The Journal of Bone & Joint Surgery

Getting it Right by Analyzing Failures and Biomechanical Models | August 01, 2008

Have Contemporary Hip Resurfacing Designs Reached Maturity? A Review

Kevin L. Ong, PhD¹; Michael T. Manley, PhD²; Steven M. Kurtz, PhD¹

¹ Exponent Incorporated, 3401 Market Street, Suite 300, Philadelphia, PA 19104. E-mail address for K.L. Ong: kong@exponent.com
² Homer Stryker Center for Orthopaedic Education and Research, 325 Corporate Drive, Mahwah, NJ 07430

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Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Stryker Orthopaedics. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

The Journal of Bone and Joint Surgery, Inc.

J Bone Joint Surg Am, 2008 Aug 01;90(Supplement 3):81-88. doi: 10.2106/JBJS.H.00574

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Abstract

Background: The increasing prevalence of hip replacements in young patients is expected to fuel the demand for hip resurfacing arthroplasty. Patient selection, surgical technique, and implant design can influence the clinical outcomes for these patients. In this review, we discuss whether contemporary hip resurfacing designs have reached maturity and suggest design considerations for future-generation implants. These design-related factors include the amount and extent of cement fixation, adoption of cementless femoral fixation, optimization of implant position, minimization of stress-shielding, improvement in modularity or sizing and geometry options, metallurgy, development of alternative bearing options, and examination of in vivo cup deformation. In addition, this review is based on an understanding of the causes of failure of revision hip resurfacing arthroplasty, which is essential to help guide research, implant design, and clinical decision-making.

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Introduction

The number of total hip replacement arthroplasty procedures in the United States is expected to increase threefold by 2030¹. The aging of the baby boomers, who will start turning sixty-five years old in 2011, will contribute to this increased future demand¹. Furthermore, due to the increasing prevalence of total hip arthroplasty in younger patients, patients who are younger than sixty-five years of age are expected to account for 53% of the hip replacements in 2030, compared with 44% in 2005². It is expected that the number of hip resurfacing procedures that are most often performed in this younger patient population^3,4 will consequently increase.

The outcomes of hip resurfacing arthroplasty are commonly reported by single institutions or regional registries from Europe or Australia^5-12. Although these studies provide insight into the epidemiology of joint arthroplasty, they cannot be extrapolated to the national level in the United States due to their limited sample sizes. Presently, national joint registry data from Australia, England, and Wales^3,4 indicate that the risk of needing early revision after hip resurfacing arthroplasty is greater than that after conventional total hip arthroplasty. For osteoarthritic patients in Australia, the revision rate at five years is 3.8% after hip resurfacing arthroplasty and 2.8% after conventional total hip arthroplasty. Similarly, the data from the England and Wales registry indicate that the revision rate at three years is 2.4% after hip resurfacing arthroplasty and 1.3% after conventional total hip arthroplasty.

Short-term failure of hip resurfacing prostheses is most commonly due to periprosthetic (femoral neck) fractures^3,4, which account for 37% to 47% of the revisions. In particular, postmenopausal women are at greater risk for needing revision, while the risk is very low in young men⁴. Although careful patient selection can optimize the outcomes with regard to hip resurfacing¹², other factors, such as surgical technique and implant design, should also be considered.

This review summarizes several design-related factors that can influence the biomechanics and results of hip resurfacing arthroplasty. We consider whether contemporary designs have reached maturity, and we discuss present design considerations for future generations of hip resurfacing prostheses. We conclude with recommendations for future research to improve our knowledge of hip resurfacing.

Implant Fixation

Cemented Femoral Implants

The majority of presently available femoral component designs employ cementation into the dome portion of the device¹³. Previous analyses of retrieved femoral components and proximal femoral bone following hip resurfacing arthroplasty have shown large variations in the thickness of the cement mantle and the interdigitation with cancellous bone^14,15. In one study, the proportion of retrieved femoral-head sections that were filled with cement ranged from 11% to 89%¹⁴. The variability in the amount and distribution of bone cement within the femoral heads (Fig. 1) was noted as a potential cause for implant failure because greater amounts of cement were measured in loosened femoral components (p = 0.001). Cement filled 51% of loosened femoral heads, compared with 36% of fractured heads and 40% of heads retrieved from nonfemoral failures. Cement penetration into bone cysts was also found to be more prevalent in femoral failures (p < 0.025). Of note, Morlock et al.¹⁵ found that only 31% of the retrieved heads had cementing performed according to recommended techniques. Twenty percent of the heads had both excessive cement penetration and excessive mantle thickness, while only 6% had too little cement.

