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Computed tomography (CT) may more accurately assess the healing of grafted osteolytic lesions around acetabular components compared with plain radiographs, although clinical validation is lacking. To determine whether clinical or micro-CT imaging could assess accurately the grafted lesion compared with histology, we therefore quantified bone healing and ingrowth to determine an effective rhBMP-2 dose and ratio to allograft bone when grafted adjacent to a cementless porous-coated component. We grafted surgically created acetabular defects in canines (n = 20) before uncemented total hip arthroplasty. At 6 weeks, embedded acetabula were imaged and the CT slice images matched to histology section images. The percentage of bone in the defect and growth into the porous surface was assessed quantitatively. Low-dose rhBMP-2 with allograft (1:5 ratio) resulted in a higher percentage of defect healing (43.8%) than rhBMP-2 alone (29.2%) and a higher percentage of bone ingrowth (15.7%) than allograft bone alone (1.1%) as measured by histology. Micro-CT measurements were similar to histologic measurements of defect healing, whereas clinical CT overestimated periprosthetic bone by 38%. Neither clinical CT nor micro-CT techniques are adequate for assessing ingrowth or the bone-implant interface with metal artifacts. [ABSTRACT FROM AUTHOR]

Background: Osteochondral defects continue to be a clinical treatment challenge, and when left untreated, may cause pain and functional impairment. Pyrolytic carbon is a unique isotropic biomaterial used in heart valve and small joint replacements due to its excellent wear properties and biocompatibility with bone and articular cartilage. Therefore, a proposed solution is to utilize a focal pyrolytic carbon hemiarthroplasty implant as an alternative resurfacing treatment strategy for isolated cartilage lesions., Methods: A canine model (n = 9) was used to evaluate the in vivo histologic response and function of a pyrolytic carbon implant replacing a full-thickness osteochondral defect in the medial femoral condyle (MFC) of the knee. The gross appearance and histologic results were compared to an identical cobalt-chromium (Co-Cr) alloy implant placed in a defect in the contralateral MFC and evaluated up to 52 weeks., Results: Extensive bone incorporation to the stem portion was observed for both implant types. The total mean histologic score for the cartilage of the MFC surrounding the pyrolytic carbon implants was significantly improved compared to that of the Co-Cr alloy implants at all evaluation periods (p < 0.05). Histologic grading and gross observations at 52 weeks for pyrolytic carbon implants were similar to those of Co-Cr alloy implants at 24 weeks. At 24 weeks, the mean total histologic score for Co-Cr alloy implants was 11.6 ± 0.7 (0-16 range point; 16 = normal appearance), while at 52 weeks, the mean total score for the pyrolytic carbon implants was 11.7 ± 1.3. Mean total histologic score of opposing medial tibia cartilage for the pyrolytic carbon implants was superior to that of the Co-Cr alloy group at all evaluation periods and significantly improved over the Co-Cr alloy implant group at 24 weeks (p = 0.001) and 52 weeks (p < 0.001)., Conclusions: Use of a pyrolytic carbon implant for reconstruction of a focal cartilage defect demonstrated effective implant fixation and superior in vivo response compared to an identical Co-Cr alloy implant.

Background: Low-intensity pulsed ultrasound promotes the enchondral portion of fracture healing, which has a direct stimulatory effect on cartilage formation and maturation., Hypothesis: Daily ultrasound treatment positively affects the repair and incorporation of modified autologous osteochondral plugs in a canine model., Study Design: Controlled laboratory study., Methods: In 18 dogs, 2 autologous plugs separated from host cartilage by a 1.5-mm gap were created on the medial femoral condyle in both knees of each dog. One knee was treated daily with a clinically available ultrasound bone stimulator. Animals were sacrificed after 6 and 12 weeks of therapy and the articular surfaces evaluated grossly and histologically., Results: Ultrasound-treated sites had significantly improved gross appearance at 6 weeks and histologic appearance at 6 and 12 weeks. The interface repair tissue of ultrasound-treated sites had a more normal translucent appearance than control sites. Ultrasound treatment improved the cell morphologic characteristics of the interface repair tissue and increased subchondral bone regeneration. Bonding of the interface repair tissue between plug and adjacent cartilage was significantly improved compared with control sites., Conclusion: Low-intensity pulsed ultrasound improved interface cartilage repair of autologous osteochondral plugs compared with controls in a canine model., Clinical Relevance: Improvements in the quality and rate of repair of autologous osteochondral plugs may reduce postoperative recovery time and improve functional outcome.

