The nanocrystalline hydroxyapatite paste Ostim may … · treated with tension band wiring. The histological and microbiologi- ... fully used in the fields of oral and maxillofacial

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For citation purposes: McArthur N, Fomuki WT, Tanner MC, Huber FX. The nanocrystalline hydroxyapatite paste Ostim® may present a new possibility in the treatment of persistent nonunion. OA Case Reports 2013 Oct 21;2(12):118. Co

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The nanocrystalline hydroxyapatite paste Ostim® may present a new possibility in the treatment of persistent

non-unionN McArthur1*, WT Fomuki2, MC Tanner3, FX Huber4

AbstractIntroductionDespite correctly performed ortho-paedic surgery of fractured bones, non-union presents one of the se-vere complications that occur in the field of traumatology. The aim of this study was to discuss the nanocrystal-line hydroxyapatite paste Ostim® as analternative in the treatment of per-sistent non-union.Materials and MethodsBetween 2003 and 2009, 10patients (five male, five female) were diag-nosed with a persistent atrophic non-union and subsequently treated by resection of the non-union fracture ends and a bone defect filling with the nanocrystalline hydroxyapatite paste Ostim®.ResultsIn all cases, the fractures were pri-marily treated with an appropriate type of osteosynthesis. Seven cases were treated with plate osteosyn-thesis, one was treated with an in-tramedullary nail and two were treated with tension band wiring. The histological and microbiologi-cal results obtained from the frac-ture site did not reveal any form of infection. Full weight-bearing of the treated extremities was allowed on

an average offour months after op-erative treatment of the non-union. Conventional radiographs were used to confirm a complete bone union be-fore full weight-bearing was granted.ConclusionThe nanocrystalline hydroxyapatite paste Ostim® may offer new possi-bilities in the treatment of persistent non-union.

IntroductionDespite correctly performed ortho-paedic surgery of fractured bones, non-union presents one of the se-vere complications which occur in the field of traumatology. If further non-operative treatment does not amount to any further bone healing, standard practice calls for surgical debridement, autologous bone graft-ing and osteosynthetic stabilisation of the fracture site1,2. Furthermore, the treatment must also take the patients’ wishes, comorbidities and fracture localisation into account. Over the last decades, experience in the treatment of non-union has shown that autologous cancellous bone grafts can be used to fill bony defects, which also results in high success rates of bone union3–7. On the other hand, autologous bone har-vesting still presents an unaccepta-ble high complication rate at the do-nor site and may also be very limited in some patients8–12. A new treatment option for bone defect filling follow-ing resection of the non-union frac-ture ends involving the application of nanocrystalline hydroxyapatite has recently become available. Ostim® represents a brand new develop-ment among the purely synthetically

produced and rapidly absorbable hy-droxyapatite compounds. It is mainly characterised by its needle-shaped nanosized hydroxyapatite crystals. Ostim® has recently been success-fully used in the fields of oral and maxillofacial surgery and ortho-paedic and trauma surgery13–20. The aim of this retrospective study is to summarise the initial results of Os-tim® in the treatment of non-infected nonunions.

Materials and MethodsThis study conforms to the values laid down in the Declaration of Helsinki (1964). The protocol of this study has been approved by the relevant ethical committee related to our in-stitution in which it was performed. All subjects gave full informed con-sent to participate in this study.

Between 2003 and 2009,10pa-tients (five male, five female) were diagnosed with a persistent atrophic non-union and subsequently treated by resection of the non-union frac-ture ends and a bone defect filling with Ostim®. An absolute contrain-dication for the use of Ostim® was the diagnosis or even suspicion of a septic non-union. Moreover, we did not use Ostim® in the case of hyper-trophic non-union as experience in our department has shown this is normally the result of inadequate stabilisation and thus sufficient re-osteosynthetic surgery alone would normally result in fracture union. General surgical technique—in all cases, the non-union fracture ends were resected to reveal vital bone. Swabs were then taken for histologi-cal and microbiological analysis. The

* Corresponding authorEmail: [email protected] Broomfield Hospital, Court Rd Chelmsford,

