Uncemented stems in hip replacement--hydroxyapatite or plain porous: does it matter? Based on a prospective study of HA Omnifit stems at 15-years minimum follow-up.

For many years, acrylic cement has been regarded as the unique available means for a long term and secure fixation of components in hip arthroplasty. A new generation of uncemented implants coated in hydroxyapatite (HA) has arisen since the mid-1980s, aiming to provide a 'biological interface' between metal and surrounding bone, and thus the hydroxyapatite interface was defined some years ago as a distinct entity from both cemented and 'plain porous' fixation. Based upon our 20-year experience with the HA Omnifit stem, this paper aims to discuss the efficiency of hydroxyapatite as a means of fixation for femoral components in hip arthroplasty, then examine whether the addition of a calcium phosphate layer induces any adverse effects, and finally make comparisons between HA-coated versus porous hip stems reported in the literature. With respect to fixation of femoral components in hip arthroplasty we report excellent results from the partially coated HA Omnifit stem in our series, with 99.20% of survival rate at 17-year follow-up, these results being consistent and similar to other HA series in the literature. HA 'uncemented' fixation can therefore be considered reliable and efficient. Furthermore, two decades of hydroxyapatite coatings have resulted in the identification of no major adverse effects. In fact calcium phosphate ions participate in the physiological turn-over of bone remodelling, and the HA coating is replaced by new bone formation without any fibrous tissue layer. Since HA particles are biodegradable and do not produce any inflammatory reaction in the surrounding bone, fears of osteolysis or third body wear due to HA debris have not been confirmed. Finally, comparison between HA versus plain porous femoral components through the literature has demonstrated better results with HA than porous alone both in terms of the quantity and quality of bone remodelling, and the potential migration and subsidence of the stem.

Hydroxyapatite-coated total knee replacement: clinical experience at 10 to 15 years.

This study describes 146 primary total knee replacements, either fully or partially coated with hydroxyapatite of which 74 knees in 68 patients were available for clinical and radiological assessment at a mean of 11.2 years (10 to 15). The global failure rate was 1.37% and survival rate with mechanical failure as the end-point was 98.14%. Radiological assessment indicated intimate contact between bone and the hydroxyapatite coating. Over time the hydroxyapatite coating appears to encourage filling of interface gaps remaining after surgery. Our results compare favourably with those of series describing cemented or porous-coated knee replacements, and suggest that fixation with hydroxyapatite is a reliable option in primary total knee replacement.

Biomechanics of the Birmingham hip resurfacing arthroplasty.

The effects of the method of fixation and interface conditions on the biomechanics of the femoral component of the Birmingham hip resurfacing arthroplasty were examined using a highly detailed three-dimensional computer model of the hip. Stresses and strains in the proximal femur were compared for the natural femur and for the femur resurfaced with the Birmingham hip resurfacing. A comparison of cemented versus uncemented fixation showed no advantage of either with regard to bone loading. When the Birmingham hip resurfacing femoral component was fixed to bone, proximal femoral stresses and strains were non-physiological. Bone resorption was predicted in the inferomedial and superolateral bone within the Birmingham hip resurfacing shell. Resorption was limited to the superolateral region when the stem was not fixed. The increased bone strain observed adjacent to the distal stem should stimulate an increase in bone density at that location. The remodelling of bone seen during revision of failed Birmingham hip resurfacing implants appears to be consistent with the predictions of our finite element analysis.

Hydroxyapatite femoral stems for total hip arthroplasty: 10- to 13-year followup.