One consideration for the practical use and application of osteogenic proteins is an effective method of delivery. This study evaluated a putty-type collagen carrier with recombinant human osteogenic protein-1 (rhOP-1) ability to heal canine critical sized (2.5 cm) ulna segmental defects compared to rhOP-1 with a particulate collagen carrier (OP device). The addition of carboxymethylcellulose (CMC) to the particulate collagen carrier (OPCMC device) to form the putty consistency was evaluated in two doses (3.5 and 1.75 mg rhOP-1/g carrier). The CMC greatly improved the intraoperative handling and site containment of the device. For the one-half dose and full-dose sites there were no statistically significant differences in the radiographic grading of defect healing when treated with the particulate OP-1 device and the device with CMC added. However, there was a dose effect with greater and earlier new bone formation observed with increased rhOP-1. Mechanically, there were no differences between particulate and putty formulations, although again, a significant effect was observed for treatment dose with the full-dose OPCMC device restoring 94% of the strength of the intact ulna compared to only 65% for the identical one-half dose implant. Regardless of rhOP-1 dose, the quality of union grading and total histologic score appearance were improved with the addition of CMC, although differences in histologic scoring were not statistically significant. Overall, the radiographic, mechanical, and histologic bone-healing characteristics with the one-half dose OPCMC device were similar to sites treated with the full-dose OP device. The observed improvement in healing may allow for lesser amounts of the device or a device with less rhOP-1 to be used., ((c) 2005 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2005.)

The use of graft materials to restore bone stock and promote healing and implant stabilization is a crucial part of total knee arthroplasty, especially in revision surgery. Recent research has centered on the use of osteoinductive materials to promote bone formation. Osteogenic proteins are members of a superfamily of proteins called transforming growth factor-beta that, either alone or in combination with other regulatory molecules, induce new bone formation. The cloning and genetic expression of recombinant human osteogenic proteins has led to production of quantities sufficient for their clinical use. Recombinant human osteogenic protein-1 has been combined with bone-derived Type I collagen for delivery to an implant site. Preclinical studies have shown that the osteoinductive capacity of autograft and allograft bone and bone graft substitute materials can be notably improved with the addition of osteogenic protein-1. The use of this protein consistently improved the amount and rate of new bone formation compared with graft alone, resulting in earlier graft incorporation and consolidation. In addition, because osteogenic proteins are chondrogenic, they also may have a role in the treatment of cartilage injury and degeneration. Osteogenic protein-1 has been shown to induce hyalinelike cartilage repair of full thickness osteochondral defects in animal models with no degradation of the tissue with time. Although no detailed clinical studies in knee surgery have been reported with the use of osteogenic protein-1, in anecdotal cases its use alone and with bone graft materials indicate results consistent with those obtained in preclinical studies.

Background Context: Obtaining adequate purchase with standard pedicle screw techniques remains a challenge in poor quality bone. The development of alternate insertion techniques and screw designs was prompted by recognition of potential fixation complications. An expandable pedicle screw design has been shown to significantly improve fixation compared to a conventional screw in poor quality bone., Purpose: The purpose of this study was to determine if polymethylmethacrylate (PMMA) bone cement augmentation of an expandable pedicle screw can further improve fixation strength compared to the expandable screw alone in severely osteoporotic bone. A technique for cement insertion into the pedicle by means of the cannulated central portion of the expandable screw is also described., Study Design: The axial pullout strength, stiffness and energy absorbed of cemented and noncemented expandable pedicle screws was determined in cadaveric vertebrae., Methods: Twenty-one fresh unembalmed vertebrae from the thoracolumbar spine were used. Radiographs and bone mineral density measurements (BMD) were used to characterize bone quality. Paired cemented and noncemented pedicle screw axial pullout strength was determined through mechanical testing. Mechanical pullout strength, stiffness and energy to failure was correlated with BMD., Results: Overall, there was a 250% increase in mean pullout strength with the cemented expandable screw compared with a noncemented expandable screw including a greater than twofold increase in pullout strength in the most severely osteoporotic bone. The mean stiffness and energy absorbed to failure was also significantly increased. A cemented conventional screw achieved a pullout strength similar to the noncemented expandable screw., Conclusions: PMMA cement augmentation of the expandable pedicle screw may be a viable clinical option for achieving fixation in severely osteoporotic bone.

