Novel autograft bone harvesting device used in 232 consecutive patients who underwent cervical or lumbar fusion: initial experience, outcome, and cost analysis in a retrospective study

Introduction

Background

Trends in spine surgery show significant growth in the number of cervical and lumbar fusions. The volume of elective lumbar fusions increased by 62.3% (or 32.1% per 100,000 US adults), growing from 122,679 cases (60.4 per 100,000) in 2004 to 199,140 cases (79.8 per 100,000) in 2015 (1). In parallel to this growth, aggregate hospital costs increased 177% during these 12 years, exceeding $10 billion in 2015, and averaging more than $50,000 per admission (1). Another study showed the number of spinal fusion procedures increased by 64% between 2002 and 2014, from approximately 268,000 to 414,000 respectively. The average cost per procedure increased from $15,868 to $28,954 over the same period and was more than $12 billion in total in 2014 (2). Associated with increase fusion procedures is additional instrumentation and grafting products such as allograft that add significant cost.

Rationale and knowledge gap

As healthcare becomes more expensive, hospitals and providers need to look towards “value engineering” as a method to deliver the same quality of care for a lower cost. One key concept is to look at the entire cost of a procedure and begin to reduce incremental costs one at a time. A continually rising cost in spine surgery is the price of the allograft and related materials such as stem cells and recombinant proteins. It has been estimated that the average cost of allograft in cervical spine surgery is $700 to $1,500 whereas the average cost in lumbar spine surgery is $1,500 to $5,000 (3).

Objective

Autologous local bone (ALB) created during high-speed drilling has been noted as a source of graft material for supporting fusion during posterior lumbar fusion and anterior cervical diskectomy and fusion (ACDF) (4,5). ALB has been shown to be a source of anabolic factors which can contain Mesenchymal Stem Cells, support osteoblast proliferation, and upregulate genes needed in bone formation (6,7). Here we describe the use of the Bone Dust Collector (BDC-15, Capseus, Inc.), and report procedure safety and efficacy during ACDF and lumbar fusion procedures. The BDC-15 is a method to harvest high quality bone graft and at a low cost while maintaining excellent results. We present this article in accordance with the STROBE reporting checklist (available at https://jss.amegroups.com/article/view/10.21037/jss-25-43/rc).

Methods

Patients underwent either cervical or lumbar fusion by the authors, J.M.A. & B.I.K., over a time a period from January 2021 until June 2023 at a single institution, Northern Westchester Hospital (Mt. Kisco, NY, USA). Patient data was collected from outpatient and inpatient medical records. Patient demographics, surgery date, procedure, number of fusion levels, length of stay, 90-day complications, re-admissions, number of devices used in surgery, volume of bone collected, and fusion rates were collected. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was exempt from institutional review board approval because of the simple data analysis and did not require any deviations in treatment algorithms. Informed consent was obtained.

The BDC-15 is a single use device used to harvest ALB during any surgery with drilling. The surgical site is usually cleared by vacuum suction and the BDC-15 uses this existing vacuum suction to capture local bone generated during drilling into the device via inline suction. The cost savings by collecting the LB in this manner (as compared to allograft) is also projected.

Cervical fusion procedure: patients underwent either a one-level (38 patients), two-level (58 patients) or three-level (11 patients) ACDF. All patients had the LDR ROI-C (Zimmer Biomet, Warsaw, USA) implant placed as the fusion device. The LDR ROI-C device is a stand-alone cage device with titanium blades to secure the cage in place. During the procedure, bone dust was collected using the BDC-15 (Capseus Medical, Mnorville, NY, USA) to be placed in the device central core during the procedure. To prevent migration of bone dust within the LDR ROI-C, we placed a thin layer of Hemasorb Plus (Abyrx, Irvington, NY, USA) above and below the cage opening after packing with the graft material.

