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Hindawi Publishing Corporation Advances in Orthopedic Surgery Volume 2014, Article ID 863748, 6 pages http://dx.doi.org/10.1155/2014/863748 Clinical Study Clinical and Radiological Outcome of the Newest Generation of Ceramic-on-Ceramic Hip Arthroplasty in Young Patients 1 1 2 1 Avishai Reuven, Grigorios N. Manoudis, Ahmed Aoude, Olga L. Huk, 1 1 David Zukor, and John Antoniou Department of Orthopaedics, McGill University, Jewish General Hospital, 3755 Cote-St.-Catherine Road, Room E-003, Montreal, QC, Canada H3T 1E2 Medical School, University of Montreal, P.O. Box 6128, Station Centre-Ville, Montreal, QC, Canada H3C 3J7 Correspondence should be addressed to Grigorios N. Manoudis; gregmanou@yahoo.com Received 11 September 2013; Accepted 29 December 2013; Published 12 February 2014 Academic Editor: Mel S. Lee Copyright © 2014 Avishai Reuven et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Ceramic-on-ceramic articulations have become an attractive option for total hip arthroplasty in young patients. In this study, we retrospectively evaluated the short- to midterm clinical and radiographic results in 51 consecutive patients (61 hips) using the newest generation of ceramic implants. Results obtained in our study showed positive clinical and radiological outcomes. Both HHS and UCLA activity scores doubled aeft r surgery and tended to increase over time. There was one infection requiring a two-stage revision and a case of squeaking that began 2 years postoperatively aeft r a mechanical fall. eTh overall survival rate of the implants was 98.4% at six years with revision for any reason as the end point. Based on these results, fourth generation ceramics oeff r a viable option for young and active patients. 1. Introduction to the fabrication of a highly purified alumina (BIOLOX forte; CeramTec AG, Plochingen, Germany) with increased mate- One of the most challenging problems that orthopaedic rial density, decreased grain structure, and less impurities surgeons are facing today is the increasing number of young [10, 11]. All these material improvements yielded a noticeable and active patients requiring long lasting and reliable primary decrease in therateofimplant components fracture and total hip arthroplasty (THA) [1]. It is well known that bearing chipping [12, 13]. Despite the advancements made in the surface wear and particle-driven osteolysis remain the major quality of alumina ceramic, substantial concerns remain factors threatening the longevity and limiting the perfor- regarding CC bearings including stripe wear, limited sizing manceofthe implant[2, 3]. Ceramic-on-ceramic (CC) hip option, squeaking, and ceramic implant fracture. Limitations articulations made form alumina have become an attractive of pure alumina characteristics required the development of option for young and active patients who require THA. This an advanced ceramic material. is partially due to the excellent wear characteristics and Ceramic composites were the next step in the develop- outstanding tribological properties of alumina over metal- ment of CC bearings. eTh newest generation of BIOLOX on-polyethylene (MP) bearings [4, 5]. In addition, the inert delta ceramic bearings was introduced in 2000 by CeramTec nature of alumina gives the CC surfaces a great advantage AG (Plochingen, Germany). BIOLOX delta is an alumina- over metal-on-metal (MM) surfaces [6]. matrix composite (AMC) consisting of 81.6% aluminium Alumina CC bearings have a long history of use [7]. oxide, 17% yttria-stabilized tetragonal zirconia particles, and Initial attempts of ceramic-on-ceramic THA had high failure traces (1.4%) of chromium dioxide and strontium crystals rates that were mainly related to bad design and flaws engineered to increase material density and reduce grain size in the material [8, 9]. Further advancements in alumina (less than 0.8𝜇 m compared with the grain size of alumina 1– manufacturing technology such as hot isostatic pressing led 5𝜇 m) [14–16]. With these improvements, the risk for crack 2 Advances in Orthopedic Surgery propagation and component fracture