The biologic behavior of hydroxyapatite implanted into the maxillofacial skeleton

Eleven patients who previously had undergone elective facial osteotomy and in whom blocks of porous hydroxyapatite were implanted into osteotomy gaps later consented to open biopsy of the implant material. A total of 24 biopsies were harvested at a mean time of 10.2 months following implantation. Gross anatomic findings were recorded at the time of biopsy. Specimens were harvested from the zygomatic buttress of the maxilla (12), the piriform buttress of the maxilla (4), the maxillary interdental premolar region (2), and the anterior mandible (6). Histologic sections were examined undecalcified using a modified trichrome stain. Eight of the 11 patients were followed radiographically for a minimum of 24 months. In the absence of infection, there was rapid fibrovascular ingrowth and, provided there was contact with host bone, bone ingrowth. This was observed in 21 of 24 biopsy specimens. The extent of bone ingrowth, as judged qualitatively, was highly variable and did not correlate with the time interval from implantation, anatomic site, or surface area of bone-implant interface. A healing process involving an osteoid phase of bone maturation and suggestive of continued net bone production was consistently found. The gross anatomic, radiographic, and histologic findings are discussed and provide further insight into the biologic behavior of porous block hydroxyapatite implanted into the maxillofacial skeleton.     

Porous hydroxyapatite as an onlay bone-graft substitute for maxillofacial surgery

This paper chronicles 3 years of a continuing study comparing porous hydroxyapatite to autogenous bone grafts as onlays in maxillofacial surgery. Twenty-five patients, seen from June of 1984 to May of 1985, underwent onlay augmentation on various maxillary and mandibular locations. A total of 68 onlay augmentation sites comparing Interpore porous hydroxyapatite and autogenous bone were followed for 2 years or more. This long-term study compares these substances in radiologic longevity, histologic incorporation, clinical function, and aesthetic appearance.     

Porous hydroxyapatite as a bone graft substitute in cranial reconstruction: a histometric study

To assess the potential of a porous hydroxyapatite matrix to serve as a bone graft substitute, bilateral 15 X 20 mm craniectomy defects were reconstructed in 17 dogs with blocks of implant and split-rib autografts. Specimens were retrieved at 3, 6, 12, 24, and 48 months, and undecalcified sections were prepared for microscopy and histometry. The implant and graft cross-sectional areas did not change with time, documenting their equivalent ability to maintain cranial contour. Bone ingrowth extended across the implant from one cranial shelf to the other in 15 specimens. Little apparent bone ingrowth was seen in most graft specimens. Two implants and three grafts were nonunited, possibly due to lack of fixation or the orientation of the histology sections. The implant specimens were composed of 39.3 percent hydroxyapatite matrix, 17.2 percent bone ingrowth, and 43.5 percent soft-tissue ingrowth. The graft specimens were composed of 43.7 percent bone and 56.3 percent soft tissue. This study supported the thesis that a porous hydroxyapatite matrix may function in part as a bone graft substitute. The brittle hydroxyapatite matrix undoubtedly became stronger with bone ingrowth, but the degree of cranial protection achieved was not measured in this study. The size of the cranial defect used in this study did not permit estimation of the distance over which bone ingrowth may be reliably expected. There remains a need for greater understanding of the causes of nonunion, the extent of predictable ingrowth depth, and the strength of the resultant implant-bone composite.     

Bone regeneration within a coralline hydroxyapatite implant.

The hypothesis that incomplete resorption of osteons in an autogenous cortical bone graft may limit its replacement by new bone regeneration was explored by implanting a hydroxyapatite replica of a coral skeletal structure into bone gaps. This implant contained channels and interconnections similar to those in osteon-evacuated bone grafts. In 6 implanted mandibular defects in dogs, two of which were examined at two, 4, and 6 months, 11 percent, 46 percent, and 88 percent of the implant areas were filled with regenerated bone. The regenerated bone was a woven type at two months, but changed to a lamellar type by 6 months. In two implanted defects examined at 12 months, biodegradation of 29 percent of the implant had occurred. The bone regeneration was physiological, the implant was biocompatible, and the biodegradation began after the bone had regenerated.     

