Injury, Int. J. Care Injured 45S (2014) S72–S79

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Balloon-assisted reduction, pin fixation and tricalcium phosphate augmentation for calcanear fracture D. Vittore, G. Vicenti *, G. Caizzi, A. Abate, B. Moretti Department of Neuroscience and Organs of Sense, Orthopaedic Section, Faculty of Medicine and Surgery, University of Bari, Bari, Italy

A R T I C L E I N F O

A B S T R A C T

Keywords: Calcanear fractures Balloon reductions Tricalcium phosphate

Two-thirds of hindfoot fractures involve the calcaneus. The best treatment for intraarticular fractures is still debated. The goal of treatment has been focussed for years on the anatomical reduction of the articular surface. Open reduction and internal fixation enables the surgeon to view the articular surface directly, but it is associated with a high rate of wound breakdown and infection. Therefore, length, width and angular replacement of the great tuberosity are actually the main parameters to consider when treating this type of fracture. This is a report of our experience of 20 patients treated with a minimally invasive technique of reduction using an inflatable bone tamp filled with tricalcium phosphate, with a mean follow-up of 12.25 months (range 7–26 months). Percutaneous K-wires were used to help reduction and to direct balloon inflation. Surgical goals were restoration of the mechanical stability for earlier full weight-bearing and patient mobilisation. ß 2014 Elsevier Ltd. All rights reserved.

Introduction Fractures of the calcaneum constitute approximately 60% of all tarsal injuries, and are usually the result of a fall from a height [1]. The economic importance of the injury is considerable because 80–90% of these fractures occur in men in their prime working years [2]. As a result, these men may be disabled for several years after the injury and many are unable to return to their original occupation [3]. Calcaneal fractures are a challenging clinical problem due to the complex anatomy of the os calcis, the frequent subtalar joint involvement and frequent articular displacement [4–6]. Involvement of the posterior thalamic joint is seen in approximately 80% of cases and is a strong predictor of the eventual clinical outcome [7]. The treatment of these injuries remains controversial [2,8]. In the past, conservative treatment was preferred, generally with unsatisfactory results [9]. The goal of the treatment of intraarticular displaced fractures is to focus on the anatomical reduction of the articular surface, avoid complications, and correct the length, width

* Corresponding author at: Department of Neuroscience and Organs of Sense, Orthopaedic Section, Faculty of Medicine and Surgery, University of Bari, Piazza Giulio Cesare 11, 70124 Bari, Italy. Tel.: +39 3480128360. E-mail address: [email protected] (G. Vicenti). http://dx.doi.org/10.1016/j.injury.2014.10.027 0020–1383/ß 2014 Elsevier Ltd. All rights reserved.

and angulation of the tuberosity. The ORIF technique enables the surgeon to view the articular surface directly during the reduction and fixation process [10]. ORIF with a lateral plate has been established as a standard therapy [11]. The development of major wound complications is a serious concern in the treatment of calcaneal fractures. The soft-tissue envelope around the calcaneus is particularly thin and vulnerable over the lateral wall, which is exposed for surgery in most cases [12], particularly in patients predisposed to infection because of systemic illness or local factors, such as blisters, swelling and open wounds. Surgery is difficult and is plagued with potential problems, such as skin necrosis, imperfect reduction and subtalar osteoarthritis [13]. Satisfactory reduction can be obtained using less invasive, percutaneous techniques; however, reduction remains difficult and fixation precarious, necessitating multiple screws and multiple incisions [14,15]. Indirect, closed reduction and percutaneous osteosynthesis of displaced calcaneal fractures may minimise the incidence of soft tissue-related complications; however, these methods carry the risk of incomplete reduction, particularly with complex fracture patterns [16]. This fact should not be underestimated, because even minor residual steps of about 2 mm in the posterior facet lead to a significant load shift within the subtalar joint [17,18] and have an adverse effect on functional outcome [19–23].