Three hundred eighty hydroxyapatite-coated titanium alloy stems were implanted in a young and active patient population from 1987 through 1990. Within the population, 274 patients (314 hips) had a minimum 10-year and maximum 13-year followup. The average age of the population was 51 years. Thirty-seven percent of the population was 50 years or younger when operated on (average age, 39 years). Osteoarthritis was seen in 63.7% and avascular necrosis in 16.6% of patients. Fifty-four percent of patients were men. Clinically, these patients had early pain relief and rapid restoration of function. The Harris hip score averaged 92 points, and only 1.6% of patients had mild or moderate activity-related thigh pain. Radiographically, progressive remodeling occurred around the implants, 100% were bone stable, and no patient had endosteal distal osteolysis. Two patients had revision surgery for aseptic loosening: one at 2 years postoperative because of a nonunion of a concomitant subtrochanteric osteotomy and one at 9.5 years postoperative because of polyethylene wear and progressive osteolysis. The mechanical failure rate was 0.5%. The results show excellent lasting fixation of this tapered titanium alloy stem coated proximally with a thin, dense layer of hydroxyapatite. The stem has performed well in a young, active, high-risk population and in the hands of various surgeons.

A ported, proximally-cemented femoral stem for total hip arthroplasty. Development and clinical application.

We describe the development and early clinical application of a ported, proximally-cemented titanium stem for cemented total hip arthroplasty. PMMA bone cement is delivered to the proximal femur under pressure after the stem has been positioned within the femoral canal. A mid-stem cement occluder contains the cement to the proximal stem only. A tapered body is incorporated in the design of the stem to reduce the structural stiffness and hence the degree of stress shielding within the reconstructed joint. We performed preclinical studies to measure the reduction in porosity and the pressurisation achieved. The porosity, as measured by the void percentage within the cured cement mantle, was reduced by more than 50% and there was an almost threefold increase in the mean pressure. Mechanical testing of the stem, using a three-point bend test, showed that the addition of cement injection ports on the anterior and posterior sides of the body of the proximal stem did not reduce its strength. Finite-element analysis indicated that, compared with a fully-cemented conventional stem, there was no change in the stresses within the cement mantle. In a series of 40 proximally-cemented stems followed for up to six years (mean 51 months) the mean Harris hip score was 91, and 85% of patients had good or excellent results. There was excellent pain relief, an increased level of activity and good patient satisfaction. One mechanical failure of the stem required revision at three years after implantation. The early results indicate that the clinical performance was equal to that achieved with other modern cemented stems. Radiological evaluation showed excellent results with no evidence of stress shielding. Further follow-up will determine if long-term stress shielding is reduced and if revision is made easier by the absence of a distal cement mantle.

Fixation of acetabular cups without cement in total hip arthroplasty. A comparison of three different implant surfaces at a minimum duration of follow-up of five years.

We evaluated 377 patients (428 hips) who had been managed, by a total of fourteen surgeons at twelve clinical sites in the United States and Europe, with a porous-coated press-fit acetabular cup, a hydroxyapatite-coated threaded screw-in cup, or one of two similar designs of hydroxyapatite-coated press-fit cups between April 1987 and November 1992. The same type of hydroxyapatite-coated femoral stem was inserted without cement in all patients. After a minimum duration of follow-up of five years (mean, 7.9 years; range, 5.3 to 9.1 years), one (1 per cent) of the 131 hydroxyapatite-coated threaded cups, two (2 per cent) of the 109 porous-coated press-fit cups, and twenty-one (11 per cent) of the 188 hydroxyapatite-coated press-fit cups had been revised because of aseptic loosening. A common radiographic sign of impending failure of the hydroxyapatite-coated press-fit cups was radiolucency at the interface between the implant and the subchondral bone beneath it. This radiolucency usually was seen initially more than two years after implantation. Radiographic evaluation of the 383 acetabular implants that were in situ at the time of the most recent follow-up showed that 123 (99 per cent) of the 124 hydroxyapatite-coated threaded cups, 101 (98 per cent) of the 103 porous-coated cups, and 139 (89 per cent) of the 156 hydroxyapatite-coated press-fit cups were stable with osseous ingrowth (as indicated by the absence of radiolucency at the interface and the absence of migration within the acetabulum). The probability of revision due to aseptic loosening was significantly greater for the hydroxyapatite-coated press-fit cups than it was for the hydroxyapatite-coated threaded cups or the porous-coated press-fit cups (p < 0.001 for both comparisons). Within the group of patients who had a hydroxyapatite-coated press-fit cup, the probability of revision due to aseptic loosening was significantly greater in association with a young age (p = 0.003), female gender (p = 0.02), the use of a femoral head with a diameter of thirty-two millimeters (p = 0.018), and the use of a thin polyethylene liner (p < 0.001). We found that the hydroxyapatite-coated threaded cups and the porous-coated press-fit cups continued to perform well more than five years after the operation. The hydroxyapatite-coated press-fit cups that were revised probably failed because the fixation interface beneath the cup could not sustain the tensile stresses that were imposed between the cup and the bone by the activity of the patient. Our data suggest that, in the specific biomechanical environment of the acetabulum, physical interlocking between the cup and the supporting bone beneath it may be a prerequisite for long-term stability.