Multiple-segment osteotomy in maxillofacial surgery

Multiple-segment osteotomy is defined as an osteotomy that divides the tooth-bearing arch of the maxilla or mandible into three or more segments. Combining large-segment orthognathic surgery and unitooth or small-segment surgery is an effective approach for dealing with a wide range of dentofacial deformities with occlusal problems. The indications for a multiple-segment osteotomy included dentofacial deformities and malocclusions requiring stable correction within a short overall treatment period. From 1991 to 1997, a total of 85 patients had multiple-segment osteotomy orthognathic procedures performed at Chang Gung Memorial Hospital. The indications for surgery were maxillary protrusion/deformity (31 patients), mandibular prognathism (51 patients), and noncleft maxillary retrusion (three patients). The types of osteotomies performed were Le Fort I, anterior segmental osteotomies of the maxilla or the mandible, palatal split, posterior segment, and unitooth or double-tooth segments. Follow-up ranged from 6 months to 7 years; stability was seen in movements, with only three complications (one partial gingival loss and two inferior mental paresthesias). No osteotomized segments were lost. The average overall treatment time was approximately 15 months, including 3 to 6 months of preoperative and 9 to 12 months of postoperative orthodontic treatment. This is at least 6 months shorter than traditional orthognathic surgery. Experience with 85 consecutive patients has shown that the results are good and the procedure is safe, with minimal complications.     

Orthognathic surgery in cleft patients treated by early bone grafting

For the past 25 years at Children's Memorial Hospital in Chicago a protocol has been followed for complete clefts that involves placement of an infant maxillary orthopedic appliance prior to lip closure, surgical closure of the lip, autogenous split-rib grafts to the alveolus to stabilize maxillary segments, and palatal closure, generally within the first year of life. The oldest 36 patients whose skeletal growth was for all practical purposes finished have been followed to determine the need for and type of orthognathic surgery. Of the total sample, 8 patients (22.2 percent) required some type of sagittal orthognathic surgery (1 patient in this group also required vertical maxillary alignment) and 2 patients required maxillary augmentation only in the form of an onlay graft. This report may serve as a baseline for others who wish to report on the incidence and type of orthognathic surgery in their cleft palate centers.     

Functional rehabilitation of the atrophic mandible and maxilla with fibula flaps and implant-supported prosthesis

Historically, nonvascularized bone grafts have been the standard treatment for severe mandibular and maxillary atrophy, followed by immediate or delayed implant placement. Extreme atrophy is an unfavorable biological and mechanical location for nonvascularized autologous bone transplants. The authors present the results of a multidisciplinary treatment protocol for rehabilitation of extreme mandibular and maxillary atrophy by use of the vascularized fibular flap. This protocol includes bone augmentation, implant surgery, soft-tissue management, and prosthetic restoration. Since 1993, 18 patients with a mean age of 47.5 years presented with extreme mandibular and/or maxillary atrophy and underwent alveolar crest augmentation with vascularized fibular flaps. Bone healing was achieved in 17 of the 18 patients. Seventy-three osteointegrated implants were inserted in 12 of 17 fibular flaps. Altogether, 62 implants were loaded and 11 dental prostheses were made. Average follow-up of the loaded implants was 41 months. The success rate of loaded implants was 100 percent. The authors strongly recommend the use of the fibular bone flap when dealing with extreme atrophy of the mandible and maxilla and suggest the protocol outlined in this review.     

