The influence of surface roughness on stem-cement gaps

We have compared the interface morphology at the stem-cement interface of standard Charnley stems with a satin finish (Ra = 0.75 microm) with identical stems which had been grit-blasted over their proximal third (Ra = 5.3 microm) to promote a proximal bond. The stems were cemented into cadaver femora using conventional contemporary cementing techniques. After transverse sectioning, we determined the percentage of the perimeter of the stem which had a gap at the interface. There were substantial gaps (mean 31.4 +/- 17.1%) at the stem-cement interface in the grit-blasted region. This fraction was significantly (paired t-test, p = 0.0054) higher than that found around the contralateral satin-finished stems (mean 7.7 +/- 11.7%). Although studies of isolated metal-cement interfaces have shown that the bond strength can increase with surface roughness it cannot be assumed that this effect will be observed under clinical conditions.     

Fluid flow around model femoral components of differing surface finishes: in vitro investigations

We studied fluid flow at the stem-cement interface of bonded and debonded, polished and rough model femoral components. In a first series of experiments, fluid flow along the interface between bone cement and well-fixed model femoral components, differing in surface finish, and in shape, was measured. Fluid migration along the bone-cement interface of rough stems (Ra 3 microm) was greater than that on polished stems (p < 0.001). This was true of cylindrical and conical tapered stems. On stems with the same surface finish, shape did not influence fluid migration. In a second series of experiments, fluid flow along the stem-cement interface of 5 highly polished and 10 rough-finished (5 of Ra approximately 1.5 microm and 5 of Ra approximately 3 microm), debonded, tapered circular stems was measured. None of the rough stems could prevent fluid flow along the stem-cement interface. Polished tapered stems sealed the interface and, after 48 hrs of continuous pressure, no fluid flow was observed. This difference in the ability to seal the stem-cement interface between rough and polished stems was significant (p < 0.001). The difference in fluid migration along the stem-cement interface of rough and polished stems which we observed offers a plausible explanation of the occurrence of osteolysis distal to the articulation of cemented THR in the presence of cement mantle defects. It may also explain why osteolysis is uncommon with polished double-tapered stems.     

The significance of stem-cement loosening of grit-blasted femoral components

This study analyzed 15 patients who underwent revision for loosening at the stem-cement interface. The femoral components were from the same manufacturer and had grit-blast roughened surfaces. An apparent radiographic deficiency in the cement mantle was present in at least one zone in 1 3 patients. In 9 of 12 patients with localized osteolysis, the osteolysis developed in a zone with an apparent radiographic cement mantle defect. Loosening occurred due to tension failure of the stem-cement interface followed by axial subsidence and movement into relative retroversion. Motion between the stem and the cement mantle fueled an abrasive wear mechanism between the roughened metal surface and the cement mantle, generating excessive metal and cement particles that gained access to endosteal bone via defects in the cement mantle and resulting in localized osteolysis. Although the roughened surface played a central role in these failures, it is unlikely the layer of polymethylmethacrylate (precoat) played a role in the mechanism of failure. In some cases, debonding occurred as a result of tension failure of the metal-precoat interface. In others, tension failure occurred within the cement mantle, leaving the precoat and some cement from the mantle on the stems. There was no difference in the mechanism of failure of stems with precoat proximally compared to stems with precoat proximally and distally. One stem had no precoat; findings in this patient were indistinguishable from the others. The significance of debonding depends on the surface roughness of the stem. Debonding carries a poorer prognosis with a rougher stem surface because of abrasive wear with the generation of numerous metal and cement particulates, which can lead to rapid osteolysis if there are cement mantle defects. Stems with a higher metal-cement bond strength may require a higher quality cement mantle for long-term success.     