Hydroxyapatite in total hip arthroplasty. Clinical results and critical issues.

Surgeons who perform arthroplasties have posed some critical questions about hydroxyapatite. Does hydroxyapatite coating enhance bone ingrowth or ongrowth? Will hydroxyapatite lead to increased polyethylene wear or an increased incidence of osteolysis? Will the hydroxyapatite coating disappear, and if so, what will be left to maintain implant fixation? A multicenter study of 316 hips (282 patients) with a proximally hydroxyapatite coated stem and either a hydroxyapatite or porous coated cup were followed up 8.1 years (range, 5.6-9.9 years). The average patient age was 50 years (range, 16-81 years), and 61% of the patients were male. One (0.3%) stem, three (2.7%) porous coated cups, and 25 (11.9%) hydroxyapatite coated cups were revised for aseptic loosening. Disappointing results on the acetabular side indicate that substrate design is critical. There were no cases of intramedullary femoral osteolysis, and the incidence of acetabular and proximal femoral osteolysis- and polyethylene wear was no greater than that seen with other cementless or cemented components. Based on these clinical results and a critical review of the literature, it is concluded that hydroxyapatite coated hip components do enhance ingrowth or ongrowth with no increased incidence of osteolysis for as many as 10 years. Concern about the disappearance of the hydroxyapatite coating with time seems moot in light of the above clinical findings.

Hydroxyapatite coated implants. Total hip arthroplasty in the young patient and patients with avascular necrosis.

Two high risk groups for total hip arthroplasty, 136 patients (155 hips) younger than 50 years of age (average age, 38 years) and 44 patients (53 hips) with the diagnosis of avascular necrosis, have a minimum followup of 5 years and a mean followup of 6.8 years. The average Harris Hip Score at last followup totaled 93 and 90, respectively, and thigh pain was reported in 1.3% and 3.8%, respectively. All patients in both groups received the same hydroxyapatite coated femoral stem and the mechanical failure was 0%. No stem was revised for aseptic loosening, 100% of stems were bony stable by radiographic criteria, new bone formation was progressive about the femoral stem, and 0% endosteal lysis was found. The acetabular components had a mechanical failure rate of 10% and 7.5%, respectively, without osteolysis, and an additional 7% and 7.5% failure as a direct result of progressive osteolysis. The results with the porous press fit and hydroxyapatite threaded sockets were far superior to that of the smooth hydroxyapatite press fit sockets and socket failure was associated with thin polyethylene liners and the use of 32-mm head diameters. These findings show a high success rate with a nonporous hydroxyapatite coated titanium femoral stem. However, hydroxyapatite on a smooth acetabular component yielded less predictable results indicating that for long term fixation of the acetabulum an interlock of bone is preferred.

Fracture toughness of CoCr alloy-PMMA cement interface.

An unsymmetric cantilever geometry was used experimentally to determine the critical energy release rate values for cobalt chromium alloy-polymethylmethacrylate cement (CoCr alloy-PMMA) interfaces with satin finished, grit blasted, and plasma sprayed surface treatments applied to the CoCr alloy. Critical energy release rates of 0.013, 0.181, and 0.583 N/mm were found for the satin finish, grit blasted, and plasma sprayed CoCr alloy-PMMA interfaces, respectively. A finite element model of the experimental test specimen was used to determine the crack tip phase angles (-8.73 degrees to -27.1 degrees) that indicated that the tensile load applied to the specimens resulted in a tensile (mode I) and in-plane shear (mode II) loading at the crack tip. The experimental data suggest that a satin finish CoCr alloy-PMMA interface has minimal resistance to crack propagation when compared to grit blasted or plasma sprayed surface treatments.