Surgical correction of the vertically deficient chin

Surgical correction of the vertically deficient chin has received relatively little attention. This paucity of information is most likely related to the failure to diagnose vertical microgenia and the questionable stability of its surgical correction utilizing autogenous bone grafts. This paper reports on eight patients who have undergone vertical augmentation genioplasty utilizing a transverse symphyseal osteotomy and interpositional implantation of porous, block hydroxyapatite. All patients had preoperative measured decreases in lower face height. Mean vertical lengthening of the chin was 5.3 mm. Seven of the eight patients had class II occlusions and underwent simultaneous sagittal advancement of the chin. Follow-up at a mean time of 11.1 months revealed complete stability of the vertically repositioned symphyseal segment. Mean ratio of the vertical soft to hard tissue augmentation was 0.89:1. There were no instances of operative complications. Vertical facial aesthetics and their application in the evaluation and treatment of patients with vertically deficient lower faces and chins are reviewed.     

Mechanical behavior of a new biphasic calcium phosphate bone graft

The aim of this study was to create a new porous calcium phosphate implant for use as a synthetic bone graft substitute. Porous bioceramic was fabricated using a foam-casting method. By using polyurethane foam and a slurry containing hydroxyapatite-dicalcium phosphate powder, water, and additives, a highly porous structure (66 ± 5%) was created. The porous specimens possess an elastic modulus of 330 ± 32 MPa and a compressive strength of 10.3 ± 1.7 MPa. The X-ray diffraction patterns show hydroxyapatite and beta-pyrophosphate phases after sintering. A rabbit model was developed to evaluate the compressive strength and elastic modulus of cancellous bone defects treated with these porous synthetic implants. The compressive mechanical properties became weaker until the second month post implantation. After the second month, these properties increased slightly and remained higher than control values. New bone formed on the outside surface and on the macropore walls of the specimens, as osteoids and osteoclasts were evident two months postoperatively. Considering these properties, these synthetic porous calcium phosphate implants could be applicable as cancellous bone substitutes.     

The biomaterial influences the ossification after sinus floor elevation using tissue-engineered bone grafts

Sinus floor elevation is the standard procedure that allows dental implant insertion in the atrophic posterior maxilla. Instead of autogenous bone, tissue-engineered bone grafts can be used, but clear comparative clinical studies also assessing the influence of the biomaterial are missing. In six patients, tissue-engineered bone grafts were used in eight sinus floor elevations. After culturing osteoblast-like cells from biopsies of the maxilla, they were seeded on scaffolds made either from demineralised bovine bone matrix (DBBM) or from solvent-dehydrated mineralised bone (SDBB), and grafted. In all patients primary wound healing was without complications, except for one patient in the SDBB group. After 12 months, implant insertion was possible only in the SDBB group; in the DBBM group, fibrous connective tissue was found in an attempt of implant insertion. After 5 months, implant placement was performed in one patient of each group. However, the two implants inserted in the DBBM group were lost after 6 weeks. Histology of the bone cores in the DBBM group at 5 months showed lamellar bone and osteoid, and at 12 months showed fibrous connective tissue. Inflammation and some resorption of the scaffold was found 5 months after SDBB grafting, and after 12 months cancellous bone formation encapsulating SDBB remnants were observed. These preliminary data suggest that the preparation method of the bovine bone matrix, in particular the mineral content, and therefore the mechanical stability may have some influence on the generation of new bone.     

Definitive surgical correction of vertical maxillary deficiency

Inferior repositioning of the maxilla to correct vertical maxillary deficiency has been associated with variable degrees of instability and subsequent relapse. Resorption of bone-graft material has been incriminated as the primary cause of postoperative instability. This paper reports on nine patients who have undergone inferior maxillary repositioning resulting in no residual bone contact between the down-fractured maxilla and superior midface. Mean inferior maxillary repositioning was 6.2 mm. Osteotomy gaps were implanted with porous block hydroxyapatite (Interpore 200), and maxillae were rigidly fixed in position with miniplates. No postoperative intermaxillary fixation was utilized in any patient. Follow-up ranged from 11 to 28 months, with a mean of 19.6 months. Cephalometric analyses at follow-up revealed excellent stability of the repositioned maxillae, with a mean vertical relapse of 4.3 percent. No complications were associated with this procedure. The biomechanical rationale contributing to the success of this operative technique is discussed.     

