1
Empty Fig 1. A) Im gap packed B) Post-harves Fig 2. Gap (grey) and Calcium Based Fillers Pro 1 Lim, L Z; + 1,2 Bo +Divisions of 1 Experimental Medicine and 2 O Introduction: Revision arthroplasty surgery often involves loss o cavitary defects that result in suboptimal implant f stability, and reduced potential for biologic fixation o Several types of biomaterials have been proposed fo substitutes for autogenous bone graft; these include c (CaP) and calcium sulfate (CaS) compounds. formulations of Ca-based biomaterials have been porosity and bio-degradation characteristics that enco cells, blood supply and osteoconduction, all of which bone regeneration. The purpose of this study was to i healing potential of two different Ca-based materials in model using porous titanium implants. Materials and Methods: Gap-type intramedullary implants were fabricated f pure titanium with a 5mm diameter central porou diameter solid end and central spacers to create two s regions between host bone and porous metal implant (Fig 1). The titanium foam core was 55% porous with an average pore size of 400μm. One gap filling material was a commercial formulation of nanocrystalline apatitic CaP (Etex Corp, MA). The CaS material was in the form of small granules ranging between 20-400 μm in diameter. Adding sterile saline to the materials at the time of surgery produced compounds with handling characteristics conducive to molding and shaping into the implant gap regions. Prior to compound was relatively soft and paste-like while th was harder and more putty-like. The proximal 3mm i manually filled with either CaP or CaS, leaving the di controls. Six dogs underwent bilateral surgery, each implant containing each material into the left or right (institutionally approved protocol). After 12 weeks, harvested to yield 6 sets of paired data from each anim with CaS. The humeri were scanned with a high voltag microCT (μCT) scanner to obtain 18μm thick seri complete bone-implant construct. The resulting 1000 of each gap were used to quantify the extent of reso based materials and bone formation within the implan as a volume percentage of the gap. Specimens w embedded in acrylic and undecalcified transverse se imaged with backscattered scanning electron micros enable analysis of bone growth within the 3mm gaps the porous implant regions. Statistical comparisons paired and unpaired Student's t-tests and multiple two models, with p0.05. Results: MicroCT quantified both native bone and residual C the gaps, without discriminating one material from the with time zero, the total material within CaP-filled gaps diminished by a mean volume of 25%±13% (Fig 2). Compared with time zero, the total material within CaS-filled gaps diminished by a greater mean volume of 49%±7% (p=0.001). Compared with CaP at 12 wks, the CaS material resorbed into a more porous scaffold within and on which new, interconnected trabeculae had formed in continuity with surrounding host bone (Figs 3, 4). Empty gaps were only 5% ± 1% filled at 12 wks (p=0.001). y CaP CaS mplant with proximal with CaS material. st radiograph. p filling at time zero d at 12 weeks (blue). omote Bone Defect Healing Around Porous Titanium I obyn, J D; 2 Okyere, M J; 3 Barralet, J E; 2 Bobyn, K M; 2 Tanzer, M Orthopaedics, Faculty of Medicine, 3 Faculty of Dentistry, McGill Univers [email protected] of bone stock and fit, reduced initial of porous implants. or defect filling as calcium phosphate Medical grade n developed with ourage invasion of h are necessary for investigate the gap n a canine implant from commercially us rod and 11mm separate 3mm gap o setting, the CaS he CaP compound implant gaps were istal gaps empty as dog receiving one proximal humerus the humeri were mal comparing CaP ge, high resolution ial images of the 0 serial CT images orption of the Ca- nt gaps, expressed were subsequently erial sections were scopy (BSEM) to s as well as within were made using o-level hierarchical CaS or CaP within e other. Compared Fig 3. Images from μ CT scans of CaP-filled gap zero. B) Longitudinal and C) transverse images Fig 4. Images from μ CT scans of CaS-filled gap zero. B) Longitudinal and C) transverse images BSEM images more clearly showed th predominantly filled by the material, with and around the material pores (Fig 5). In most of the CaS had resorbed by 12 week with dense bony trabeculae connecting surrounding host bone (Fig 5). CaP-fille apposition at the porous implant perimete although the latter was associated with a ingrowth (p=0.04). Discussion: Previous studies have shown that a 3m in the proximal humerus does not spontan weeks. At time zero both Ca-based materi By 12 weeks both materials resorbed and the gap, on and within the porous im surrounding host bone. The CaS resorb facilitating more gap filling with new bon that the CaP compound is a more mec property that could be advantageous in re strength is important. Longer implantation additional resorption of the CaP and repla Significance: While possessing different properties both Ca-based materials demonstrated po within a clinically relevant time frame. Acknowledgments: Canadian Institutes for Health Resear Canada, Etex Corporation. Fig 5. Transverse BSEM images of A) CaP implant after 12 weeks (the darker grey is bone arrows show bone in the implant pores. Implants sity, Montreal, Canada p. A) Longitudinal image at time at 12 weeks. p. A) Longitudinal image at time at 12 weeks. hat CaP-filled gaps remained h some new bone formation in n contrast, BSEM revealed that ks, with most of the gaps filled the porous implant core with ed implants showed more bone er than the CaS group (p=0.06) a greater mean extent of bone mm gap around a porous implant neously heal with bone after 12 ials filled almost the entire gap. d new bone was evident within mplant and in continuity with bed to a much greater extent, ne. It should be noted, however, chanically resistant material, a evision surgery where construct n periods would likely result in acement with new bone. and resorption characteristics, otential for use in gap healing rch, National Research Council P-filled implant and B) CaS-filled e, lighter grey is residual CaS). Red Poster No. 0979 ORS 2012 Annual Meeting