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Fig. 1: Microcomputed tomography images of sectioned slices from femoral heads retrieved from a fifty-nine-year-old man (left) and a forty-nine-year-old man (right) after hip resurfacing arthroplasty. Both hips were revised as a result of femoral neck fracture at two months. Note the variability in the amount and distribution of bone cement, including penetration into the stem canal (left). (Specimens were provided courtesy of Patricia Campbell, PhD, Joint Replacement Institute, Los Angeles, California.)

Excessive cementing may have biomechanical consequences in terms of decreased bone-loading in the proximal aspect of the femur¹⁶. Radcliffe and Taylor¹⁶ compared the changes in bone strain following the inclusion of 1, 3, and 5-mm-thick cement mantles in several cadaver femoral finite-element models. Increasing cement-mantle thickness tended to increase strain-shielding, particularly in the area anterior and inferior to the implant. Furthermore, excessive cementing may also promote thermal necrosis. In their histological evaluation of retrieved heads, Campbell et al. found a higher prevalence of necrotic bone beneath the cement, with evidence of healing necrosis commonly near the cement¹⁴.

Whether or not to cement the stem is also unclear. Cementing the stem has sometimes been recommended to improve initial fixation and to avoid the development of radiolucencies about the stem⁶. Conversely, other clinical studies that did not involve stem cementation have also led to good clinical outcomes¹⁷. Other biomechanical studies have found that cementing the stem or fixation of the stem can increase stress-shielding and/or strain-shielding within the femoral shell^16,18, which may introduce overloading and fatigue fracture of the unsupported implant.

Cementless Femoral Implants

Presently, there are a limited number of femoral components designed for cementless applications¹³. The cementless Cormet 2000 femoral design (Corin, Cirencester, Gloucestershire, United Kingdom), which is fully coated with hydroxyapatite on the inner surface except for the polished stem, has produced excellent survival rates and clinical outcomes. At a minimum of two years of follow-up, patients experienced significant improvement (p < 0.0001) in pain and function¹¹. However, these results should be viewed with caution, as 27% of the sixty-three patients with radiographic follow-up also demonstrated >10% narrowing of the femoral neck.

Cementless designs may alleviate concerns regarding thermal necrosis from cementing and difficulty in controlling uniform mantle thickness and cement penetration. Site-specific fixation may be possible by identifying preferential regions on the implant surface to incorporate hydroxyapatite or porous coating to influence bone remodeling. In contrast, the ability to cement only isolated regions of the implant interface is more challenging due to limited control of cement penetration and mantle thickness as well as concerns regarding limited cement coverage for long-term fixation. In the absence of cement, femoral implants will need to be able to attain short-term mechanical stability, either through press-fit mechanisms or other geometrical features, until osseointegration into surrounding bone occurs. The extent of intimate contact between the implant and the osseous surface should also be considered because imprecise osseous preparation may produce gaps at the bone-implant interface, which would likely inhibit osseointegration and fixation. Bone-surface preparation during fixation with use of cement may be more forgiving because the bone cement compensates for any lack of conformity between the bone and implant. In summary, as contemporary femoral designs mature, there is a tremendous potential for cementless fixation in hip resurfacing.

Acetabular Fixation

Biological fixation of cementless cups requires initial implant stability and physical interlocking between the cup and the supporting bone for successful long-term stability. Manley et al. evaluated the fixation of three total hip arthroplasty cup designs with various implant surfaces at a minimum follow-up of five years¹⁹. Their clinical findings indicate that hydroxyapatite coating alone on a smooth cup is not sufficient for acetabular fixation. Additional stability has to be provided from a porous-coated surface or an adjunct fixation. The fixation surfaces on contemporary acetabular components are primarily cobalt-chromium beaded or titanium sprayed with or without a hydroxyapatite coating. Considering the known historical performance of conventional total hip arthroplasty cups with similar ingrowth or ongrowth surfaces, the various fixation surfaces for hip resurfacing arthroplasty should perform well, although fewer long-term data on ongrowth fixation surfaces are available²⁰ and some concerns have been raised about bead-shedding^13,21.

