Delta Ceramic-on-Alumina Ceramic Articulation in Primary THA: Prospective, Randomized FDA-IDE Study and Retrieval Analysis Prospective multi-centre study on a composite ceramic femoral component in total knee arthroplasty: Five-year clinical and radiological outcomes. Alumina Ceramic Bearings for Total Hip Arthroplasty: Five-year Results of a Prospective Randomized Study Ceramic-on-ceramic total hip arthroplasty: update. Use of an alumina-on-alumina bearing system in total hip arthroplasty for osteonecrosis of the hip. Alumina ceramic bearings for total hip arthroplasty. A randomized trial of ceramic-on-ceramic bearing versus ceramic-on-crossfire-polyethylene bearing in total hip arthroplasty: five-year outcomes. Mobile Bearings Do Not Improve Fixation in Cemented Total Knee Arthroplasty Staged bilateral mobile-bearing and fixed-bearing total knee arthroplasty in the same patients: a prospective comparison of a posterior-stabilized prosthesis A randomised prospective evaluation of ceramic-on-ceramic and ceramic-on-highly cross-linked polyethylene bearings in the same patients with primary cementless total hip arthroplasty EBRA migration patterns of the Plasmacup with ceramic or polyethylene inserts: a randomised study. An Oxidized Zr Ceramic Surfaced Femoral Component for Total Knee Arthroplasty A prospective randomised controlled trial comparing three alternative bearing surfaces in primary total hip replacement. Conventional versus computer-navigated TKA: a prospective randomized study THA With Delta Ceramic on Ceramic: Results of a Multicenter Investigational Device Exemption Trial Clinical results of posterior cruciate ligament retaining TKA with alumina ceramic condylar prosthesis: comparison to Co–Cr alloy prosthesis Large-diameter Delta ceramic-on-ceramic versus common-sized ceramic-on-polyethylene bearings in THA.
Wear and osteolysis continue to be major reasons for revision surgery in THA .  Ceramic-on-ceramic bearings eliminate polyethylene wear debris . The newest generation of these bearings incorporate nanosized , yttria-stabilized tetragonal zirconia particles producing an alumina matrix composite . We asked whether this new material would perform as well as a conventional bearing in terms of functional hip scores , radiographic migration and osteolysis , complications and survival . As part of a US FDA investigational device exemption study ( G000075 ) , we conducted an initial prospect i ve safety study of 21 alumina matrix composite femoral heads articulating on alumina liners followed by a prospect i ve , r and omized study with 44 more of these articulations and 45 zirconia femoral heads on polyethylene liners .  The minimum followup for all patients was 26 months ( mean , 73 months ; range , 26–108 months ) . Harris hip scores and radiographic findings were similar in the two groups as was survivorship ( trial 95 % versus control 93 % ) . There were three reoperations in the trial group and three in the control group . A fractured head retrieval showed a 33 % monoclinic transformation with an increase in surface roughness from 3 to 5 nm at the main wear zone . While our numbers were insufficient to compare device-related complications , the trial device performed as well as the control device in terms of reoperation , and clinical and radiographic outcome . The alumina matrix composite femoral head on an alumina liner provided high survivorship . Level of Evidence : Level II , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence BACKGROUND Enhanced wear resistance of ceramics in general and improved mechanical characteristics of composite ceramics in terms of strength and resistance meet the dem and s for application in TKA . The aim of this prospect i ve international multi-centre study was to evaluate the 5-year clinical and radiological outcomes of an unconstrained TKA with a composite ceramic femoral component . METHODS A total of 107 patients ( 109 knees ) underwent TKA with the MULTIGEN-PLUS Ceramic Knee at seven centres in three European countries .  Clinical and radiological assessment s were performed preoperatively and postoperatively at 3 , 12 , 24 and 60 months , using HSS , WOMAC , SF-36 and st and ardised radiographs . RESULTS Mean HSS and WOMAC increased significantly from 55.1±11.5 ( 21 - 83 ) and 48.1±16.6 ( 3 - 90 ) preoperatively to 85.6±9.6 ( 49 - 98 ) and 73.3±20.4 ( 17 - 100 ) at 60 months . Mean SF-36 showed significant improvements in patients ' quality of life ( 49.1±17.6 ( 12 - 96 ) preoperatively versus 67.7±23.1 ( 12 - 100 ) at 60 months ) . Non-progressive radiolucent lines ( < 1 mm ) were observed around the femoral component in four cases . Neither implant migration nor loosening were registered . Kaplan-Meier survivorship was 96.0 % at 60 months ( 92.1 - 100 % , CI 95 % ) . CONCLUSIONS