Fatigue testing of a proximal femoral hip component.

The Gothenburg Osseointegrated Titanium (GOT) implant is a novel total hip replacement including a metaphyseal loading proximal femoral component fixed in the retained femoral neck. Endurance testing was performed under conditions analogous to ISO 7206-4: 1989. The cement-free implant is not fixed distally within the intramedullary canal, so distal embedding (as specified in the standard) would have been unrealistic. Instead glass-fibre-reinforced epoxy (GFRE) bushings were used to model reduced bone support mid-length at the medial cortex and distally at the lateral cortex. Such support simulated proximal bone loss, realistically reproducing the effect of osteolysis or fixation failure. Under such conditions the component survived unbroken for 10 million cycles at 3.0 kN peak load.

A proximal femoral implant preserves physiological bone deformation: a biomechanical investigation in cadaveric bones.

The aim of this study was to compare the perturbances in bone deformation patterns of the proximal femur due to a conventional cemented femoral stem and a novel uncemented implant designed on the principles of osseointegration. Five matched pairs of fresh frozen human femora were mechanically tested. Bone deformation patterns, measured with a video digitizing system under 1.5 kN joint force, showed that the cemented Spectron femoral implant caused significant alterations to the proximal femoral deformation pattern, whereas the Gothenburg osseointegrated titanium femoral implant did not significantly alter the bone behaviour (p < 0.05). Vertical micromotions measured under 1 kN after 1000 cycles were within the threshold of movement tolerable for bone ingrowth (21 microm for the Gothenburg system and 26 microm for the cemented implant).

Friction in orthopaedic zirconia taper assemblies.

The torque resistance of zirconia ceramic heads/titanium taper trunnion junctions was tested in accordance with ISO 7206-9:1994(E); using twelve modified heads of 32 mm diameter under representative physiological conditions. Test parameters studied included assembly force, vertical load during test (test load) and head length. Mean torque resistances measured were 8.9 N m for a 1 kN test load and 15 N m at 4 kN test load. Coefficients of friction calculated for the torsional stability ranged from 0.06 to greater than 1.0. Multiple regression analysis confirmed that the failure torques measured were significantly dependent on test load (beta = 0.77; P < 0.001) whereas assembly force and head length played a lesser, insignificant, part in the variation. Data from push-on/pull-off tests were used to calculate coefficients of friction under axial loading, which were significantly correlated with taper angle and material. Torque testing shows greater variability than push-on/pull-off tests for similar combinations, and for zirconia heads on other tapers. The coefficients of friction measured (0.16-0.31) are significantly different from values typically used in stress analyses.

Inaccuracy of acetabular reaming under surgical conditions.

Press-fit uncemented acetabular components require accurate implant-bone cavity fit. Ten cavities produced during actual hip arthroplasty using debris-retaining reamers were replicated in dental alginate. An experimental reamer with better cutting prepared 12 acetabulae in mortuo under similar conditions. Positives in dental stone were measured on a coordinate measuring center. Spheres of best-fit and variation of each point from these spheres were calculated. Control cavities in polyurethane foam were measured to estimate casting errors. Diametral errors of conventionally reamed cavities averaged 2.1%, whereas experimental reamers' cavities varied by 0.5% (P < .005). Overall surface variation from hemispheric form in conventionally reamed cavities exceeded the experimental reamer's results (P < .005). Conventional acetabular reamers cut bone inaccurately. Reamers designed for improved bone cutting reduce cavity errors.

Press-fit acetabular cup fixation: principles and testing.

Pre-clinical testing of the fixation of press-fit acetabular components of total hip prostheses relies on cadaver or synthetic bone, but the properties and geometry of bone models differ from those of physiological bone. Cup designs use varied mechanisms for initial stability in bone; therefore, using different analogues and tests is appropriate. Press-fit cup stability was tested in the following: firstly, polyurethane (PU) foam modelling cancellous support; secondly, glass-fibre reinforced epoxide (GFRE) tubes modelling acetabular cortical support; thirdly, cadaveric acetabula. Three commercial cups [Harris-Galante II (H-G-II), Zimmer; Optifix, Smith & Nephew, Richards; porous coated anatomic (PCA), Howmedica] and an experimental cup with enhanced rim fixation were tested in three modes: direct pull-out, lever-out and axial torque. The fixation stabilities measured in the PU and the GFRE models showed trends consistent with those in cadaver bone, differing in the oversizing and cup geometry. The experimental cup was significantly more secure in most modes than other cups; the H-G II and Optifix cups showed similar stabilities, lower than that of the experimental cup but greater than that of the PCA cup (analysis of variance and Tukey's highly significant test; p < 0.001). The stabilities measured in cadaver bone more closely approximated those in GFRE. The use of several bone analogues enables separation of fixation mechanisms, allowing more accurate prediction of in vivo performance.

Bone mineral and migratory patterns in uncemented total knee arthroplasties: a randomized 5-year follow-up study of 38 knees.

