Locally delivered rhBMP-2 enhances bone ingrowth and gap healing in a canine model.

The purpose of the present study was to determine if recombinant human bone morphogenetic protein-2 (rhBMP-2) enhances bone ingrowth into porous-coated implants and gap healing around the implants. In the presence of a 3-mm gap between the implant and host bone, porous-coated implants were placed bilaterally for four weeks in the proximal humeri of skeletally mature, adult male dogs. In three treatment groups, the test implant was treated with HA/TCP and rhBMP-2 in buffer at a dose of 100 microg/implant (n=5), 400 microg/implant (n=6), or 800 microg/implant (n=5) and placed in the left humerus. In these same animals, an internal control implant was treated only with HA/TCP and buffer and placed in the right humerus. These groups were compared with a previously reported external control group of seven animals in which no growth factor was delivered [J. Orthop. Res. 19 (2001) 85]. The BMP treated implants in the two lower dose groups had significantly more bone ingrowth than the external controls with the greatest effect in the 100 g/implant group (a 3.5-fold increase over the external control, p=0.008). All three dose groups had significantly more bone formation in the 3-mm gap surrounding the BMP treated implants than the external controls with the greatest effect in the 800 microg group (2.9-fold increase, p<0.001). Thus, application of rhBMP-2 to a porous-coated implant stimulated local bone ingrowth and gap healing. The enhancement of bone formation within the implant (bone ingrowth) was inversely related to dose.     

Additive enhancement of implant fixation following combined treatment with rhTGF-beta2 and rhBMP-2 in a canine model

BACKGROUND: Gaps at the interface between implant and bone increase the risk of diminished implant fixation and eventual loosening. The purpose of the present study was to determine if combined use of recombinant human transforming growth factor-beta 2 (rhTGF-beta2) and bone morphogenetic protein 2 (rhBMP-2) led to greater implant fixation strength in the presence of interface gaps than the use of either growth factor alone. METHODS: Twenty-eight skeletally mature adult male dogs received one porous-coated titanium implant in the proximal part of each humerus, for a total of fifty-six implantation sites. Spacers were used to establish an initial 3-mm gap between the implant and the host bone at all fifty-six sites. Forty-two implants were coated with hydroxyapatite-tricalcium phosphate and were used in three growth-factor-treatment groups in which the implants placed in the left humerus were loaded with 12 microg of rhTGF-beta2 (Group 1, seven animals), 25 microg of rhBMP-2 (Group 2, seven animals), or 12 microg of rhTGF-beta2 combined with 25 microg of rhBMP-2 (Group 3, seven animals). In these animals, the twenty-one implants that were placed in the right humerus were loaded with buffer only to serve as contralateral controls. In Group 4 (seven animals), the implants were not coated with hydroxyapatite-tricalcium phosphate, the gap in the left humerus was lightly packed with autogenous bone graft, and the gap in the right humerus was left empty to serve as a contralateral control. All animals were killed at twenty-eight days. The primary end points included three mechanical variables: fixation strength, interface stiffness, and energy to failure. Secondary end points included bone ingrowth and bone volume and trabecular architecture in the gap and in a region located 2 mm medial to the implantation site. RESULTS: The hydroxyapatite-tricalcium phosphate coating had no effect on implant fixation, bone ingrowth, or bone formation in the 3-mm gap. Individual growth factor treatments led to 2.3 to 3.2-fold increases in fixation strength and stiffness as compared with the values for the contralateral controls (p < 0.05). The combined growth factor treatment led to 5.7-fold increases in fixation strength and stiffness compared with the values for the contralateral controls (p < 0.01). Autogenous bone graft treatment was associated with 4.5 to 6.4-fold increases in implant fixation strength and stiffness as compared with the values for the contralateral controls (p < 0.01). Compared with the relevant contralateral controls, energy to failure was increased 3.5-fold in association with TGF-beta2 alone (p < 0.05), 4.5-fold in association with TGF-beta2 combined with BMP-2 (p < 0.01), and 2.5-fold in association with autogenous bone-grafting. As much as 63% of the variance in the mechanical end points was associated with variance in bone volume and architecture in the 3-mm gap and in the region of interest located 2 mm medial to the implantation site (p < 0.01). CONCLUSIONS: In this animal model, the combined use of TGF-beta2 and BMP-2 led to more secure mechanical fixation of the implant than did the use of either growth factor alone and demonstrated results that were similar to those associated with the use of autogenous bone graft.     