Essex CM1 7ET, UK2 Urologische Praxis, Hammarskjöldring 133

60439 Frankfurt, Germany3 Orthopädische Universitätsklinik, Schlierbacher Landstraße 200a 69118 Heidelberg, Germany

4 Klinikum Ansbach, Escherichstraße 1 91522 Ansbach, Germany

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ResultsIn our retrospective analysis,10 pa-tients were identified with an atroph-ic, aseptic non-union between 2003 and 2009. The age of the patients at surgery ranged from 13 to 78 years (Table 1). In all cases, the fractures were primarily treated with an ap-propriate type of osteosynthesis. Seven cases were treated with plate osteosynthesis, one was treated with an intramedullar nail and two were treated with tension wires. The his-tological and microbiological results obtained from the fracture site did not reveal any form of infection. The histological results also revealed that in all 10cases an atrophic non-union was present. In five cases an implant breakage occurred at the site of the non-union (Figure 2a–h). The mean amount of Ostim® applied at each bone defect was 5ml. In four cases further supplemental autologous bone graft was used. A systemic or lo-cal reaction to the bone replacement material Ostim® was not observed. In two cases, an alternate method of os-teosynthesis was necessary. Two cas-es were observed with a prolonged serous wound secretion without any signs of infection. A surgical revision was not necessary and the secre-tion ceased on the fifth and seventh post-operative days in each case, respectively. Full functional mobili-sation was allowed after soft tissue consolidation. Full weight-bearing of the treated extremities was allowed on average at four months after op-erative treatment of the non-union. Conventional radiographs were used to confirm a complete bone union be-fore full weight-bearing was granted.

DiscussionThe current standard treatment of persistent atrophic non-union involves surgical debridement of the fracture end, autologous bone graft transplan-tation and stabilisation with a suitable form of osteosynthesis. The success rate of fracture consolidation follow-ing autologous bone transplantation Figure 1: Hydroxyapatite crystals in suspensions.

fracture was then stabilised with an appropriate form of osteosynthesis and the bone defectzone was filled with a maximum of 10 ml of Ostim®. In four cases autologous bone graft was used for supplementary defect filling.

Material properties of the hydroxyapatite compound Ostim®

Ostim®(Fa. Osartis, Obernburg, Germany) is a newly developed, fully synthetic and fully resorbable injectable nanocrystalline paste

[Ca10(PO4)6(OH)2] and consists of a suspension of pure hydroxyapatite in water prepared by a wet chemi-cal reaction. The needle-shaped hydroxyapatitecrystals form ag-glomerates in transmission elec-tron microscopy (Figure 1). Ostim® paste does not harden after appli-cation into the bone and is free of endothermal heating. It is char-acterised by a large bioactive spe-cific surface area of 106 m2g-1. The atomic ratio of calcium–phospho-rus is 1.672.

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Tabl

e 1

Sum

mar

y of

pati

ent d

ata

Patie

ntSe

xAg

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op-

erati

onFr

actu

reO

stim

®

Spon

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a-Au

gmen

-tie

rung

zusä

tzlic

h

Prim

ary

os-

teos

ynth

esis

Impl

ant

brea

kage

Ost

eosy

nthe

sis

used

at o

pera

-tiv

e re

visi

on

Tim

e of

full

wei

ght-

bear

ing

Com

plic

a-tio

ns

(yea

rs)

(ml)

(mon

ths)

LEM

ale

46Pa

tella

3N

ein

Tens

ion

wire

No

Tens

ion

wire

an

d sc

rew

s4

SPM

ale

32Ra

dius

shaft

5N

ein

Non

-ang

ular

ly

stab

le p

late

Yes

Non

-ang

ular

ly

stab

le p

late

4

SDM

ale

26Pi

lon

tibia

le5

JaAn

gula

rly

stab

le p

late

No

Angu

larly

stab

le

plat

e an

d sc

rew

s8

Prol

onge

d w

ound

se

creti

on

HIFe

mal

e71

Ole

cran

on3

Nei

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n w

ireN

oHo

ok p

late

3

EDFe

mal

e60

Prox

imal

hu-

mer

us5

JaAn

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rly

stab

le p

late

Yes

Angu

larly

stab

le

plat

e2

JHFe

mal

e74

Hum

erus

sh

aft5

Nei

nIn

tram

edul

lar

nail

No

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larly

stab

le

plat

e5

GMM

ale

37Di

stal

fem

ur10

JaAn

gula

rly

stab

le p

late

No

Angu

larly

stab

le

plat

e4

ANFe

mal

e35

Pilo

n tib

iale

5Ja

Non

-ang

ular

ly

stab

le p

late

Yes

Angu

larly

stab

le

plat

e5

Prol

onge

d w

ound

se

creti

on

IWM

ale

13Su

prac

ondy

-la

r hum

erus

3N

ein

NW

S Pl

atte

Yes

Non

-ang

ular

ly

stab

le d

oubl

e pl

ate

4

TWFe

mal

e78

Hum

erus

sh

aft10

Nei

nAn

gula

rly

stab

le p

late

Yes

Angu

larly

stab

le

plat

e5

47 ±

225

±34

±2

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(a) (b) (c) (d)