Calcium Based Fillers Promote Bone Defect Healing A round ... · substitutes for autogenous bone graft; these include calcium (CaP) and calcium sulfate (CaS) compounds . Medical grade

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Empty

Fig 1. A) Implant with proximal

gap packed with

B) Post-harvest radiograph.

Fig 2. Gap f

(grey) and

Calcium Based Fillers Promote1Lim, L Z; +1,2Bobyn

+Divisions of 1Experimental Medicine and 2Orthopaedics

Introduction:

Revision arthroplasty surgery often involves loss of bone stock and

cavitary defects that result in suboptimal implant fit, reduced initial

stability, and reduced potential for biologic fixation of porous implants.

Several types of biomaterials have been proposed for defect filling as

substitutes for autogenous bone graft; these include calcium

(CaP) and calcium sulfate (CaS) compounds. Medical grade

formulations of Ca-based biomaterials have been developed with

porosity and bio-degradation characteristics that encourage

cells, blood supply and osteoconduction, all of which are necessary

bone regeneration. The purpose of this study was to investigate the

healing potential of two different Ca-based materials in a canine implant

model using porous titanium implants.

Materials and Methods: Gap-type intramedullary implants were fabricated from commercially

pure titanium with a 5mm diameter central porous rod and 11mm

diameter solid end and central spacers to create two separate 3mm gap

regions between host bone and porous

metal implant (Fig 1). The titanium

foam core was 55% porous with an

average pore size of 400µm. One gap

filling material was a commercial

formulation of nanocrystalline apatitic

CaP (Etex Corp, MA). The CaS

material was in the form of small

granules ranging between 20-400 µm in

diameter. Adding sterile saline to the

materials at the time of surgery

produced compounds with handling

characteristics conducive to molding

and shaping into the implant gap regions. Prior to setting, t

compound was relatively soft and paste-like while the

was harder and more putty-like. The proximal 3mm implant gaps were

manually filled with either CaP or CaS, leaving the distal gaps empty as

controls. Six dogs underwent bilateral surgery, each dog receiving one

implant containing each material into the left or right proximal humerus

(institutionally approved protocol). After 12 weeks,

harvested to yield 6 sets of paired data from each animal

with CaS. The humeri were scanned with a high voltage, high resolution

microCT (µCT) scanner to obtain 18µm thick serial images of the

complete bone-implant construct. The resulting 1000 serial CT images

of each gap were used to quantify the extent of resorption of the

based materials and bone formation within the implant

as a volume percentage of the gap. Specimens were subsequently

embedded in acrylic and undecalcified transverse serial sections were

imaged with backscattered scanning electron microscopy

enable analysis of bone growth within the 3mm gaps a

the porous implant regions. Statistical comparisons were made using

paired and unpaired Student's t-tests and multiple two

models, with p≤0.05.

Results:

MicroCT quantified both native bone and residual CaS or CaP within

the gaps, without discriminating one material from the other.

with time zero, the total material within

CaP-filled gaps diminished by a mean

volume of 25%±13% (Fig 2). Compared

with time zero, the total material within

CaS-filled gaps diminished by a greater

mean volume of 49%±7% (p=0.001).

Compared with CaP at 12 wks, the CaS

material resorbed into a more porous

scaffold within and on which new,

interconnected trabeculae had formed in

continuity with surrounding host bone

(Figs 3, 4). Empty gaps were only 5% ±

1% filled at 12 wks (p=0.001).

Empty CaP CaS

mplant with proximal

gap packed with CaS material.

harvest radiograph.