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The authors have extensive experience in kyphoplasty and vertebroplasty techniques in the spine, and are confident that such techniques can be used to achieve adequate reduction, as confirmed by the literature [24]. In the current study, the use of these techniques was extended to patients with calcaneal fracture by using a percutaneous balloon reduction technique similar to that used in vertebral compression fractures. Bano et al. [25], in 2009, published one case treated using a percutaneous technique with a double lateral approach to reduce the thalamic surface and the shape of the os calcis, with an excellent outcome. Gupta et al. [24], in 2009, reported three cases using a technique very similar to the one used here, with a good outcome. The technical details of the technique have been described recently in several papers [7,27–29]; however, these studies lack follow-up and clinical evidence of efficacy. The authors propose a new technique of reduction using an inflatable bone tamp filled with tricalcium phosphate. Percutaneous pinning with K-wires was used to orientate balloon inflation and maintain reduction after device removal. Surgical goals are restoration of the mechanical stability for earlier full weightbearing and patient mobilisation. Materials and methods From 2010 to 2013, 20 patients underwent surgery for fractures of the calcaneus with thalamic articular involvement. This cohort represents the first patients managed by this technique. Patients were treated as consecutive cases by the same surgeon. Patients There were 11 males and nine females in the study and the mean age of patients was 59 years (range 34–79 years). The demographic data are shown in Table 1. Three patients had suffered a work-related accident. The initial accident was a fall on the stairs in 10 patients, from a ladder in five, from a window in one and on the rocks in one, and during a vehicle accident in three. Fractures Eleven fractures were located on the right side and nine on the left side. Fractures occurred after a low energy fall from a height of 1–3 m in all cases, apart from one patient who sustained a fall at work from higher than 3 m.

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Fracture types according to Sanders are shown in Table 2. The mean Bo¨hler angle at the time of presentation was 1.358 (range 208 to 228). There were no open fractures. Patients underwent surgery on 2–21 days (mean 7.7 days) after the trauma, according to the timing of resolution of soft tissue pain and oedema. Technique All patients had epidural anaesthesia; perioperative antibiotic (Cefazoline) and antithromboembolic prophylaxis were always adopted. No adjuvant pharmacologic or physical therapy was adopted and no tourniquet was used. All cases underwent surgery in the prone position, with a double image intensifier control in the lateral and AP/thalamic view, as already described [7,29,30]. Additional reduction techniques were always used; calcaneal traction wire was applied to help correction of varus/valgus (Fig. 1). Fluoroscopy was used to determine the quality of calcaneal alignment and fracture reduction. A stylet and cannula were placed into the calcaneus followed by insertion of a bone tamp attached to a digital manometer. The balloon was inflated gradually under fluoroscopy. Bone cement was prepared immediately prior to its injection into the defect and the balloon was removed (Figs. 2 and 3). To avoid secondary loss of correction after balloon deflation, subchondral K-wires were kept in place for 7 days until the cement hardened. No cast was applied. All patients had the same rehabilitation-protocol; they started passive and active mobilisation of the ankle 24 h after surgery. The patient was able to walk with partial weight-bearing at the removal of K-wires (7th day). Full weight-bearing was performed after 4 weeks. The resultant reduction force of the expanding balloon was usually directed by constraining it with the help of K-wires, which acted as a palisade medially and distally (Fig. 4). Assessment Postoperative clinical evaluation was performed by the surgeon after 1, 2, 3, 6, 12 months and each year after the fracture. Radiographs were made at each time point. All patients had a CT scan evaluation prior to the operation, and at 3 months postoperatively to evaluate length, width, height, subtalar joint congruency and position of the sustentaculum tali through the Score analysis of Verona (SAVE) [31] (Fig. 5). An accurate preoperative planning was always taken to exclude multifragmentary articular fractures, to avoid tricalcium

Table 1 Demographic data. Case no.

Sex

Age

Work related

Side

Day op

Accident

Follow up

Work

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

M F M F M M F F F M M M F F M F M F M M

45 72 47 57 53 63 78 57 77 37 79 54 69 79 38 59 43 72 34 67

Yes No No No No No No No No Yes No No No No Yes No No No Yes No

R L R L L R L L R R R R L R R L R R L L

21 12 2 16 9 2 6 12 6 6 11 4 5 8 3 5 4 9 3 10

Fall/ladder Fall/ladder Fall/window Fall/stairs Fall/stairs Fall/stairs Fall/stairs Fall/stairs Fall/stairs Fall work/ladder Car accident Fall/stairs Fall/stairs Fall/stairs Fall work/ladder Fall sea rocks Car accident Fall stairs Fall work/ladder Car accident

15 26 12 11 10 8 7 12 11 8 9 8 12 24 11 12 13 14 9 13

Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

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S74 Table 2 Fracture pattern. Case no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Bo¨hler angle (8) pre-op 20 15 12 10 10 15 12 6 4 22 10 12 15 20 10 15 10 13 10 10

