Initial Experience with BoneBac Press<sup>TM</sup>: A Novel Autologous Bone Graft Harvesting and Collecting Device

doi:10.4236/ojo.2013.35045

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Open Journal of Orthopedics, 2013, 3, 243-247

http://dx.doi.org/10.4236/ojo.2013.35045 Published Online September 2013 (http://www.scirp.org/journal/ojo) 243

Initial Experience with BoneBac PressTM: A Novel

Autologous Bone Graft Harvesting and Collecting Device

Mick Perez-Cruet, Evan M. Begun, Robert Collins, Daniel Fahim

Department of Neurosurgery, William Beaumont Hospital, Royal Oak, USA.

Email: [email protected]

Received July 12th, 2013; revised August 15th, 2013; accepted August 29th, 2013

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Object: The objective of this study is to analyze the utility of a novel autologous bone graft harvesting and collecting

device in spinal fusion surgeries. Methods: 35 patients underwent fusion procedures in the cervical or lumbar spine

using the BoneBac PressTM. Procedures included anterior cervical discectomy with fusion (ACDF), lumbar laminectomy

and posterolateral arthrodesis, and transforaminal lumbar interbody fusion (TLIF). The amount of bone graft collected

from each level was determined as well as the need for additional bone graft extenders. Fusion rates were determined

based on an independent radiographic evaluation performed 5 to 12 months postoperatively. Results: 54 total levels

were operated upon, collecting a total of 176.0 cc of autograft. The average amount of bone collected was 3.26 cc/level.

In the cervical and lumbar spine the average amount of bone collected per level was 2.30 cc and 6.77 cc respectively.

The fusion rate was 94.3% at 10 months postoperatively. In most cases no additional bone graft extender was needed.

Autologous bone collected had excellent handling characteristics and was easily packed into cages or placed poster-

olaterally. Conclusions: The use of autograft bone material collected using the BoneBac PressTM is cost-effective, sig-

nificantly reduces bone graft cost, and eliminates donor graft site morbidity while promoting successful fusion.

Keywords: Minimally Invasive; Autograft; Fusion; Transforaminal Lumbar Interbody Fusion

1. Introduction

Spinal fusion surgery has become more common as in-

dications have expanded and clinical data regarding sus-

tained outcomes improvements are published. Spine fu-

sion is used to treat traumatic fractures, degenerative

disease, and pain from abnormal motion. For successful

fusion, there must be growth of new bone, which pro-

vides a more ideal modulus of stiffness than instrumenta-

tion alone.

Even though there has been tremendous growth in the

number of bone graft extenders, biologically active

agents, and other materials to replace or regenerate bone,

autograft remains the gold standard for fusion surgery.

Several investigations have reported fusion rates >95%

for procedures utilizing autograft bone [1-4]. Autologous

bone exhibits properties that are ideal for grafting in-

cluding osteoinduction (growth factors), osteoconduction

(scaffold), osteogenesis (osteoprogenitor cells), and a

lack of immunogenicity [5,6]. Spinal fusion procedures

have traditionally been performed with the use of iliac

crest autograft. This requires an additional incision, and

can result in significant donor site morbidity including

chronic pain, infection, hematoma, and fracture [7]. This

technique has largely been abandoned secondary to a

high rate of complications, ranging from 8% - 34% [7-

11].

Autograft material can also be harvested from bone at

the surgical site, which eliminates morbidity resulting

from an additional donor site. The piecemeal resection of

bone involving rongeurs and kerrisons for the acquisition

of bone graft can be time-consuming and cumbersome

when compared to the utilization of a high-speed drill.

Furthermore, the yield of this piecemeal technique is

largely dependent on the surgical technologist’s ability to

retrieve the various bone fragments from a gauze sponge.

All these factors make the local acquisition of bone graft

inefficient.

Ideally, the surgeon would be able to gather autolo-

gous bone graft consistently and efficiently while per-

forming the decompression portion of the procedure.

Using the drill to decompress while simultaneously col-

lecting the drilled bone fragments would be optimal.

Several additional factors are necessary to promote fu-

Initial Experience with BoneBac PressTM: A Novel Autologous Bone Graft Harvesting and Collecting Device

244

sion with the use of autograft bone material. It is impor-

tant to reduce the harvest-to-implant interval for auto-

graft bone to increase the probability o f successful fusion

[5]. The graft material should also have good handling

characteristics so that it may be packed into cages or eas-

ily placed posterolaterally.