Initial stability on some resurfacing cups has also been provided by ancillary aids such as spikes and screws. The addition of these design features also provides resistance to frictional torque transmission if binding occurs and reduces the risk of cup loosening. In vitro experiments on conventional cementless acetabular components have shown that a hemispheric design produces greater and more uniform bone-implant contact after implantation than dual-geometry or spiked designs do²². Of particular relevance to resurfacing cups, experiments have also shown that the spiked cups produced more variability in bone-implant contact. Specifically, the initial stability was influenced by how deep the spikes advanced into the bone. More uniform contact patterns are exhibited when the spikes perforate the inner table of the pelvis. The use of screws is also expected to improve initial stability. Cook et al. found greater and more evenly distributed bone ingrowth in cups that used screws for adjunct fixation²³. However, in the pursuit of design features to improve implant stability, one should consider the potential deleterious effects that these features may have on disturbing the load distribution in the acetabulum. Furthermore, adjunct fixation may not be necessary if the cup is inherently stable from press-fit implantation. In summary, the initial stability of resurfacing cups in vivo will depend on the design of the cup as well as on the technique in which the cup is implanted.

Revision

During femoral revision, the failed femoral component can be removed by resection distal to the implant, followed by reimplantation of a conventional total hip stem. This is theoretically an easier conversion than revision of a conventional long-stem total hip prosthesis^5,24. Furthermore, because the femoral canal is left intact during the index hip resurfacing arthroplasty, more bone stock is available for the revision stem. Modularity in hip resurfacing arthroplasty also provides an advantage during revision of a failed femoral component when the cup is well fixed²⁴. The cup may be left in place to mate with a large-diameter modular femoral head with a standard stem.

Bone Changes

Bone Remodeling

Densitometric studies have shown preservation of bone mineral density around the stem of the component and femoral neck^25,26. However, due to the screening effect of the metallic femoral head, bone changes within the femoral head have not been quantified clinically. Computational models^18,27 and retrieval studies^8,27 have shown that bone loss, in part from stress-shielding and/or strain-shielding, is present within the femoral head (Figs. 1 and 2)²⁸. Initial bone resorption was predicted beneath the prosthetic head in a high-resolution hip resurfacing arthroplasty model¹⁸, along with bone formation about the distal stem.

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Fig. 2: Image intensity distribution (in Hounsfield units) in the resurfaced proximal part of the femur following iterative remodeling. Less bone resorption was demonstrated when the femoral component was completely debonded from bone (top). During subsequent adaptive remodeling, the proximal resorption and distal formation progressed such that increased bone density was predicted adjacent to the medial calcar and around the distal stem, while decreased superolateral and central bone density was observed. t = iteration time step.

Narrowing of the Femoral Neck

Narrowing of the femoral neck has also been reported for first-generation resurfacings, with stress-shielding and polyethylene wear as the proposed causes²⁹. However, in the absence of polyethylene in newer-generation metal-on-metal hip resurfacings, the etiology is unclear, and neck narrowing could result from a combination of stress-shielding and osteonecrosis¹⁰. Recent clinical studies have reported neck narrowing in association with various implant designs^7-11, although this does not appear to have any adverse effects on short or medium-term outcomes and appears to stabilize after about three years¹⁰. Lilikakis et al. observed appreciable thinning of more than 10% for seventeen of sixty-three cementless resurfaced hips at a minimum period of follow-up of two years¹¹. Narrowing of the neck has also been detected in other studies^7,8. More recently, a retrospective review of 163 hip resurfacings demonstrated appreciable reductions of more than 10% of the neck width in forty-five hips (28%)¹⁰. It has been suggested that patients with appreciable neck narrowing may be predisposed to femoral component loosening in the future¹¹.

Effects of Implant Orientation

Implant orientation may have an influence on bone-remodeling changes about the femoral component. The results of previous biomechanical studies have shown reduced loading in the proximal part of the femur when the implant is placed in valgus^30,31 but have suggested that, when compared with varus placement of the components, these conditions will minimize the risk of femoral neck fractures^5,7,32. However, the reduction in loading may be of sufficient magnitude to increase the potential for bone resorption compared with neutral or extreme varus-positioned implants³³. Previous studies that made use of finite-element models have suggested that the bone resorption stimulus can extend distally and peripherally toward the middle portion of the stem and the femoral neck, possibly associated with neck narrowing³³ (Figs. 3 and 4). Thus, an implant placed in extreme valgus may increase the risk of loosening through the greater loss of osseous support from stress-shielding. Conversely, according to the surface arthroplasty risk index of Beaulé et al.⁷, increased varus orientation increases the fracture risk. Those authors reported that patients with femoral neck fractures had an average implant orientation of 133° as compared with 139° in the remaining patients⁷. In another study, varus placement of more than 5° relative to the native neck was present in 71% of forty-five patients with a fractured femoral neck³².