Lumbar fusion: patients underwent a posterior lumbar interbody fusion and fixation using image guidance, pedicle screws, and an expandable interbody cage. There were a total of 61 patients who underwent a one-level fusion (61 levels) and 64 patients (128 levels) who underwent a two-level fusion. All patients had surgery using Image guidance and O-Arm Navigation (Medtronic, Minneapolis, USA) with Solera ATS Pedicle Screws (Medtronic) and the Catalyft Expandable, Interbody Cage (Medtronic). During the procedure, bone dust was collected using the BDC-15 (Capseus Medical, Manorville, NY, USA), as well as collected bone from the Kerrison and Rongeur. Collected bone was then mixed with Hemasorb Plus (Abyrx, Irvington, NY, USA) to make the bone graft adhere for easier placement. Once hardware placement was confirmed, autograft was placed along decorticated bone along the transverse process and/or sacral ala.

All patients underwent follow up at two weeks, one month, three months, six months and one year with X-Ray imaging at each visit. We placed patients into Bone Growth Stimulators (BGS) from DJO (Dalla, TX, USA) in the first three months after surgery or until fusion documented by X-ray. Patients were offered physical therapy at one month as an option. X-ray Imaging was continued for 12 months and used as the primary method to assess fusion unless the patient complained of new symptoms or worsening pain. Fusion was determined by the authors (J.M.A., B.I.K.) using standard criteria for bone from across either the disc space and/or the transverse process and ala when fusion to S1.

The BDC-15 was used to collect 3–6 mL for cervical cases and 15–25 mL during lumbar cases. This was enough volume to fill the space. The BDC-15 is shown in Figure 1A as part of the inline suction with resulting collected bone dust in Figure 1B.

Figure 1 Picture of the BDC-15 device showing at one end the connection to the suction line and the other end, the connection to the suction tip. Bone is harvested in the central chamber. (A) BDC-15 device. (B) Autograft harvested by the BDC-15.

Statistical analysis

All data were reviewed using a simple comparative analysis to determine fusion rates and outcome.

Results

Over the study period, there were a total of 232 patients enrolled in the study: 107 cervical fusion patients and 125 lumbar fusion patients (Table 1). Patient demographics were 55.6% male and 44.4% female; mean age of 58.3 years with age ranging from 33 years to 86 years of age; and all patients either underwent a cervical or lumbar fusion. Follow up period ranged from 8 months to 21 months with a mean of 13.4 months. All surgical procedures were elective with a diagnosis of degenerative disc disease and did not include trauma or cancer patients. Insurance demographics were as follows: commercial (131 patients), medicare (62 patients), medicaid (11 patients), no fault (7 patients), and worker’s compensation (30 patients).

Cervical fusions

For the cervical fusion group (Table 2), there 107 patients who underwent one-level surgery (38 patients, 38 levels), two-level surgery (58 patients, 116 levels), and three-level surgery (11 patients, 33 levels) for a total of 187 levels. Most patients were discharged the same day (89.7%) unless it was a three-level fusion, who stayed overnight. Mean length of stay was 1.01 days. X-ray imaging was used to assess fusion with an overall fusion rate of 96.2% at last follow up.

Lumbar fusions

For the lumbar fusion group (Table 2), there 125 patients who underwent one-level surgery (61 patients, 61 levels), and two-level surgery (64 patients, 148 levels). Mean length of stay for lumbar fusion patents was 1.86 days with most patients discharged to home and only five patients (4%) transferred to an acute rehabilitation facility. X-ray imaging was used to assess fusion with 115 patients fused at 12 months (92.0%), and 10 patients who did not fuse at last follow up (8.0%) with an overall fusion rate of 92.0% at last follow up.

Complications

The overall complication rate for the procedures was 4.7% or 11 patients over the study period (Table 3). The most common reason was readmission for post-operative pain (6 patients), infection (3 patients), and hardware failure (2 patients).

Device & cost analysis

One device was used per procedure with an average collection volume of 3 cubic centimeters for cervical fusion procedures and 15 cubic centimeters for lumbar fusion procedures. The average range of allograft costs in cervical spine surgery is $700 to $1,500 with an average cost of $1,200. The average rang of allograft costs in lumbar spine surgery is $1,500 to $5,000 with an average cost of $3,250 (3). In this study, we spent approximately $92,800 (232 devices × $400 per device) for BDC-15 devices compared to a surgeon who would use allograft where they would spend approximately $534,650 on the same case profile (Table 4).