The response of porous hydroxyapatite to contiguous tissue infection.

Two patients are presented in whom severe clinical infection developed in tissue adjacent to and contiguous with previously implanted blocks of porous hydroxyapatite. Both infections resolved with appropriate antibiotics, debridement, and drainage of infected tissues. Hydroxyapatite blocks were left in situ. This unusually favorable response of an alloplast to infection is attributable to the abundant vascular supply of this porous implant. Although reliable dogma can hardly be concluded from two clinical examples, these experiences suggest that once ingrown, porous hydroxyapatite does not behave in a fashion that is typical of foreign bodies in the midst of infection. For the first time, clinical evidence has been offered to support the experimental data that vascularized hydroxyapatite has the ability to resist infection.     

Surgical management of the anophthalmic orbit, part 2: post-tumoral

Ablative surgery for tumors of the globe and its adnexal structures is frequently the cause of major orbitofacial deformity. Radiotherapy compounds the problem because it suppresses skeletal growth in the growing patient and induces a contraction of the remaining soft tissues in the orbit. Goals for reconstruction in these patients include the restoration of orbital structures to allow the fitting of an ocular prosthesis and the correction of distorted orbitofacial relationships. The authors present a series of 53 patients (mean age, 29 years; 28 male) who were treated over the past 18 years by composite reconstruction of the post-tumoral anophthalmic orbit. The follow-up ranged from 5 months to 18 years (mean, 7.75 years). Four patients were treated primarily (immediate reconstruction after tumor ablation), and 49 were treated secondarily (mean oncological follow-up since ablative surgery, 14.8 years). Twenty-eight patients underwent orbital enucleation (including three bilateral cases), 23 underwent orbital exenteration, and two underwent evisceration. Forty-two patients received radiotherapy, including 20 enucleation patients, 15 exenteration patients, and seven others in whom details of primary therapy were incomplete. A staged reconstruction was undertaken in each case; it considered, in turn, the bony orbital volume (orbital remodeling and cranial bone grafts), orbital contents (implant, temporalis muscle transposition, cranial bone grafts, and dermafat grafts), conjunctival sac (mucosal and skin grafts), ocular prosthesis, eyelids (local flaps and skin grafts), and additional procedures to restore orbitofacial symmetry. The authors conclude that the long-term results of post-tumoral orbital reconstruction are favorable, and they particularly recommend the use of autogenous tissues in irradiated orbits.     

Hydroxyapatite ceramics in multilevel cervical interbody fusion - is there a role?

The aim of this study is to evaluate the efficacy of hydroxyapatite grafts in multilevel cervical interbody fusion during the one year follow-up. A total of 86 patients with degenerative cervical disc disease underwent all together 224 cervical interbody fusion procedures in which either Smith-Robinson or Cloward type hydroxyapatite grafts were used. The surgeries included radiculopathy in 38 cases, myelopathy in 20 cases and myeloradicuopathy in 28 patients. In 65 out of 86 patients, fusion was followed by an anterior instrumentation (plating). Postoperatively, patients were followed for a mean of 15.64 (range 11-23.3) months. All patients underwent radiography to evaluate fusion and the axis curvature. Excellent clinical results (86%), described as a complete or partial relief of symptoms with full return to preop activity, were obtained in patients with radiculopathy. There were 5 grafts mobilizations and one graft fracture. Two grafts extruded in non-instrumented patients and required repeated surgery. There were other three reoperations due to the hardware problems. One year fusion rate was obtained at 86% for two-level surgery, 80.1% for three-level surgery and 74% for four-level surgery. The mean (SD) hospital stay was 3.8 (0.7) days. A hydroxyapatite cheramic can be a very effective synthetic material for multilevel cervical interbody fusion. It is characterized by a high fusion rate and a small percentage of graft-related complications, especially when fusion procedure is followed by plating.     