This study sought to evaluate a novel device for har-

vesting and collecting autologous bone fragments from

the surgical site. Graft material amount data were col-

lected from a series of 35 consecutive patients who un-

derwent various spine surgeries. All procedures required

fusion, for which autograft bone from the BoneBac

PressTM (Thompson-MIS, Traverse City, MI) was used.

2. Methods

Between November 2010 and June 2011, 35 consecutive

patients underwent fusion in the cervical or lumbar spine

with autogr aft bone that was collected us ing the BoneBac

PressTM. All procedures were performed at a single insti-

tution by the senior author. Procedures included anterior

cervical discectomy with fusion (ACDF), laminectomy

and posterolateral arthrodesis, and transforaminal lumbar

interbody fusion (TLIF). The amount of bone graft mate-

rial collected from each level was recorded, and the need

for additional bone graft extender was determined on a

case-by-case basis. Fusion rates were determined based

on radiographic evaluations at 3 - 12 months postopera-

tively conducted by an independent radiologist. Radio-

graphic criteria for successful fusion were as follows:

bridging bone between vertebrae on CT scan, lack of

motion and absence of lucencies on flexion/extension

X-ray views, and lack of hardware loosening or break-

age.

Operative Technique

The BoneBac PressTM is a device that was developed to

efficiently capture and utilize the bone drilled at the sur-

gical site during spine surgery. The device is composed

of an inlet port that has suction tubing going from the

device to the patient as shown in Figure 1(A). At the end

of this tubing is attached a suction tip of the surgeon’s

choice. We typically use a number 12 French suction to

facilitate bone graft capture. In addition, a #2 Kerrison

rongeur can be used to remove bone fragments that can

be captured in the BoneBac PressTM. The BoneBac

PressTM outlet port is connected to suction hose tubing

that goes off the surgical field to the traditional suction

canister or similar suction apparatus.

A matchstick M8 burr is typically used to drill bone,

which is suctioned and flows into the BoneBac PressTM

canister along with blood products. Attempts are made

just to drill bone and avoid cartilage or other soft tissue.

Thus a second suction tip is typically on the field to re-

Figure 1. The BoneBac PressTM. (A) BoneBac Press device

with inlet and outlet port hoses attached. (B) After rotation/

compression of the BoneBac Press leaving a bone plug and

move non-bone tissue. Once decompression of the neural

elements with the drill has been completed, the suction

tubing attached to the inlet port is disconnected. A metal

stylet is inserted into the inlet port and the device turned

on it side so that the outlet port with the suction still at-

tached is in the dependent position. A back and forth

compressing motion with rotation of the filter piston is

preformed. This maneuver compresses out the blood by

filtering the blood through the filter mesh. The rotation

of the filter piston detaches the bone/blood plug so that

more blood can pass through the filter pores. At times the

filter canister fills with clotted blood, and the technique

just described allows the clotted blood to pass through

the filter pores, leaving behind a bone plug with excellen t

handling characteristics as shown in Figure 1(B). Main-

taining the canister in the dependent position allows the

blood to flow out of the outlet port. At times when the

filter canister is filled with clotted blood and bone, there

is considerable resistance to pressing and filtering out the

blood. Persistent compression and rotation of the filter

piston with break up the blood seal and leave a plug of

bone. The bone p lug blanches slightly as suf ficient blood

is compressed out of the BoneBac PressTM canister. This

indicates that it is ready to be removed from the canister.

At this point, the suction tubing from the outlet port is

disconnected and the bottom of the canister is removed.

The filter piston is pushed to allow the clearance of the

bone plug from the canister. The bone is removed and is

ready for use as shown in Figure 1(C).

The technique described above produces a bone plug

Initial Experience with BoneBac PressTM: A Novel Autologous Bone Graft Harvesting and Collecting Device 245

with excellent handling characteristics. It can be packed

into cages, placed postero laterally, or used to fill the disc

space directly. If additional bone graft is needed, the

autograft bone can be mixed in a 1:1 ratio with bone graft

extenders such as demineralized bone matrix.

