Duran Yetkinler

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.

Mechanical properties of carbonated apatite bone mineral substitute: strength, fracture and fatigue behaviour

The synthesis and properties of carbonated apatite materials have received considerable attention due to their importance for medical and dental applications. Such apatites closely resemble the mineral phase of bone, exhibiting superior osteoconductive and osteogenic properties. When formed at physiological temperature they present significant potential for bone repair and fracture fixation. The present study investigates the mechanical properties of a carbonated apatite cancellous bone cement. Flexural strength was measured in three and four point bending, and the fracture toughness and fatigue crack-growth behaviour was measured using chevron and disc-shaped compact tension specimens. The average flexural strength was found to be ∼0.468 MPa, and the fracture toughness was ∼0.14 MPa√m. Fatigue crack-growth rates exhibited a power law dependence on the applied stress intensity range with a crack growth exponent m=17. The fatigue threshold value was found to be ∼0.085 MPa√m. The mechanical properties exhibited by the carbonated apatite were found to be similar to those of other brittle cellular foams. Toughness values and fatigue crack-growth thresholds were compared to other brittle foams, bone and ceramic materials. Implications for structural integrity and longer term reliability are discussed.

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.

Tibial plateau fracture repairs augmented with calcium phosphate cement have higher in situ fatigue strength than those with autograft.

Objectives: This study compared the biomechanical fatigue strength of calcium phosphate augmented repairs versus autogenous bone graft (ABG) repairs in lateral tibia plateau fractures. Methods: Eight matched pairs of tibias (six male, two female; age, 75 ± 14 years) were harvested from fresh-frozen cadavers. Reproducible split-depression fractures were simulated and repaired by an orthopaedic traumatologist using a lateral tibial plateau plate. One tibia from each donor was randomly assigned to either calcium phosphate (Callos; Acumed, Hillsboro, OR) or ABG as augmentation. The femoral component of a hemitotal knee arthroplasty was attached to the actuator of a servohydraulic press and centered above the repair site. Cyclic, physiological compression loads were applied at 4Hz starting with a maximum load of 15% body weight and increasing by 15% body weight every 70,000 cycles. Loading conditions were determined from calculations of weight distribution, joint contact area, and gait characterization from existing literature. Repair site depression and stiffness were measured at regular intervals. Specimens were then loaded to failure at 1 mm/min. Results: Calcium phosphate augmented repairs subsided less and were more stiff during the fatigue loading than were ABG repairs at the 70,000, 140,000, and 210,000 cycle intervals (P < 0.03) All repairs survived to 210,000 cycles. The average ultimate load of the calcium phosphate repairs was 2241 ± 455 N (N = 6) and 1717 ± 508 N (N = 8) for ABG repairs (P = 0.02). Conclusion: Calcium phosphate repairs have significantly higher fatigue strength and ultimate load than ABG repairs and may increase the immediate weightbearing capabilities of the repaired knee.

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.