Sanders IIIBC IIA IIIAB IIA IV IIIBC IIIAC IIB IIC IV IIIAB IIC IIIAB IIIAC IIB IIIAC IIIAB IIIAC IIIAB IV

deep infections were observed. One patient had residual hypoesthesia on the dorso-lateral side of the hindfoot and middlefoot. All patients had resumed their previous professional activities after 15 days to four months. One patient had retired from his previous work and is still unemployed. Clinical results The mean AOFAS score was 80.05 (range 52–100); 10 patients had good or excellent scores while the remaining 10 cases were poor or fair. The mean MFS was 77.85. Clinical results were rated good or excellent in 14 cases and poor or fair in 6 cases. Full or almost full range of motion of the ankle joint was achieved in 17 cases (85%). At the final follow-up, there were two cases of plantar heel tenderness, three cases of chronic venous insufficiency with oedema, and one case of dorso-lateral midfoot and hindfoot dysaesthesia; two patients had residual pain at the hindfoot when walking a lot and one patient had ankle and midfoot pain at rest. Radiological results

phosphate diffusion at the joint spaces, and to plan the direction of the K-wires. Clinical and radiological evaluation was performed by an independent orthopaedic surgeon. The American Orthopaedic Foot and Ankle Society (AOFAS) score and the Maryland foot score (MFS) [32] were obtained at the latest follow-up and as rated by the independent observer. Both score systems were used to avoid AOFAS-score confounding factors linked to its lack of validation, of a VAS-based data acquisition, and its problematic pseudoobjective assessment. MFS is a validated scoring system. It evaluates subjective and objective elements, such as pain, cosmesis, movement of the ankle, and subtalar, midfoot and metatarsophalangeal joints. Results Mean operative time was 76.5 min, and there was no significant blood loss. One patient had a more difficult reduction as a longer time had passed since the trauma occurred (21 days). A total of 16 patients showed immediate pain relief; five patients reported pain when mobilising the subtalar joint. Mean follow-up was 12.25 months (range 7–26 months). No patient was lost to followup and there were no revisions. During surgery there was tricalcium phosphate migration at the subtalar joint in two patients (Fig. 6), but the patients did not complain about additional stiffness or pain. There were two superficial wound infections, which solved with oral antibiotic. No

Fig. 1. Transcalcaneal traction facilitates external manoeuvres to enable correction of varus/valgus.

The mean pre-operative Bo¨hler angle was 1.358 (range 208 to 228) and the mean postoperative value was 25.058 (range 88–368). The cases in which there was little or no improvement in Bo¨hler’s angle corresponded with the cases of poor clinical results according to the MFS and AOFAS score. SAVE was used to correlate post-operative CT images and functional outcome; five CT parameters were considered and associated with a numerical value: vertical alignment, longitudinal alignment, calcaneal height, position of the sustentaculum tali and congruity of the subtalar joint. Excellent and good scores were observed in 11 of 20 cases (55%), fair in seven (35%), and poor in two (15%) (Table 3). The cases with poor SAVE score were the ones with lower AOFAS and MFS scores. One patient only (one fracture) had evidence of subtalar arthritis on the last X-rays; they had a new CT scan and were offered a subtalar fusion, but refused this offer. This is the patient who had a poor clinical result and for whom the 3-month postoperative scan showed important articular defect at the subtalar joint with a 138 Bo¨hler’s angle and a failure at SAVE score. This clinical failure correlates with the importance of obtaining and retaining a good reduction prior to the bone tamp inflation; balloon pressure must be directed to maintain reduction and often temporary K-wires could help this. Discussion Jiang’s metaanalysis [33] confirmed that surgery can lead to better functional recovery of displaced intraarticular calcanear fracture than non-surgical treatments. Anatomic restoration of the articular surfaces was traditionally considered of great importance: as little as 1–2 mm of articular incongruity in the posterior facet of the calcaneus can cause disturbances in load distribution and gait mechanics [17]. Multiple studies have shown excellent results following ORIF through a lateral extensile exposure, with fixation using a laterally based, periarticular plate [34–36]. Potter and Nunley reported recently on the long-term functional outcomes (mean 12.8 years) of 81 intraarticular calcaneal fractures and found their results to parallel those of other studies that have supported operative care [37]. Furthermore, ORIF is associated with wound-healing problems that occur in 16–25% of all patients after ORIF, with some series reporting even higher numbers [38–40]. Factors such as workers’

