Up.
| Variable | Fibergraft Matrix (n = 62) | Fibergraft Matrix Controls (n = 62) | Fibergraft Putty (n = 51) | Fibergraft Putty Controls (n = 51) | ANOVA/Fischer's Exact |
|---|---|---|---|---|---|
| Inpatient Status (%) | 0.12 | ||||
| Yes | 90 | 90 | 92 | 78 | |
| No | 8 | 10 | 8 | 22 | |
| Time to Last Follow-Up (days) | 184 (111) | 168 (113) | 168 (126) | 159 (104) | 0.68 |
4. Discussion
The objective of this study was to characterize demographics and perioperative variables for patients treated with Fibergraft bioactive glass bone substitute at the time of fracture fixation. By examining these variables in patients who received Fibergraft compared to those who did not, the clinical scenarios in which surgeons prefer to use bioactive glass can be better appreciated. This single-academic institution retrospective study found that vitamin D supplementation, length of surgery, number of implants, and billable cost varied significantly across our cohort, with Fibergraft Matrix and Putty patients exhibiting greater cost and time in surgery compared to matched controls. Although vitamin D supplementation status varied significantly across our cohort, vitamin D status at the time of surgery was only significantly different between FM and FM controls. Similarly, the number of implants only differentiated within the FP and FP controls and not the FM and FM controls. Regarding the postoperative variables of inpatient hospital status and postoperative follow-up time, no significant differences were observed across our patient cohorts for either variable.
This analysis revealed that subjects receiving Fibergraft for the treatment of traumatic orthopaedic fractures had a greater billable costs and length of surgery compared to matched controls. Hospital charges can increase with respect to Injury Severity Scoring (ISS) and polytrauma status.15,16 Patients requiring bone grafting often have more complex, high-energy fracture patterns.2,17 Matched controls in this study were heterogeneous with respect to the implementation of alternative bone graft substitutes, or complete lack thereof. Thus, the lack of bone graft in some subjects of our matched control subjects may suggest lower severity compared to FM subjects. Factors contributing to prolonged operative times in the context of orthopaedic trauma are not well established, however, some literature suggests that fracture severity and complexity is associated with increased length of surgery.18 Increased billable costs would also be expected in more complex surgical cases.15,16 The increased surgical time and associated costs seen in patients treated with Fibergraft suggest that it is being used in patients with more severe fractures.
Although the number of implants used and vitamin d supplementation status varied significantly across groups, their between-group comparisons were only significantly different for FP vs FP controls and FM vs FM controls respectively. The number of implants used in orthopaedic surgery has been shown to increase with respect to fracture severity.19 This could explain why FP subjects required more implants than controls, however it remains unclear why this difference was not observed for FM vs FM controls. Similarly, an explanation for the significant difference found between FM vs FM controls in vitamin d supplementation at the time of surgery is not apparent. Future studies with a larger sample size of FM, FP, and matched control subjects may provide more clarity on the statistical significance of differences in implants received and vitamin D supplementation between groups.
The capacity for bioactive glass to promote bone healing is supported by animal models and human studies. The majority of clinical studies have been done in the fields of oral maxillofacial, spine and orthopaedic tumor surgeries.8, 9, 10, 11, 12, 13, 20 The literature is much more limited for the use of synthetic bioactive glass grafts in orthopaedic trauma patients. Therefore, our goal was to understand the clinical situations where these grafts are being used. This study revealed that length of surgery, billable costs, and to some degree, number of implants, are higher for Fibergraft patients compared to their controls. This may suggest greater case complexity for clinical scenarios when Fibergraft is used to augment fracture repair.