was minimized. Labo- Table 1: Demographic data. ratory mechanical and hip simulator wear tests have shown Characteristic Finding that these manufacturing advances have indeed resulted in a Number of hips 60 high-strength material with increased fracture toughness and Number of patients 50 lower wear rates over pure alumina [15, 17]. These enhanced mechanical properties should decrease Age (range) 41.8 (21–56) the ceramic fracture rate, allowing the manufacturing of Gender 10 males/40 females thinner acetabular liner inserts and therefore the use of Side of surgery 31 right/29 left larger femoral head options. This increased head size should Etiology improve joint stability and reduce dislocation rates [18, 19]. Osteoarthritis 24 (40%) One study also suggests that material properties of the AMC Congenital dislocation 13 (22%) may lead to a different wear response and may decrease or Rheumatoid arthritis 8 (13%) eliminate squeaking [17]. These favorable material character- Avascular necrosis 4 (7%) istics make AMC a very promising material and particularly Juvenile rheumatoid arthritis 3 (5%) desirable for long lasting bearing surfaces. However, AMC Developmental dysplasia 1 (2%) has a relatively short clinical history and further monitoring Multiple causes 7 (11%) is necessary. The aim of this study was to retrospectively evaluate the Femoral head short- to midterm clinical and radiographic outcome aeft r BIOLOX delta28mm 25hips(42%) primary total hip replacements using the fourth generation BIOLOX delta36mm 35hips(58%) ceramic BIOLOX delta implants. Femoral stem S-ROM 41 (69%) Prodigy 11 (18%) 2. Material and Methods Summit 3 (5%) Corail 3 (5%) Prior to the onset of the study, institutional review board Trilock 2 (3%) approval was obtained. We conducted a retrospective evalua- Acetabular cup tion of all patients who received a cementless CC BIOLOX Pinnacle 100 37 (62%) delta THA between December 2004 and December 2009. Our exclusion criteria were a previous total hip replacement, Pinnacle 300 19 (31%) previous hemiarthroplasty, or fusion on the ipsilateral side. Pinnacle Bantam 3 (5%) In all, we evaluated 60 hips in 50 patients. Among these Pinnacle Multihole II 1 (2%) patients, 10 underwent staged bilateral THAs. There were iTh svalue is reported as themeaninyears. 10 males (11 hips) and 40 females (49 hips) (Table 1). The mean age at the time of the surgery was 41.8 years (range 21– 56 years). All patients underwent primary hip arthroplasty for both noninflammatory and inflammatory degenerative joint diseases. Preoperative diagnoses were osteoarthritis this study was 2 years, and average followup was 4.6 years (40%), developmental dysplasia of the hip (22%), rheumatoid (range 2–6.8 years). Preoperative and postoperative Harris arthritis (13%), avascular necrosis (7%), juvenile rheumatoid hip score (HHS) [20] was recorded. HHS score of 90 points arthritis (5%), and other causes (11%). Three arthroplasty or more was defined as an excellent outcome; 80 to 89 surgeons performed all procedures through a direct lateral points, a good outcome; 70 to 79 points, a fair outcome; (77%) or posterior approach (23%). Bilateral cases were and less than 70 points, a poor outcome. Activity score was assessed preoperatively and postoperatively using the conducted on separate dates with a mean interval of 10.3 months (3–42 months) between the two procedures. University of California, Los Angeles (UCLA) activity level Twenty-five hips (42%) received 28 mm ceramic heads rating scale from 1 to 10 [21]. Presence of hip squeaking and and 35 hips (58%) received 36 mm ceramic heads, depending all postoperative complications were documented. In each on patient anatomy and implant stability. Head size was visit, serial anteroposterior (AP) radiographs of the pelvis determined by the inner diameter of the ceramic liner for and AP and lateral radiographs of the operated side were the corresponding cup size. All patients received one of four obtained. Radiographic analysis was performed using Einzel- cementless Pinnacle acetabular cups (Pinnacle 100, Pinnacle Bild-Roentgen-Analyse (EBRA) by two of the