Reliable ingrowth of bone into porous-coated cementless total hip components can be expected in primary surgery. In the revision scenario, however, bone deficiency frequently is encountered and the remaining bone may have less ingrowth potential. Allograft bone and bone graft substitutes may be successful in healing bone defects, but have virtually no capacity to induce bone growth from the defect into the porous surface. To evaluate the role osteoinductive bone proteins may play in enhancing bone ingrowth, six canines had bilateral total hip arthroplasties with a cementless press-fit porous-coated acetabular component. A defect 8 mm in diameter and 5 mm in depth was created in the superior weightbearing area of each acetabulum. One defect in each animal was filled with recombinant human osteogenic protein-1. Each contralateral defect was filled with allograft bone, left empty (defect healing control), or no defect was created (intact) to serve as a control for ideal conditions for bone ingrowth. The osteogenic protein-treated defects healed more completely than allograft bone-treated or empty defects and achieved a bone density equivalent to the intact acetabulum. Bone ingrowth also occurred to a significantly higher degree in the osteogenic protein group compared with the allograft or empty defects achieving a degree of ingrowth equivalent to the intact acetabulum controls. The osteogenic bone protein was successful in achieving complete defect healing and inducing extensive ingrowth from the defect into the adjacent porous coating.

The use of autograft and allograft material to restore bone stock and promote healing and implant stabilization is a crucial part of total hip arthroplasty, especially in the revision situation. Recent research has centered on the use of osteoinductive materials such as osteogenic proteins or bone morphogenetic proteins to promote bone formation. These proteins are members of the transforming growth factor-beta superfamily of proteins that either alone or in combination with other regulatory molecules induce new bone formation. The cloning and genetic expression of recombinant human bone proteins has led to production of quantities sufficient for their clinical development. Preclinical studies have shown that the osteoinductive capacity of autograft and allograft bone can be improved with the addition of osteogenic proteins. Although these proteins are effective alone, their use with cancellous and cortical allograft and autograft consistently improved the amount and rate of new bone formation compared with graft alone resulting in earlier graft incorporation and consolidation. When placed in defects adjacent to porous acetabular components, the use of an osteogenic protein resulted in earlier defect healing and improved component fixation by the enhancement of bone ongrowth and ingrowth. Although no detailed clinical studies have been reported to date, an anecdotal report of their use with and without bone graft indicate results consistent with those obtained in preclinical studies.

Background: Articular cartilage injury has a poor prognosis for repair. Mesenchymal cells, when exposed to osteogenic proteins and other cytokines, can differentiate into cells that behave phenotypically as chondrocytes. In this study, we examined the ability of recombinant human osteogenic protein-1 (rhOP-1 or rhBMP-7) to elicit the repair of osteochondral defects in dogs., Methods: Bilateral osteochondral defects that were 5 mm in diameter by 6 mm deep were surgically created in the medial femoral condyles of sixty-five adult dogs. rhOP-1-treated (100 mg of a 3.5-mg rhOP-1/g bovine bone-derived Type-I collagen device) and control defects (untreated or treated with 100 mg bovine bone-derived collagen implants) were evaluated grossly and histologically at six, twelve, sixteen, twenty-six, and fifty-two weeks postoperatively. The influence of protected initial weight-bearing and surgical placement of periosteal flaps was also evaluated., Results: Gross and histologic grading of the defect repair indicated improvement in the rhOP-1-treated defects compared with that in the controls. Grossly, the repair tissue in the rhOP-1-treated defects was continuous with the adjacent intact cartilage and appeared translucent. By comparison, the repair tissue in the control defects was discontinuous and opaque or inhomogeneous in nature. Histologically, maturing cartilage similar in appearance to the intact articular cartilage was present in the rhOP-1-treated defects. Cartilage at the defect interface was minimally degraded. The control defects were filled primarily with fibrous tissue and fibrocartilage. Significant differences based upon treatment type were observed at twelve weeks, sixteen weeks, and for all time-periods combined (p = 0.0385, p = 0.0070, and p = 0.0026, respectively)., Conclusion: rhOP-1 (rhBMP-7) induced hyaline cartilage-like repair of full-thickness osteochondral defects in a dog model. Differences in cartilage repair were maintained at fifty-two weeks postoperatively with no significant degradation of the rhOP-1-induced repair tissue.

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., (Copyright 2002, Elsevier Science (USA).)