(e) (f) (g) (h)

Figure 2: (a–c) This 60-year-old patient suffered an atrophic non-union of the proximal humerus with implant failure (PHILOS-System from Synthes). (d) The intraoperative image shows the implant breakage at the non-union level. (e) The broken plate was completely removed, the non-union ends were resected and a new plate was placed. (f) The intraoperative radiograph shows the defect zone now filled with bone replacement material. (g, h) The radiographs done 66 days after surgical revision of the non-union depict a complete fracture consolidation. The patient was free of any pain.

has been shown to be high in a number of publications3–7. However, prospec-tive randomised studies have to be still conducted to prove the superior-ity of autologous bone transplantation over other methods. Extremely high complication rates of up to 38% have also been described at the donor sites. These involve chronic pain, infection and fractures8–12.

Bone allografts offer an abun-dantly available alternative, which circumvents the potential morbidity

of autograft harvest, but carries the potential of disease transmission, im-munogenicity and possibly lower un-ion rates10,21. Moreover, the structural, mechanical and resorption proper-ties of allografts are usually much altered by processing, preservation and sterilisation techniques10,22–24. Depending on the localisation, there is also the possibility of using vas-cular pedicle bone grafts especially when trying to fill a long segment of bone defect25–27. The successful use of

recombinantly-produced growth fac-tors has also been described in the treatment of non-union2,28,29.

Ostim® represents a brand new development among the purely syn-thetically produced and rapidly ab-sorbable hydroxyapatite compounds, which have been widely and success-fully used in the fields of oral and maxillofacial surgery, and orthopae-dic and trauma surgery13,15–17,19,20,30,31.

Ostim® is synthesised by a wet chemical reaction of precipitation

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in order to assess the significance of Ostim® in the treatment of persistent atrophic non-union.

AcknowledgementsNicholas McArthur designed the study, wrote the majority of the man-uscript, analysed data and also col-lected data. Walters Fomuki collected data and wrote a part of the manu-script. Michael Tanner collected and analysed data. He also reviewed the manuscript. Prof. Huber supervised the entire project, reviewed the manuscript and performed the op-erations of the patients mentioned in this manuscript.

References1. Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evi-dence? Injury. 2008 Apr;39(4):419–29.2. Mahendra A, Maclean AD. Available biological treatments for complex non-unions. Injury. 2007 Sep;38(4):7–12.3. Calkins MS, Burkhalter W, Reyes F. Traumatic segmental bone defects in the upper extremity. Treatment with ex-posed grafts of corticocancellous bone. J Bone Joint Surg Am. 1987 Jan;69(1): 19–27.4. Dos Reis FB, Faloppa F, Fernandes HJ, Albertoni WM, Stahel PF. Outcome of diaphyseal forearm fracture-nonunions treated by autologous bone grafting and compression plating. Ann Surg Innov Res. 2009 May;3:5.5. Matti H. Über freie transplantation von knochenspongiosa. Langenbecks Arch Klin Chir. 1931;168:236–58.6. Ring D, Allende C, Jafarnia K, Allende BT, Jupiter JB. Ununited diaphyseal fore-arm fractures with segmental defects: plate fixation and autogenous cancellous bone-grafting. J Bone Joint Surg Am. 2004 Nov;86(11):2440–5.7. Shevtsov VI. Professor G.A. Ilizarov’s contribution to the method of transos-seous osteosynthesis. Bull Hosp Jt Dis. 1997;56(1):11–5.8. Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA. Complica-tions of iliac crest bone graft harvesting. Clin Orthop Relat Res. 1996 Aug;329: 300–9.

under permanent pH control using CaO dispersed in water under con-stant stirring to maintain a suspen-sion state and H3PO4 as starting mate-rial32,33. According to the hypotheses put forward by Constanz and Knaack, such hydroxyapatitecompounds ac-celerate the bony ingrowth into the critical size defect as they closely mimic the required resorptive and osseointegrative properties of poor crystalline apatitic structure of natu-ral bone18,34,35. This, in turn, allows for rapid osteogenesis and angiogenesis to take place, both critical steps for successful bone defect augmenta-tion36. A further study from Guo et al.37 showed that nanocrystalline hy-droxyapatite not only promotes the first stage of cell attachment, adhe-sion and spreading, but also improves the long-term cell proliferation and differentiation. The increased prolif-eration rate of PDL cells in the pres-ence of nano-hydroxyapatite paste was mechanistically linked to activa-tion of the epidermal growth factor receptor and its downstream targets ERK1/2 and Akt38.