Discussion

Key findings

The cervical and lumbar fusion procedures performed using local bone collected with the BDC-15 demonstrated safety and achieved acceptable fusion rates. Cervical fusion was 96.2% at 12 months, which is comparable to reports of large outcome studies reporting the fusion rate of ACDF of 95% (1-level) at 1 year (8,9). In lumbar cases, the fusion rate was 92% at 12 months and fell within the range of other PLIF procedures reporting anywhere from 51% to 100% fusion at 12 months and above (6,10-12). It is also similar to another study evaluating the fusion using local bone reported between 83–90% (13). Complication rates were comparable in cervical (4.67%) (14) and lumbar (4.8%) (15), and not reported to be due to the graft use. Our estimated savings per case is $800–$2,850 (cervical-lumbar). Previously, cost savings for using local bone products has a wide range of savings between $326–$4116 driven by the reduced need for allograft which is estimated to cost $460 per cubic centimeter (16,17). The cost savings from LB may only increase as the prevalence and cost of using osteobiologic allografts are considered (18).

Strengths & limitations

The strengths of the study show that the fusion rates are comparable to acceptable practice standards. In addition, the produce reduces the overall cost while preserving quality. Limitations include the fact that this is an initial study and the two of the authors (J.M.A., M.R.B.) developed the product from conception to market approval to widespread usage. Another limitation of the study is that fusion was assessed with X-ray rather than CT scan imaging as CT scan is well-known to be more accurate in assessing bone growth after fusion procedures.

Comparison with similar research

Local bone collected from the surgical site is recognized as an established autograft source (12). Local bone dust has shown high fusion success rates in spinal fusion surgery (16,19), increased quality-adjusted life year (QALY) of 0.04 (17), contained viable osteoblasts (20) and been shown to have increased local osteoblast proliferation up to 7 times controls (6). Cells from local bone harvesting have been shown to exhibit osteoblast phenotype (alkaline phosphatase, and calcium deposition) (21). The BDC-15 captured 3 mL for cervical cases and 15 mL for lumbar cases without adding time constraints or disruption to the overall workflow.

Explanation of findings

The BDC-15 is positioned to provide a simple and cost-effective solution to effectively capture and provide a source of local bone generated during cervical and lumbar fusion procedures. In all cases, it successfully collected the requisite amount of bone and achieved its goals.

Implications and actions needed

Autograft and further collection with the BDC-15 is safe and effective. Larger trials are required, and we recommend other surgeons pursue ways maintain quality and reduce cost in other parts of fusion procedures.

Conclusions

The BDC-15 is a safe and effective tool to harvest autograft during spinal fusion surgery. Fusion rates were comparable or better than reported in the literature for both cervical fusion (96.2%) and lumbar fusion (92.0%) with an acceptable complication rate of 4%. This device provides the surgeon with a simple and safe method for collecting autograft while reducing the overall cost of the procedure.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jss.amegroups.com/article/view/10.21037/jss-25-43/rc

Data Sharing Statement: Available at https://jss.amegroups.com/article/view/10.21037/jss-25-43/dss

Peer Review File: Available at https://jss.amegroups.com/article/view/10.21037/jss-25-43/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-25-43/coif). J.M.A. is a co-inventor on a provisional patent application (No. 20200138417, submitted November 1, 2019) related to the BDC-15 device discussed in this article. He is also a majority shareholder in Capseus, Inc., who manufactures and distributes the BDC-15. M.R.B. is a co-inventor on a provisional patent application (No. 20200138417, submitted November 1, 2019) related to the BDC-15 device discussed in this article. He is also the President and a minority shareholder of Capseus, Inc. B.I.K. is an employee of Optum Tristate Orthopedics. The authors have no other 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. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was exempt from institutional review board approval because of the simple data analysis and did not require any deviations in treatment algorithms. Informed consent was obtained.

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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