authors (AR 300, Pinnacle Bantam, Pinnacle Multihole II; DePuy Warsaw, and AA). IN) and one of vfi e cementless femoral stems (Summit, Survival analysis was performed with use of the Kaplan- Prodigy, Trilock, Corail, or S-ROM; DePuy, Warsaw, IN) Meier method [22]. The patient demographics were cal- (Table 1). Acetabular fixation with screws was used based on culatedwitharithmeticmeanand allerrorsare reported the patient’s bone quality. as standard deviation. A nonparametric Mann-Whitney𝑈 All patients were evaluated clinically and radiographically test was conducted to determine the significance between at 6 weeks, 3 months, and one year postoperatively, followed preoperative and the last postoperative HHS and UCLA by subsequent annual examinations. Minimum followup for activity scores. All other comparisons between different time Advances in Orthopedic Surgery 3 Average HHS score over time for all patients (± std) Average UCLA score over time for all patients (± std) Excellent outcome Good outcome Fair outcome Poor outcome Pre-op 0 1 2 3 4 5 6 Pre-op0 1 2 3 4 5 6 Followup (years) Followup (years) Figure 1: Average and standard deviation (SD) values of HHS scores Figure 2: Average and standard deviation (SD) values of UCLA for all patients over time. activity scores for all patients over time. points of followup groups were performed using a nonpara- Table 2: Clinical and radiographic results at the last followup. metric Kruskal-Wallis test followed by a Dunn’s multiple Preoperative Final followup comparisons. GraphPad Prism software (GraphPad Software, Clinical parameters La Jolla, CA, USA) was used for all data analyses. A𝑃 value of less than 0.05 was considered to be statistically significant. Harris hip score 45 88 (40–90) UCLA activity score 3 6 (2–10) Radiographic parameters 3. Results ∘ ∘ ∘ Acetabular anteversion n/a 7 (2 –22 ) ∘ ∘ ∘ All 50 patients had complete clinical and radiographic data at Acetabular inclination n/a 46 (28 –56 ) 2years of followup. The values are reported as the mean. The mean HHS and UCLA scores at last followup sig- n/a = not applicable. nificantly improved ( 𝑃 = 0.00087 ) from their preoperative values.ThemeanHHS scorefor allpatientsattheir last Table 3: eTh number of hips showing the clinical outcome based on followup was 88 points (range, 40–99). eTh mean UCLA HHS score. activity score was 6 (range, 2–10). Table 3 shows the number of hips showing excellent(HHS > 90), good(90 > HHS > Total Excellent Good Fair Poor 80),fair (80 > HHS > 70),orpoor (HHS < 70) 60 40 (67%) 9 (15%) 8 (13%) 3 (5%) All THAs outcomes based on HHS score for all patients as well as 25 18 (72%) 4 (16%) 3 (12%) 0 (0%) 28 mm THRs those who received 36 mm and 28 mm femoral heads. In all 35 22 (63%) 5 (14%) 5 (14%) 3 (9%) 36 mm THRs cases, excellent outcomes were observed in 67% of hips, while poor resultswereonlyobservedinminorityof5%ofhips. There were no outcome differences between the two head diameters. reproduce the squeaking in the oce ffi with walking. The cup We also looked at the evolution of HHS and UCLA was found to be in a nonoptimal position, measuring 58 of activity score over time. Both scores significantly increased inclination and 19 of anteversion (Figures 3(a) and 3(b)). The until 4 years postoperatively reaching a plateau thereaeft r patient was completely pain-free and she refused a revision (Figures 1 and 2). surgery. The third patient presenting with poor result was a At thetimeofthe nfi al followup,there wasnoradio- femalepatientwithjuvenilerheumatoidarthritisandreduced graphic evidence of component loosening and no evidence of mobility. implant subsidence, liner fracture or dislocation. All compo- The Kaplan-Meier survival with revision for any reason as nents were stable and osseous-integrated. eTh mean acetabu- the end point was 98.4% at 6 years. In summary, no patients lar inclination and anteversion were 46 degrees (range, 28 to showed osteolysis, one patient had audible squeaking, and 58 degrees) and 7 degrees (range, 2 to 22 degrees), respectively only one patient required revision surgery for infection. Both (Table 2). HHS and UCLA activity scores