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Balloon Reduction And Minimally Invasive Fixation (BRAMIF) for Extremity Fractures with the Application of Fast-Setting Calcium Phosphate

Jake P. Heiney, Jill A. O’Connor

ProMedica Health System
2109 Hughes Drive, Suite 840

Address for Correspondence:

Jake P. Heiney
ProMedica Health System
2109 Hughes Drive, Suite 840
Toledo, Ohio 43606

Phone : 419-291-5900
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J.Orthopaedics 2010;7(2)e8



There is a relatively high prevalence of calcaneus, tibial plateau, tibial pilon, and distal radius fractures in modern society with a growing economic cost related both to the expense of treatment as well as ongoing disability 1-4.  Calcaneus, tibial plateau and tibial pilon fractures are especially known for their high rates of wound complications 5-10.  Wound complications and disturbed fracture healing are further complicated by medical comorbidities that are increasingly common, including obesity, diabetes mellitus and smoking 11-19.  The significance of these complications is heightened by the fact that these fractures tend to occur in younger patients, and our society continues to live longer 1, 20-21.

In order to reduce fracture non-unions and wound complications, new minimally invasive techniques for fracture management continue to be developed.  One such technique that has had great success is balloon kyphoplasty (Kyphon / Medtronic, Inc, Sunnyvale, CA) 22-24, which until now has been relegated to the treatment of compression fractures of the spine.  Kyphoplasty is generally performed using an inflatable balloon, which is inserted from a posterior transpedicular or extrapedicular approach in the affected vertebral body.  The height of the compressed vertebra is restored by insufflation of the balloon with carefully-regulated pressurized liquid.  This device is known as the Inflatable Bone Tamp (IBT, Kyphon / Medtronic, Inc, Sunnyvale, CA).  The IBT is designed to “compress cancellous bone and/or move cortical bone as it inflates”25.  It is comprised of three biocompatible parts: a proximal luer fitting, a central catheter, and a distal inflatable tip with radiopaque markers.  Inflation of the balloon is achieved by using an external inflation syringe filled with radiopaque dye (i.e. OmnipaqueTM) connected to the proximal luer-lock connection.  This inflation syringe measures the volume (cc) and the pressure (psi) of the inflation.  These characteristics allow the device to be used in any bone simply as a conventional bone tamp or as a percutaneous bone tamp with fluoroscopic guidance.  The inflatable bone tamp is FDA-approved for use “as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus” 26.  

Pre-market testing in cadaveric fractured tibial plateaus and unfractured vertebrae has been performed, demonstrating that the IBTs can reduce cortical fractures and create voids in cancellous bone in the same manner as conventional bone tamps.  Safety testing also demonstrated no increase in risk over conventional bone tamps 25.  Interestingly, despite years of successful use in the spine, the IBT has never been formally developed by surgeons as a reduction tool in extremity fractures, despite having FDA approval for such applications.

The lead author (henceforth referred to as the author) has explored and developed a novel technique for reduction of peri-articular extremity fractures using an IBT and a fast-setting calcium phosphate cement.  The placement of fast-setting calcium phosphate cements into fresh orthopaedic fracture sites has been proven beneficial in filling bone voids, such as those that remain after reduction of impacted articular fractures 27-36.  In practice, the reduction of impacted articular fractures as well as bone-grafting of residual metaphyseal defects can be difficult, especially when using minimally invasive methods.  The author has found that the technique of kyphoplasty balloon-assisted reduction of impacted lower extremity articular fractures to be a reproducibly successful approach that is adaptable to many fractures.  This minimally invasive technique includes the reduction of articular surfaces using a percutaneous balloon and fluoroscopic control, followed by insertion of an appropriate amount of fast-setting calcium phosphate cement into a well developed and positioned void, and finally placement of fracture fixation hardware as needed.