Bone grafts impregnated with antibiotics as a tool for treating infected implants in orthopedic surgery – one stage revision results

Infection of an orthopedic implant is considered a devastating complication, necessitating its complete removal and thorough debridement of the site. Osseous defects are common in such conditions and need to be addressed before a new implant may be inserted. So far bone grafting has been contraindicated in bacterially contaminated areas and could only be performed as soon as all signs of infection have ceased. Usually long term antibiotic treatment and a multitude of surgical interventions within a period of several months is required until a definitive supply can be achieved. Allograft bone may be impregnated with high loads of antibiotics using special incubation techniques. Based on this technology 48 exchange procedures of infected orthopaedic implants were performed in a single stage, all of them without the use of bone cement. There were 37 infected hips, 8 knees and 3 infected osteosyntheses. Two hips required re-revision because of persisting infection, the remaining 46 patients stayed infect free for a period between 1 and 7 years after surgery. No adverse side effects could be found. Incorporation appeared as after grafting with unimpregnated bone grafts. Antibiotic loaded allograft bone is a powerful tool in septic revision surgery, enabling restoration of bone stock, insertion of a new implant and control of infection in a single operation.     

Experimental hydroxyapatite cement cranioplasty.

Hydroxyapatite cement is a calcium phosphate-based material that when mixed with water forms a dense paste that sets within 15 minutes and isothermically converts in vivo to a microporous hydroxyapatite implant. This cement was used to reconstruct bilateral 2.5-cm-diameter full-thickness critical-sized parietal skull defects in six cats. One side was reconstructed with 100 percent hydroxyapatite cement, and the other with a mixture of 50 percent hydroxyapatite cement and 50 percent ground autogenous bone by weight. These animals were sacrificed at 6 and 12 months after implantation. Positive and negative controls also were prepared. The anatomic contour of the soft tissue overlying all hydroxyapatite cement implants was well maintained, there were no wound infections or structural failures, and the implants were well tolerated histologically. None of the negative (unreconstructed) control defects was completely filled with repair bone, and all positive (methyl methacrylate) controls demonstrated foreign-body giant-cell formation and fibrous encapsulation of the implants. Examination of decalcified and undecalcified sections revealed progressive but variable replacement of the cement by new bone and soft tissue without a change in the shape or volume of the hydroxyapatite cement-reconstructed areas. New bone comprised 77.3 and 64.7 percent of the tissue replacing the hydroxyapatite cement and hydroxyapatite cement-bone implants, respectively. Replacement of the hydroxyapatite cement implants by new bone is postulated to occur by a combination of osteoconduction and implant resorption. These results indicate that further experimental research leading to the possible application of hydroxyapatite cement for full-thickness calvarial defect reconstruction in humans is warranted.     

Soldering without transition (osteoassimilation) between the human maxillary bone and a compact dental implant in natural calcite from marine invertebrate

We present evidence for the formation of woven bone between human maxillary lamellar bone (the target site) and a coral implant (Corallium johnsoni Gray). This newly formed bone is characterized by numerous osteocytes located in spherical lacunae and having many ramified processes directed towards the coral; some of these processes continue into the implant surface. Healthy osteocytes were detected within the superficial part of the coral, next to the newly formed bone. Neither osteoclast nor surface of resorption has been noticed. All these observations indicate tight welding or osteoassimilation without any transition between the maxillary bone and the graft. We have obtained analogous results by using grafts of molluscan mother-of-pearl. Our results differ from those reported by other authors, probably due to the compactness of the biomaterial used here.     