Effects of preheating of hip prostheses on the stem-cement interface

BACKGROUND: Debonding of the cement from metal implants has been implicated in the loosening of cemented total hip prostheses. Strengthening of the stem-cement interface has been suggested as a way to prevent loosening of the component. Previously, it was reported that preheating the stem to 44 degrees C reduced the porosity of the cement at the stem-cement interface. The purpose of this study was to determine the effect of stem preheating on the characteristics of the stem-cement interface. METHODS: The effects of stem preheating, at temperatures of 37 degrees C, 44 degrees C, and 50 degrees C, on the stem-cement interface were studied in a test model and a preparation that closely simulated the clinical situation. Static interface strength was determined initially and after the stems had been kept in isotonic saline solution at 37 degrees C for two weeks. Fatigue lifetimes were measured, and the nature and extent of porosity at the interface were quantified. RESULTS: Stem preheating had significant effects on the stem-cement interface. Stems preheated to 37 degrees C had greater interface shear strength than stems at room temperature both initially (53% greater strength) and after simulated aging (155% greater strength). Fatigue lifetimes were also improved, and there was a >99% decrease in interface porosity. The setting time of the cement decreased 12%, and the maximum temperature at the cement-bone interface increased 6 degrees C. Similar effects were found after preheating to 44 degrees C and 50 degrees C. CONCLUSIONS: Stem preheating had significant effects on the stem-cement interface, with significant improvements in the shear strength and cement porosity of the interface. Also, polymerization temperatures at the cement-bone interface increased. The possible biological effects of these increased interface temperatures at the cement-bone interface require further study.     

Radiographic analysis of a low-modulus titanium-alloy femoral total hip component. Two to six-year follow-up

We performed a detailed serial radiographic analysis of the femoral component of 323 cemented low-modulus titanium-alloy total hip prostheses. There was a low incidence of femoral component loosening as manifested by radiolucent zones at the stem-cement interface or cement fractures. There was also a low incidence of resorption of the calcar and cortical hypertrophy. Comparison of our data with those of others indicated that the incidence of loosening, calcar resorption, and cortical hypertrophy was usually lower than with similarly designed conventional high-modulus Charnley stems. These findings appear to support computer-modeling studies that have predicted a more even distribution of stresses along the entire length of the stem of the titanium-alloy prosthesis. Of the two configurations of femoral components used, the straight stems demonstrated a significantly lower incidence of radiographic evidence of loosening, calcar resorption, and cortical hypertrophy than the curved stems did. These findings have provided sufficient biomechanical rationale for the evolutionary development of the second-generation femoral components, which incorporate many features of the straight stem.     

In vitro long-term fatigue endurance of the secondary "Cement Injection Stem" hip prosthesis

A secondary cementation hip stem (Cement Injection Stem; Aesculap, Tuttlingen, Germany) was designed to reduce the risk of fat embolism, and achieve precise implant position and high-quality cement mantle. A validated long-term in vitro simulation was carried out that replicated 24 years of activity of a very demanding patient. Inducible and permanent micromotions were monitored. The cement mantle was sectioned and inspected for signs of fatigue damage. The stem-cement interface was inspected for fretting. Results were compared against previously published results for a conventionally implanted stem with comparable design (Centrament; Aesculap) from which this project was derived. Comparable micromotions were found (slightly larger proximally, in correspondence to the precured centralizer). No sign of fretting was observed. All fatigue damage indicators were comparable or significantly better than those for the conventionally implanted stem. The few cement cracks found were mainly localized in proximity of a proximal drainage hole. It is foreseen that when this detail is optimized, long-term endurance will further improve.     

Experimental study on the cement mantle in hip arthroplasty: effect of defects on the property of the materials used

The study simulated implantation of a hip prosthesis stem in the femur. The cement mantle produced in vitro was observed under an optic microscope. A higher concentration of porosity in the cement mantle at the stem-cement interface was observed. By heating the stem to 45 degrees C and 55 degrees C the authors observed a reduction in porosity in the three surfaces examined: stem-cement interface, internal surface, and cement-pseudofemur interface. Heating of the stem causes a reduction in polymerization time and an increase in maximum temperature achieved during the polymerization process. A reduction in porosity at the stem-cement interface influenced bending strength of the specimens extracted from the mantle. A significant difference between resistance to flexion in the specimens produced with the stem at 55 degrees, and in those with the stem at 23 degrees C was observed.     