Surgical Technique

Since early 2009, the author has successfully used the KyphX Xpander® Inflatable Bone Tamp (IBT, Kyphon, Sunnyvale, CA) balloon for extremity fracture reduction in numerous cases.  The author is experienced using the KyphX Xpander® IBT (Kyphon / Medtronic, Inc, Sunnyvale, CA), therefore the technique described herein will refer to this device.  However, this technique is not limited to this particular IBT and other inflatable devices could potentially be used.  This technique was used in a variety of fractures, including distal radius, tibial plateau, tibial pilon and calcaneus.  The general technique is described in this report, and two specific case examples are presented to illustrate the technique used.  Finally, we will briefly present technical tips for use in two other fracture locations.

Step 1: Pre-operative planning

Radiographs of the affected extremity are essential for preliminary assessment of the fracture.  Depending on the extent of the fracture (e.g. comminution, cortical shell integrity, etc.) and the condition of the soft tissues, a patient may need to be placed into an external fixator prior to definitive fracture reduction and fixation.  A computed tomography (CT) scan is recommended in cases with intra-articular involvement or comminution.  To best plan for the procedure, all images should be carefully examined to assess deformity, number and location of bone fragments, location and amount of articular depression, and other areas of concern to determine the size of balloon and type of reduction equipment needed.  Prior to the case, it is important to take inventory of all the equipment necessary for the case.  The basic equipment used to carry out balloon reduction and minimally invasive fixation (we have coined the term BRAMIF) is the KyphX® Osteo Introducer® system, an additional single Kyphon Balloon®, bone filler (a fast-setting calcium phosphate cement), OmnipaqueTM, C-arm fluoroscopy, and typical reduction tools such as forceps, k-wires, plates, plate-holding clamps, power drill, etc.  Additionally, all radiographs and CT scans should be available in the operating room for reference.  The approach for minimal soft-tissue damage and internal fixation should be pre-determined.  The desired internal fixation hardware should be available.

Step 2: Provisional Reduction & Fixation

The initial surgical tactic should focus on provisional fracture reduction and fixation. First, a small incision is made and the fracture line is exposed as needed.  The primary fracture fragments should be provisionally approximated using k-wires, clamps, reduction forceps, and/or the plate.  In the case of intra-articular fractures and/or joint line depression, it is recommended that stable reduction and fixation of all fracture lines on the diaphyseal side of the defect or desired balloon location be carried out first.  This ensures the balloon, once inflated, will take the path of least resistance and act upon the desired area of impacted articular surface and cancellous bone, rather than serve to displace another portion of the fracture.  Also, hardware (such as k-wires or screws) may be applied around the area of articular depression to “frame” the impacted area, which helps to ensure that expansion of the balloon occurs in the desired direction to affect reduction of the articular fragments.  This allows the balloon to reduce the depressed portion of the fracture appropriately without “escape” of the balloon or calcium phosphate when inserted.

Step 3: Balloon Preparation and Insertion

The desired location of the balloon is determined during pre-operative planning, and the balloon is inserted percutaneously into this area once provisional fixation (and reduction if necessary, see Step 2) is achieved.  The balloon should be positioned so that the long axis of the balloon is parallel to the joint line and just beneath the impacted defect in the bone, but with a shelf of bone between the balloon and any articular surfaces.  Using fluoroscopic guidance, the KyphX® Osteo Introducer® system is used to position the uninflated balloon in the desired location.  The introducer system includes a cannula, hand drill, and spade- and diamond-tip trocars.  First, a trocar and cannula is placed on the outer cortex of the bone, and a mallet is used to impact the trocar through the cortex and into the cancellous bone.  In the event that this access is difficult, a power drill may be used to facilitate entry through cortical bone.  It is important that this be done gently in order to not cause further fracture, especially in osteoporotic bone.

Once access is gained to cancellous bone, the trocar is removed while leaving the cannula in place, and a hand drill is used to make a path for the balloon through the cancellous bone.  The depth of entry should be determined by using the depth markers on the hand drill and the appropriate balloon size can be determined (e.g. 10mm, 15mm, 20mm).  Therefore, it is beneficial to have several balloon sizes available.  The appropriate balloon/inflation syringe assembly is filled with contrast medium (i.e. OmnipaqueTM) and is readied for insertion.  It is important to make sure that the area within the bone where the balloon will be deployed is clear of any sharp bone fragments, screws or k-wires that might damage the balloon or cause it to break upon inflation.  The balloon is then inserted through the KyphX® Osteo Introducer® system until the two radiopaque markers (representing both ends of the balloon) are seen outside the cannula and are completely within the bone in the desired location.

