Robert D. Poser

Biomechanical and Histological Evaluation of a Calcium Phosphate Cement

It is often difficult to achieve stable fixation of a comminuted fracture associated with a metaphyseal defect. The injection of a resorbable cement into an osseous defect may help to stabilize the fracture and to maintain osseous integrity as the cement is resorbed and replaced by bone. The purpose of the present study was to evaluate the repair of a metaphyseal defect after treatment with an injectable calcium-phosphate cement. The injectable cement undergoes isothermic curing in vivo to form a carbonated apatite (dahllite) with a compressive strength of twenty-five megapascals. Either the cement or allograft bone was placed in proximal tibial metaphyseal and distal femoral metaphyseal defects in seventy-two dogs and was evaluated from twenty-four hours to seventy-eight weeks postoperatively. Histological examination showed that the cement was osteoconductive; nearly the entire surface area was covered with bone two weeks after the injection. The resulting bone-cement composite underwent gradual remodeling over time in a pattern that was qualitatively similar to the remodeling of normal cortical and cancellous bone. Osteoclasts were found to resorb the cement and were usually associated with adjacent new-bone formation. With increasing time in vivo, the cement was penetrated by small blood vessels that became surrounded by circumferential lamellae of bone and that closely resembled evolving haversian systems. This process occurred more rapidly in the cortex than in the medulla. Mechanical testing showed that, by eight weeks, the tibiae that had been treated with cement had reached nearly 100 per cent of the torsional strength of the contralateral, control (intact) tibiae; this finding paralleled the histological observations of bone apposition to the cement and rapid restoration of the cortex. At no time was fibrous tissue present between the cement and the bone, and there was no evidence of acute inflammation. Small particles of cement were present within occasional macrophages during the process of cement resorption, but the macrophages disappeared over time and were not associated with fibrosis or unexpected resorption of bone. Resorption of the cement was incomplete in the medullary area at seventy-eight weeks, but the pattern of cement resorption and bone-remodeling suggested gradual restoration of a physiological proportion of bone and narrow in both the cortical and the medullary region with maintenance of mechanical function. CLINICAL RELEVANCE: The result of the present study suggest that an injectable calcium-phosphate cement that sets in situ may be an attractive, structurally competent augmentation material for the repair of compromised metaphyseal bone. The high compressive strength of this material, as well as its gradual replacement by bone, supports its continued evaluation for use in complex metaphyseal fractures or osseous defects.

Histological, chemical, and crystallographic analysis of four calcium phosphate cements in different rabbit osseous sites

Four calcium phosphate cement formulations were implanted in the rabbit distal femoral metaphysis and middiaphysis. Chemical, crystallographic, and histological analyses were made at 2, 4, and 8 weeks after implantation. When implanted into the metaphysis, part of the brushite cement was converted into carbonated apatite by 2 weeks. Some of the brushite cement was removed by mononuclear macrophages prior to its conversion into apatite. Osteoclastlike cell mediated remodeling was predominant at 8 weeks after brushite had converted to apatite. The same histological results were seen for brushite plus calcite aggregate cement, except with calcite aggregates still present at 8 weeks. However, when implanted in the diaphysis, brushite and brushite plus calcite aggregate did not convert to another calcium phosphate phase by 4 weeks. Carbonated apatite cement implanted in the metaphysis did not transform to another calcium phosphate phase. There was no evidence of adverse foreign body reaction. Osteoclastlike cell mediated remodeling was predominant at 8 weeks. The apatite plus calcite aggregate cement implanted in the metaphysis that was not remodeled remained as poorly crystalline apatite. Calcite aggregates were still present at 8 weeks. There was no evidence of foreign body reaction. Osteoclastlike cell remodeling was predominant at 8 weeks. Response to brushite cements prior to conversion to apatite was macrophage dominated, and response to apatite cements was osteoclast dominated. Mineralogy, chemical composition, and osseous implantation site of these calcium phosphates significantly affected their in vivo host response.