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Fig. 2. We usually direct the resultant reduction force of the expanding balloon by constraining it with the help of K-wires acting as a palisade medially and distally.

compensation and comorbidities also affect the outcome of patients who undergo ORIF. Folk et al. reported 48 early wound complications in 179 surgically treated calcaneal fractures and identified smoking, diabetes, and open fractures as risk factors [38]. In addition to inadequate reduction, unstable fixation with subsequent hardware failure is also a relatively common complication. According to Howard and Buckley, 60% of intraarticular calcaneal fractures of Sanders type lV had one or more major complications [41]. ORIF may be unfeasible in those cases associated with severe comminution and/or soft-tissue compromise; it has also proven to be a technically difficult procedure, with limited ability to reproduce anatomically the alignment of the subtalar joint and shape of the calcaneus [42]. Epstein et al. highlighted how the final outcome of calcaneal fracture is the combination of multiple factors; the outcome of these fractures often depends more on psychosocial factors

(sex, work-related accident, tobacco smoking) than on surgical anatomical reduction or surgeon experience [38,43]. Moreover, recent studies identify that the main goal of treatment for displaced fractures of the calcaneum should be the restoration of the three-dimensional structure, with emphasis on correct alignment in the coronal and axial planes and the height of the calcaneal body [1,3,135,44,45], rather than the traditional belief about the necessity to obtain an anatomical reconstruction of the congruency of the subtalar articular fragments [35,45–47]. Percutaneous reduction and fixation techniques were described as a means to obviate the need for dissection, with extensive additional damage to the tissues and the peroneal tendon sheath [48]. Satisfactory reduction can be obtained using these techniques; however, reduction remains a difficult goal and fixation is precarious, often necessitating multiple screws and thus multiple incisions [14,15]. The learning curve for these techniques is steep, with unsatisfactory results being difficult to manage and ultimately a

Fig. 3. Fluoroscopy during balloon inflation and tricalcium phospate injection; K-wires acting as a palisade to direct injection.

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D. Vittore et al. / Injury, Int. J. Care Injured 45S (2014) S72–S79 Table 3 Radiological and clinical data at follow-up.

Fig. 4. Post-op X-rays; upper K-wires act to sustain subtalar facet; lower K-wires act to direct balloon inflation.

Fig. 5. 3 months CT scan shows bone defect filled by tricalcium phospate; good subtalar joint congruency; good calcaneal height and volume.

number of patients needing subtalar fusion as a salvage procedure [7]. Percutaneous reduction techniques using balloons inflated with contrast medium as a means of reduction have been used for several years in the spine. The balloon was designed to provide upward lifting of the vertebral endplate in the context of a vertebral body compression fracture. This may be achieved completely, mainly in acute fractures, and provides accurate reduction. Balloon reduction and fixation using various types of cement and bone substitutes has been described elsewhere in different metaphyseal fracture locations [49–52] and also in articular displaced calcaneal fractures [25,26,28]. As with any new technique in articular trauma, there is a lack of studies with large patient numbers and significant follow up, and the majority of studies enrolled only selected patients who classically differ from patients who usually suffer this condition.

Case no.

AOFAS

MFS

Bo¨hler angle (8) post-op

SAVE

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

100 75 84 80 65 85 75 94 52 75 77 93 83 65 89 87 90 77 84 71

95 77 80 75 77 89 65 96 40 92 65 92 79 60 87 81 85 73 80 69

36 20 35 25 24 32 19 34 8 36 12 30 22 13 19 30 27 27 34 18

Good Good Good Good Fair Excell Fair Good Failure Excell Fair Excell Fair Failure Fair Good Excell Fair Good Fair

Bano et al. [25] treated a Sanders type III fracture with closed reduction and balloon-assisted augmentation with calcium phosphate cement and 2 years’ follow-up. Early full weightbearing was performed at the end of the first week postoperatively. Good functional patient outcomes and a low complication rate were reported. Gupta et al. [26] conducted percutaneous balloon reduction followed by injection of calcium sulphate in three patients selected by the presence of depressed posterior facet of the os calcis. They concluded that this procedure has the potential to provide successful earlier fracture treatment with reduced complications and faster recovery. Heiney et al. [28] reported a novel technique, balloon reduction and minimally-invasive fixation (BRAMIF), which utilises an inflatable balloon bone tamp for reduction of articular fractures (distal radius, calcaneus, and proximal and distal tibia), bone void creation, and insertion of fast-setting calcium phosphate cement bone filler using a minimally-invasive approach. The authors of the report believed 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, and proximal and distal tibia. They also referred to the economic costs as an important aspect of this technique. Theoretically, the cost of treating one wound complication is much more than the incremental expense of the BRAMIF technique [53–55]. Jacquot et al. performed a percutaneous approach and local balloon reduction followed by polymethylmethacrylate (PMMA) fixation in four patients presenting articular subtalar fractures with displacement [30]. Clinical outcome after at least 3 years of follow-up indicates that this technique may be promising and may