Step 4: Balloon Expansion and Fracture Reduction

Before inflating the balloon, be sure to check its position with fluoroscopy.  Two radiopaque markers, representing both ends of the balloon, should be seen outside the cannula, and beneath the impacted bone fragment.  Once it is confirmed that the balloon is properly placed (parallel to the joint line, beneath the impacted bone), the knob on the inflation syringe is slowly turned to inflate the balloon with the contrast.  A fluoroscopic image should be taken with each additional 0.5 to 1 cc of balloon inflation to ensure the balloon has not moved or deformed, and to assure that fracture reduction and bone void formation is occurring as desired.  Continue inflating the balloon without exceeding the volume or pressure recommendations determined by the manufacturer.  The volume of expansion should be recorded in order to estimate the volume of bone void filler that will be needed.  The balloon may be deflated once the desired fracture reduction, cancellous bone impaction and bone void formation has been achieved.  Upon deflation of the balloon, if it is apparent that further reduction is needed, the balloon may be repositioned and reinflated by repeating the above steps, all while obtaining appropriate fluoroscopic images and recording the total volume of expansion.

In the case of a large bone defect or void, the “double stacking” technique may be used (most often necessary in the calcaneus).  This technique requires the availability and use of two separate balloons.  This technique is used when the defect in the bone is too large for one balloon to fill.  When this is the case, repositioning the original balloon closer to the impacted bone and attempting reinflation for further reduction may not be successful because the balloon may simply expand back into the original void and not affect any further fracture reduction.  However, with the additional deployment of a second balloon along with the still-inflated first balloon, the defect can be fully filled and the fracture properly reduced.  To use the stacked balloon technique, first deploy and inflate one balloon according to the above instructions and leave it in place.  Next, carefully introduce a second cannula parallel to the first balloon and closer to the still-displaced bone segment, while being careful not to damage the first balloon with any of the instrumentation.  Finally, inflate the second balloon as previously instructed until the fracture is properly reduced and a void is created.  As before, the total volume of both balloons should be noted to estimate the amount of bone void filler that will be needed to graft the defect.  At this point, the balloons should have compacted the cancellous bone supporting the comminuted fragments and created a tightly sealed void for the bone filler to be placed. 

Step 5: Bone Filler Preparation and Insertion

The appropriate amount of bone filler is chosen according to the volume measurements obtained from the inflated balloon(s).  The authors have used a drillable, fast-setting calcium phosphate cement, such as HydrosetTM (Stryker; Kalamazoo, MI) 37-38.  The luer lock of the HydrosetTM kit works directly with the Kyphon® bone filler device, facilitating introduction of the bone filler.  Although the remainder of this technique is described for this particular product, another fast-setting calcium phosphate substitute (e.g. Norian SRS®) may be chosen.  Some surgeons may choose to use the more traditional cancellous autograft or allograft.  Please note that if the surgeon chooses to use another bone-graft substitute, an alternative method to deliver the bone void filler into the defect will have to be used.  For example, a transfer syringe may be needed if the luer lock of the delivery system for the desired material does not match that of the Kyphon® bone filler device. 

The calcium phosphate is prepared according to manufacturer’s instructions, paying particular attention to time constraints, and making sure that enough volume of filler is available.  Once mixed, the syringe is assembled and filled with the material.  A Kyphon® bone filler device is attached to the luer lock of the syringe and filled with the calcium phosphate cement.  Several bone filler devices are filled with the calcium phosphate cement until all available material is used.

Each fully-loaded bone filler device with a pusher stylet should be handed to the surgeon as soon as it is filled.  It is important to emphasize that one must work quickly during this step so that the calcium phosphate cement does not harden before it can be injected into the bone.  Each filled bone filler device is inserted into the cannula to a distant point in the void and its position confirmed with fluoroscopy.  Insert the pusher into the back of the bone filler device and slowly inject the calcium phosphate while gradually pulling back on the bone filler device as needed to “backfill” the entire space.  Several bone filler devices may be required to fill the entire void.  Be sure the scrub technician is well-instructed prior to starting this process, since time is of the essence and efficiency is important during the bone filler exchange process.  Once the void is filled with calcium phosphate, the bone filler device and cannula are removed.  Please note that this step in the process is very similar to that of kyphoplasty.  Therefore, if the surgeon does not perform kyphoplasty as a part of their practice, they should gain assistance from their Kyphon® or alternative IBT representative.