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Fig. 3: Effect of implant orientation on the initial bone-remodeling stimulus. The resorption stimulus extended distally and peripherally about the neck when the implant was placed in extreme valgus.

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Fig. 4: Retrieved femoral head at six years after surgery, demonstrating proximal bone loss underneath the femoral shell. Ant = anterior; Inf = inferior. (Specimen provided courtesy of Richard Field, PhD, FRCS, FRCS(Orth), South West London Elective Orthopaedic Center, Surrey, United Kingdom.)

The lack of modularity in hip resurfacing poses some challenges in restoring hip mechanics. Most hip resurfacing patients also have abnormal bone anatomy^34,35, which makes it difficult to restore hip mechanics and determine appropriate implant alignment. Hip resurfacing patients tend to have abnormal femoral head-neck offset³⁴ as well as a greater valgus preoperative neck-shaft angle and less horizontal femoral offset in the affected hip than in the normal, contralateral hip³⁵. Therefore, implant designs that can minimize stress-shielding within the femoral shell and also around the femoral neck, while restoring the normal anatomy or improving on the abnormal anatomy, may help enhance the amount and quality of osseous support, thereby improving long-term fixation. This may be achieved through any combination of implant geometry, composite materials, or modularity. Some of these bone changes may also be inevitable due to other biological factors, such as osteonecrosis and disruption of the blood flow following reaming of the femoral head^36,37. The onset of osteopenic changes in the aging patient and the initial bone quality at the time of surgery further complicate bone loss.

Metallurgy

Metal ion exposure continues to be a concern with contemporary metal-on-metal hip resurfacing arthroplasty. Osteolysis due to metal ion release and hypersensitivity reactions are a clinical concern^38,39. It has been suggested that pronounced joint effusion, joint pain, and osteolysis following metal-on-metal joint replacement may be evidence of an immunological reaction³⁹. Prospective clinical studies have shown that there is a significant increase (p < 0.05) of cobalt and chromium ions in blood and urine levels after hip resurfacing arthroplasty⁴⁰. Although changes in serum cobalt and chromium levels following metal-on-metal hip resurfacing appear to have no effect on renal function⁴¹, the potential toxicity in patients who have renal failure is unclear. The accumulation of metal particles in the kidneys of these patients and the consequent immune response is poorly understood.

In addition to implant malpositioning, impingement, or loosening, the amount of metal ion release may be affected by implant design and manufacturing processes. For example, the quality of surface finish, amount of bearing clearance, metal carbon content, and type of metal processing (forged or cast) may influence the wear behavior of the bearing. The effect of microstructure on wear performance is clear. Due to their better abrasion resistance, high-carbon alloy designs, such as those used by all of the manufacturers, exhibit lower wear than do low-carbon alloy designs^42,43. Hip simulator studies have also shown no significant difference in wear performance among implants that have undergone various heat-treatment methods, such as wrought-forged, cast (no heat treatment), or double-heat-treated (hot isostatic pressed and solution-annealed) conditions^42-44.

It has also been suggested that surface-engineered metal-on-metal bearings provide improved wear performance^45,46. These involve modification of the surface with chromium nitride, titanium nitride, or chromium carbon nitride coatings, which can produce at least a thirty-six-fold reduction in wear rates compared with conventional cobalt-chromium alloy hip resurfacing arthroplasty bearings in simulator studies⁴⁵. Some of these modified couples, such as chromium nitride, also produce wear particles that demonstrate lower cytotoxicity⁴⁶. Hence, this approach may allow future application of similar manufacturing and processing techniques in alleviating concerns with metal wear particles. In addition, the potential may exist to investigate the use of other materials, such as revisiting the use of ceramics used in the 1970s, for hip resurfacing.

Potential Alternative Bearing Options

Ceramic-on-metal or ceramic-on-ceramic hip resurfacing arthroplasty bearings may be potential alternatives to metal-on-metal articulations to further reduce ion release. For example, ceramic-on-metal bearings have been shown to produce up to a tenfold lower wear volume than metal-on-metal implants in hip simulators⁴⁷. However, the design of a ceramic femoral component would have to take into consideration the risk of notch fractures. In addition, smaller-diameter ceramic cups may have to be considered in order to maintain sufficient cup thickness so as to prevent ceramic fracture while still preserving bone. With the development of highly cross-linked polyethylene that has been shown to produce lower wear rates, designers may be able to revisit the use of metal-on-polyethylene hip resurfacing arthroplasty articulations⁴⁸. Furthermore, recent innovations have resulted in the development of a ceramic-on-polyetheretherketone (PEEK) bearing combination for resurfacing applications⁴⁹, which could lead to additional design possibilities.