Fixation of titanium and hydroxyapatite-coated implants in arthritic osteopenic bone.

Retrieval studies of porous-coated prostheses have demonstrated deficient bony ingrowth in high percentages. Possible reasons for this are lack of initial mechanical stability and the presence of osteopenia. The authors studied ingrowth of osteopenic bone into titanium alloy (Ti) porous-coated implants with and without hydroxyapatite (HA) coating in an experimental dog model. Unilateral osteopenia of the knee with a 20% reduced bone density as judged by computed tomography (CT) scanning (P less than .001) was induced in 12 mature dogs by weekly intraarticular injections of Carragheenin into the right knee for 12 weeks, with the left knee serving as control. Ti porous-coated cylinders were inserted in press-fit bilaterally in the lateral femoral condyles in six dogs. HA-coated titanium plugs were implanted similarly in another sex-, age-, and weight-matched group of six dogs. Bony ingrowth after 4 weeks was significantly reduced for Ti implants in osteopenic bone compared to control bone, but HA-coated implants were covered by equal amounts of bone tissue. Bone-implant shear strength of Ti implants also was reduced in osteopenic bone compared to control bone. In control bone, the anchorage of Ti implants was stronger than HA-coated implants, whereas the fixation of Ti and HA-coated implants was equal in the osteopenic bone. The results demonstrate that the bony fixation of Ti porous-coated implants is weakened by the presence of experimentally induced osteopenia. However, the fixation of HA-coated implants was not affected by the osteopenic condition in the surrounding bone. The fixation of Ti and HA-coated implants was equal in osteopenic bone, whereas the fixation of Ti porous-coated implants was superior to that of HA-coated implants in control bone.     

Effects of hydroxyapatite tricalcium phosphate coating and intracancellous placement on bone ingrowth in titanium fibermetal implants

The purpose of this study was to compare the host—bone response to hydroxyapatite/tricalcium phosphate (HA/TCP)-coated and noncoated titanium fibermetal implants placed in a load-sharing cancellous bone environment of the distal femurs of rabbits. The influence of implantation site was also investigated by comparing these intracancellous implants with intramedullary implants evaluated in a previous study. Three parameters were measured: percentage implant perimeter surface length in contact with new bone, percentage internal fibermetal surface length in contact with ingrown bone, and percentage of available pore space filled with bone. The HA/TCP coating significantly accelerated and increased bone ongrowth, new bone formation on the perimeter and internal surface of the implants. This effect was evident as early as 2 weeks after implantation. In contrast, there was no difference between HA/TCP-coated and noncoated implants in the bone ingrowth parameter, percentage of available pore space filled with bone, or pull-out strength. Scanning electron microscopy in the backscatter mode demonstrated that new bone formed directly onto the HA/TCP-coated fibers and did not usually form directly on noncoated fibers. Analysis of fluorochrome labeling revealed that bone formation in weeks 1 through 4 was primarily woven and there-after lamellar. Compared with intramedullary placement, intracancellous placement significantly accelerated the apposition of bone to the perimeter and internal surface of HA/TCP-coated implants and both accelerated and increased bone ingrowth as a percentage of available pore volume. These data show that the host response to titanium fibermetal implants is influenced both by HA/TCP coating and by the implantation site.     