Step 6: Internal Fixation

The final step is to complete the internal fixation of the fracture with the desired hardware, as determined during the pre-operative planning stage.  Please refer to the manufacturer’s instructions on recommendations in regards to drilling or placing screws into the bone filler. 

Illustrative Cases

Example Case #1: Distal Radius Fracture

A sixty-seven year-old female presented to the emergency room after slipping on black ice, injuring her left wrist.  She had obvious deformity of her wrist, and radiographs revealed a dorsally-displaced left distal radius fracture (Figure 1A).  The patient was given moderate sedation and her wrist was manipulated and reduced by closed means. Her wrist was initially splinted and post-reduction films were obtained, which revealed the distal carpus continued to be displaced dorsally (Figure 1B).  At that time, she was counseled on the options of closed versus open treatment and the patient selected open treatment.

Figure 1: (A) Initial presentation showing dorsal displacement of the distal radius and (B) a lateral post-reduction radiograph.

The patient was taken to the operating room.  Her arm was placed on a radiolucent table and was sterilely prepped and draped.  A small volar incision was made and dissection was carried out down to the bone to expose the fracture line.  A volar, locking distal radius plate was chosen.  Other specific steps of this case are described through the following series of images and descriptions (Figures 2-4).

Figure 2: (A) Provisional reduction and fixation was carried out by using a volar, locking distal radius plate, k-wires and non-locking screws framing the fracture.  (B) Using the KyphX® introducer system, the port for the balloon was created using a radial approach with a trocar and a path was created with a hand drill through the cannula. (C) The balloon was inserted through the cannula until the two radiopaque markers were seen outside the cannula and in the desired location while remaining completely within the bone. (D) The balloon was then inflated as to not exceed the pressures indicated by the manufacturer.  The inflation of the balloon better reduced the joint line, moved the distal fragment to the plate and impacted all the surrounding cancellous bone in order to create a void that would not allow escape of the bone filler through the intra-articular split.  The volume of the balloon was recorded in order to prepare the proper amount of bone filler needed in the next step.  Finally, the balloon was deflated and removed while leaving the cannula in place.

Figure 3: (A-B) The void created by inflating the balloon is seen with the cannula in place. At this point, after taking note of the balloon inflation volume, 3cc of calcium phosphate cement was mixed and prepared for insertion.  These steps were all done in a rapid, efficient manner as to not allow the fast-setting calcium phosphate to harden prior to insertion.  The syringe was attached to the Kyphon® bone filler device and two bone filler devices were filled with calcium phosphate (1.5cc each). The authors began filling the void by inserting the bone filler device to the furthest point and “backfilling” the void while steadily pulling back on the bone filler device as needed.  The void was completely filled with calcium phosphate while experiencing no leaks and minimal waste as seen from both the (C) AP and (D) lateral views.

Figure 4: Internal fixation was completed with application of various non-locking and locking screws in the volar distal radius plate, shown by both (A) AP and (B) lateral views.

Example Case #2: Tibial Plateau Fracture

A fifty-six year old female involved in a motor vehicle accident complains of right knee pain.  Initial radiographs reveal a displaced fracture of the right lateral tibial plateau and right proximal fibula fracture (Figure 5A-B).  Due to the poor condition of the soft tissues, the patient was placed into a knee-spanning external fixator and a CT scan was obtained to further evaluate the extent of the tibial plateau fracture (Figure 5C-D).

Figure 5: (A) Initial radiograph at presentation. (B) Radiograph after application of external fixator. (C) Axial and (D) coronal CT scan sections following external fixation. The CT scan was obtained to analyze the severity of comminution and articular involvement. 