significantly improved aeft r There was a case of deep infection requiring a two- surgery and tended to increase over time. Of all procedures, stage revision. One female patient presented with audible 72% of 28 mm heads and 63% of 36 mm heads had excellent repetitive “squeaking” noise that began aeft r a fall 2 years HHS outcomes. No statistically significant difference was postoperatively. Shehad a36mmheadand shewas able to noted between 28 mm and 36 mm heads in both HHS HHS score UCLA 4 Advances in Orthopedic Surgery (a) (b) Figure 3: (a) AP radiograph of the patient presenting with audible hip squeaking. (b) Analysis with the EBRA software revealed cup inclination of 58 degrees and anteversion of 19 degrees. (𝑃=0.277 ) and UCLA activity score (𝑃=0.1029 )atthe last from 0.017% to 0.013% for the alumina ceramic acetabular followup or at any time point of followup. insert and is more likely to occur within the rfi st three years following implantation [27]. Furthermore, fractures of 28 mm heads occur more frequent than 32 mm and 36 mm heads [28]. Because of the BIOLOX delta’s increased fracture 4. Discussion toughness and burst strength, the expectation is that fracture would occur with far less frequency than the estimated Wear debris-induced osteolysis and subsequent implant loos- ening are major factors limiting the survivorship and per- fracture rate of alumina ceramic heads (0.02%) [27, 29]. In formance of THA. This problem may be overcome with the our study, there was no incidence of head or liner fracture. use of CC bearings known to produce the lowest volumetric Moreover, there was no difference between 28 mm and 32 mm wear rate and reduced incidence of periprosthetic osteolysis heads in terms of clinical and radiological outcome. [23, 24]. Despite their elevated hardness and toughness, the In their prospective randomized study, D’Antonio et al. CC surfaces are not immune to wear or surface damage and showed that liners that were not fully seated were prone to concerns arising about ceramic implants are chipping and peripheral chipping during impaction [30]. They observed component fracture, stripe wear, and the poorly understood a peripheral chip in 1.2% of cases; however, none of these phenomenon of squeaking [12]. Moreover, the lack of large resulted in a fracture or in revision surgery. A subsequent modular options continues to exist [10, 13, 19]. The BIOLOX design encased the ceramic acetabular component in a delta AMC was developed to address some of the drawbacks titanium sleeve, which eliminates the risk of insertional chips of currently available alumina designs. Its increased fracture [28, 30]. toughness combined with the wider range of head sizes make Recognition of squeaking in ceramic articulations as a this implant an attractive selection. In this study our aim clinical problem has increased recently [16, 17, 31]withits was to evaluate the short- and midterm outcome of this new incidence ranging from 0.48% to 7% [11, 18, 32]. Squeaking material. has been shown to be due to ceramic or metal wear, com- One of the major disadvantages of the alumina ceramic ponent factors, implant design, impingement, implant posi- bearing is the risk of fracture. Although sporadic, these tioning [11, 18], and patient characteristics [27]. Squeaking oen ft occurs in younger, heavier, and taller patients [ 33]. Edge component fractures can be catastrophic and continue to be a clinical concern for both surgeon and patient [12]. loading appears to be the predominant causative factor for The CC fracture failure is principally related to the crack squeaking [33]. Ki et al. showed that increased BMI and propagation and is favoured by stress concentration zones certain cup designs were more prone to squeaking [34]. caused by microstructural flaws either at the surface or within Swanson et al. reviewed 233 patients comparing 4 implant the material [25]. Incremental advances in the manufacturing combinations representing 4 manufacturers and found that process, design, and quality control of alumina components Trident acetabular cups paired with Stryker Accolade femoral have addressed