Deborah J. Hall

Increased bone formation using calcium sulfate-calcium phosphate composite graft.

Calcium phosphates (CaPO4) and faster-resorbing calcium sulfate (CaSO4) are successfully employed as synthetic bone grafts for treatment of contained defects. We used a canine critical-sized bone defect model to study an injectable CaSO4/CaPO4 composite graft that incorporated a matrix of CaSO4 and dicalcium phosphate dihydrate into which β-tricalcium phosphate granules were distributed. The area fraction, ultimate compressive stress, and elastic modulus of restored bone and the relative rates of material resorption were compared between the CaSO4/CaPO4 composite graft and pure CaSO4 pellets and to normal canine bone. The area fraction of bone in stained sections and the ultimate compressive stress of the regenerated bone were greater using the CaSO4/CaPO4 composite graft compared to pure CaSO4 pellets after 13 and 26 weeks and were greater than normal bone. The elastic modulus of restored bone in defects treated with CaSO4/CaPO4 composite graft was greater than in defects treated with CaSO4 pellets after 26 weeks, but similar to specimens of normal bone. A small amount of CaSO4/CaPO4 composite graft and no CaSO4 pellets remained after 13 or 26 weeks. This novel CaSO4/CaPO4 composite holds promise for clinical applications where a strong, injectable, slower-resorbing, and biocompatible bone graft substitute would be advantageous.

Vertebroplasty comparing injectable calcium phosphate cement compared with polymethylmethacrylate in a unique canine vertebral body large defect model

BACKGROUND CONTEXT Vertebroplasty was developed to mechanically reinforce weakened vertebral bodies. Polymethylmethacrylate (PMMA) bone cement has been most commonly used but carries risks of thermal injury and respiratory and cardiovascular complications. Calcium phosphate (CaP) offers the potential for biological resorption and replacement with new bone, restoring vertebral body mass and height. PURPOSE To compare compressive strength, elastic modulus of the adjacent motion segments, and histologic response of vertebral bodies injected with either CaP or PMMA in a canine vertebroplasty model. STUDY DESIGN By using a canine vertebroplasty model, two level vertebroplasties were performed at L1 and L3 and studied for 1 month (n=10) and 6 months (n=10). In each canine, one vertebral defect was randomly injected with either CaP cement (BoneSource; Stryker, Freiberg, Germany) or PMMA. METHODS Twenty dogs had an iatrogenically created cavitary lesion at two nonadjacent levels injected with either CaP or PMMA. Canines from each group were tested mechanically (n=5) and histologically (n=5). Histology consisted of axial sections of the L1 and L3 vertebral bodies and high-resolution contact radiographs. Sections from each specimen were embedded in plastic without decalcification to study the bone-cement interface. Bone-cement interfaces were compared for evidence of necrosis, fibrosis, foreign body response, cement resorption, and new bone formation between the PMMA and CaP treatments groups. Mechanical compression testing was performed on specimens from the 1-month (n=5) and 6-month (n=5) time periods. The T13 vertebral body was used as an intact control for the destructive compression testing of L1 and L3. Each vertebral body was compressed to 50% of its original height under displacement control at 15 mm/min to simulate a nontraumatic loading situation. Force and displacement data were recorded in real time. RESULTS Vertebral sites containing PMMA were characterized by a thin fibrous membrane. PMMA was detected within the trabeculae, vascular channels, and the spinal canal. Unlike PMMA, CaP underwent resorption and remodeling with vascular invasion and bone ingrowth. Woven and lamellar bone was found on the CaP cement surface, within the remodeled material, and on the surrounding trabeculae. Vertebral body compression strength testing revealed no significant difference in vertebral body height and compressive strength between PMMA and CaP. There was a trend for CaP-treated vertebrae to increase in compressive strength from 1 month to 6 months, whereas PMMA decreased compressive strength when compared with adjacent nontreated vertebrae. CONCLUSION For both short and intermediate time periods, the injection of CaP cement can be an effective method to treat large vertebral defects. Early results indicate that CaP remodeling might result in the resorption of the majority of the cement with replacement by lamellar bone.