The patient was discharged for two weeks and returned at that time for definitive fixation of her tibial plateau fracture.  She was placed on a radiolucent surgical table and was sterilely prepped and draped.  A small vertical anterolateral incision was made and dissection was carried out down to the bone to expose the vertical-split fracture and the knee joint line.  An injury was noted to the lateral meniscus, so stay sutures were placed in the meniscus until it could be repaired at the end of surgery.  A large C-arm was used throughout the procedure to check the reduction and placement of hardware.  Next, the appropriate proximal tibial plate was chosen and the other specific steps of this case are described though the following series of images and captions (Figures 6-8).

Figure 6: Provisional reduction and fixation was carried out by placing a lateral proximal tibia plate in position and holding this position with large reduction forceps and k-wires. Using the KyphX® introducer system, a port for the balloon was created using a lateral approach and gently tapping a trocar through the cortical bone. (A) A path was then created with a hand drill through the cannula. (B) The balloon was inserted through the cannula until the two radiopaque markers were seen outside the cannula.  The proximal k-wire holding the provisional reduction was removed so the balloon could act upon the joint line. (C) The balloon was then inflated as to not exceed the pressures or volume indicated by the manufacturer.  The balloon reached maximum capacity while remaining low in pressure with incomplete reduction, therefore indicating a void too large for one balloon (see discussion regarding balloon pressure readings).  We then carried out the “double stacking” technique.  We left the first balloon inflated inside the bone and introduced a second balloon just above the first, using the same technique as for the first balloon.  An additional trocar was used to make a port through the cortical bone and (D) the hand drill was carefully introduced using fluoroscopy guidance as to not damage the first balloon.  Once the appropriate path was made for the balloon, (E) the balloon was inserted so the two radiopaque markers were seen outside the cannula while remaining within the bone. (F) The balloon was inflated until the void was filled and the joint line reduced as to not exceed the volume and pressure indicated by the manufacturer.  The volume of both balloons was recorded in order to prepare the proper amount of bone filler needed in the next step.  Finally, the balloons were deflated and removed while leaving the two cannulas in place.

Figure 7: At this point, after taking note of the balloon inflation volume, the calcium phosphate was mixed and prepared for insertion as previously described in the general technique. (A) We began filling the void by inserting the bone filler device to the furthest point and (B) “backfilling” the void while steadily pulling back on the bone filler device as needed. (C) The void was completely filled with calcium phosphate while experiencing no leaks and minimal waste.

Figure 8: Finally, the tibial plateau was internally fixated using a lateral proximal tibia plate and screws shown in an (A) AP and (B) lateral view, while also showing the minimally invasive incisions used to carry out this technique. The incisions are shown (C) after hardware implantation and prior to closure and (D) after closure.

Case #3: Calcaneus Fracture

For specific tips on treatment of calcaneus fractures see Figure 9.

Figure 9: These figures illustrate the general use of BRAMIF in the calcaneus. (A) Pre-surgical image. The general technique follows that of the previous cases, but (B) this image shows the provisional fixation while, most importantly, highlighting the balloon position through a posterior calcaneal approach, which is a notable difference from the usual position parallel to the joint line. (C) The balloon was inflated to raise the joint line.  Also, in the calcaneus, the bone void is typically large enough that complete reduction requires use of the “double stacking” technique. (D) The final image shows the void filled with the appropriate volume of calcium phosphate and internally fixated with a calcaneal plate and screws. Alternatively, completely percutaneous internal fixation may be used in some cases.

Case #4: Tibial Pilon Fracture

This tibial pilon fracture is a good example of the “framing” technique, which involves application of hardware around the area of articular depression and the cancellous bone void that will be present after reduction (Figure 10).  This best reduces the depressed portion of the fracture without allowing “escape” of the calcium phosphate.

