Donald B. Longjohn

Total Hip Arthroplasty with Use of the Metasul Metal-on-metal Articulation: Four to Seven-year Results*

Background: Total hip replacements with a metal-on-metal articulation were commonly used until the mid-1970s; most were then abandoned in favor of hip replacement with a metal-on-polyethylene articulation. The reason for this change was primarily early cup loosening, which was more prevalent with these metal-on-metal designs than it was with metal-on-polyethylene designs. In the late 1980s, a metal-on-metal design with improved clearance (adequate space between the femoral head and the acetabular articulation surface to allow fluid film lubrication and clearance of any debris from within this joint), metal hardness, and reproducible surfaces was introduced by Sulzer Orthopedics in Switzerland. Orthopaedic surgeons were interested in this Metasul articulation because the contribution of polyethylene wear particles to the failure of total hip replacements had become evident. This study was undertaken to review the clinical performance of this implant and to determine if early acetabular loosening or revision and wear and osteolysis were prevalent. Methods: Between 1991 and 1994, seventy patients (seventy hips) had a total hip replacement with the Metasul metal-on-metal articulation and a cemented Weber cup. Nine patients died less than four years after the replacement; none of these deaths were related to the operation. Five patients were not available for radiographic evaluation, but they were contacted and it was known that the hip was not painful and had not been revised. Fifty-six patients (fifty-six hips) had complete clinical and radiographic data four to 6.8 years after the operation, and they made up the study group. The patients were evaluated with use of the Harris hip score, a patient-self-assessment form, and radiographs. Results: At an average of 5.2 years (range, four to 6.8 years) after the operation, the average total Harris hip score for the fifty-three patients who did not have a revision was 89.6 points (range, 62 to 100 points). The average Harris pain score was 41.0 points (range, 30 to 44 points), and the average Harris limp score was 9.4 points (range, 5 to 11 points). One patient had revision of a loose cup, but there were no other loose acetabular components in the series. Two patients had revision of the acetabular component because of dislocation. No patient had a loose or revised femoral component. Therefore, the mechanical failure rate was one (2 percent) of fifty-six patients. Thirty-six of forty-seven patients who completed the patient-self-assessment form rated their result as excellent; seven, as very good; two, as good; one, as fair; and one, as poor. Wear could not be measured on radiographs because of the metal-on-metal articulation. No hip had radiographic evidence of acetabular osteolysis and two hips had calcar resorption, but there was no other radiographic evidence of focal osteolysis. Conclusions: Our four to seven-year experience with this articulation surface indicates that the clinical results are similar to those of total hip replacements with a metal-on-polyethylene articulation. We believe that the Metasul articulation may have a role in reducing the wear that occurs with total hip replacement. The Metasul articulation appears to be particularly indicated for more active patients. A historical comparison with the reports in the literature of which we are aware indicated that the hips in our study had a lower rate of acetabular revision and loosening than did those with previous metal-on-metal designs and that they had no more acetabular loosening or osteolysis than did those with metal-on-polyethylene articulations followed for an average of five years.

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.

Soft tissue balance of the hip.

Release of static and dynamic contractures around the hip provides significant immediate benefits for the patient and accelerates postoperative rehabilitation. Knee pain is decreased, groin pain is eliminated, range of motion of the hip is increased, and functional leg-length difference is reduced. This article emphasizes the importance of techniques used to ensure soft tissue balance.

Effects of dorsal flanges on fixation of a cemented total hip replacement femoral stem.

BACKGROUND Although current designs of cemented femoral stems for total hip replacement include both those with and those without a flanged shape at the proximal end, the influence of anteroposterior dorsal flanges on the fixation of the stem is not completely understood. The purpose of this study was to assess the effects of flanges on femoral stem stability and load transfer to the femur with use of an in vitro model. METHODS We measured femoral surface strains and three-dimensional micromotion in synthetic femora under cyclic loading with four types of stems: those with flanges and those without flanges in two sizes each. The four types of stems were otherwise identical; that is, all of them were straight, polished, and collarless. Stem-cement micromotion measurements and strain measurements were repeated with three stems of each type, whereas bone-cement micromotion measurements were made with one stem of each type. RESULTS Flanges had a greater influence on femoral strains and micromotion than did the difference in the cement thickness resulting from the different stem sizes. Specifically, the flanged stems produced greater strains on the medial femoral surface but smaller strains on the anterior surface than did the non-flanged stems. Flanged stems achieved tighter mechanical interlock within the cement, but these stems increased bone-cement micromotion. Specifically, the motion per cycle of flanged stems within the cement mantle was smaller than that of non-flanged stems, whereas the motion per cycle of the cement mantle within the femoral canal was greater with the flanged stems than with the non-flanged stems. CONCLUSIONS Flanges on a total hip femoral stem increase the interlock between the stem and the cement and decrease the proximal-medial stress-shielding. However, these advantages occur with increased bone-cement interface motion, which may be detrimental to the survival of the implant.