Twelve African green monkeys were implanted with recombinant human osteogenic protein-1 (rhOP-1) placed on a bovine bone-derived Type I collagen carrier to characterize healing in an ulna segmental bone defect model at 1, 3, 12, and 20 weeks postoperative. Defect healing was evaluated by plain film radiography, computed tomography (CT), magnetic resonance imaging (MRI), bone mineral density (BMD), and histologic analysis. Radiographically, new bone formation was observed as early as 3 weeks postoperative. By 6 weeks, new bone was visible in five of six defects. Increased quantity and mineralization of the new bone were apparent by 12 weeks. Reformation of the medullary cavity with appearance of marrow elements was demonstrated by CT and MRI at 20 weeks. BMD studies revealed a significant increase in the presence of bone with time. Histology at 1 week demonstrated that the implant material was well contained in the defect, and a proliferation of cells occurred at the defect borders. At 3 weeks cell proliferation continued and cell phenotype differentiation was recognized. By 12 weeks substantially less residual carrier was found in the defects, and calcifying tissues with plump chondrocytes, osteoblasts, and immature woven bone were observed. Areas of lamellar and woven bone were identified at 12 weeks, with advanced remodeling and revascularization observed at 20 weeks. The use of osteoinductive implants may provide an alternative to autologous and allogeneic bone tissue in the therapeutic approach to bone defects and promotion of fusion by eliminating the donor site morbidity associated with autogenous bone and the decreased efficacy and potential for disease transmission associated with allogeneic bone.

Low-intensity pulsed ultrasound accelerates bone healing via upregulation of cartilage formation and maturation phases of endchondral bone formation. The current authors evaluated the effect of ultrasound therapy on the repair of full-thickness osteochondral defects. Bilateral, 3.2 mm diameter by 5.0 mm deep osteochondral defects were created in the patellar groove of 106 adult male New Zealand rabbits. The defects were treated with daily low-intensity pulsed ultrasound therapy on the right knee. The left knee was not treated. In Part I, the effect of ultrasound therapy was evaluated at 4, 8, 12, 24, and 52 weeks after surgery. In Part II, the effect of the length of treatment (5, 10, or 40 minutes of daily ultrasound therapy) compared with standard 20 minute therapy was evaluated. The repair cartilage was evaluated and graded on a standard scale for the gross and histologic appearance. Ultrasound treatment significantly improved the morphologic features and histologic characteristics of the repair cartilage compared with nontreated controls. Earlier, better repair with less degenerative changes at later times was observed in defects treated with ultrasound. Doubling the treatment time to 40 minutes daily significantly increased the histologic quality of the repair cartilage. In the current animal model, daily low-intensity pulsed ultrasound had a significant positive effect on the healing of osteochondral defects.

Background Context: Increasing the incidence of solid bony fusion is a primary goal in spine surgery. Daily low-intensity pulsed ultrasound therapy has been shown to improve and accelerate the bone healing process., Purpose: The purpose of this study was to evaluate the efficacy of daily low-intensity pulsed ultrasound therapy to improve the rate and quality of spinal fusion., Study Design: Canine fusion model prospective study., Patient Sample: Fourteen adult male dogs were used., Outcome Measures: Radiographic grading of plain films, computed tomography (CT) and magnetic resonance imaging (MRI), gross palpation, torsional stiffness and histologic grading were used to determine the presence or absence of fusion., Methods: Posterior noninstrumented bilateral fusions were evaluated at the L2-L3 and L5-L6 levels. Treatment with low-intensity pulsed ultrasound for 20 minutes per day over the fusion site (stimulated) was compared with fusion sites that received no stimulation (nontreated controls) at 6 and 12 weeks after surgery. Plain film radiographs, CT and MRI, mechanical torsion testing and histologic examination were performed., Results: At 6 weeks, ultrasound treated sites were more frequently fused compared with nontreated controls, although the difference in fusion rate was not statistically significant. At 12 weeks after surgery complete radiographic and histologic fusion occurred in 100% of ultrasound-treated sites. In the nontreated control sites 78% had achieved complete radiographic fusion and 44% had complete histologic fusion. Compared with control sites, the histological and mechanical fusion rate was significantly greater in ultrasound-treated sites (P<.05) at 12 weeks. A statistically significant increase in mechanical stiffness in ultrasound-treated sites was also found at 12 weeks after surgery., Conclusions: Low-intensity pulsed ultrasound therapy may be a useful means to ensure successful spine fusion.