Norian Srs Cement Augmentation in Hip Fracture Treatment: Laboratory and Initial Clinical Results

Bone quality, initial fracture displacement, severity of fracture comminution, accuracy of fracture reduction, and the placement of the internal fixation device are important factors that affect fixation stability. New high strength cements that are susceptible to remodeling and replacement for fracture fixation may lead to improved clinical outcome in the treatment of hip fractures. Norian SRS is an injectable, fast setting cement that cures in vivo to form an osteoconductive carbonated apatite of high compressive strength (55 MPa) with chemical and physical characteristics similar to the mineral phase of bone. It can be used as a space filling internal fixation device to facilitate the geometric reconstruction, load transfer, and healing of bone with defects and/or fractures in regions of cancellous bone. Furthermore, this cement can improve the mechanical holding strength of conventional fixation devices. Use of this material potentially could improve fracture stability, retain anatomy during fracture healing and improve hip function, thus achieving better clinical outcomes. In vivo animal studies have shown the materials biocompatibility, and cadaveric studies have shown the biomechanical advantage of its use in hip fractures. Initial clinical experience (in 52 femoral neck fractures and 39 intertrochanteric fractures) showed the potential clinical use of this innovative cement in the treatment of hip fractures.

Biomechanical evaluation of fixation of intra-articular fractures of the distal part of the radius in cadavera: Kirschner wires compared with calcium-phosphate bone cement.

BACKGROUND The purpose of this study was to compare the biomechanical efficacy of an injectable calcium-phosphate bone cement (Skeletal Repair System [SRS]) with that of Kirschner wires for the fixation of intraarticular fractures of the distal part of the radius. METHODS Colles fractures (AO pattern, C2.1) were produced in ten pairs of fresh-frozen human cadaveric radii. One radius from each pair was randomly chosen for stabilization with SRS bone cement. These ten radii were treated with open incision, impaction of loose cancellous bone with use of a Freer elevator, and placement of the SRS bone cement by injection. In the ten control specimens, the fracture was stabilized with use of two horizontal and two oblique Kirschner wires. The specimens were cyclically loaded to a peak load of 200 newtons for 2000 cycles to evaluate the amount of settling, or radial shortening, under conditions simulating postoperative loading with the limb in a cast. Each specimen then was loaded to failure to determine its ultimate strength. RESULTS The amount of radial shortening was highly variable among the specimens, but it was consistently higher in the Kirschner-wire constructs than in the bone fixed with SRS bone cement within each pair of radii. The range of shortening for all twenty specimens was 0.18 to 4.51 millimeters. The average amount of shortening in the SRS constructs was 50 percent of that in the Kirschner-wire constructs (0.51+/-0.34 compared with 1.01+/-1.23 millimeters; p = 0.015). With the numbers available, no significant difference in ultimate strength was detected between the two fixation groups. CONCLUSIONS This study showed that fixation of an intra-articular fracture of the distal part of a cadaveric radius with biocompatible calcium-phosphate bone cement produced results that were biomechanically comparable with those produced by fixation with Kirschner wires. However, the constructs that were fixed with calcium-phosphate bone cement demonstrated less shortening under simulated cyclic load-bearing.

Superior Compressive Strength of a Calcaneal Fracture Construct Augmented with Remodelable Cancellous Bone Cement

Twenty-six paired, fresh-frozen cadaveric feet were disarticulated at the ankle joint, and the dome of the talus was potted. Stress-risers were placed along the medial, lateral, and posterior aspects of the calcaneus, and the specimen was loaded rapidly to failure in a testing machine to produce a type-IIB displaced intra-articular fracture according to the classification system of Sanders et al. One specimen of each pair was treated with standard internal fixation with bone-grafting (the control group), and the other was treated with similar fixation but with SRS (Skeletal Repair System) calcium phosphate bone cement placed in any osseous defect. All of the specimens were cured for twenty-four hours in a bath of saline solution at 37 degrees Celsius. The specimens were tested cyclically for ten cycles from zero to 100 newtons at one hertz and for 1010 cycles from zero to 350 newtons at one hertz. The deformation per cycle (millimeters per cycle), first-cycle deformation (millimeters), number of cycles to failure, and number of specimens withstanding the cyclical testing were calculated. The specimens were examined radiographically before and after fracture and after reconstruction and testing. A large difference in the results of the cyclical testing was noted. The specimens that had been augmented with the SRS bone cement had an average deformation of 0.00195 millimeter per cycle compared with 1.013 millimeters per cycle in the control group (p < 0.005). A similar magnitude of difference was noted when the results were stratified for good and poor-quality bone. Visual examination and radiographs demonstrated that a type-IIB displaced intra-articular fracture had been created reproducibly, and computed tomographic scans showed that nearly anatomical reconstruction had been achieved in all of the specimens. The computerized tomographic scans revealed good filling of the osseous voids and no evidence of failure of the cement after cyclical loading.