The influence of proximal stem geometry and surface finish on the fixation of a double-tapered cemented femoral stem.

In this study, the in vitro fixation of four otherwise identical double-tapered stem-types, varying only in surface finish (polished or matte) and proximal stem geometry (with or without flanges) were compared under two conditions. First, four specimens of each stem type were tested with initially bonded stem-cement interfaces, representing early post-operative conditions. Then, simulating conditions a few weeks to months later, stems were implanted in unused synthetic femurs, with a thin layer coating the stem to prevent stem-cement adhesion. Per-cycle motions were measured at both cement interfaces throughout loading. Overall, surface finish had the smallest relative effect on fixation compared to flanges. Flanges increased axial fixation by 22 μm per-cycle, regardless of surface finish (P=0.01). Further, all stems moved under dynamic load at the stem-cement interface during the first few cycles of loading, even without a thin film. The results indicate that flanges have a greater effect on fixation than surface finish, and therefore adverse findings about matte surfaces should not necessarily apply to all double-tapered stems. Specifically, dorsal flanges enhance the stability of a tapered cemented femoral stem, regardless of surface finish.

Systematic Analysis of Bisphosphonate Intervention on Periprosthetic BMD as a Function of Stem Design

The purpose of this study was to determine the effects of bisphosphonates periprosthetic BMD in THA patients as a function of stem design. Specifically, the goals were to determine if bisphosphonates as a group could significantly inhibit periprosthetic bone loss, time needed to see an effect, if one drug was more effective than the others, and if there was a difference due to stem design or cement. Thirteen articles met the inclusion criteria. Overall, groups treated with bisphosphonate therapy preserved significantly more BMD than the control groups as early as six months postoperatively, and orally delivered bisphosphonates were most effective. Furthermore, the biggest differences were in patients with non-cemented stems, and of those, the largest differences were seen in patients with fully coated CoCr stems.

Radiographic comparison of diaphyseal grit blasted with smooth surface stems by matched pair analysis.

A matched pair comparison of two groups of 42 patients who had a total hip arthroplasty with uncemented fixation of the femoral stem with proximal porous coating and distal grit blasting were compared with a stem of identical design except with diaphyseal smooth surfaces. Radiographic analysis was done to determine differences in fixation and bone remodeling at the 2-year followup, and these results were compared with clinical results. The method used for measuring cortical thickness was semiquantitative, with measurements done at 15 1-cm increments beginning at 3 cm distal to the midlesser trochanter. This study determined whether, with an identical stem design, diaphyseal biologic fixation, rather than mechanical fixation, would provide better fixation without significant stress shielding differences. Seven percent of grit blasted stems had radiolucent lines in Gruen Zones 3 to 5, compared with 79% of smooth stems. The smooth stem was on average one size larger so the stress shielding was not different between matched pairs. There was a distinct pattern of adaptive remodeling that occurred in the femur with both stem surfaces. Bone loss was greatest in the proximal medial and proximal posterior bone and occurred along the entire anterior cortex. Bone thickening occurred in the distal medial and posterior cortices and extended below the tip of the prosthesis.

Challenges in relating experimental hip implant fixation predictions to clinical observations.