Mechanical characteristics of the stem-cement interface

The mechanical characteristics of the interface between a metallic stem and the surrounding poly(methyl methacrylate) bone cement were determined from experimental tests and finite element analyses. Push-through-stem tests of straight and tapered titanium alloy stems, surrounded by cement columns, were performed and the resulting load-displacement behavior and strain distribution on the surface of the cement column were measured for loading, unloading, and reloading. Test geometries were modelled using nonlinear, axisymmetric, finite element analyses, which incorporated Coulomb friction elements at the titanium alloy-cement interface. Initial residual stresses, due to curing of the cement column, were modeled by thermal contraction of the cement. Good agreement was obtained between load-displacement curves and surface strains predicted from the nonlinear analysis and those obtained from experiments, when a coefficient of friction of 0.3 was assumed for the stem-cement interface. These results show that, in the absence of chemical adhesion, the load-displacement behavior of a stem-cement composite can be described completely in terms of the friction at the interface and the residual stresses normal to the interface.     

Stem-cement porosity may explain early loosening of cemented femoral hip components: experimental-computational in vitro study.

A combination of laboratory experiment and computational simulation was performed to assess the role of interface porosity on stem migration. The early motion of in vitro prepared cemented femoral components was measured during application of cyclic stair climbing loads. Following testing, transverse sections were obtained and the distribution of pores at the stem-cement interface was determined. Finite element models of cemented stem constructs were developed and a scheme was implemented to randomly assign pores to the stem-cement interface. For a series of 14 in vitro prepared components, pore fractions at the stem-cement interface ranged from 23% to 67%. The majority of pores at the stem-cement interface were less than 1 mm in length with a mean length of 1.27 +/- 2.7 mm and thickness of 0.12 +/- 0.11 mm. For stems with large pore fractions, pores tended to coalesce in longer extended gaps over the stem surface. Finite element and experimental models both revealed strong positive correlations (r(2) = 0.55-0.72; p < 0.0001) between stem-cement pore fraction and stem internal rotation, suggesting that the presence and extent of pores could explain the early motion of the stems. There was an increased volume of cement at risk of fatigue failure with increasing stem migration. Pore fractions greater than 30% resulted in large increases in stem internal rotation, suggesting that attempts to maintain surface porosity at or below this level may be desirable to minimize the risk of clinical loosening.     

Precooling of the femoral canal enhances shear strength at the cement-prosthesis interface and reduces the polymerization temperature.

Preheating of the femoral stem in total hip arthroplasty improves the cement-prosthesis bond by decreasing the interfacial porosity. The main concern, however, is the potential thermal osteonecrosis because of an increased polymerization temperature. In this study, the effects of femoral canal precooling on the characteristics of the cement-stem interface were evaluated in an experimental model for three test conditions: precooling of the femoral canal, preheating of the stem (44 degrees C), and a control in which stems were inserted at room temperature without thermal manipulation of the implant, cement, or bone. Compared to the control group, precooling of the femoral canal and preheating of the stem had similar effects on the cement-stem interface, with greater interfacial shear strength and a reduced porosity. Femoral canal precooling also produced a lower temperature at the cement-bone interface. No difference was found in the ultimate compressive strength of bone cement for the three preparation conditions. Based on this laboratory model, precooling of the femoral canal could improve shear strength and porosity at the stem-cement interface, minimize thermal injury, and maintain the mechanical strength of the cement.     

The Charnley versus the Spectron hip prosthesis: radiographic evaluation of a randomized, prospective study of 2 different hip implants.