The current investigation is instrumental in understanding orthopaedic trauma populations where bioactive glass was implemented to augment fracture healing; however, as with all studies, there are limitations. One limitation of our investigation is an uneven distribution of subjects between FM and FP patients. However, to achieve 0.8 power with an effect size of 0.26 (calculated from the present data), a sample of 93 subjects was needed for post-hoc tests. This value was exceeded by every Group combination in the current analysis. Another limitation of this study is that fracture location of Fibergraft application was unknown prior to data abstraction; thus, was not restricted within the exclusionary criteria. As such, fracture location was heterogeneous within this cohort. There were more femur fractures in the FM and FM control groups than the FP and FP control groups. Likewise, there were no humerus fractures in the FM and FM control groups, but humerus fractures were present in the FP and FP control groups. However, we propose that the current results present a wholistic population scope of outcomes. Future studies would benefit from more targeted analyses that isolate patients based on the affected bone and fracture type. At present, volumes of orthopaedic trauma patients treated with bioactive glass are insufficient to conduct such specific analyses. However, a long-term prospective study that controls for anatomic location and documents when Fibergraft is used as well as the total volume employed, would help provide greater context for the fracture repairs that can be appropriately treated with bioactive glass. An additional limitation to the homogeneity of the matched control population within this observed cohort was the use of alternative bone grafting products. Similarly, Fibergraft patients could have received other bone grafting materials concomitantly with bioactive glass substitutes. Thus, comparisons drawn should again be considered holistic of orthopaedic fracture populations. It was not the intent of this report to compare outcomes of bioactive glass cohorts directly against bone grafts, alternative bone graft supplements, or fracture patients isolated from such treatments. Rather, this work helps improve our understanding of what patients are most likely to receive augmentation with bioactive glass. Future work would benefit from addressing these potential confounders.
5. Conclusion
Understanding the underlying context of the patient population for which bioactive glass is being deployed in orthopaedic trauma fractures is essential to the assessment of how this material contributes to patient outcomes. The use of Fibergraft was associated with numerous surgical variables suggesting increased fracture severity and case complexity when compared to patients not receiving augmentation with Fibergraft. Overall, demographic characteristics and postoperative variables were evenly distributed in our cohort, but Vitamin D supplementation at the time of surgery was significantly different between FM subjects and FM controls. Significant differences were observed within our cohort with respect to surgical variables including the number of implants received, billable cost, and length of surgery. Fibergraft subjects had greater billable costs and operative durations when compared to matched controls. The number of implants received was only significantly greater for FP subjects when compared to FP controls. Accordingly, when assessing outcomes for orthopaedic trauma treated with bioactive glass, variables of billable cost, number of implants used, length of surgery, and Vitamin D supplementation should be incorporated as confounders to statistical models. To gain a deeper understanding of the clinical scenarios in which bioactive glass is favorable over other grafting materials, future studies examining surgeon preference would provide valuable insights. Additionally, while this work suggests Fibergraft is often used in the treatment of more severe fractures, it is not clear from the current data if this provides a clinical benefit to the patient; however, the ratio of inpatient care did not increase for these greater complexity cases treated with bioactive glass. Future work should determine if the use of Fibergraft has a positive effect on patient outcomes when used in acute fracture care.
6. Guardian/patient's consent
This study did not require consent from any patients.
7. Ethical committee statement
This study was approved by the Biomedical Institutional Review Board of The Ohio State University (#2022H0240).
Funding statement
The authors of this article declare a financial competing interest, as this investigation was funded by Prosydian, the former manufacture of FIBERGRAFT products. None of the authors or study staff have any direct or intrinsic conflicts of interest or relationships with Prosidyan, Inc. All authors are direct students or employees of The Ohio State University Wexner Medical Center and Ohio University. Prosidyan, Inc. had no role in the collection, analyses, or interpretation of data; in the writing of this manuscript; or in the decision to publish the results.
CRediT authorship contribution statement
Alexander H. Fischbach: Writing – original draft, Writing – review & editing. Carmen E. Quatman: Conceptualization, Data curation, Investigation, Methodology, Supervision, Writing – review & editing. Alexandra N. Sheldon: Data curation, Methodology, Writing – review & editing. Kenan Alzouhayli: Data curation, Methodology. James R. Warnes: Data curation, Methodology. Andrew R. Phillips: Data curation. Angela C. Collins: Writing – review & editing. Nathaniel A. Bates: Conceptualization, Data curation, Investigation, Formal analysis, Supervision, Writing – review & editing, Methodology.
Declaration of competing interest
The authors of this article declare a financial competing interest, as this investigation was funded by Prosydian, the former manufacture of FIBERGRAFT products. None of the authors or study staff have any direct or intrinsic conflicts of interest or relationships with Prosidyan, Inc. All authors are direct students or employees of The Ohio State University Wexner Medical Center and Ohio University. Prosidyan, Inc. had no role in the collection, analyses, or interpretation of data; in the writing of this manuscript; or in the decision to publish the results.
Acknowledgements
Funding for this investigation was provided through a grant from Prosidyan, Inc. [NAB].
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