Five-year implant survival rate of the ceramic knee is comparable to other metallic and ceramic unconstrained TKA systems . Although the assessment of long-term implant survivorship is still pending , the ceramic implants represent a promising solution for patients with allergies against metallic components and furthermore for the general osteoarthritis population due to enhanced wear resistance Three hundred twenty-eight ceramic bearings were implanted by six surgeons in 316 patients as a part of a prospect i ve r and omized US Investigational Device Exemption study comparing alumina ceramic bearings with cobalt chrome-on-polyethylene bearings . There was no difference between the control metal-on-polyethylene and the alumina bearing couple patient cohorts regarding demographics or clinical scores through 7 years . Revision for any reason occurred in 2.7 % of the patients with alumina bearings and 7.5 % of the control patients with polyethylene bearings .  Osteolysis was found in 1.4 % of the patients with alumina bearings and in 14.0 % of the control patients . At an average followup of 5.0 years ( range , 1 - 86 months ) no ceramic fractures or ceramic bearing failures have occurred . Results of this study suggest that alumina ceramics  perform as well as the metal-on-polyethylene in clinical scores , but the patients with ceramic bearings had fewer revisions and less osteolysis . These results lead us to think that this new alumina ceramic bearing provides a safe option for younger and more active patients . Level of Evidence : Therapeutic study , Level I-1b ( r and omized controlled trial , no significant difference , but narrow confidence intervals ) . See the Guidelines for Authors for a complete description of levels of evidence This prospect i ve , r and omized , multicenter study of alumina ceramic-on-alumina ceramic bearing couples includes 452 patients ( 475 hips ) . Their average age was 53 years with approximately two thirds men and 82 % with osteoarthritis . At an average 8-year follow-up , clinical results were excellent and cortical erosions significantly less than in the conventional polyethylene-on-metal bearing group . Nine hips have undergone revision of one or both components for any reason . Of the 380 ceramic liners , 2 ( 0.5 % ) have fractured requiring reoperation , and 3 ( 0.8 % ) ceramic patients reported a transient squeaking sound , one of which had a head and liner change due to groin pain secondary to psoas tendinitis at 5 years . With no revisions for aseptic loosening and minimal cortical erosions , alumina-ceramic bearing couples are performing in a manner superior to the polyethylene-on-metal bearing in this young , active patient population BACKGROUND The results of total hip arthroplasty in patients with osteonecrosis of the femoral head are not always optimal . The use of alumina-on-alumina interfaces in young and active patients may decrease wear and lower the rate of aseptic loosening of the implant and appears to be an attractive alternative to the use of conventional cobalt-chromium-on-polyethylene bearings . The purpose of this study was to evaluate the safety and efficacy of the alumina-on-alumina bearing in patients with osteonecrosis and to compare this group of patients to a group of similarly treated patients with osteoarthritis and a group of patients who received conventional cobalt-chromium-on-polyethylene bearings . METHODS Patients were selected from a United States Investigational Device Exemption multicenter prospect i ve r and omized clinical study that was initiated in 1996 . Seventy patients with osteonecrosis of the femoral head ( seventy-nine hips ) received a cementless alumina-on-alumina bearing system and were directly matched to seventy-six patients with osteoarthritis of the hip ( seventy-nine hips ) who were managed with the same implant . Both groups were compared with twenty-five patients ( twenty-six hips ) with osteonecrosis and twenty-five patients ( twenty-six hips ) with osteoarthritis who were managed with a cementless cobalt-chromium-on-polyethylene bearing system . All patients received a cementless hydroxyapatite-coated femoral stem and were followed both clinical ly and radiographically . RESULTS The clinical outcomes for alumina-on-alumina bearings were similar for both osteonecrotic and osteoarthritic hips . The seven-year survival probability was 95.5 % for the osteonecrotic hips and 89.4 % for the osteoarthritic hips in the alumina-on-alumina bearing group and 92.3 % for the osteonecrotic hips and 92.9 % for the osteoarthritic hips in the cobalt-chromium-on-polyethylene bearing group . At the time of the most recent follow-up , the mean Harris hip score was 96 points for both the osteonecrotic and the osteoarthritic hips in the alumina-on-alumina