A total of 410 hips were randomized to treatment with either a Charnley (206 hips) or a Spectron (204 hips) total hip arthroplasty. The patients were operated on by a standardized procedure using a contemporary cementing technique and were followed after 1, 3, 5 to 6, and 10 years. The postoperative radiographs showed a significantly increased rate of malalignment and consequently low grade of cement mantle quality of the Charnley stem compared to the Spectron. No differences concerning cement mantle quality or positioning were found between the Charnley ogee cup and the metal-backed Spectron. Evaluation of the follow-up radiographs revealed 10 loose Charnley stems and 1 loose Spectron stem and 4 loose Charnley ogee cups and 23 loose Spectron metal-backed cups. The differences of revision rate for the femoral and acetabular components of the 2 prostheses were significant (P = .03, Charnley femoral component more frequent; P = .03, Spectron acetabular component more frequent). The radiographic evaluation strengthened this disparity. Poor wear characteristics of the metal-backed Spectron cup are perhaps the main reason for the highly significant difference in mechanical failure rate between the 2 cups. We therefore propose that metal-backing of cemented cups should be avoided, at least when combined with larger femoral heads. The difficulty in positioning the Charnley stem with an adequate cement mantle, especially in the absence of trochanteric osteotomy, might explain the inferior Charnley stem longevity in this study.     

Effects of stem length on mechanics of the femoral hip component after cemented revision

Bone loss in the proximal femur at the time of revision hip arthroplasty for a failed primary cemented femoral component can substantially reduce the stability of the revision stem, Use of an extended-length femoral component has been suggested to aid in achieving long-term fixation; however, the optimal stem length is unknown, A three-dimensional finite element model of a charnley-type revision femoral component in a sclerotic shell of cortical bone devoid of cancellous bone was developed, and five different stem lengths ranting from 140 to 273 mm were used. The interface between the sclerotic bone and cement mantle consisted of fibrous tissue. Distal to the sclerotic bone, bonding was allowed between the cement and bone. Relative motion between the cement and bone was reduced substantially when the stem extended beyond the original defect. Maximum principal stresses in the proximal cement mantle decreased from 7.7 to 5.5 MPa, but cement stresses near the distal tip increased from 7.9 to 10.7 MPa when the stem just bridged the defect. Further increases in stem length reduced the distal cement stresses. Increases beyond two femoral diameters had a minor effect on changes in relative motion, cement mantle stresses, and stresses across the cement-bone interface. The results suggest that a femoral component that extends beyond the area of cancellous bone defect by two femoral diameters will be most effective in minimizing stresses and motion that could be associated with clinical loosening of the cemented revision. A shorter stem that just bridges the cancellous bone defect left from the primary procedure may not provide adequate distal fixation due to high cement-bone shear stresses.     

Initial stability of cemented femoral stems as a function of surface finish, collar, and stem size

BACKGROUND: The optimum surface roughness of cemented femoral stems used for total hip replacement is a subject of controversy. While rougher surfaces provide stronger cement adhesion, it has been hypothesized that polished, tapered, noncollared stems settle into the cement mantle, providing improved stability. However, the effects of surface finish on the stability of straight, cemented stems tapered only in the coronal plane are not known. METHODS: Using composite model femora, we assessed the initial stability of a straight, cemented femoral stem as a function of surface roughness, the presence or absence of a collar, stem size, and the resultant cement thickness under simulated walking and stair-climbing loads. Otherwise identical stems were manufactured with polished or rough surfaces, with or without a collar, in two different sizes. We isolated these three variables and compared their relative contributions to the motion at the stem-cement interface throughout cyclic loading. We defined three indicators of stability: per-cycle motion, rate of migration, and final migration. RESULTS: Surface roughness had a greater influence on per-cycle motions than did the presence or absence of a collar or cement thickness. Specifically, in the medial-lateral direction, per-cycle motion of polished stems was 43 micro m greater than that of rough stems (p < 0.01). None of the per-cycle motions decreased over the 77,000 load cycles. In contrast, with all stems, the rate of migration decreased over the course of cyclic loading, but the rate of migration of the polished stems was greater than that of the rough stems. Final migrations of the stems over the course of loading were generally distal, medial, and into retroversion. Compared with rough stems, polished stems had 8 to 18 micro m more axial migration (p < 0.001), 48 micro m more anterior-posterior migration (p < 0.001), and 0.4 degrees more rotational migration (p = 0.01). CONCLUSIONS: and Clinical Relevance: The results indicated that, for cemented, straight femoral stems tapered only in the coronal plane, a rough surface offers the advantage of less per-cycle motion. These results may apply to widely used cemented stem designs based on the profile of the original Charnley femoral component, which has approximately parallel anterior and posterior aspects.     