Influence of pH on the tribocorrosion behavior of CpTi in the oral environment: synergistic interactions of wear and corrosion †

UNLABELLED Dental implants made of titanium alloys have been used as a predictable therapy approach to replace missing teeth. The oral environment subjects titanium implants to varying conditions like changes in pH, temperature, and saliva contamination leading to chemical corrosion together with mastication process. OBJECTIVE In this study, the combined effect of chemical corrosion and wear (so-called tribocorrosion) in the degradation of dental implant material (CpTi) under varying pH oral environment was investigated. METHODS Titanium (CpTi) discs were subjected to sliding tests in artificial saliva at varying pHs: 3.0, 6.0, and 9.0. A custom made tribocorrosion apparatus was used to perform the tests. The tribological system consisted of a ceramic ball of 28 mm diameter articulating against the flat face (titanium). RESULTS Electrochemical impedance spectroscopy results indicated an increase in electrochemical double layer capacitance (C(dl)) at pH 3.0 and 6.0 after sliding. Surprisingly, in the presence of tribological stresses, the measured current evolution was highest and fluctuated the most at pH 6.0. In addition, the greatest weight loss was measured at pH 6.0. CONCLUSIONS Despite reports of CpTi being electrochemically stable down to pH 2.0, this study suggests degradation peaks at near neutral pH values in the presence of motion. At pH 6.0, the passive film layer, typically protecting the surface of titanium may not be reformed cohesively, resulting in more tribocorrosion products at the surface, which are easily sheared off. These findings elevate concern with regard to dental implants because the average pH of the oral cavity is 6.3.

Local and systemic levels of tobramycin delivered from calcium sulfate bone graft substitute pellets.

We asked if tobramycin-loaded calcium sulfate pellets could be used to maintain high local site antibiotic concentrations for an extended period with minimal systemic levels and without adverse effects on vital organs. Calcium sulfate pellets loaded with 10% tobramycin were implanted in contained medullary defects in the proximal humeri of canines. The number of pellets implanted was calculated to yield an equivalent human maximum prescribed dose, and 1.8-fold this dose. These doses converted to approximately 20 mg/kg, and 36 mg/kg, respectively, for the canine. Local and systemic tobramycin levels, pellet resorption, bone response, clinical pathology parameters, and histopathologic responses of potential target organs were analyzed to determine if there was any adverse response for a 28-day period. Serum tobramycin was elevated for less than one day while local levels remained elevated for at least 14 days, and in some animals, 28 days. Tobramycin delivered locally from calcium sulfate pellets had no apparent adverse effect on clinical pathology parameters or on any of the organs that were analyzed. In addition, bone formation and pellet resorption followed patterns typically seen with calcium sulfate materials.

Healing of large defects treated with calcium sulfate pellets containing demineralized bone matrix particles.

Calcium sulfate (OsteoSet, Wright Medical Technology, Inc, Arlington, Tenn) and calcium sulfate/demineralized bone matrix (DBM) pellets (OsteoSet DBM, Wright Medical Technology, Inc) have been evaluated preclinically in a bilateral medullary defect model of a canine humerus. In this model, both short (6 week) and long (26 week) time points have been evaluated. An analysis of bone response to the pellets was conducted using radiological, histological, mechanical, and quantification techniques. The calcium sulfate/DBM pellets exhibited more rapid trabecular bone remodeling as demonstrated by the absence of the ringlet bone structure typically seen with calcium sulfate pellets. We concluded that calcium sulfate and calcium sulfate/DBM pellets are both effective bone graft substitutes.

Bone Ingrowth Through Porous Titanium Granulate Around a Femoral Stem

The procedure of using of porous titanium granules for cementless fixation of a hip replacement femoral stem was studied in a hemiarthroplasty model in 10 canines for 6 months. A vibrating instrument was used to facilitate both the delivery and distribution of the irregularly shaped porous titanium granules into the femoral canal as well as the subsequent insertion of a titanium alloy stem into the intramedullary bed of granules. Histological examination revealed lamellar bone formation through the mantle of porous titanium granules in continuity with the surrounding cortex resulting in the formation of an integrated mantle of bone and titanium granulate around the prosthesis.

Restoration of large bone defects using a hard-setting, injectable putty containing demineralized bone particles compared to cancellous autograft bone.