Hydroxyapatite-coated total hip femoral components in patients less than fifty years old. Clinical and radiographic results after five to eight years of follow-up.

One hundred and thirty-three patients (152 hips) who were an average of thirty-nine years old (range, sixteen to forty-nine years old) received a proximally hydroxyapatite-coated femoral prosthesis as part of a total hip arthroplasty and were followed for a minimum of five years (average, 6.4 years; range, five to 8.3 years) or until revision. The average Harris hip score was 47 points (range, 22 to 77 points) preoperatively and 93 points (range, 49 to 100 points) at the time of the latest clinical evaluation. Two patients who had a well fixed femoral implant had activity-limiting pain in the thigh at the time of the most recent examination. Radiographic changes consistent with bone-remodeling (cortical hypertrophy and bone condensation) typically were seen around the mid-part of the shaft of the prosthesis. Forty-eight (32 per cent) of the 148 hips that were included in the radiographic analysis demonstrated a small amount of erosive scalloping in either zone 1 or zone 7 of Gruen et al., and intramedullary osteolysis was suspected in only one hip. All stems were radiographically osseointegrated according to a modification of the criteria described by Engh et al. Four stems were revised, but none of the revisions were performed because of mechanical failure (two stems were revised in conjunction with a revision of the cup because of pain; one, because of an infection; and one, after a traumatic femoral fracture that occurred six years postoperatively). Thus, the rates of aseptic and mechanical failure were both 0 per cent. The combined rate of failure, which included the two stems that were revised because of pain and the two stems that were associated with pain that limited activity, was 2.6 per cent (four of 152 stems). The over-all clinical results associated with hydroxyapatite-coated femoral components were excellent in this group of young patients after intermediate-term follow-up. A review of serial radiographs showed mechanically stable implants with osseous ingrowth, evidence of stress transmission at the middle part of the stem, and minimum endosteal osteolysis.

Transesophageal echocardiographic monitored events during total knee arthroplasty.

Although the risk of pulmonary embolism or other embolic events associated with total joint arthroplasty have been recorded for some time, to date no direct means of monitoring these events in human arthroplasty have been reported. The authors used transesophageal echocardiography to monitor directly the release of embolic particles into the circulatory system during the course of total knee arthroplasty. The transesophageal echocardiography, in conjunction with intramedullary instrumentation, revealed that showers of embolic particles entered the heart in repeated and unpredictable patterns during the course of conventional intramedullary instrumented total knee procedures. In response to the presence of these embolic showers in the heart, an extramedullary pneumatically positioned system of instrumentation permitting automatic and accurate alignment of the knee with the mechanical axis of the femur has been developed. This new instrumentation establishes proper knee kinematics by semiautomatically determining and maintaining accurate positioning of the femoral component along the mechanical axis of the knee. Qualitative and quantitative monitoring of embolic events using transesophageal echocardiography in conjunction with conventional intramedullary and the new instrumentation suggests that the embolic risk is substantially reduced using the new procedure. Furthermore, the new extramedullary instrumentation was able to align the femoral knee component to within 1 degree of the mechanical axis in an initial series of 25 procedures. Excellent component alignment in conjunction with a substantially reduced quantity of embolic particles in the right heart as seen using transesophageal echocardiography was achieved using the newly developed extramedullary positioning and alignment arm.

Remodeling of bone around hydroxyapatite-coated femoral stems.