The skeletal response to matt and polished cemented femoral stems

We studied the effect of the surface finish of the stem on the transfer of load in the proximal femur in a sheep model of cemented hip arthroplasty. Strain-gauge analysis and corresponding finite-element (FE) analysis were performed to assess the effect of friction and creep at the cement-stem interface. No difference was seen between the matt and polished stems. FE analysis showed that the effects of cement creep and friction at the stem-cement interface on femoral strain were small compared with the effect of inserting a cemented stem.     

Clinical outcome in total hip arthroplasty using a cemented titanium femoral prosthesis

Between 1988 and 1993, 118 total hip arthroplasties were carried out using cemented titanium alloy stems with modular cobalt-chrome heads. At a mean follow-up of 66.2 months, the overall clinical failure rate as a result of aseptic loosening of the femoral stem was 11.5%. Most failures occurred with smaller stems, especially in heavier patients. Clinical and radiographic data suggest that failure of femoral component fixation was due to high stresses in the cement mantle associated with the increased flexibility of the smaller stems. Radiographs of successful arthroplasties in patients with larger stems showed proximal stress shielding in most. The findings in this study do not support the contention that titanium alloys provide an advantage over more rigid materials in the manufacture of cemented femoral components for total hip arthroplasty.     

In vitro influence of stem surface finish and mantle conformity on pressure generation in cemented hip arthroplasty

Background and purpose Under physiological loads, debonded cemented femoral stems have been shown to move within their cement mantle and generate a fluid pump that may facilitate peri-prosthetic osteolysis by pressurizing fluid and circulating wear debris. The long-term physiological loading of rough and polished tapered stems in vitro has shown differences in performance, with greater interface pressures generated by the rough stems. In this study we investigated the individual effects of stem surface finish, degree of mantle wear, and mode of loading on the stem pump mechanism.Method Rough and polished stems were loaded under different regimes in artificially worn cement mantles that permitted either 2 or 5 degrees of rotational stem movement, and the interface pressures were compared.Results The pressures generated by the rough and polished stems were similar in either type of mantle. The pattern of pressure generation in the 2-degree mantles was similar to the pressures generated by rough stems after long-term loading, but the high posterior wall pressures fell and the tip pressures increased in the 5-degree mantles. The torsional loads were principal drivers of pressure generation in all areas of the interface other than the implant tip, where axial loading predominated.Interpretation Femoral stems with rotational instability under cyclic torsional loads generate elevated interface fluid pressures and flows independently of stem surface finish. The rough surface finish is only important in creating this instability in tapered stems.     

Dependency of cement mantle thickness on femoral stem design and centralizer

Deficient cement mantles may be detrimental with regard to long-term outcome of cemented femoral stems. We performed a cadaver study on 48 left femora with 4 different stem designs (1 anatomic, 3 straight) to study the influence of stem design, centralizer, and femur type on cement mantle thickness. A radiographic and microradiograhic analysis was done. Overall, 88% of stems were aligned within 1 degrees of neutral in the frontal plane. In Gruen zones 1 through 7, we measured 24 thin cement mantles (<2 mm) in 19 specimens with no correlation to stem design or zone. In the sagittal plane, typical areas of thin cement mantles were identified in Gruen zones 8 and 9 (n = 39) and 12 (n = 21). The anatomic stem design carried the lowest risk (54%) of producing a thin cement mantle proximally in Gruen zones 8 and 9. The risk for straight stem designs was >90%. Straight stems without centralizer showed the highest risk of thin cement mantles in Gruen zone 12 (93%). Centralizers were efficient to prevent thin cement mantles in zone 12 but had no effect proximally. Lateral radiographs are essential to allow for adequate radiographic assessment of the cement mantle and stem alignment. There is a high risk of producing thin cement mantles in Gruen zones 8 and 9, in particular when straight stems are used. Posterior canal entry and low neck osteotomies are essential. Anatomic stems respect the anatomy, allow for more even cement mantles, minimize the risk of thin cement mantles without the use of centralizers, and may be considered in the femur with marked proximal bow.     