An injectable, hard-setting, calcium sulfate-based putty containing demineralized bone matrix particles (AlloMatrix II, Wright Medical Technology, Inc, Arlington, Tenn) was compared to autogenous cancellous bone graft to evaluate healing in a canine model. Area fraction of new bone, modulus of elasticity, and compressive strength of new bone were evaluated, as was radiographic and histologic healing. Bilateral defects were created in the proximal humeri, and each defect was implanted with either the putty or autogenous bone according to a randomized schedule. Dogs were euthanized at 6, 13, and 26 weeks. The area fraction, modulus of elasticity, and compressive strength of newly formed bone was not significantly different between the putty and autogenous bone at 6, 13, or 26 weeks. The putty had excellent handling characteristics, was biocompatible, and was as effective as autograft bone in achieving near complete bony restoration of a large, critical-sized defect.

Successful long-term fixation and progression of osteolysis associated with first-generation cementless acetabular components retrieved post mortem.

BACKGROUND Primary cementless acetabular reconstruction has shown durable long-term fixation. Late failures secondary to aseptic loosening are rare but may occur in patients with previously well-fixed components. In the present study, the histopathological characteristics of postmortem specimens were correlated with wear damage and radiographic data in an attempt to better understand the long-term events in the periacetabular tissue around well-functioning devices. METHODS Seventeen primary cementless Harris-Galante I acetabular components with adjacent tissues were harvested after a mean of eleven years (range, four to twenty-five years) from patients whose implants were well functioning at the time of death. Undecalcified and paraffin sections were used to quantify the extent of bone and soft tissues within the porous coating and at the interface between the coating and the surrounding bone. Wear particles were identified with use of polarized light microscopy and energy-dispersive x-ray analysis. Bearing-surface volumetric wear and backside wear damage of the polyethylene liner were assessed. RESULTS All of the components were fixed by bone ingrowth (mean extent, 33% ± 21%). Particle-induced granulomas were present in the porous coating and along the interface and progressed through screw holes, ballooning into the retroacetabular bone in the longer-term specimens. Particles of femoral and acetabular origin were identified in the granulomas. Bearing-surface volumetric wear (mean, 41.6 mm3/year) increased with duration and correlated with increasing extent of granuloma in the porous coating and the increasing size of pelvic granulomas. Radiolucencies on radiographs correlated with the extent of bone and fibrous tissue ingrowth. Of the six pelvic granulomas that were identified histologically, only one was apparent on routine radiographs. CONCLUSIONS Acetabular fixation by bone ingrowth can be successful into the third decade after implantation. Osteolysis and secondary replacement of bone with particle-induced granuloma are commonly seen in the presence of excellent clinical function. Strategies designed to minimize bearing-surface wear and backside damage are important to maintain long-term bone ingrowth fixation.

Osseous healing using injectable calcium sulfate-based putty for the delivery of demineralized bone matrix and cancellous bone chips.

Three formulations of injectable calcium sulfate-based putties containing demineralized bone matrix (DBM), 50% DBM/50% cancellous bone (CB) chips, and 30% DBM/70% CB were studied in canines. Four humeral defects per dog were implanted with one of each of the putty formulations while the fourth defect was left untreated. After 6 weeks, the dogs were euthanized. Radiographs and histology showed that the area fraction of new bone in the defects was greater for the three putty formulations than the untreated defects. The area of residual cancellous bone graft remaining in the defects was <10% in both CB putties. Residual calcium sulfate was not apparent in any of the histological sections. We conclude that fast-resorbing calcium sulfate-based putties are effective delivery means of bone graft materials for the successful restoration of bony defects.

An Injectable Calcium Sulfate-Based Bone Graft Putty Using Hydroxypropylmethylcellulose as the Plasticizer

The addition of a plasticizer to synthetic bone graft substitutes can improve handling characteristics, injectability, and the ability to uniformly fill defects. Restoration of large medullary bone defects using an injectable calcium sulfate-based putty using hydroxypropylmethylcellose as the plasticizer was compared to conventional calcium sulfate paste in a canine model. Beginning 2 weeks following implantation, serial clinical and specimen radiographs demonstrated a similar progressive resorption of the implanted materials and replacement with new bone for both the putty and paste forms of calcium sulfate. The area fraction of new bone and remaining implant material in bone defects treated with the putty were not significantly different from defects treated with conventional calcium sulfate paste after 13 and 26 weeks. In addition to its handling characteristics, the putty was biocompatible and as effective as conventional calcium sulfate paste in achieving substantial bony restoration of a large, critical-size bone defect.