Biomechanical Comparison of Conventional Open Reduction and Internal Fixation Versus Calcium Phosphate Cement Fixation of a Central Depressed Tibial Plateau Fracture

Objective To evaluate the effect of calcium phosphate bone cement on stability and strength of the fracture repair in a central depressed tibial plateau fracture cadaveric model. Design Paired human cadaveric tibial specimens. Setting Biomechanics laboratory. Patients Uniform pure depression fractures of lateral tibial plateau were created in twenty human cadaveric tibial specimens. Intervention The first part of the study used thirteen pairs of tibiae in two groups: a control group receiving the conventional treatment of morselized bone graft and two cancellous screws and an experimental group receiving calcium phosphate bone cement only. The second part of the study used seven pairs of tibiae in two experimental groups: one receiving calcium phosphate bone cement with a more extensive void preparation and the other group receiving calcium phosphate bone cement with a more extensive void preparation and two screws. Main Outcome Measurements Each tibia was loaded on a Material Testing Systems machine from twenty newtons to 250 newtons for 10,000 cycles to simulate immediate postoperative load transmission to the tibial plateau. Specimens were then loaded to failure to determine the ultimate strength of the reconstruction. Displacement of the articular fragment and stiffness at each cycle were measured during dynamic loading. Peak load, deformation at peak load, and resistance to depression were measured during the load to failure. Results The treatment of depressed tibia plateau fractures with a calcium phosphate cement provides equivalent or better stability than conventional open reduction and internal fixation in pure depression tibial plateau fractures. If the fracture void is prepared by eliminating the cancellous bone under the subchondral plate, the results are further improved. Conclusions This study suggests that the non–weight-bearing postoperative period may be significantly reduced without clinically significant articular collapse.

Factors influencing changes in articular cartilage following hemiarthroplasty in sheep

This study examined the relationship between acetabular cartilage properties after hemiarthroplasty surgery and surgical variables including femoral head size and position. Nineteen sheep received unilateral hip arthroplasties and were euthanized one year post‐operatively to harvest the femora and acetabula. Cartilage histology, biochemistry and material properties were determined from samples located in the superior load‐bearing region. Femoral head size mismatch, leg length difference, anterior‐posterior and medial‐lateral offset and anteversion were measured. In the acetabulum, substantial cartilage degradation occurred with widespread fibrillation and significant changes in the biochemical and material properties compared to the intact contralateral joint. Regression analyses on the surgical variables explained 75–80% of the changes in tissue biochemistry but did not explain the material changes. Head size mismatch and leg length difference were the most significant contributors of the five variables examined and therefore may be critical to successful outcome in hemiarthroplasty.

Mechanical evaluation of a carbonated apatite cement in the fixation of unstable intertrochanteric fractures

We created three-part unstable intertrochanteric fractures in 6 pairs of aged, osteopenic, human, cadaveric femora. Fractures were reduced and fixed with a Dynamic Hip Screw (DHS) (Synthes, Paoli, PA). Two test groups were evaluated: 1. Fixation with a DHS, and 2. Fixation with a DHS and calcium phosphate bone cement (Norian SRS (Skeletal Repair System)) augmentation of the fracture line and posteromedial calcar region of the proximal femur. Each femur was loaded to 1,650 N (2.5 body weight) for 10,000 cycles to simulate postoperative load transmission across the fracture construct during normal gait. The load was further increased successively by one body weight for another 10,000 cycles until failure. We evaluated fixation by measuring the amount of sliding of the lag screw of the DHS (shortening) and stiffness of the overall fracture construct (stability). SRS cement-augmented specimens had less shortening (1 mm versus 17 mm) and twice the initial construct stiffness compared to control specimens.