Femoral alignment of the Charnley stem: a randomized trial comparing the original with the new instrumentation in 123 hips

Deficient cement mantles are associated with aseptic loosening of the stem component of total hip replacement. In a former study of 206 Charnley stems, we found high frequencies of stem malalignment, especially on the lateral view, consequently resulting in a high percentage of low cement mantle grading. If the "true" lateral radiographic projection is not used, there is a risk that the frequency of mantle defects is underestimated. A logistic regression analysis showed a high correlation between low cement mantle grading and stem loosening after a mean follow-up of 10 years. The new Charnley instrumentation was introduced in 1994 and we started a randomized trial including 123 prostheses to determine whether the new instrumentation improved the position of the stem in both the AP and lateral planes. Postoperative radiographs revealed a significant change in AP positioning-i.e., from a high percentage of varus with the original method to valgus with the new instrumentation. However, there was no difference on the lateral view, with a persisting high frequency of stems with implant-inner cortex contact resulting in high percentages of low cement-mantle grading in both systems. If this deficiency, in a long-term perspective, is associated with aseptic loosening, as many authors have claimed, the manufacturers should address the problem.     

Femoral alignment of the Charnley stem: A randomized trial comparing the original with the new instrumentation in 123 hips

Deficient cement mantles are associated with aseptic loosening of the stem component of total hip replacement. In a former study of 206 Charnley stems, we found high frequencies of stem malalignment, especially on the lateral view, consequently resulting in a high percentage of low cement mantle grading. If the "true" lateral radiographic projection is not used, there is a risk that the frequency of mantle defects is underestimated. A logistic regression analysis showed a high correlation between low cement mantle grading and stem loosening after a mean follow-up of 10 years. The new Charnley instrumentation was introduced in 1994 and we started a randomized trial including 123 prostheses to determine whether the new instrumentation improved the position of the stem in both the AP and lateral planes. Postoperative radiographs revealed a significant change in AP positioning - i.e., from a high percentage of varus with the original method to valgus with the new instrumentation. However, there was no difference on the lateral view, with a persisting high frequency of stems with implant-inner cortex contact resulting in high percentages of low cement-mantle grading in both systems. If this deficiency, in a long-term perspective, is associated with aseptic loosening, as many authors have claimed, the manufacturers should address the problem.     

Collarless polished tapered stem: clinical and radiological results at a minimum of ten years' follow-up

We retrospectively reviewed 175 patients (191 hips) who had undergone primary cemented total hip replacement between November 1992 and November 1995 using a collarless polished double-tapered femoral component after a minimum of ten years (mean 11.08; 10 to 12.8). All stems were implanted using contemporary cementing techniques with a distal cement restrictor, pressurised lavage, retrograde cementing with a gun and proximal pressurisation. Clinical outcome was assessed using the Harris Hip score. Radiological analysis was performed on calibrated plain radiographs taken in two planes. Complete radiological data on 110 patients (120 hips) and clinical follow-up on all the surviving 111 patients (122 hips) was available. The fate of all the hips was known. At final follow-up, the mean Harris Hip score was 86 (47 to 100), and 87 of 116 patients (75%) had good or excellent scores. Survival with revision of the stem for aseptic loosening as the endpoint was 100%; and survival with revision of the stem for any reason was 95.9% (95% confidence interval 87.8 to 96.8) at ten years. All the stems subsided vertically at the stem-cement interface in a predictable pattern, at an overall mean rate of 0.18 mm per year (0.02 to 2.16), but with a mean rate of 0.80 mm (0.02 to 2.5) during the first year. The mean total subsidence was 1.95 mm (0.21 to 24). Only three stems loosened at the cement-bone interface. There was excellent preservation of proximal femoral bone stock. There was a high incidence of Brooker III and IV heterotopic ossification affecting 25 patients (22%). The collarless polished tapered stem has an excellent clinical and radiological outcome at a minimum of ten years' follow-up. The pattern and magnitude of subsidence of the stem within the cement mantle occurred in a predictable pattern, consistent with the design philosophy.