Osteogenic protein 1 device stimulates bone healing to hydroxyapaptite-coated and titanium implants

This study evaluated the effects of osteogenic protein 1 (OP-1) placed in a gap around uncoated and hydroxyapatite (HA)-coated implants. Unloaded cylindrical titanium alloy implants were inserted in the femoral condyles of 16 skeletally mature dogs surrounded by a 3-mm gap. The gap around the implants was filled with 325 microg OP-1 in 130 mg bovine collagen type I as carrier (OP-1 device) or collagen carrier alone or left empty. All groups were tested with both HA-coated and uncoated implants, and the animals were sacrificed after 6 weeks. Implant fixation was determined by push-out test. Bone ongrowth and bone formation were evaluated by quantitative histomorphometry. OP-1 device enhanced mechanical fixation of uncoated and HA-coated implants, resulting in a higher shear strength than implants with collagen matrix and control implants. Bone ingrowth and bone formation in the gap were also stimulated 3-fold for OP-1 groups when compared with empty controls, but no difference was found between OP-1 groups and collagen matrix groups. This study suggests that the OP-1 device placed in a gap around uncoated and HA-coated implants is capable of enhancing mechanical fixation and periimplant bone formation. The collagen carrier alone also enhanced bone ongrowth and fixation significantly.     

Comparative study of human cancellous bone remodeling to titanium and hydroxyapatite-coated implants

The human cancellous bone response was compared in weight-bearing porous hydroxyapatite (HA) and titanium-coated implants placed in the distal medial femoral condyles of consenting staged bilateral knee patients. The Institutional Review Board approved study quantified the amount of bone ingrowth, the mineral apposition rate, and the bone mineral content. Results showed that the osteoconductive HA coating increased the amount of bone ingrowth by 8% (P=.018). The HA coating did not effect the mineral apposition rate of the bone but had an 8% lower bone mineral content at the implant interface (P=.042). The influence of HA coatings on human cancellous bone appears highly focal along the coating surface. Gaps of 50–500 μm filled with fibrous connective tissue were observed along the porous-coated surfaces of both implant types suggesting that HA coatings still require precision placement adjacent to human cancellous bone.     

A long-term study on defect filling and bone ingrowth using a canine fiber metal total hip model.

When performing primary and revision total hip arthroplasty (THA), bone defects are often encountered. At present, grafting osseous defects with autogeneic bone is a common means of treatment. In this study, defects in bone were created in the femora and acetabula of dogs being treated with cementless THA with a fiber metal implant (Group A) or a hydroxyapatite tricalcium phosphate (HA/TCP) sprayed implant (Group B). The following methods of defect filling were compared: (1) leaving defects unfilled, (2) filling with autogeneic bone graft, (3) filling with a 50:50 mixture of autograft and a biphasic ceramic composed of HA/TCP, and (4) filling with a collagen-HA/TCP-bone marrow mixture. Analysis of defect healing and the extent of ingrowth into the overlying fiber metal, at defect sites and sites distant from defects, was made at six, 12, and 24 weeks postimplantation. Defect healing was enhanced at six and 12 weeks in all grafted groups when compared with ungrafted controls. Bone ingrowth into the porous fiber metal overlying the defects was not significantly affected by grafting the defects, compared with the ungrafted defects. The extent of bone ingrowth into the fiber metal acetabular implant at sites away from the defects increased during the entire study. In contrast, the extent of bone ingrowth on the femoral side was maximal at 12 weeks. The HA/TCP coating enhanced ingrowth into the acetabular component at 12 weeks, compared with the uncoated prosthesis, but did not enhance ingrowth on the femoral side. The data from this study demonstrate that defect healing is enhanced with graft materials. However, this does not necessarily result in increased ingrowth into porous surfaces overlying osseous defects. General bone ingrowth and ingrowth at defect sites at 12 weeks postimplantation can be enhanced on the acetabular side with the use of HA/TCP-sprayed implants. However, no positive effect is seen with the use of an HA/TCP-sprayed femoral implant.     