Figure 10: (A) Shows an initial attempt at provisional fixation, which will provide no balloon capture.  The fracture is too unstable, so if the balloon were inflated, the fractured fragments would spread in all directions, while leaving the joint line depressed.  Instead, (B) the depressed joint line was “framed” with k-wires laterally, distally and proximally, and a plate medially.  As an additional tip, the k-wires can have cannulated screws placed over them should the surgeon desire a more sturdy “frame”.  A balloon was then placed above the area of articular depression and inflated to reduce the impacted articular segment and compact the underlying cancellous bone.  Once a bone void was created and the balloon was removed, a large posterior fragment was fixed with screws and a distal screw was placed in the plate. (C) These screws provided a medial, lateral and superior frame around the previously created bone void to assist in preventing escape of the bone filler and while stabilizing the bone surrounding the void.  Calcium phosphate cement was then inserted using the Kyphon® bone filler devices. (D) The void was completely filled without escape of calcium phosphate and the distal tibia was internally fixed with the plate and screws.

Discussion :

While the application of an inflatable balloon tamp (IBT) as an internal bone reduction device is not a new concept, the application of this balloon reduction and minimally invasive fixation, BRAMIF, method to periarticular fractures of the extremities is a novelty.  The IBT, particularly the Kyphon ® balloon, is best known for the reduction of vertebral body fractures; a technique known as balloon kyphoplasty.  During kyphoplasty, the balloon is percutaneously inserted into the vertebral body under fluoroscopic control, and then inflated to reduce the fracture and impact cancellous bone 22-24.  Next, bone cement (i.e. polymethylmethacralate, PMMA) is inserted into the residual bone void in the vertebral body in order to support the fracture reduction and maintain the vertebral body height.  By compacting cancellous bone, the balloon also reduces the likelihood of PMMA from escaping outside the vertebral body 22, 39-41

This technique has been used in over 600,000 spinal fractures to date (electronic mail: Denise Moore, Communications, Kyphon Products, Sunnyvale, CA).  Several studies, including a prospective randomized control trial 22, have reported improved quality of life, improved disability measures and a reduction of back pain using this technique 22-23, 39.  Therefore, the authors believe it would be beneficial to achieve the same benefits of percutaneous fracture reduction in the extremities, especially fractures associated with soft – tissue compromise that increases the risk of (or precludes) open intervention.

The author first explored this technique in cadavers and then did a comprehensive literature review to see if anything similar to BRAMIF had been developed previously.  Two case reports and one brief abstract from a poster presentation were found that described the use of a balloon to aid in reduction of fractures outside the spine.  The first case was done in Japan using a primitive urology balloon to aid in creating a void for placement of fast-setting calcium phosphate in a comminuted distal radius fracture with an arteriovenous fistula 42.  The authors of this case report referenced Jupiter et al. 28, who noted the benefits of calcium phosphate cement in distal radius fractures, and were trying to find a way to insert the calcium phosphate in an effective manner due to the comminuted nature of their patient’s fracture with nearby fistula.  The second case report describes the percutaneous insertion of a balloon for a nutcracker fracture in the cuboid bone to aid in reduction.  The authors noted good results using an IBT for the cuboid reduction, but they used calcium sulfate as a bone filler 43.  The third literature citation was an abstract for a poster presentation by Reiley (co-founder of Kyphon, Inc.) 44 describing balloon-plasty of osteoporotic fractures of the distal radius, distal femur, proximal tibia and calcaneus.  This brief abstract highlights several promising aspects of the use of an IBT, including percutaneous reduction and cavity formation with augmentation using minimal hardware.  However, this description of the percutaneous balloon-plasty technique makes mention of only cancellous, osteoporotic fractures and no guidance or specifics on technique were ever developed in the extremity 44

This paucity of literature has left a deficit of experience with a potentially revolutionary technique for fracture treatment.  The authors believe that the principals of minimally invasive or percutaneous surgery should be applied whenever possible in order to minimize wound complications, and have found the BRAMIF technique to be safe, reproducible, and valuable.  Fractures in areas such as the proximal tibia, distal tibia and calcaneous are particularly prone to complications 5-10.  The BRAMIF technique described in this report provides an ideal setting to support these periarticular, metaphyseal fractures with a fast-setting calcium phosphate bone substitute.  This technique using an IBT, minimally invasive hardware, and calcium phosphate bone filler is a logical evolution in extremity fracture care. 