Background: Large amounts of bone graft are frequently used to elicit the healing of bone defects resulting from reconstructive procedures. Autograft and allograft bone are often used, but each has its limitations. Bone morphogenetic proteins (BMPs) improve the healing of segmental bone defects treated with autograft or allograft. The objective of the present study was to determine the effect of implantation of a recombinant osteogenic protein-1 (OP-1) in combination with bone graft on the healing of a critical-sized (2.5-cm) segmental defect in canine ulnae., Methods: Either autograft bone, allograft bone, osteogenic protein-1 (OP-1) mixed with type-1 bovine collagen, or various combinations of OP-1 and collagen (OP-1 device) mixed with allograft or autograft were implanted in the segmental bone defects. The combinations included 67% bone graft with 33% OP-1 device and 33% bone graft with 67% OP-1 device. The healing of the defects was assessed with radiographic, biomechanical, and histological studies. The animals were killed at twelve weeks postoperatively., Results: The use of the OP-1 device alone or any combination of autograft or allograft bone and the OP-1 device demonstrated improved healing on radiographic, mechanical, and histological studies compared with that demonstrated after use of autograft or allograft bone alone. The highest radiographic and histological grades and the greatest mechanical strength were achieved with the use of 33% allograft and 67% OP-1 device, although no significant differences were observed among the different groups containing the OP-1 device. At twelve weeks postoperatively, the defects treated with any amount of the OP-1 device obtained greater mechanical strength than that obtained by autograft bone alone., Conclusions: Major bone defects may be treated with allograft bone combined with the OP-1 device, instead of autograft alone, to avoid complications associated with the use of autograft. The combination of allograft bone and the OP-1 device resulted in optimum healing of the defect, according to the radiographic, mechanical, and histological parameters measured in this study., Clinical Relevance: The combination of freeze-dried allograft bone with the OP-1 device is an attractive graft material for the treatment of large bone defects. Although similar results were observed when autogenous bone graft was used in combination with the OP-1 device, the results of the present study suggest that allograft, because of its relatively unlimited supply, can be substituted without reduced efficacy. In addition, avoiding the need to harvest autogenous bone eliminates the additional operative time and risk associated with a second surgical procedure.

The role of spinal instrumentation is to provide mechanical stability, obtain and maintain anatomic alignment, and promote fusion. The American Society for Testing and Materials (ASTM) introduced guidelines and procedures so that biomechanical properties of different implant designs could be compared in a consistent manner. Combined with biomechanical analyses, clinical evaluation allows the safety and efficacy of a spinal implant system to be determined before construction. The objective of our study was to determine the biomechanical properties and clinical performance of the OMEGA-21 Spinal Fixation System. Static and dynamic (fatigue) biomechanical testing was performed per ASTM guidelines and recommendations on individual components and on the system assembled in a corpectomy model. Clinical and radiographic evaluation of 57 consecutive patients with indications for instrumented spinal arthrodesis of the lower dorsal lumbar and sacral segments of the spine was performed at a mean follow-up of 31.9 months. Static and fatigue testing revealed superior biomechanical properties of the individual components and of the assembled system. The mechanical-strength values of the system were comparable with maximum reported values for existing implant designs. At final clinical follow-up, 86% of patients obtained relief of their symptoms; 84% considered their clinical results to be excellent or good. Ninety-one percent of patients satisfied radiographic criteria for bony fusion. There were 5 implant-related complications: 2 misplaced screws (2 patients), local pain above the implant (2 patients), and 2 broken expansive screws (1 patient). Biomechanical and clinical results indicate that the OMEGA-21 system is feasible and performs well as a spinal instrumentation system for the lower dorsal, lumbar, and sacral spine.

Background Context: Pedicle screw fixation in osteoporotic bone and in revision of previous pedicle screw fixation cases presents a significant challenge to spine surgeons. Biomechanical tests have shown that a pedicle screw that expands within the vertebrae body can substantially improve fixation in the presence of compromised bone., Purpose: To review the clinical and radiographic results with the use of expandable pedicle screws., Study Design: One hundred forty-five patients received one or more expandable pedicle screws from the Omega21 spinal fixation system (EBI, L.P., Parsippany, NJ) to obtain thorocolumbar or lumbosacral stabilization., Patient Sample: The indications for use of the expandable screws were osteoporosis (21 cases), reoperation of previous pedicle instrumentation (27 cases), intraoperative screw relocation (17 cases), construct reinforcement (23 cases), and sacral anchoring to avoid the necessity of anterior penetration of the sacral cortex (57 cases)., Outcome Measures: The presence of radiographic fusion and complications arising from the instrumentation were reviewed at a mean follow-up period of 35 months (range, 24-72 months)., Methods: A retrospective clinical and radiographic review was performed. Fusion was evaluated based on anterior-posterior and lateral radiographs as well as dynamic radiographs in flexion and extension., Results: Radiographic evidence of fusion was obtained in 125 of the 145 cases (86%). Eighty-six percent of patients with osteoporosis and 89% of reoperations fused. There were no instances of screw loosening or pullout of the expandable screws. Screw breakage occurred in four patients (2.8%), including three patients where fusion was not obtained. In six patients the expandable screws were removed without difficulty after fusion because of local discomfort., Conclusion: The results of this study have shown that expandable pedicle screws can be efficacious in cases in which pedicle screw fixation is difficult and adds a valuable tool to the growing armamentarium of spinal instrumentation.