The effect of demineralized bone matrix gel on bone ingrowth and fixation of porous implants

The presence of demineralized bone matrix (DBM) gel did not enhance or accelerate attachment strength or bone ingrowth and resulted in a significant decrease in implant interface attachment strength at 3 weeks. Hydroxyapatite (HA) coating resulted in significant increases in interface shear strength and bone ingrowth compared with non-HA-coated porous implants at all time periods. The HA-coated implants achieved greater attachment strength and bone ingrowth at earlier time periods and maintained greater attachment strength at long-term periods. The results of this study indicate that in the presence of a good bone-implant interference fit, there is no beneficial effect in applying DBM gel to a porous-coated or HA-coated porous implant surface. The small amount that can be applied and the degree of osteoinductivity of DBM seem to preclude it from having a significant biologic effect.     

Postmortem comparative analysis of titanium and hydroxyapatite porous-coated femoral implants retrieved from the same patient: A case study

The results of bilateral postmortem analysis of titanium and plasma-sprayed hydroxyapatite (HA) porous-coated femoral components of the same Anatomic Porous Replacement design retrieved from a 35-year-old female donor are reported. Analysis was conducted using backscattered electron imaging, histology, and radiographic techniques. The appositional bone index, percent bone ingrowth, and mineral content were measured for both implants. The results showed a 177% higher appositional bone index (P=.014) for the HA porous-coated Anatomic Porous Replacement component compared to the titanium Anatomic Porous Replacement component. Backscattered electron analysis showed 50% more bone in the HA porous-coated implant (P=.028). The mineral content analysis demonstrated that the bone ingrown into the HA porous-coated device was 23% less mineralized (P=.016). The data from this case study suggested that plasma-sprayed HA porous-coated implants may assist in increasing the amount of bone ingrowth and skeletal attachment in total hip arthroplasties.     

Restoration of bone defect and enhancement of bone ingrowth using partially demineralized bone matrix and marrow stromal cells

PURPOSE: This study aimed to investigate the capability of combining marrow stromal cells (MSC) and partially demineralized bone matrix (PDBM) to fill bone defect and enhance bone ingrowth using a canine non-weight-bearing gap model. METHODS: Custom-made implants with 3mm gap between the porous surface and the host bone were used. The implants were inserted into the distal femurs of 25 mongrel dogs and the gaps were randomly assigned to be filled with culture-expanded autologous MSC-loaded PDBM, autograft, fresh-frozen allograft, PDBM alone, or nothing as controls. Histomorphometry using backscattered scanning electron microscopic examination, and mechanical push-out test were performed at 6 months after surgery. RESULTS: Histomorphometry showed that amounts of bone regeneration in the gap and bone ingrowth into the porous-coated surface in the MSC-loaded PDBM-treated group were comparable to those of autograft-treated group and were significantly greater than those of allograft-treated, PDBM-treated, or non-grafted groups. Mechanical test showed the same differences. CONCLUSION: The results of this study showed that combining PDBM and autologous culture-expanded MSC restored bone stock and enhanced bone ingrowth into the porous-coated area in a canine non-weight-bearing gap model. This combination may provide an option for reconstructing bone defect when we perform a cementless revision arthroplasty.     

Calcium phosphate coatings for fixation of bone implants: Evaluated mechanically and histologically by stereological methods