Two hundred and twenty-four total hip arthroplasties were performed in 201 patients with use of a femoral component with hydroxyapatite coating of the proximal portion of the stem. The mean duration of follow-up was seventy-one months (range, fifty-eight to eighty-seven months). Of the 224 arthroplasties, 208 (93 per cent; 190 patients) yielded a good or excellent clinical result. Four patients (2 per cent) reported mild-to-moderate activity-related pain in the thigh, and two (1 per cent) had aseptic loosening. The radiographic findings of progressive new-bone formation (cancellous condensation and cortical hypertrophy) throughout the zones adjacent to the middle and distal portions of the stem were evidence of early, extensive proximal fixation of the implant, with distal stress transfer through the implant, which is stiffer than the surrounding bone. Remodeling of the femur began early, was predictable, and progressed throughout the follow-up period. Cortical hypertrophy about the middle and distal portions of the stem occurred predominantly in the mediolateral plane (in 105 hips [47 per cent], compared with thirteen hips [6 per cent] in the anteroposterior plane), and it was more common in patients who had had poorer bone quality preoperatively. Intramedullary osteolysis was present in one femur (0.4 per cent) at five years; the osteolytic area was less than five millimeters in its greatest dimension and had not progressed at the time of the six-year follow-up evaluation. This low rate of osteolysis suggests that a circumferential coating of hydroxyapatite may effectively minimize migration of wear debris along the femoral stem. The progressive remodeling of the femur about the middle and distal portions of the stem, as evidenced by cancellous condensation and cortical hypertrophy, has not, to our knowledge, been described previously to this magnitude in association with proximally coated (porous or hydroxyapatite-coated) femoral implants.

Wear debris. An environmental issue in total joint replacement.

There is a growing concern that osteolytic lesions, often adjacent to otherwise stable implants, are a recent phenomenon caused by some recent change in polyethylene, metal, or other aspect of the total hip construction. This study investigates the possibility that bearings and modular connections used in modern hip replacements are an unappreciated source of particulate debris. Measurements taken from contemporary femoral bearings show a significant mismatch in both surface finish and sphericity of mating metal and polyethylene components, with sphericity of inserts being much worse then sphericity of femoral heads. The tolerances for sphericity of polyethylene inserts were further changed by the placement of an insert into its metal shell. Hip simulator tests of assembled inserts and shells showed greater polyethylene weight loss for metal-backed shells than for inserts alone. Bending and torsional tests of metal/metal modular connections showed that dynamic loads can release large numbers of debris particles from taper junctions. Because osteolytic lesions clearly are associated with overload of tissue by debris particles, the design, manufacture, and tolerances of modular connections in total hip replacement all seem to require reevaluation.

Mixed mode fracture characterization of hydroxylapatite-titanium alloy interface.

Cantilever beam and four-point bend specimen geometries were used to experimentally determine the critical energy release rates for a plasma sprayed hydroxylapatite-titanium alloy (HA-Ti alloy) interface. A locus of energy release rates as a function of crack tip phase angle was determined where a 0 degree phase angle represented tensile opening (mode I) loading and a 90 degree phase angle represented in-plane shear (mode II) loading. Energy release rates were found to increase substantially with an increase in phase angle. An energy release rate of 0.108 N/mm was determined for a phase angle of 0 degrees (mode I). Energy release rates of 0.221, 0.686, and 1.212 N/mm were determined for phase angles of 66 degrees, 69 degrees, and 72 degrees, respectively. The experimental data was matched to a phenomenological model for which crack propagation depended on mode I loading alone indicating that crack propagation at the Ha-Ti alloy interface is dominated by the mode I loading component. Therefore, regions of HA coated implants that experience compressive or shear loading across the HA-Ti alloy interface may be much less likely to debond than regions that experience tensile loading.

Torsional resistance and wear of a modular sleeve-stem hip system.

The torsional resistance and wear debris generation of the modular sleeve and stem S-ROM total hip system was evaluated. The results indicate that slippage of the sleeve-stem interface may occur under physiological loading conditions. Slippage is more likely to occur if the junction is contaminated by blood or tissue, or if the stem is disengaged and reimplanted into the sleeve. Significant wear debris was generated during cyclic fatigue loading. The wear debris was of the size (less than 10 mum) readily ingested by macrophages. Particles of these dimensions have been associated with osteolysis, implant loosening and pain. Based upon the findings of this study the implantation of this type system must be carefully considered.