3. Results

A total of 54 levels were operated upon in the series of

35 patients, which included 21 females and 14 males

with a mean age of 62 years old (range, 19 - 84). Patient

disease pathology included degenerative disc disease

with bilateral foraminal stenosis (n = 7), disc herniation

with spinal cord compression (n = 7), spondylolisthesis

(grade I or II) with bilateral foraminal stenosis and/or

spinal cord compression (n = 13), traumatic spine injury

causing spinal cord compression (n = 3), large osteophyte

causing foraminal stenosis and/or spinal cord compres-

sion (n = 2), metastatic tumor causing spinal cord com-

pression (n = 1), lumbar spondylolysis of the bilateral

pars (n = 1), and ossification of the longitudinal ligament

causing spinal cord compression (n = 1).

The number of patients undergoing procedures in the

cervical and lumbar spine was 13 and 22, respectively.

Cervical levels fused included C3-4 (n = 2), C4-5 (n = 5),

C5-6 (n = 11), and C6-7 (n = 5). Lumbar levels fused

included L1- 2 (n = 1), L2-3 (n = 4) , L3-4 (n = 7), L4 -5 (n

= 12), and L5-S1 (n = 7). A total of 176.0 cc of autogr aft

bone was collected, and the average amount of bone col-

lected was 3.26 cc/level (range 1 - 17 cc/level). In the

cervical and lumbar spine the average amount of bone

collected per level was 2.30 cc and 6.77 cc, respectively.

No additional bone graft extender was needed in any of

the cases.

Thirty three patients had evidence of stable fusion at 5

months to 12 months postoperatively as shown in Fig-

ures 2(A) and (B), for an overall fusion rate of 94.3%.

Two patients experienced resorption of bone graft mate-

Figure 2. L4-5 Interbody Fusion using the BoneBac PressTM.

(A) Coronal and (B) Saggital computer tomography recon-

struction showing L4-5 interbody fusion after using Bone-

Bac press bone.

rial, both at the C3-4 level. The Average time to fusion

was 6.1 month s.

4. Discussion

The history of spine fusion has progressed as the overall

number of surgeries has increased and novel materials to

extend bone graft and regenerate bone are discovered. In

the past, harvesting bone from the iliac crest was a popu-

lar method of obtaining autograft bone for fusion proce-

dures. Autograft bone is ideal for fusion and can be

packed into cages or placed posterolaterally to regrow

bone and fuse unstable spinal segments. The placement

of graft material into the interbody space can improve

fusion rates, restore sagittal alignment, and increase fo-

raminal height and canal diameter [12].

Allograft bone and bone extenders have frequently

been used in spine fusion. Allograft is obtained from ca-

daveric sources and is the most widely used graft mate-

rial other than autogenous bone [13]. Allograft bone has

several downsides including a lack of osteogenicity and

osteoinductivity, greater tendency to undergo resorption,

and less tensile strength than autograft [14]. In addition,

allograft is costly, and has been occasionally associated

with disease transmission [5,14]. This combination of

factors may lead physicians and patients to seek more

attractive alternatives such as autograft.

Autograft bone possesses qualities that allow for re-

growth of bone and complete arthrodesis between verte-

brae [6]. This includes osteoinduction, or the presence of

growth factors that stimulate osteoblast production, os-

teoconduction, or the graft material’s ability to act as a

scaffold for new bone growth, and osteogenesis, which

involves osteoblasts from the graft material producing

new bone [5,6]. Autograft bone has the added advantage

of not provoking an immunogenic response or transmit-

ting disease [14].

One of the most popular bone graft extenders is bone

morphogenetic protein (BMP). BMP is an osteoinductive

morphogen capable of inducing de novo bone formation

and stimulating bony healing [15]. In a clinical and eco-

nomic review of recombinant human bone morphoge-

netic protein-2 (rhBMP-2) use in the United Kingdom,

Song et al. reported a 6.4% probability of rhBMP-2 be-

ing cost effective, and an estimated total cost for using

rh-BMP in the UK of about 4.2 million pounds per year

[16]. Although there have been a wide range of opinions

on the viability of BMP presented in the literature, more

economically feasible strategies of implanting BMP

should be develop ed before it is widely accepted [14].

Iliac crest bone graft (ICBG) is the most commonly

used autologous bone graft as compared to other donor

sites, and can produce larg e quantities of cancellous, co r-

tico-cancellous, or vascularized bone graft [9]. However,

ICBG harvesting has been widely reported to be associ-

Initial Experience with BoneBac PressTM: A Novel Autologous Bone Graft Harvesting and Collecting Device

246

ated with significant morbidity. A 6449 patient study re-

ported a 19.37% morbidity rate with ICBG for maxillo-

facial surgery, including infection, postoperative hema-

toma, iliac crest fracture, and chronic donor site pain [9].