The osteoconductive properties of HA coatings are well-documented. HA coating is able to enhance bone ingrowth and to reduce early migration of both hip and knee prostheses. Despite the clinical use of HA-coated prostheses several aspects relevant to HA coatings have not been elucidated. The optimum coating quality and surface texture is still a matter of debate. Moreover, the significance of coating resorption is controversial. It has been suggested that resorption disintegrates the coating and reduces the bonding strength between implant and bone and the strength of the coating-implant interface, which might lead to implant loosening, coating delamination and acceleration of third body wear processes. This thesis aimed to investigate the effects of Ca-P coating type, quality and surface texture on mechanical fixation, bone ingrowth and loss of coating in experimental models in dogs and man. Furthermore, the significance of systematic sampling in bone histomorphometry using the unbiased stereological vertical section method was analyzed. Results . The first group of studies showed that HA-coated implants with porous-coated surface demonstrated increased energy absorption compared with grit-blasted implants during both non weight-bearing and weight-bearing conditions with controlled micromotion of 500 &#119 m. In addition, the HA coating delaminated on gritblasted implants during mechanical testing in contrast to porous-coated implants. Histomorphometry showed increased bone ingrowth to grit-blasted implants demonstrating that surface topology influenced surface activity. The next series of studies focused on the effects of Ca-P coating type, HA versus FA, during stable weight-bearing and non weight-bearing conditions. In dogs, no difference in mechanical fixation and bone ingrowth was demonstrated. However, in humans, HA-coated implants had significantly greater bone ongrowth than FA-coated implants after one year. The third group of studies evaluated the effects of HA coating crystallinity during controlled micromotion of 250 &#119 m. After 16 weeks, low crystalline (50%) HA coating accelerated mechanical fixation and bone ingrowth compared with high crystalline HA (75%). High crystalline HA achieved significantly better anchorage from 16 to 32 weeks whereas mechanical fixation of low crystalline HA was unchanged. In all studies, loss of Ca-P coating was evaluated. It was demonstrated that the coatings were resorbed, partially, in vivo irrespective type and quality of the coating. HA coverage on porouscoated implants was significantly more reduced than on grit-blasted implants in dogs. No difference in overall resorption between HA and FA coatings was demonstrated. However, in humans, significantly less HA and FA coating was resorbed when bone was present on the coating surface compared with bone marrow or fibrous tissue. In addition, resorption of HA was greater than FA in the presence of bone marrow indicating that FA was more stable than HA. Low (50%) crystalline HA coating was significantly more reduced compared with high (75%) crystalline HA at both 16 and 32 weeks. However, no further coating loss was observed from 16 to 32 weeks suggesting two phases of coating resorption: Phase I (0-16 weeks) with rapid coating loss, and phase II (16-32 weeks) with slow loss. Another important finding was that continuous loading and micromovements of 150 &#119 m accelerated resorption in contrast to immobilization of the implant. In addition, unstable fibrous anchored implants had significantly more loss of HA coating as compared with bony anchored implants. In all studies, resorbed coating was partly replaced by bone in direct contact with the implant surface suggesting durable implant fixation. Sampling efficiency in the unbiased stereological vertical section method was analyzed in order to find an optimal sampling design for histomorphometric analyzes at different sampling levels (humans, sections, fields of view and number of counting items) with different sampling intensities. The analysis showed that only minor changes in variances were observed when the initial scheme of 14 sections from each implant was reduced to include only one of the two possible implant sides, every third field of view and half the probe density, reducing the total workload at the microscope to less than 10% on all sections. In addition, the number of sections for analysis could be reduced to every fourth section per implant (3-4 sections for evaluation) without significantly increase in variance. The study demon strated that biological variation contributed to the majority of the total observed variance. Conclusion . The present series of investigations demonstrated that Ca-P coating type and quality and the underlying surface texture had significant influence on either mechanical fixation, bone in/ongrowth and loss of coating in dogs and man. In addition, the sampling design for histomorphometry could be optimized without reducing the quality of the data.     

Effect of local TGF-��1 and IGF-1 release on implant fixation: comparison with hydroxyapatite coating: A paired study in dogs