Long-term clinical follow-up studies have shown that radiolucent lines at the cement interfaces of total hip replacement femoral components develop gradually, ultimately leading to loosening. In this experimental study, 32 synthetic femurs implanted with cemented femoral components were cyclically loaded with a dynamic joint reaction force, torque, and muscle force, to assess the relative effects of surface finish and collars on interface fixation. Four each of four otherwise identical straight femoral stems, varying only in surface finish and presence or lack of collars were used. Specimens were tested under two conditions: (1) with intact interfaces simulating immediate post-operative conditions and (2) with a thin-film at the stem-cement interface, simulating conditions several weeks to months post-operative when fibrous tissue has formed with the implant still stable. Micromotion was measured at both interfaces in three directions. Surface finish had a larger relative effect than collars, regardless of whether or not a thin-film was present. For example, a proximal grit-blasted finish enhanced fixation at the stem-cement interface by 7-12 μm per-cycle (p<0.05) and decreased early cement mantle loosening by 7-13 μm. For straight stems, rougher surfaces provided greater stability than polished, even with a thin film at the stem-cement interfaces, contradicting the theory that once debonded, rough stems are less stable than polished at the stem-cement interface. The findings of this experimental study exemplify the need to take advantage of all available tools for the preclinical evaluation of orthopaedic implants, including long-term clinical observations of related devices, analytical and numeric models, and experimental bench-top simulations.

Simulation of extreme loads on the proximal femur for implant fixation assessment

Total joint replacement patients today are younger, heavier, and more active than total joint replacement patients 40 yrs ago. Consequently, patient expectations and prosthesis requirements have increased and there is a need to re-evaluate preclinical testing methods. We present the design rationale for a novel load simulator for the proximal femur, capable of applying a more aggressive load profile than previous simulators. This simulator was used to measure three-dimensional micromotion of a cemented total hip replacement femoral stem under simulated physiological loading. We assessed the influence of a separate abductor muscle force, a higher joint reaction force, and a more accurate implant stability measurement system included in the new simulator and compared the results to the lower, single joint reaction force included in a previously published simulator. Per-cycle motion at both cement interfaces and stem and cement mantle migration obtained from both simulators using the same femoral stem design, are compared. Although the new simulator applied higher loads, per-cycle motions were lower than previously reported. In both studies, regardless of the presence or lack of a separate muscle force, the greatest motions were in the medial-lateral direction (new: 27 +/- 4 mum, old: 67 +/- 21 mum). The findings indicate that magnitude and direction of peak joint reaction force and inclusion of a separate muscle force have a significant effect on femoral stem stability measurements. We recommend that future femoral stem stability studies consider using load simulation techniques and a direct motion measurement system comparable to the one presented in this study.

Effects of total hip arthroplasty cemented femoral stem surface finish, collar and cement thickness on load transfer to the femur

Stress shielding and load transfer to the femur following total hip arthroplasty have been studied extensively. A number of models have addressed the effects of surface finish of double-tapered, non-collared cemented stems on load transfer to the femur. However, a great number of cemented femoral stem designs in wide use today are not double tapered, and many, such as the Charnley, have collars. The effects of surface finish of such stems on load transfer to the femur are not completely understood. In this study, we measured the effects of surface finish of a straight, non-tapered cemented femoral stem, with and without a collar, in two stem sizes, on load transfer to the femur, using an in vitro laboratory model. Eight types of straight stems were fabricated, with polished or rough surfaces, with and without a collar, and in two sizes. All stems were based on the same template, and varied only in the desired combination of parameters studied. Three each of the eight unique stem types (total of 24 specimens) were cyclically loaded for 77,000 cycles at 1 Hz, alternating between walking and stair-climbing load profiles. Surface strains were measured at ten locations in each femur during designated initial and final periods. Of the three design variables, stem surface finish had the greatest effect on femoral surface strains. Specifically, compared to rough stems, with polished stems, mean proximal medial compressive strains were smaller, whereas mean distal medial compressive strains were greater. In contrast, on the anterior surface, mean proximal anterior tensile strains were greater, whereas mean distal anterior strains were smaller. All femoral surface strains increased with cyclic loading, however, strains increased at a greater rate with polished stems than with rough stems. Proximal medial strains were somewhat increased with the presence of a collar, however, these differences were small (< 100 microå ) and/or not statistically significant. Similarly, distal medial strains were increased with the presence of a collar but, again, the differences were not consistent (p > 0.16). Compared to large stems, with small stems, proximal medial compressive strains were greater. The results emphasize the importance cemented femoral stem surface roughness and the manner in which this changes stem-cement bond strength, affecting the distribution of stresses in the femur. This is an important consideration in the design of femoral stems. (Journal of Applied Biomaterials & Biomechanics 2003; 1: 76-83).