Early clinical experience with hydroxyapatite-coated femoral implants.

As part of a multi-center study, 238 titanium stems that were proximally coated with hydroxyapatite were implanted in 220 patients between January 1988 and December 1989. Ninety-two of these stems in eighty-three patients had a minimum of two years of follow-up, including analysis of the clinical and radiographic data. Clinically, the patients were essentially pain-free before six months and had a low (4 per cent) prevalence of pain in the thigh and a very high composite Harris hip-score (mean, 95 points) at two years. Radiographically, subsidence was detected in 8 per cent of the implants; no implant had more than three millimeters of subsidence. Radiolucencies were characteristically seen around the uncoated distal part of the stem, in 70 per cent of the implants. Contrastingly, radiolucencies were rare in the hydroxyapatite-coated proximal zones and were most often found anteriorly, in only 5 per cent of the implants. Areas of increased formation of cancellous bone were seen beneath femoral cortical bone at the interface between the hydroxyapatite-coated and uncoated parts of the stem, in 67 per cent of the implants. Calcar resorption was found in 49 per cent of the implants. Cortical thickening was present in 17 per cent of the implants at the uncoated distal part of the stem. Two of the 238 femoral implants were revised: one because of infection and one because of aseptic loosening associated with non-union of a subtrochanteric osteotomy.

Clinical results with the hydroxyapatite-coated Omnifit hip stem.

A 2-year follow-up from a prospective clinical trial investigation of the hydroxyapatite (HA)-coated Omnifit-HA Hip Stem is presented. Assessment of clinical and functional evaluation parameters demonstrates the excellent results obtained with the femoral stem. Radiographic observations indicate a complete lack of fibrous tissue in the HA-coated regions of the stem, thus promoting direct load transfer between the stem and bone. Comparison with published studies suggests that the clinical results obtained with the HA-coated Omnifit-HA Hip Stem compare favorably with the prior reports.

A new model to assess tibial fixation in knee arthroplasty. I. Histologic and roentgenographic results.

A model to assess tibial fixation in knee arthroplasty is described. Eighteen mongrel dogs were implanted with a right tibial hemiarthroplasty. Implantation was of a press-fit, smooth implant (eight dogs) or a titanium alloy beaded device (ten dogs). Animals were studied at six, 12, 18, and 24 weeks. Roentgenographic and histologic analysis was performed for all implants. All animals were ambulatory. Roentgenographically, smooth implants showed progressive radiolucencies with increasing trabecular sclerosis under the implants. These changes were less prominent under the porous implants. Histologically, fibrous interfaces were identified focally under all implants but were thicker under smooth devices. Eighteen- and 24-week specimens showed substantial ingrowth into the porous pegs but minimal ingrowth into the porous plateau. Concurrent histologic and biochemical evaluation in dogs demonstrates the possible fate of implants in knee arthroplasty in human beings. As has been observed, histologic analyses suggest that clinically satisfactory results do not constitute evidence of stabilization by bone ingrowth.

A new model to assess tibial fixation. II. Concurrent histologic and biomechanical observations.

A tibial hemiarthroplasty model was designed to allow concurrent histologic and biomechanical analysis of the tibial implant-bone interface. In this study, micromotion was visually observed at the implant-bone interface of cemented and uncemented implants. Six dogs had staged bilateral implantation. Biomechanical analysis of three- and 12-month specimens was correlated with histologic analysis of the same specimen. Load transmission involved compression of trabecular bone and fibrous tissue at the interface. Failure of the interface occurred through cyclic fatigue and microfracture of trabeculae. Micromotion was seen at all interfaces, porous or smooth, cemented or uncemented. Displacement was greatest under an eccentrically loaded plateau. Micromotion at ingrown and cemented interfaces was because of trabecular compression. Uncemented smooth devices and uncemented porous devices with fibrous fixation of the plateau appeared unstable. The cemented implants and a single uncemented implant studied at 12 months showed no interface micromovement. The absence of micromovement in the uncemented implant was associated with subsidence and with ingrowth of 30% into the porous peg and porous plateau.