Background and purpose Hydroxyapatite (HA) coating stimulates the osseointegration of cementless orthopedic implants. Recently, locally released osteogenic growth factors have also been shown experimentally to stimulate osseointegration so that bone fills gaps around orthopedic implants. Here, we have compared the effect of local release of TGF-β 1 and IGF-1 with that of hydroxyapatite coating on implant fixation.Method Weight-bearing implants with a 0.75-mm surrounding gap were inserted bilaterally in the knees of 10 dogs. Growth factors were incorporated in a biodegradable poly(D,L-lactide) coating on porous coated titanium implants. Plasma-sprayed HA implants served as controls. The dogs were killed at 4 weeks and the implants were evaluated by mechanical push-out test and by histomorphometry.Results There was no difference in any of the mechanical parameters. Bone ongrowth was 3-fold higher for HA-coated implants (p < 0.001). For growth factor-coated implants, bone volume was 26% higher in the inner half of the gap and 28% higher in the outer half compared to HA (p < 0.03).Interpretation- The mechanical fixation of porous-coated titanium implants with local growth factor release is comparable to that of HA coating. While HA mainly stimulated bone ongrowth, local release of TGFβ 1 and IGF-1 stimulated gap healing.     

Effect of noninvasive low intensity ultrasound on bone growth into porous-coated implants

Noninvasive low intensity ultrasound has been shown to be an effective means of accelerating bone fracture healing in both animal and clinical studies. An in vivo canine study was designed to determine if noninvasive low intensity ultrasound could influence the rate and extent of bone growth into porous-coated implants. Twenty-two pairs of fully porous transcortical implants were inserted bilaterally into the femora of 12 dogs. In each dog, one femur served as a control and the other was subjected to daily ultrasound stimulation for 2, 3, or 4 weeks. Overall, the ultrasound-stimulated implants demonstrated an 18% increase in bone ingrowth compared with their contralateral controls (p = 0.02). Noninvasive low intensity ultrasound had its greatest effect in the first 2–3 weeks of stimulation. At 2 and 3 weeks, the ultrasound-stimulated implants showed 21 and 16% more ingrowth than their respective contralateral controls. Because noninvasive low intensity ultrasound had a positive effect on bone ingrowth in this experimental investigation, further research is suggested to assess the clinical potential for application to noncemented porous-coated total joint replacements.     

Aging does not lessen the effectiveness of TGFbeta2-enhanced bone regeneration.

Controversy exists over the potency of bone healing in the aged skeleton, and there is concern that enhancement of bone regeneration after use of bone-stimulating growth factors may not be effective in the aged. In this study, 30 skeletally mature beagles (1-2 or 10-12 years old) had titanium implants placed bilaterally in the proximal humerus for a period of 4 weeks in a model of intramembranous bone regeneration. A bony defect made at the time of surgery created a 3-mm gap between the implant surface and the host bone. Some of the implants were treated with recombinant human TGFbeta2 (rhTGFbeta2) at various does (0.32-35 microg per implant), and some served as paired controls. The dose response was similar in young and old animals. The most effective dose, 35 microg, led to a 3-fold increase in the volume fraction of new bone within the gap in both the young (p = 0.001) and old (p = 0.002) animals. At this dose, there was a 5-fold increase in osteoblast surface. While age did not significantly affect the quantity of new bone formed as assessed by backscatter scanning electron microscopy, the older animals had thinner regenerated trabeculae that tended to be spaced more closely than the younger animals. Coupled with the finding that the increase in osteoid was greater in the old animals compared with the young animals, these qualitative differences suggest that there may have been a slight delay in the rate or a defect of mineralization in the old animals.     

No positive effects of OP-1 device on the incorporation of impacted graft materials after 8 weeks: a bone chamber study in goats

Background Bone morphogenetic proteins (BMPs) have the potential to improve clinical outcome after hip revision surgery by improving graft incorporation and implant fixation. However, impaction of cancellous bone grafts and TCP/HA bone substitute mixed with OP-1 device in a bone chamber in goats in a previous study led to reduced fibrous tissue ingrowth after 4 weeks. New bone formation was not promoted by OP-1. In the current study we examined whether this reduction represented a final loss of ingrowth or was just a delay, and whether the reduction can be overcome and ultimately results in a better late ingrowth.

Methods Bone chambers with impacted allografts and impacted TCP/HA granules mixed with 2 doses of OP-1 device were implanted in proximal medial goat tibias. Impacted allografts and TCP/HA not treated with OP-1 served as controls. After 8 weeks, the incorporation was evaluated using histology and histomorphometry.