We measured the amount of bone mineral in the medial tibial condyle 1 week postoperatively, after 1 year and after 4-5 years in 38 arthrotic knees randomized to a Freeman-Samuelson hydroxyapatite-coated (FS HA) or a Miller-Galante II (MG II) total knee arthroplasty. Clinically excellent results were recorded in both groups after 5 years. At the last follow-up, the overall decrease in bone mineral was 26%, as measured by triple-energy X-ray absorptiometry. The decrease was larger in FS HA knees than in MG II knees after 4-5 years, indicating stress-shielding of the proximal tibia. Radiostereometry at 1 and 5 years showed smaller maximum total point motion, maximum subsidence and varus or valgus tilt in the FS HA group. There was a tendency towards a reversed relationship between subsidence and change in bone mineral after 1 year, but not after 4-5 years. Distal fixation of the stem in the Freeman-Samuelson hydroxyapatite-coated (FS HA) components might explain the more pronounced loss of bone mineral in the medial tibial condyle.

Gothenburg osseointegrated hip arthroplasty. Experience with a novel type of hip design.

The culmination of more than 10 years of laboratory and clinical research has been the clinical trial of a novel hip arthroplasty for osseointegration. The femoral component of this Gothenburg hip is a neck retaining, threaded fixture with rotational symmetry, produced in commercially pure titanium with a specific surface texture. Proximally, a standard orthopaedic taper trunnion mates with a 28-mm diameter zirconia head that articulates against the acetabular component. The latter is also of textured commercially pure titanium, encapsulating a thick ultra high molecular weight polyethylene liner. Dedicated alignment guides and cutting instruments ensure accurate bone preparation and implant placement. Limited clinical trials commenced in 1992 and expanded to multicenter clinical trials in 1997. Every hip has been monitored with radiostereometry to measure migration to an accuracy of 0.1 mm. All calcar implanted femoral components show excellent function at 4 to 5 years followup, with no migration revealed by radiostereometry.

A new radiographic method for detection of tibial component migration in total knee arthroplasty.

In a prospective study the accuracy of a new radiographic method, Matched Indicators for Radiographic Assessment (MIRA), used to assess tibial component migration in total knee arthroplasty was evaluated. Radiopaque markers were placed in the tibial component and the tibial metaphysis in a standardized way so that four vertical distances could be measured on standard radiographs. Subsidence during the first postoperative year was measured both with this new method and with roentgen stereophotogrammetric analysis in 27 Freeman-Samuelson total knee arthroplasties. The error of measurement of MIRA was determined using the known error of roentgen stereophotogrammetric analysis. The new method was found to be promising with an accuracy of 1 mm, and the correlation between MIRA and roentgen stereophotogrammetric analysis was high when subsidence exceeded this value. Therefore, subsidence of clinical importance should be detected with MIRA. The method is simple and well suited for routine follow-up examination of large patient materials.

Proximally cemented versus uncemented Freeman-Samuelson knee arthroplasty. A prospective randomised study.

We studied the effect of a layer of cement placed under the tibial component of Freeman-Samuelson total knee prostheses with a metal back and an 80 mm intramedullary stem, using roentgen stereophotogrammetry to measure the migration of the tibial component during one year in 13 uncemented and 16 cemented knees. The addition of cement produced a significant reduction in migration at one year, from a mean of 1.5 mm to one of 0.5 mm (p less than 0.01), including a significant reduction in pure subsidence. One year postoperatively the clinical results were similar between the groups, but, at three years, one uncemented knee had required revision.

A histomorphometric study of unthreaded hydroxyapatite-coated and titanium-coated implants in rabbit bone.

Hydroxyapatite-coated and titanium-coated IMZ dental implants were investigated in an animal study. The implants were placed in the distal femurs of rabbits. Six months after placement, histomorphometric evaluation of the bone-to-implant contact was conducted. The hydroxyapatite-coated specimens demonstrated significantly more direct bone contact compared to the titanium-coated controls.

The effect of a stem on the tibial component of knee arthroplasty. A roentgen stereophotogrammetric study of uncemented tibial components in the Freeman-Samuelson knee arthroplasty.

We studied the effect of a metal tray with an intramedullary stem on the micromotion of the tibial component in total knee arthroplasty. Of 32 uncemented Freeman-Samuelson knee arthroplasties performed in London and Gothenburg, nine had a metal backing and stem added to the tibial component. Micromotion of the tibial components, expressed as migration and inducible displacement, was analysed using roentgen stereophotogrammetric analysis up to two years follow-up. The addition of a metal back and a 110 mm stem to the standard polyethylene component significantly reduced both migration over two years and inducible displacement.

Bone response to plasma-cleaned titanium implants.

Glow-discharged titanium implants, with a presumed high surface energy, and conventionally prepared and sterilized titanium implants were inserted in the rabbit tibia and femur. The removal torque and histology were compared after 6 weeks in situ. No qualitative or quantitative differences were detected for implants with different preoperative preparation. The results indicate that the conventional implant treatment described is sufficient to give a surface condition with similar early healing responses as those observed with glow-discharge-treated implants.