Allograft struts are used to reinforce the deficient proximal femur in hip arthroplasty or for fixation of a periprosthetic fracture. Although the use of strut grafts wired or cabled to the proximal femur generally has been successful, the time for healing is slow. The purpose of the current study was to determine whether cortical strut graft healing to the femur could be enhanced by the addition of recombinant human osteogenic protein-1. Fourteen adult dogs underwent bilateral onlay allograft strut procedures to the midfemur using stainless steel cables. In each animal one femur received 500 mg of osteogenic protein-1 device (2.5 mg recombinant human osteogenic protein-1/g Type I collagen) interposed between the graft and host bone. The results showed that the healing of cortical strut grafts to the femur was enhanced dramatically by the addition of the osteogenic protein-1 device. The sites treated with osteogenic protein-1 had significantly greater radiographic, histologic, and microradiographic scores at all times. Rapid formation of new bone and graft incorporation was observed in sites treated with the osteogenic protein-1 device. Strut healing with the osteogenic protein-1 device at 4 weeks postoperative was superior to the healing in control sites at 8 weeks. Improving and accelerating the course of cortical strut graft healing should provide a substantial clinical benefit in lowering the risk of graft nonunion and fracture and shorten the time of protected weightbearing and functional disability.

The advantages of pedicle screw fixation depend on their ability to retain bony purchase until the fusion mass is stable. Osteoporotic bone and removal and replacement of pedicle screws in revision procedures substantially reduce screw mechanical fixation strength and can lead to clinical failure. The objective of this study was to determine if an expansive pedicle screw design could be used to improve biomechanical fixation in bone of compromised quality. Axial mechanical pullout testing was performed on paired expansive and conventional pedicle screws placed in fresh, unembalmed cadaveric vertebrae. Bone mineral density measurements (made using a dual-energy X-ray absorption meter) were used to characterize bone quality. A preliminary clinical and radiographic evaluation of 14 patients was also performed at a minimum 2-year follow-up. The mean axial pullout force in bone of all qualities was increased 30% when the expansive pedicle screw design was used. This included an appropriate 50% increase in pullout force in bone of poor quality (low bone mineral density). The preliminary clinical and radiographic results were supportive of the biomechanical design rationale and mechanical testing. The results were similar to those expected for spinal instrumentation using pedicle screws, even though compromised bone was present in two thirds of the cases in which the expansive screw was used.

Grafting to restore lost alveolar bone is frequently used to enable placement of endosseous implants and improve cosmesis. Conflicting reports concerning the osteoinductivity of demineralized bone matrix (DBM) and historical use of synthetic bone graft substitutes has limited the use of DBM in oral and maxillofacial applications. Implant placement after bone grafting provides the unique opportunity to biopsy and histologically evaluate new bone formation. Bone grafting of the mandible or maxilla was performed to fill extraction sockets and restore ridge structures in a consecutive series of eight patients. DBM prepared as malleable putty (Grafton DBM Putty) or flexible sheets (Grafton DBM Flex) was used. Biopsies were taken at reentry, and histologic analysis determined the amount and quality of regenerated bone. Extensive new bone formation and minimal residual bone graft matrix were observed at an average of 5 months postoperative. The pattern of new bone maturity and remodeling varied by patient and the time in situ. Putty and Flex regenerated excellent bone height and width for the placement of dental implants, were easy to handle intraoperatively, and readily conformed to bony defects.

Objective: To assess the radiographic, histologic, and mechanical characteristics of new bone formation in large segmental bone defects treated with a new osteoconductive material, recombinant human osteogenic protein-1 (rhOP-1)., Design: In vivo animal study., Intervention: Sixteen dogs (thirty-two limbs) with an ulna segmental defect (2.5 centimeters) were randomized to three treatment groups: rhOP-1, collagen alone, and no implant., Main Outcome Measurements: Radiographic evidence of defect healing, mechanical testing (torsional strength) as compared with thirty-one control intact dog ulnas, and histologic analysis., Results: At twelve weeks, complete radiographic healing was observed in twenty-five of twenty-eight defects (89 percent) treated with rhOP-1. The mechanical strength of the rhOP-1-treated defects at twelve weeks was 65 percent of that of intact ulnas. Histologic analysis revealed that defects treated with rhOP-1 were bridged with lamellar and woven bone that was in continuity with the host bone., Conclusions: The results indicate that osteoinductive materials, which have the ability to quickly fill and heal large defects, may have advantages over osteoconductive materials, which are typically used to fill smaller non-load-bearing bone voids.