Induction of bone formation by recombinant human osteogenic protein-1 and sintered porous hydroxyapatite in adult primates

A critical issue in tissue engineering and morphogenesis of bone is the development of novel biomimetic biomaterials that are capable of optimizing the biological activity of recombinant human bone morphogenetic and osteogenic proteins, which are molecules that initiate bone formation in vivo. From a therapeutic perspective, a carrier matrix is required for the local delivery of these proteins to evoke a desired osteogenic effect. In view of the affinity of these proteins for hydroxyapatite, which may reflect the in vivo supramolecular assembly of bone proteins bound to both the extracellular matrix and the mineral component of bone, we investigated the efficacy of single applications of different doses of human osteogenic protein-1 (hOP-1) adsorbed onto sintered porous hydroxyapatites for bone induction in orthotopic calvarial defects in 12 adult male baboons (Papio ursinus) and heterotopically in the rectus abdominis of four additional baboons. In orthotopic specimens, pretreatment of sintered porous hydroxyapatites with 100 microgram of hOP-1 in 500 microliter of 5 mM hydrochloric acid resulted in rapid and diffuse osteoinduction restricted within the porous spaces of the hydroxyapatite, as evaluated by histology and histomorphometry on day 30. Hydroxyapatites treated with 500 microgram of hOP-1 showed a different pattern of bone formation and distribution on day 30 as compared with the lower dose of the recombinant morphogen. Although bone formation was extensive with the higher dose, it was found on the endocranial and pericranial aspects of the specimens, enveloping the implanted hydroxyapatite carrier, and the internal porous spaces were occupied by a rich vascular network without any bone formation. By 90 and 365 days after the implantation of both doses of hOP-1, however, there was remodelling and complete penetration of the newly induced bone within the available porous spaces. The combination of hOP-1 and hydroxyapatite also showed extensive bone formation in heterotopic specimens harvested from the rectus abdominis muscle of the baboon using doses of 5, 25, and 45 microgram of hOP-1 per implant. These findings in the adult primate demonstrate extensive bone formation by hOP-1 adsorbed onto sintered porous hydroxyapatites and suggest that predictable osteogenesis in clinical contexts for treatment of craniofacial bone defects may be engineered using inorganic, nonimmunogenic, and carvable delivery systems that initiate osteogenesis with relatively low doses of recombinant osteogenic proteins, thus mimicking the macrostructure and microstructure of living bone.     

The rate of vascularization of coralline hydroxyapatite

Coralline hydroxyapatite (CHAP) is a porous, biocompatible bone-graft substitute manufactured by the Replamineform process. The use of this material in the experimental and clinical settings for maxillofacial onlay grafting has been recently described. This study was designed to quantitate the rate of vascularization of coralline hydroxyapatite when used in an onlay application to membranous bone in an animal model. Sixteen onlay grafts of coralline hydroxyapatite (0.5 X 0.5 X 1.0 cm Interpore 200) were placed in a subperiosteal location on the nasal dorsum of 2- to 3-kg male New Zealand white rabbits. The grafts and nasal bones were harvested en bloc at 1, 2, 3 and 4 weeks after onlay. Prior to harvest, injectable silicone visualizing agent (Microfil*) was injected by means of carotid artery cutdown. The decalcified specimens were examined on a digitizing pad to count the number of vessels appearing in the blocks of hydroxyapatite. Counting was summed and integrated by an Apple IIe microcomputer. A significant difference (p less than 0.05) was noted in both the number of vessels and the fraction of implants infiltrated by vessels between 1 and 4 weeks. The usefulness of these previously undescribed data may be in their extrapolation to onlay grafts of coralline hydroxyapatite in maxillofacial reconstruction in humans.     

Use of the cylinder osteotome for cancellous bone grafting

An instrument is described for removing iliac crest cancellous bone grafts under local anesthesia. The device has widespread applications for plastic and orthopedic surgery. The convenience of obtaining bone grafts with this device broadens the use of bone-grafting techniques in patients in whom the need for bone graft is unexpected.