Results Histology revealed evidence of bone graft incorporation, which proceeded in a similar way in both allografts and TCP/HA, with and without the addition of OP-1. After 8 weeks, no difference in bone ingrowth was found between the OP-1 groups and their controls. It was only in the allografts that the addition of OP-1 resulted in more fibrous tissue ingrowth.

Interpretation We conclude that the previously observed delay in fibrous tissue ingrowth can be only partially overcome.     

Effect of bone marrow grafting on the titanium porous-coated implant in bilateral total knee arthroplasty

Background and purpose Poor bone ingrowth into the porous coating of tibial components has been reported. We hypothesized that iliac marrow grafting might be useful to enhance bone ingrowth into a porous-coated implant. The first part of this study was to examine the presence of fibroblast colony-forming units (CFUF) containing osteogenic precursor cells in tibial bone marrow and iliac bone marrow. The second aim was to compare the clinical and radiographic results after bilateral total knee arthroplasty (TKA) with and without autologous bone marrow transplantation to the bone-implant interface.

Methods Simultaneous bilateral TKA was performed in 21 patients with osteoarthritis. Aspirated iliac bone marrow was transplanted to the interface of one randomly selected porous-coated tibial component in each patient, and contralateral knees served as controls. All of the 21 patients were followed for 5 years.

Results The average number of CFU-F was significantly lower in tibial marrow than in iliac marrow (p = 0.008). The final fluoroscopically-guided radiographs revealed a decrease in the number of knees with radiolucent lines after marrow grafting compared to those without grafting (p = 0.004).

Interpretation Iliac bone marrow is useful as a bone grafting material to enhance the biological fixation in porous-coated implants.     

Bone ingrowth into two porous ceramics with different pore sizes: an experimental study

Many properties of porous calcium phosphate ceramics have been described, but how pore size influences bony integration of various porous ceramics remains unclear. This study was performed to quantify the bony ingrowth and biodegradability of two porous calcium phosphate ceramics with four different pore size ranges (45-80 microm, 80-140 microm, 140-200 microm, and 200-250 microm). Hydroxyapatite (HA) and beta-tricalcium phosphate (TCP) cylinders were implanted into the femoral condyles of rabbits and were left in situ for up to 12 months. The percentage of bone ingrowth and the depth of ingrowth within the pores were determined. Biodegradability of the implants was also evaluated. Bone ingrowth occurred at a higher rate into the TCP than into the HA ceramics with the same pore size ranges. The amount of newly formed bone was statistically smaller (p < 0.05) into ceramics with 45-80 microm pore size than with larger pore size, whatever the implantation time for HA and until four months for TCP. No statistical difference was noted between the three highest pore size ranges. No implant degradation was noted up to four months. Our results suggest that a pore size above 80 microm improves bony ingrowth in both HA and TCP ceramics. Bone formation was higher in the TCP than in the HA implants.     

Porous-coated versus grit-blasted surface texture of hydroxyapatite-coated implants during controlled micromotion: Mechanical and histomorphometric results

Hydroxyapatite (HA)-coated implants with porous-coated and grit-blasted surface textures were inserted bilaterally in a paired design into the medial femoral condyles of eight dogs for 16 weeks. The implants were weight-loaded and initially subjected to controlled micromotion of 500 μm during each gait cycle. Histology revealed that five implants in each group had bony anchorage, and the remaining implants were surrounded by fibrous tissue. Push-out testing showed no difference in shear stiffness and strength, while energy absorption for porous-coated implants was increased significantly by threefold. The HA coating delaminated on grit-blasted implants during push-out testing, whereas porous-coated implants predominantly failed at the HA-tissue interface. Coverage, surface area, volume, and thickness of the HA coating were significantly reduced in vivo for porous-coated and grit-blasted implants. In conclusion, a plasma-sprayed porous-coated implant surface seems to give better fixation not only of the HA-coating to the implant surface but also of the implant to the surrounding tissues in comparison to a grit-blasted implant surface. The HA coating was reduced more on fibrous-anchored than on bony-anchored implants, suggesting that micromotion accelerates resorption of HA. Resorbed HA coating was replaced by more bone on porous-coated implants than on grit-blasted implants, which suggests that fixation of porous-coated implants will be durable.     