A 170 patient study by Schwartz et al. reported that 20%

of patients undergoing ICBG for cervical and lumbar

fusion experienced substantial pain and disability at the

harvest site for up to three years post surgery [11 ]. Other

studies have reported neurological or vascular injury,

cosmetic defects, seromas, and avulsion fracture of the

anterior iliac crest (in rare cases) as a result of ICBG [7].

The only way to eliminate donor site morbidity is to

avoid autologous bone harvesting from the iliac crest

altogether. Although many bone graft extenders and

synthetic substitutes have been developed to help avoid

ICBG, the high cost of these materials fuels the search

for an effective and affordable alternative. Using autolo-

gous bone drilled directly from the surgical site elimi-

nates morbidity related to ICBG and the high cost asso-

ciated with bone graft extenders.

Transforaminal lumbar interbody fusion (TLIF) is per-

formed to treat lower back pain caused by degenerative

disc disease, spondylolisth esis, and stenosis. Bo ne drilled

from the lamina and articular processes in TLIF can be

excised and collected for bone graft material, rather than

simply disposing of it. This graft material can then be

placed into an interbody cage for vertebral fusion [4,14].

A number of studies have utilized autologous bone col-

lected from laminectomy, facetectomy, or drilling the

articular processes for fusion in open and minimally in-

vasive TLIF procedures. These procedures resulted in

high fusion rates based on previously published methods

of determining vertebral fusion (92% - 100% postopera-

tively), as well as improved postoperative clinical out-

comes scores [1-4,17,18]. It is clear that autograft bone

drilled directly from the surgical site can result in out-

comes that are as good or better than those of procedu res

utilizing ICBG and bone graft extenders.

We utilized the BoneBac PressTM in a variety of spinal

fusion procedures to correct pain resulting from degen-

erative disc disease, traumatic fractures, and spondylo-

listhesis. The bone chips and dust suctioned into the de-

vice’s canister were easily compressed into a circular

disc of morselized bone. This graft material had excellent

handling characteristics an d was easily packed into cages

or placed posterolaterally for successful fusion. The har-

vest-to-implant interval was kept to a minimum, as the

graft material was almost immediately utilized for ar-

throdesis. The BoneBac PressTM was also easy to set up

and connect to the operating room wall suction. These

procedures were cost-effective and significantly reduced

our bone graft expenditures .

We found our 94.3% fusion rate to be comparable to

other studies on TLIF fusion rates as previously men-

Figure 3. Cost Savings Analysis. Cost comparison Chart for

176 cc of common allograft bone products. Costs are based

the following: BMP ($3500/case), OsteoCell® ($472/cc), De-

mineralized Bone Matrix ($180/cc).

tioned. The average time for successful fusion of 6.06

months postoperatively is also similar to these studies

[1-4,17,18]. Use of the BoneBac PressTM resulted in suc-

cessful fusion except in two cases. Both patients under-

went ACDF at the C3-4 level. This resulted in resorption

of the bone graft material, which was not incorporated

into anterior arthro desis between the vertebrae.

Cost Savings

Prior to incorporating the BoneBac PressTM, our cost for

176.0 cc of cellular bon e matrix was $63,360 ($5400 per

15 cc of material). We also conducted a cost-savings-

analysis for other allograft bone products based on cur-

rent (2012) market cost as seen in Figure 3. The equiva-

lent cost for 176 cc of Bone Morphogenic Protein (BMP)

($3500/case), OsteoCell® ($472/cc), and demineralized

bone matrix ($180/cc) would be $122,500, $83,000, and

$31,680, respectively. The BoneBac PressTM resulted in

complete elimination of th is cost for the 176.0 cc of bon e

graft that was harvested from the present series of 35

patients.

5. Conclusion

We have found the BoneBac PressTM to be a safe, effec-

tive, and cost-efficient means of collecting autograft

during spine fusions. Bone graft material collected from

the device resulted in high rates of fusion and low bone

graft costs. We will continue to follow our patients over

the coming years in order to evaluate fusion results, fur-

ther cost-analysis, and outcomes related to patient satis-

faction, health, and morbidity.

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