The balloon acts in several important ways when used in this manner.  First, it acts as a reduction tool.  This reduction tool is superior to traditional methods of reduction in many ways.  Traditional bone tamps often require the surgeon to open a split or window in the cortical bone.  This can create more damage and often limits the size of tamp that can be used to lift up the compacted surfaces.  The balloon, however, only needs a small cannula (8 gauge, 4.0mm) to be inserted in the cortical bone, and the defect or fracture can be easily reduced as long as the balloon is inflated parallel to the joint surface.  This allows a much larger volume of bone to be lifted up “en bloc” than the traditional bone tamp.  Second, there is no need to account for the often difficult angles needed to insert a larger bone tamp, as even the largest IBT is inserted through the same size cannula.  Also, the surgeon can modify the position of the balloon as needed for optimal fracture reduction, even if the IBT is not perfectly parallel to the joint line (see case example #1).  Third, instead of just having visual feedback (either fluoroscopy or straight visualization of the joint line), there is an additional feedback of a pressure gauge.  We have found if the balloon is inserted into a non-fractured area, then the balloon pressure increases very rapidly and stays high (i.e. balloon is malpositioned and not moving).  In contrast, if the pressure continues to fall or there is no increase in pressure then the void is too big or the balloon is no longer contained within the bone (see “double stacking” technique if void is too big).  If the balloon is placed correctly within a fractured area, the balloon pressure increases but stays relatively low with an initial drop from maximal pressure that levels out, allowing the surgeon to know that the IBT is in the correct position.  All these pressure readings gives feedback that the surgeon cannot appreciate when manually raising the bone with conventional bone tamps.  With enough experience, this feedback eliminates some of the need to use fluoroscopy to monitor the fracture reduction.  Finally, just as the impaction of cancellous bone in the vertebral body aids in keeping the PMMA inside the vertebral body 39, 45-47, the same is true at the articular surface.  The metaphyseal cancellous bone becomes compacted, which helps contain the calcium phosphate within the bone without escaping into the joint, as escape of cement from the vertebral body has demonstrated detrimental effects in surrounding tissues 41, 48-49.   However, just as in the kyphoplasty technique, the void filler must still be watched with fluoroscopy closely to ensure it does not leak into the joint line.

The IBT creates a well-defined bone void that facilitates the delivery of fast-setting calcium phosphate cement for support of the articular surface.  We have found that temporary fixation prior to balloon deflation is not usually necessary.  Once the balloon reduces the fragments, the fragments tend to stay reduced, thereby allowing the surgeon to go straight to permanent internal fixation after filling the void.  In some cases, hardware may be used to “frame” the fracture which acts much like blocking screws that orthopaedic surgeons are used to applying.  The “frame” contains the balloon to the area where the surgeon wants to create the bone void and achieve fracture reduction.  As an additional tip, even if doing a more traditional open approach to any fracture reduction (e.g. fragments are rotated or continued depression in spite of IBT usage), the balloon can still be useful in impacting traditional bone graft to achieve both support and a void to which other bone fillers or additional graft can be applied. 

The authors recommend using fast-setting calcium phosphate cement as a bone void filler when using this technique.  Fast-setting calcium phosphate cements have several advantages over other bone fillers.  They are isothermic and set up quickly in a wet environment 29, 50.  The calcium phosphate cement helps stabilize the fracture, providing structurally competent augmentation with high compressive strength that maintains its integrity while the cement is resorbed, and is also osteoconductive so that it is replaced by bone 27, 29-30, 36, 51.  The advantages of calcium phosphate cements have been shown clinically in multiple studies 31-34, 52.  They decrease pain at the fracture site, which may allow earlier mobilization 35, 53-57.  Three studies have demonstrated improved functional outcomes with use of calcium phosphate cement 35, 57-59.  Several authors have demonstrated that calcium phosphate cements are superior to traditional bone graft or no bone graft with respect to preventing fracture subsidence 31, 35, 54-55, 57, 60.  Also, by eliminating the need for allograft there is no risk of potential shortage of cadaveric bone material, patient objections, and allograft disease transmission.  With eliminating the need for autograft, there is no donor site morbidity, which is often a problem 61-67.