Cup Deformation

With the objective of preserving acetabular bone stock, thinner resurfacing cups are being designed⁵⁰. Thinner cups also allow for the use of larger femoral heads to reduce the risk of hip dislocation, but the use of thinner, more flexible cups has raised concerns about the potential deformation of the cup during press-fit implantation. Radial compressive forces at the periphery of the acetabulum may cause the acetabular components to deform. This deformation may be nonuniform in nature due to rim-loading by dense cortical bone along the anterior-superior and posterior-inferior margins of the acetabulum^50,51. Diametrical pinching deformation of up to 100 µm during cadaver implantation of resurfacing cups has been reported⁵⁰. This could adversely affect the fluid-film lubrication of metal-on-metal bearings and result in increased wear. Furthermore, the alteration of the bearing clearance may lead to equatorial and edge contact and could possibly cause the implants to jam. Of note, cup deformation is not isolated only to hip resurfacing cups⁵¹.

Cup deformation could also influence implant stability and fixation, producing unfavorable conditions for osseointegration and possibly affecting periprosthetic bone remodeling. It might also introduce acoustic emissions, but these could eventually dissipate with further running-in of the joint. In the months following initial surgery, De Smet⁹ noted clicking, clocking, or clunking in 19.4% (n = 49) of 252 patients who underwent hip resurfacing arthroplasty. He further reported a 1.2% prevalence of squeaking (n = 3). These acoustic emissions were attributed to a transient lack of lubrication or joint subluxation, which did not recur six to twenty-four months after surgery.

Additional research on the association between cup design and cup deformation during press-fit implantation should be conducted because the impact of cup deformation on implant performance is still unclear. It is unknown if the deformations persist on repeated joint-loading and viscoelastic bone response or following subsequent periprosthetic bone-density changes due to bone remodeling. In addition, previous resurfacing cup-deformation studies⁵⁰ were limited by the small number of cadaver experiments and the use of bone foam as a surrogate material. The variability in osseous surface preparation of the acetabulum may also affect the true extent of cup deformation in vivo. The sphericity of the reamed acetabular surface may deviate by as much as 4 mm⁵², while the overall geometry may be overreamed by 0.6 mm⁵³. In contrast to previous two-dimensional axisymmetric pelvis models⁵⁴, the use of a high-resolution three-dimensional finite-element pelvis model that incorporates nonhomogeneous bone properties may help elucidate the interaction among the above variables, cup deformation, and implant performance in a more clinically relevant manner.

Radial Clearance

Cup designs that minimize radial clearance have been shown in hip-simulator studies to improve the wear performance⁵⁵. However, the potential for cup deformation in vivo due to press-fit implantation and also possibly during joint-loading, as described above, should be considered to avoid clamping and the generation of high frictional torque when designing the bearing clearances⁵⁵. This would affect the amount of wear during the run-in period as well as the number of cycles before a steady state is reached.

Summary and Conclusions

Early hip resurfacing arthroplasty designs relied on a variety of cemented bearing couples (metal-on-metal, metal-on-polymer, polymer-on-polymer), which failed primarily due to the wear of the bearing surfaces. However, contemporary hip resurfacing arthroplasty designs are metal-on-metal implants that predominantly rely on hybrid fixation. In this review, we have identified several potential areas for further innovation in these contemporary hip resurfacing arthroplasty designs. These areas include the amount and extent of cemented fixation of the head and stem, adoption of cementless femoral fixation, optimization of implant position, minimization of stress-shielding, improvement in anatomic reconstruction through modularity or sizing and geometry options, metallurgy (surface finish, processing), development of alternative bearing options, and better understanding of the complex interactions between cup deformation and implant performance. As hip resurfacing arthroplasty designs mature and evolve, other bone-preserving femoral designs, such as short-stemmed, nondiaphyseal implants, may be developed to provide alternative design options and to bridge the gap between hip resurfacing arthroplasty and total hip arthroplasty. Image Not Available

Acknowledgements

Note: The authors thank Patricia Campbell, PhD, and Richard Field, PhD, FRCS, FRCS(Orth), for providing the retrieval samples.

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Topics

bone remodeling ; femur ; neck of femur ; hip joint ; metals ; hip replacement arthroplasty ; hip resurfacing arthroplasty

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Kevin L. Ong, Michael T. Manley, Steven M. Kurtz; Have Contemporary Hip Resurfacing Designs Reached Maturity? A Review. The Journal of Bone & Joint Surgery. 2008 Aug;90(Supplement_3):81-88.

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