Study Design: Infection of rhesus monkeys (Macaca mulatta) with simian immunodeficiency virus (SIV, HIV-II) was used to study disease transmission in allograft bone. Four allograft bone processing techniques--fresh, fresh frozen, double freeze-thaw, and double freeze-thaw with chemical decontamination--were evaluated., Objectives: To determine if SIV could be transmitted in allograft bone and if processing techniques could be used to eliminate the potential for disease transmission., Summary of Background Data: Although the risk of HIV transmission in bone allograft was reported to be low, HIV transmission had occurred. In all cases, frozen allograft was used. Donor screening and serologic testing significantly reduced the risk of transmission, although a window of time existed in which an individual was infected but had not seroconverted. Experimental infection of rhesus monkeys with SIV induced a disease syndrome similar to AIDS and provided an ideal model to study disease transmission., Methods: Corticocancellous cylinders were obtained aseptically from SIV-infected rhesus monkeys. The grafts were randomly placed into one of four processing groups and implanted into noninfected animals. The presence of SIV antibody was monitored by serologic testing. After the monkeys were killed, the graft sites were studied by histology., Results: All animals receiving fresh allograft or allograft bone that had been subjected to either single or double -70 C freeze-thaw cycles became infected with SIV. Animals receiving allograft that had been subjected to a double freeze-thaw cycle and chemical decontamination were disease-free after 26 weeks when the animals were killed., Conclusions: The results show that SIV (HIV-II) can be transmitted in bone allograft procedures. Although freeze-thaw cycles and lavaging to remove blood elements can reduce the infectivity of a graft, it appears chemical decontamination is necessary to provide a high level of confidence in its safety.

The effect of recombinant human osteogenic protein-1 on the healing of segmental bone defects was studied in twenty-eight African green monkeys (Cercopithecus aethiops). A 2.0-centimeter osteoperiosteal defect was created in the middle of the ulnar shaft in fourteen animals and in the diaphysis of the tibia in the other fourteen. The ulnar defect was filled with an implant consisting of 1000 micrograms of recombinant human osteogenic protein-1 in 400 milligrams of bovine bone-collagen carrier in six animals, with collagen carrier alone in two animals, and with autogenous cancellous bone graft from the contralateral tibia and femur in six animals. The tibial defect was filled with 250, 500 (two tibiae), 1000, or 2000 micrograms of recombinant human osteogenic protein-1 in 400 milligrams of collagen carrier in five animals, with collagen carrier alone in one animal, and with autogenous cancellous bone graft in six animals; in the two remaining animals (controls), the tibial defect was left unfilled. The tibial defects were stabilized with an intramedullary Steinmann pin. All animals were killed at twenty weeks postoperatively. Healing of the defects was evaluated with biweekly radiographs, with histological examination, and with mechanical testing. Radiographically, all of the defects that had been treated with recombinant human osteogenic protein-1 exhibited new-bone formation, but they differed in the degree of healing and remodeling. Five of the six ulnae treated with recombinant human osteogenic protein-1 and four of the five tibiae treated with this substance exhibited complete healing at six to eight weeks, with bridging of the defect by new bone first observed at four weeks. The two unhealed defects both exhibited new-bone formation but incomplete union, which precluded mechanical testing. No defect that had been filled with collagen carrier or that had been left unfilled exhibited any signs of healing or major new-bone formation. None of the six ulnae that had been filled with autogenous bone graft exhibited complete healing, compared with five of the six tibiae that had been so treated. Histological evaluation of the defects treated with recombinant human osteogenic protein-1 revealed the formation of new cortices with areas of woven and lamellar bone and normal-appearing marrow elements at twenty weeks postoperatively. The tibial defects that had been treated with autogenous bone graft had a similar appearance. All control ulnar and tibial defects and all ulnar defects that had been treated with autogenous bone graft had fibrous union with little new-bone formation.(ABSTRACT TRUNCATED AT 400 WORDS)

This study used the canine mandibular model to evaluate the efficacy of recombinant human osteogenic protein-1 (rhOP-1) for accelerating the healing of fresh dental extraction defects and in encouraging osseointegration of dental implants. Eight implants, four hydroxylapatite (HA)-coated and four non-coated, were placed in each mandible of four adult male mongrel dogs immediately after extraction of the eight premolars. The rhOP-1 was placed in all extraction sites with and without implants on the left side of the mandible. All animals were killed at 12 weeks postoperatively; histologic analysis was performed, including measurement of the new bone formation within the extraction defects, implant incorporation, and implant-bone interface characteristics, including percent bone and fibrous tissue apposition. Extraction sites treated with rhOP-1 were completely filled with new bone and were well incorporated with the host bone at 12 weeks post-operative. New bone had filled the untreated defect sites; however, the amount, density, and degree of remodeling were less than was observed in rhOP-1 sites. Small increases in osseointegration and adjacent new bone formation were apparent surrounding implants placed with rhOP-1. However, good initial implant fit and the small amount of rhOP-1 delivered to the site in this model may have mitigated any large differences. The results of this study demonstrate that new bone formation can be induced around and adjacent to a dental implant placed in a fresh extraction site with a recombinantly produced bone inductive protein.