Fig. 6. CT scan shows calcium phospate migration at the subtalar joint, a complication when treating multifragmentary fractures.

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be used in cases with closed fractures as a primary reduction and fixation tool. In a larger case series of 10 patients with a longer period of follow-up (3–5 years), Jacquot concluded that ‘‘balloon calcaneoplasty’’ was a safe and effective procedure in a variety of calcaneal fractures and was associated with lasting and excellent clinical results [29]. Patients in this series were managed in a very conservative fashion, allowing partial weight-bearing after 2 months in only two cases and total weight-bearing at 3 months in all patients. In our case series, only tricalcium phospate was used, as described by Heiney [28]. Fast-setting calcium phosphate cements have several advantages over other bone fillers, including they are isothermic and set up quickly in a wet environment [56,57]. The calcium phosphate cement helps stabilise the fracture, providing structurally competent augmentation with high compressive strength that maintains its integrity while the cement is resorbed, and it is also osteoconductive so that it is replaced by bone [56,58–60]. Bone stock is preserved for any possible further surgical procedures, such as hindfoot fusion. The advantages of calcium phosphate cements have been shown clinically in multiple studies [60–62]. They decrease pain at the fracture site, which may allow earlier mobilisation [60–68]. Three studies have shown improved functional outcomes with calcium phosphate cement [63,68–70]. Several authors have demonstrated that calcium phosphate cements are superior to traditional bone graft or no bone graft with respect to preventing fracture subsidence [61,63,65–68,71]. Also, by eliminating the need for allograft there is no risk of potential shortage of cadaveric bone material, patient objections, and allograft disease transmission. Eliminating the need for autograft means there is no donor site morbidity, which is often a problem [72–78]. There are other options for bone fillers, including PMMA and calcium sulphates. PMMA is not resorbable, and is highly exothermic as it sets [79–82], which may be a concern in a subchondral location. It is also difficult to insert screws into PMMA [81–83]. The author has found the handling properties of calcium sulphate products to be less desirable; they are also a poor choice because of their hydrophilic properties, lack of structural support and quick resorption times [58,84,85]. Due to the hydrophilic properties of calcium sulphate products, a large amount of fluid may accumulate in the area, which often leads to wound healing problems and infection [86–89]. In the current study, the technique used permitted early partial weight-bearing, and this occurred on the 7th day after surgery following removal of the K-wires. Early weight-bearing is not considered to be a cause of our case series failure. Restoring length, width and height of the calcaneus with a best congruent subtalar joint must always be kept in mind. External manoeuvres to restore normal valgus of the os calcis and K-wire positioning to act as a palisade medially and distally to direct balloon inflation are essential issues to aim for a good outcome. Conclusion Closed reduction in association with calcium phosphate injection and a balloon system may restore mechanical stability and prevent further collapse of the articular surface of the calcaneal subtalar joint, which leads to a faster rehabilitation and to a shorter period of disability with minimal complications. The conditions necessary to achieve satisfactory results include the type of fracture to be treated, a careful preoperative planning, implementation of reductive manoeuvres in fluoroscopy and constraining the reduction force of the expanding balloon through K-wires.

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In our experience, the ideal type of fracture is characterised by the presence of a large articular fragment, avoiding cases with excessive comminution. This approach was associated with pain relief by the first postoperative day, and early mobilisation with early partial weight-bearing on the 7th post-operative day. Tricalcium phosphate is a resorbable bone substitute that allows a fair bone stock for hindfoot fusion procedure. This study is a small series of patients with a short follow-up period and no major associated risk factors. Our aim was to introduce a new technique with clear indications and operative tricks. Although the final results after a few months of treatment are satisfactory in this study, studies with a larger cohort and longer follow-up are required to evaluate and confirm these results.

Conflict of interest Authors certify that they have no affiliations with, or involvement in, any organisation or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.

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