Gap healing enhanced by hydroxyapatite coating in dogs.

During prosthetic implantation, gaps between the implant surface and the surrounding bone may occur resulting in reduced implant stability. In these instances bone-conductive materials might augment the formation of hosting bone into the pores of the implant and insure earlier implant stabilization and fixation by bony ingrowth. Titanium-alloy cylinders with a porous-titanium-alloy plasma spray coating were implanted into the medial femoral condyles in six mature dogs. In another group of six dogs, matched in age, weight, and gender, hydroxyapatite (HA) coated implants were used. All implants were surrounded by a 1-mm gap. Unilateral osteopenia of the knee, with a 20% reduction of bone density as judged by computed tomography scanning, was induced by 12 weekly intraarticular injections of carrageenin into the right knee before surgery. Four weeks after implantation, the HA-coated implants were compared to the parent porous-titanium implants by mechanical testing and histomorphometry. A marked positive influence of HA coating on bone mineralization and the strength of the interfacial bone between the bone and implant was found. The increment in interface shear strength and shear stiffness was three- to fivefold in osteopenic bone and two-fold in control bone. Coating of an unloaded porous-titanium-coated implant with HA accelerates the rate of bone ingrowth and thereby provides relatively high, early interfacial shear strengths in the presence of an initial gap between bone and implant even in the presence of osteopenic host bone.     

Quantification of implant micromotion, strain shielding, and bone resorption with porous-coated anatomic medullary locking femoral prostheses.

Fourteen femora containing porous-coated anatomic medullary locking (AML) femoral prostheses were retrieved from 12 patients at autopsy. Clinical roentgenograms in 13 femora showed bone remodeling changes, indicating that the implants were fixed by osseointegration. Under simulated physiologic loading, micromotion between the implant and the bone was measured using electrical displacement transducers connected to the implant and to the adjacent cortex. The micromotion between the implants at the areas of porous coating and the adjacent cortex in the one case of failed bone ingrowth measured 150 microns. Maximum relative motion between the cortex and the implant in the areas of porous coating for the 13 cases showing signs of bone ingrowth was 40 microns, and this was completely elastic relative displacement. With all implants, the micromotion between the cortex and the stem was always greatest over the uncoated portion of the stem. Four of the implants were proximally porous coated. With these, the micromotion was greater over the uncoated areas than with more extensively coated stems and was always greatest at the uncoated tip of the prosthesis. The amount of micromotion was directly related to the extent of porous coating on the implant. Maximum tip motion for the proximally coated implants was 210 micra, whereas for the fully porous-coated implants, it was 40 microns. In nine of the autopsies, the contralateral normal femur was obtained in addition to the femur containing the AML (the in vivo remodeled femur). These were used for comparative studies of strain shielding and femoral remodeling. Cortical strains were measured in the in vivo remodeled femora and were compared with measurements made in the contralateral normal femora before and following implantation of a stem identical to that present on the clinically treated side. The data showed major strain reductions in all the postmortem implanted normal femora. Comparison of the strain data from the postmortem implanted normal femora with those from the in vivo remodeled femora clearly indicated that extensive bone remodeling did not result in restoration of cortical strain levels anywhere near normal. Strain shielding continued to exist in all of the remodeled specimens, even up to 7.5 years after surgery. This strain shielding was associated with bone remodeling changes that resulted in regional reductions in bone mineral content that ranged from 7% to 78%. These observations are unique, important, and valuable in defining the in vivo function and clinical behavior of this type of porous-coated femoral component.