An uncemented porous-coated humeral component, which functioned in vivo for over 2 1/2 years, was retrieved postmortem and examined histologically. Radiographs of the specimen revealed close approximation to the endosteal cortex medially and laterally. Apposition was limited or absent anteriorly and posteriorly. The overall extent of bone ingrowth was approximately 11% of the available pore volume with over 95% of ingrowth occurring in the medial and lateral quadrants. Bone ingrowth was limited anteriorly and posteriorly to regions in which spot welds were identified radiographically. There were no loose beads or coating failure observed.

The interface attachment strength and histology of HA-coated endosseous dental implants with surface texturing added to allow for mechanical interlocking of the implant to bone were evaluated in the canine mandibular model. Twenty-two adult mongrel dogs received eight implants (four per side) placed into healed extraction sites. Fifteen weeks post-implantation, the implants were evaluated mechanically by axial pull-out and torsional testing. Following testing, the specimens were evaluated quantitatively for histologic parameters of bone apposition, HA-coating thickness, and mode of interface failure. The addition of surface macrotexture (threads, grooves, and dimples) was not found to have a significant effect on axial pull-out strength compared with smooth implant controls. Similarly, mechanical testing in torsion failed to reveal any significant effect on implant-bone interface attachment due to surface macrotexture. Interface failure occurred primarily at the HA/substrate interface in all implant designs. Examination of HA-coating thickness revealed non-uniform coatings, particularly in the surface-textured designs. Although bone growth into the surface textures was observed in some cases, often only minimal or a thin osseous layer on the HA coating was observed. This factor most likely contributed to the lack of significant additional interface attachment strength in the textured designs. The reduction in areas of complete implant incorporation may also have exposed the HA coating to high interfacial loads and may be responsible for the greater HA coating break-up and presence of particles observed in the textured designs.

The interface attachment strength and histology of an elliptical hydroxylapatite-coated (HA) endosseous dental implant were compared with those of an otherwise identical cylindrical dental implant. The implant designs were tested in two canine in vivo models: healed mandibular extraction sites and the femoral unicortical plug. The implants were evaluated 15 weeks post-implantation. The elliptical geometry of the dental implant was not found significantly to enhance axial pull-out strength or torsional implant-bone interface attachment in either in vivo model. The cylindrical implant absorbed more energy to failure in both the mandible and the femur; however, the difference was not statistically significant. Differences in the interface shear attachment strength between the two models (mandible and femur) were statistically significant when the maximum load to failure was normalized by the actual bone contact surface area. In all cases, femoral values were significantly greater. Examination of HA-coating thickness revealed uniform coatings on both implant types which were well maintained in vivo. Mechanical failure occurred primarily at the metal substrate-HA interface in each type of implant in both models. The amounts of bone apposition to both implants in both models were identical. Coating break-up and inflammatory response to the particulate debris were minimal.

This study evaluated the rotational and bending stability of three interlocking nail systems in paired cadaveric humeri. The Russell-Taylor Humeral Interlocking Nail, the Seidel Humeral Locking Nail, and the True-Flex Humeral Nail were mechanically tested in torsion and four-point bending. The Russell-Taylor and the Seidel interlocking nails are reamed systems that rely on proximal interlocking screws and distal screws or phalanges respectively for rotational stability. However, axillary nerve damage may result during proximal screw placement, and these systems exhibit low resistance to rotation. The True-Flex intramedullary nail is an unreamed system that relies on cross-sectional geometry to achieve rotational stability. By not relying on interlocking screws for stability, nerve damage associated with the screw placement may be eliminated. However, the results indicate the cross-sectional geometry of the True-Flex nail is not able to provide the same degree of static locking as the Russell-Taylor or Seidel interlocking nails. Humeri implanted with the Russell-Taylor and Seidel nails also had a significantly greater torsional stiffness than the True-Flex nail. As expected, humeri implanted with the Russell-Taylor and Seidel nails also had a significantly greater bending stiffness than the True-Flex nail in both anterior-posterior and medial-lateral bending.