these issues improving significantly the struc- stems showed a dramatically higher incidence of squeaking. tural characteristics and fracture toughness of pure alumina They concluded that prosthetic design plays a key role in [26]. squeaking occurrence [35]. Another significant cause of Currently, component fractures with modern CC bear- squeaking is cup design that results in premature femoral ings are rare (0.004%) [26, 27]. Both D’Antonio et al. [23] neck-acetabular component rim impingement such as the and Lusty et al. [5] showed no ceramic bearing fractures in presence of modular ceramic liner designs that are placed 213 and 301 primary alumina-on-alumina THAs, respectively, within a titanium encasement with extended rims [29, 34]. at an average of ve fi years. eTh estimated risk of fracture of Most studies report that squeaking is rare with no clinical theseimplantsisfrom0.03% to 0.05%for femoralheads and consequences [17], but in some studies, squeaking has led to Advances in Orthopedic Surgery 5 revision [32, 36]. Yang et al. also suggested that squeaking [4] J. Y. Jeong, Y.-M. Kim, S. Y. Kang, K.-H. Koo, S. S. Won, and J. K. Hee, “Alumina-on-alumina total hip arthroplasty: a vfi e-year canbereduced duetomaterialproperties, such as thewear minimum follow-up study,” Journal of Bone and Joint Surgery A, response of BIOLOX delta [17]. In our study squeaking was vol. 87, no. 3, pp. 530–535, 2005. noted in only one patient with increased inclination of the acetabular component. [5] P.J.Lusty,C.C.Tai,R.P.Sew-Hoy,W.L.Walter, W. K. Our study has certain limitations. The number of patients Walter, and B. A. Zicat, “Third-generation alumina-on-alumina ceramic bearings in cementless total hip arthroplasty,” Journal of is relatively small, three surgeons were involved using two Bone and Joint Surgery A,vol.89, no.12, pp.2676–2683,2007. different approaches, and four acetabular cups matched with vfi e femoral stems were implanted. We also recognize that our [6] P. S. Christel, “Biocompatibility of surgical-grade dense study is of relatively short duration with a minimum followup polycrystalline alumina,” Clinical Orthopaedics and Related of two years and a mean followup of just over four years. To Research, no. 282, pp. 10–18, 1992. the best of our knowledge, this is the rfi st study reporting the [7] P. Boutin, “Total hip arthroplasty using a ceramic prosthesis. survival and functional outcome of solely fourth generation Pierre Boutin (1924–1989),” Clinical Orthopaedics and Related ceramic delta implants. Research,vol.379,pp. 3–11, 2000. [8] R. S. Nizard, L. Sedel, P. Christel, A. Meunier, M. Soudry, and J. Witvoet, “Ten-year survivorship of cemented ceramic-ceramic 5. Conclusion total hip prosthesis,” Clinical Orthopaedics and Related Research, Alumina-based ceramic composite materials, with its supe- no.282,pp. 53–63, 1992. rior mechanical properties and excellent wear behavior, have [9] L. Sedel, R. S. Nizard, L. Kerboull, and J. Witvoet, “Alumina- been successfully implanted and have offered outstanding alumina hip replacement in patients younger than 50 years old,” performance in the last 11 years. This retrospective study Clinical Orthopaedics and Related Research, no. 298, pp. 175–183, demonstrates that BIOLOX delta bearings provided good to excellent overall functioning outcomes with no implant [10] R. J. Heros and G. Willmann, “Ceramics in total hip arthro- related complications or osteolysis. An increase in head plasty: history, mechanical properties, clinical results, and cur- size did not lead to significantly different HHS and UCLA rent manufacturing state of the art,” Seminars in Arthroplasty, activity score results. However, the duration of followup vol. 9, pp. 114–122, 1998. is relatively short. eTh refore, we cannot conclude whether [11] Y.-Z. Cai and S.-G. Yan, “Development of ceramic-on-ceramic this new ceramic material will outperform other bearing implants for total hip arthroplasty,” Orthopaedic Surgery,vol.2, couplings over time. 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Published: Feb 12, 2014
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