Gap filling at time zero

and at 12 weeks (blue).

Promote Bone Defect Healing Around Porous Titanium Implants

Bobyn, J D; 2Okyere, M J; 3Barralet, J E; 2Bobyn, K M; 2Tanzer, M

Orthopaedics, Faculty of Medicine, 3Faculty of Dentistry, McGill University

[email protected]

arthroplasty surgery often involves loss of bone stock and

defects that result in suboptimal implant fit, reduced initial

stability, and reduced potential for biologic fixation of porous implants.

Several types of biomaterials have been proposed for defect filling as

calcium phosphate

. Medical grade

based biomaterials have been developed with

courage invasion of

n, all of which are necessary for

to investigate the gap

based materials in a canine implant

implants were fabricated from commercially

pure titanium with a 5mm diameter central porous rod and 11mm

diameter solid end and central spacers to create two separate 3mm gap

Prior to setting, the CaS

like while the CaP compound

The proximal 3mm implant gaps were

, leaving the distal gaps empty as

Six dogs underwent bilateral surgery, each dog receiving one

left or right proximal humerus

the humeri were

paired data from each animal comparing CaP

The humeri were scanned with a high voltage, high resolution

scanner to obtain 18µm thick serial images of the

000 serial CT images

ent of resorption of the Ca-

implant gaps, expressed

. Specimens were subsequently

embedded in acrylic and undecalcified transverse serial sections were

imaged with backscattered scanning electron microscopy (BSEM) to

3mm gaps as well as within

porous implant regions. Statistical comparisons were made using

and multiple two-level hierarchical

MicroCT quantified both native bone and residual CaS or CaP within

from the other. Compared

Fig 3. Images from µCT scans of CaP-filled gap. A) Longitudinal image at zero. B) Longitudinal and C) transverse images

Fig 4. Images from µCT scans of CaS-filled gap. A) Longitudinal image at

zero. B) Longitudinal and C) transverse images

BSEM images more clearly showed that

predominantly filled by the material, with

and around the material pores (Fig 5). In contrast, BSEM revealed that

most of the CaS had resorbed by 12 weeks, with most of the gaps filled

with dense bony trabeculae connecting the porous implant c

surrounding host bone (Fig 5). CaP-filled implants

apposition at the porous implant perimeter

although the latter was associated with a greater mean extent of bone

ingrowth (p=0.04).

Discussion: Previous studies have shown that a 3mm gap around a porous implant

in the proximal humerus does not spontaneously heal with bone after 12

weeks. At time zero both Ca-based materials filled almost the entire gap.

By 12 weeks both materials resorbed and

the gap, on and within the porous implant and in continuity with

surrounding host bone. The CaS resorbed to a much greater extent,

facilitating more gap filling with new bone. It should be noted, however,

that the CaP compound is a more mechanic

property that could be advantageous in revision surgery where construct

strength is important. Longer implantation periods would likely result in

additional resorption of the CaP and replacement with new

Significance:

While possessing different properties and resorption characteristics,

both Ca-based materials demonstrated potential for use in gap healing

within a clinically relevant time frame.

Acknowledgments:

Canadian Institutes for Health Research, Na

Canada, Etex Corporation.

Fig 5. Transverse BSEM images of A) CaPimplant after 12 weeks (the darker grey is bone, lighter grey is residualarrows show bone in the implant pores.

round Porous Titanium Implants

McGill University, Montreal, Canada

ed gap. A) Longitudinal image at time at 12 weeks.

ed gap. A) Longitudinal image at time

s at 12 weeks.

that CaP-filled gaps remained

by the material, with some new bone formation in

In contrast, BSEM revealed that

had resorbed by 12 weeks, with most of the gaps filled

with dense bony trabeculae connecting the porous implant core with

filled implants showed more bone

apposition at the porous implant perimeter than the CaS group (p=0.06)

although the latter was associated with a greater mean extent of bone

that a 3mm gap around a porous implant

in the proximal humerus does not spontaneously heal with bone after 12

based materials filled almost the entire gap.

and new bone was evident within

the gap, on and within the porous implant and in continuity with

resorbed to a much greater extent,

facilitating more gap filling with new bone. It should be noted, however,

ompound is a more mechanically resistant material, a

property that could be advantageous in revision surgery where construct

Longer implantation periods would likely result in

and replacement with new bone.

While possessing different properties and resorption characteristics,

based materials demonstrated potential for use in gap healing

ealth Research, National Research Council

P-filled implant and B) CaS-filled (the darker grey is bone, lighter grey is residual CaS). Red

Poster No. 0979 • ORS 2012 Annual Meeting