This confirms the results obtained in a number of different experimen-tal animal models of other studies. Grigoryan et al.30 described the rapid bone ingrowth at a low complication rate following the treatment of jaw defects with Ostim® in dogs in 2000. Our own animal experiments dealing with the filling of critical size defects with Ostim® in New Zealand white rabbits also resulted in swift and uni-form bone ingrowth39. Laschke40 re-ported a guided neovascularisation directed towards areas of Ostim® degradation in Syrian golden ham-ster. Spies et al.41 further confirmed the good biocompatibility, osteocon-ductivity and bone ingrowth in New Zealand whites, but reported a halt in the Ostim® degradation process six weeks following implantation. Comprehensive clinical experience of using the hydrated hydroxyapa-titepaste as a void filling exists in the field of maxillofacial surgery. Various

stomatology publications describe an accelerated fracture healing and bone density increase at a high de-gree of tolerance. In 1996, Zuev42 treated 395 patients with jaw de-fects and peridontal abscesses. The complication rate of the 200 patients in the Ostim® group was 1.5% com-pared to 3.6% in the group with 195 patients treated with allografts. Bez-rukow43 achieved excellent results in 1998 after treating 49 patients with Ostim® following cystectomy of be-nign cysttumours of the jaw. The de-fects in all 49 patients were replaced with fresh bone three months follow-ing the defect filling. Gerlach13 filled 44 mandibular cysts with Ostim® and reported complete material resorp-tionwith an extremelylow complica-tion rate. Strietzel et al.20 performed a lateral alveolar ridge augmenta-tion with Ostim® in 14 patients. Six months later, histological results showed good bone ingrowth of the defect and small amounts of Ostim® remnants. Stübinger et al.44 was also able to demonstrate that new tra-becular bone is formed after grafting with the nanocrystalline bone substi-tute after six months.

ConclusionOur data verifies the importance of the nanocrystalline hydroxyapatite as a new option in the treatment of persistent atrophic non-union. We would recommend its use for bone defects with a volume of less than 10ml, but it could also be used as a supplement to autologous bone graft augmentation. In our opinion, the ap-plication of Ostim® should always be combined with some form of stable osteosynthesis, preferably with an angularly stable plate, due to its lack of dimensional stability. Our retro-spective study does present limita-tions with regard to the fact that we have analysed a heterogeneous group of fractures and have made no direct comparison with autologous bone transplantation. Further prospec-tive studies need to be performed

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nano-structured biomaterial: prelimi-nary clinical and histological results. Eur Surg Res. 2009;42(3):143–9.45. Schmökel HG, Weber FE, Seiler G, von Rechenberg B, Schense JC, Schawal-der P, et al. Treatment of nonunions with nonglycosylated recombinant human bone morphogenetic protein-2 deliv-ered from a fibrin matrix. Vet Surg. 2004 Mar–Apr;33(2):112–8.

diseases. Stomatologiia (Mosk). 1996;75(5):31–4.43. Bezrukov VM, Grigor’iants LA, Zuev VP Pankratov AS. The surgical treatment of jaw cysts using hydroxyapatite with an ultrahigh degree of dispersity. Stoma-tologiia (Mosk). 1998;77(1):31–5.44. Stubinger S, Ghanaati S, Orth C, Hilbig U, Saldamli B, Biesterfeld S, et al. Maxillary sinus grafting with a

41. Spies C, Schnurer S, Gotterbarm T, Breusch S. Animal study of the bone substitute material Ostim within os-seous defects in Gottinger minipigs. Z Orthop Unfall. 2008 Jan–Feb;146(1): 64–9.42. Zuev VP, Dmitrieva LA, Pankratov AS, Filatova NA. The comparative character-istics of stimulators of reparative osteo-genesis in the treatment of periodontal

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