There are other options for bone fillers (excluding the prior mentioned allograft and autograft), such as PMMA and calcium sulfates.  PMMA is not resorbable, and is highly exothermic as it sets 68-71, which may be of concern in a subchondral location. One cannot easily insert screws into PMMA 70-72.  The author has found the handling properties of calcium sulfate products to be less desirable. Calcium sulfates are also a poor choice because of their hydrophilic properties, lack of structural support and quick resorption times 30, 73-74.  Due to their hydrophilic properties, a large amount of fluid may accumulate in the area that often leads to wound healing and infection problems 75-78.  The authors believe that the BRAMIF technique is not only applicable for osteoporotic fractures, but may become a common treatment for acute fractures of the distal radius, calcaneus, proximal and distal tibia.  

There are additional properties of the IBT that makes it beneficial to use in intra-articular extremity fractures with the BRAMIF technique.  The balloon, while performing the reduction, generates a well-defined void to deliver and contain the calcium phosphate cement.  Also, the balloon indicates exactly how much calcium phosphate will be needed by simply reading the inflation gauge.  The author developed this technique not only from the concern of wound complications, but also the struggles of getting calcium phosphate into the correct position in the bone.  Often, due to the high injection pressures inside the bone, calcium phosphate would find cracks and come out of the cortical shell.  Worse yet, calcium phosphate will also follow cracks through the articular cartilage and diffuse into the joint.  Instead, with use of the IBT there is a void that readily receives the bone filler in the exact position as the balloon was placed to give support to the fracture at the articular surface, ideally where it is most needed. 

Economic costs are an important aspect of this technique as well.  Theoretically, the cost of treating one wound complication is multiples more than the incremental expense of the BRAMIF technique 1-2, 21, 79-81.  This technique also saves money by avoiding wastage of the typically expensive bone void filler, since the volume of the void can be precisely measured from the balloon(s).  The incremental difference in cost from using one volume of calcium phosphate cement to the next larger volume (i.e. a 5cc to 10cc or a 10cc to a 15cc) is typically more than the entire cost of an IBT system, and surgeons without the balloon tend to err on the “safe” side, by requesting the larger volume of filler. Overall, this novel technique has a number of positive attributes that come at a relatively small, or in some cases, negative economic cost.  This percutaneous technique allows reduction of fractures in a manner that is minimally invasive while facilitating effective application of ideal bone filler; perhaps more effectively than is done with traditional open techniques in which there is a lot of waste.  These benefits may, in turn, provide a means to perform reductions and internal fixations in patients that we may have been rightfully hesitant to operate on in the past (e.g. a diabetic, smoker with a joint-depression calcaneus fracture, etc).  This technique also allows placement of fast-setting calcium phosphate cement in a reproducible manner, directly beneath the impacted bone, with less likelihood of intraarticular spillage or leaking out of the wound.  Other surgical approaches to these fractures require a delay while the soft tissues settle down, often with temporary use of an external fixator.  Future research must be done to evaluate whether the BRAMIF technique allows earlier definitive surgery and leads to better outcomes, including earlier mobilization, earlier discharge from the hospital, fewer surgeries and even more overall cost savings.  For now, these potential benefits remain speculative.


In conclusion, the authors report a novel technique, BRAMIF, which utilizes an inflatable balloon bone tamp for reduction of articular fractures, bone void creation, and insertion of fast-setting calcium phosphate cement bone filler using a minimally invasive approach.  This technique may be readily applied by orthopaedic surgeons to accomplish the list of goals outlined herein.  This includes a decrease in complications and improving patient outcomes.  We expect further refinements in our technique as we and others gain experience with it.  We believe this already FDA-approved application of an inflatable bone tamp can be learned and safely used by orthopaedic surgeons who treat acute fractures of the distal radius, calcaneus, and proximal and distal tibia.  Hopefully, this report explains the rationale and development of the BRAMIF technique and will lead to further refinements in treatment of these difficult fractures.

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This is a peer reviewed paper 

Please cite as: Jake P. Heiney:  Balloon Reduction And Minimally Invasive Fixation (BRAMIF) for Extremity Fractures with the Application of Fast-Setting Calcium Phosphate

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