group and 96 points for the osteonecrotic hips and 97 points for the osteoarthritic hips in the cobalt-chromium-on-polyethylene bearing group . CONCLUSIONS The results of the use of alumina-on-alumina and cobalt-chromium-on-polyethylene bearings in cementless st and ard total hip implants in patients with osteonecrosis and osteoarthritis were comparable . The low revision rate for the alumina-on-alumina bearing is encouraging and offers a promising option for younger , more active patients who have this challenging disease . LEVEL OF EVIDENCE Therapeutic Level III . See Instructions to Authors on jbjs.org for a complete description of levels of evidence This article presents an experience with alumina ceramic bearings involving the use of improved ceramic material s as well as new design considerations . The alumina-alumina ceramic hard bearing is a safe option for the younger , more active patient This study determined how ceramic-on-ceramic bearing THA affected joint-specific pain , function and stiffness in the first five postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing THA .  Subjects less than 61 years of age were r and omized  to ceramic-on-ceramic ( CERAMIC ) [ n = 48 ] or ceramic-on-highly-crosslinked-polyethylene ( POLYETHYLENE ) [ n = 44 ] bearing THA . Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index ( WOMAC ) and the R AND 12-Item Health Survey ( R AND -12 ) preoperatively , and at one and five years postoperatively . 92 subjects(50 ( 54 % ) males ; average age = 52 ( SD 6.6 ) years ) were enrolled . 78 ( 85 % ) subjects returned five years postoperatively . All subjects reported improvements at one and five years in all measured indices with no group differences detected . Seven ( 8 % ) subjects experienced postoperative THA complications , none related to bearing surfaces ; two subjects ( POLYETHYLENE ) required revision for instability . Both bearing surfaces provided excellent short-term results in younger subjects Mobile bearings were introduced to improve wear and knee kinematics . By uncoupling the forces generated at the articulation from the implant-bone interface this would , theoretically , also improve the fixation of the implant to bone . We did this study to evaluate whether mobile bearings  improve the fixation of the tibial component to bone .  Fifty-two consecutive knees in 47 patients ( average age , 72 years ; range , 62 - 84 years ) with primary osteoarthrosis were r and omized into two groups to receive a cemented total knee arthroplasty with either a fixed-bearing or mobile-bearing tibial component . The quality of fixation was analyzed with radiostereometric analysis for up to 2 years . Mobile bearings did not improve fixation . Both magnitudes and directions of component rotations were similar , and the number of implants with continuous migration was almost identical . Both implant types had a combination of subsidence and lift-off , but where the mobile bearing implants displayed more of subsidence , the fixed bearing knees showed more lift-off . It might be that the somewhat stiffer cobalt-chromium baseplate or the different joint conformity used in the mobile-bearing knees counteracts any potential effects of the mobile bearing . Level of Evidence : Therapeutic Level I. See the Guidelines for Authors for a complete description of levels of evidence Mobile-bearing total knee arthroplasty ( TKA ) has several theoretical advantages over fixed-bearing TKA . We conducted a prospect i ve r and omized trial to compare the results of mobile-bearing and fixed-bearing posterior-stabilized TKA in the same patients using the same femoral component design of a mobile-bearing prosthesis in one knee and a fixed-bearing prosthesis in the other knee in 25 patients with osteoarthritis . The mean follow-up was 40 months . No significant differences were found in the mobile-bearing and fixed-bearing knees in terms of clinical and radiographic results . No osteolysis , loosening , or revision occurred . One knee with a mobile-bearing prosthesis had a dislocation of the rotating bearing ; however , spontaneous reduction occurred and the dislocation did not recur . Satisfactory early results can be achieved in both mobile-bearing and fixed-bearing knees . We could not demonstrate an advantage of a mobile-bearing TKA Purpose Very few studies have compared alumina-on-alumina ceramic and alumina-on-highly cross-linked polyethylene bearings in the same patient . The purpose of this prospect i ve r and omised study was to compare the clinical and radiographic results and the prevalence of osteolysis in cementless total hip arthroplasty using an alumina-on-alumina and alumina-on-highly cross-linked polyethylene bearings in young active patients . Methods We prospect ively compared the results of 100 patients ( 200 hips ) who had undergone a cementless total hip arthroplasty with an alumina-on-alumina ceramic bearing in one hip and an alumina-on-highly cross-linked polyethylene in the other . There were 66 men and 34 women with a mean age of 45.3 years ( range , 21–49 years ) at the time of surgery . The mean follow-up was 12.4 years ( range , 11–13 years ) . The patients were assessed clinical ly and radiographically at three months , one year , and annually thereafter . Results Harris hip , Western Ontario and McMaster Universities Osteoarthritis Index , and University of California , Los Angeles activity scores did not show statistically significant differences between the two groups of bearings preoperatively or at the time of final follow-up . Radiographic findings of the component were not significantly different between the two groups . The mean polyethylene linear penetration was 0.031 ± 0.004 mm per year . No hips in either group displayed osteolysis . The Kaplan-Meier survivorship with revision as the end point at 12.4 years was 100 % ( 95 % confidence interval [ CI ] , 94–100 % ) for the femoral component in both groups and 99 % ( 95 % CI , 93–100 % ) for the acetabular component . Conclusion The clinical and radiographic results of using an alumina-on-alumina ceramic and alumina-on-highly cross-linked polyethylene bearings were similar AIM In this prospect i ve r and omised study , the influence of different bearing material s on migration and wear was measured and their effect on the function of the artificial joint and the patient outcome was investigated . Mid-term results were recorded so that recommendations can be made on the use of certain bearings , which minimise wear and thus the danger of subsequent aseptic loosening . METHOD Sixty-six patients met the inclusion criteria and were willing to take part in the study . These patients were r and omised to 2 groups . All of them had total hip arthroplasty with implantation of a cementless Bicontact stem and Plasmacup using a cementless press-fit technique . Thirty-five of these patients were given a ceramic-ceramic bearing and 31 patients a ceramic-polyethylene bearing ( gamma sterilised/nitrogen environment ) . At the most recent follow-up , they underwent detailed clinical and radiological examination and evaluation by means of the Harris Hip Score , Hannover function question naire and single-film X-ray analysis ( EBRA ) . RESULTS The overall follow-up rate was 65.2 % ( 43 of 66 ) and the mean follow-up period was 8.1 ( 7.1 - 9.2 ) years . The median Harris Hip Score at the time of follow-up was 90.1 ( 58.7 - 99.9 ) points . The average Hannover function score was 87.14 % ( 63.9 - 100 ) . In 4 of 66 cases ( 6.1 % ) there was a tendency for the Plasmacup to subsidence in the first postoperative months that was slight but detectable by EBRA ; however , this stopped subsequently . This primary subsidence was independent of the chosen bearing material . No significant difference in the clinical and radiological parameters was found between the two groups . CONCLUSION The very good results with regard to the rate of loosening confirm the press-fit cup fixation concept . The study shows a similar medium-term result for the ceramic-ceramic and ceramic-polyethylene bearing so that use of both bearings can continue to be recommended . Only long-term studies with sufficiently large numbers of patients will be able to show whether significant differences can be detected between the two slide bearings with regard to wear and migration behaviour and so that a recommendation can be given to the surgeon A ceramic surfaced oxidized Zr femoral component  was used in total knee replacemdent . Prior mechanical testing had shown a decrease in adhesive and abrasive wear using this material as compared with CoCrMo suggesting its use in younger patients in whom long-term PE wear is a consideration . The alloy had no demonstrable Ni impurities and was applicable to patients with Ni or Co allergies . In a r and omized prospect i ve study comparing femoral components of the same design but fabricated either of cast CoCrMo or oxidized Zr , there was a more rapid return of flexion and regaining functional milestones in the oxidized Zr group . No adverse effects had been observed at the 2-year evaluation The ideal bearing surface for young patients undergoing total hip replacement ( THR ) remains controversial . We report the five-year results of a r and omised controlled trial comparing the clinical and radiological outcomes of 102 THRs in 91 patients who were < 65 years of age . These patients were r and omised to receive a cobalt-chrome on ultra-high-molecular-weight polyethylene , cobalt-chrome on highly cross-linked polyethylene , or a ceramic-on-ceramic bearing . In all , 97 hip replacements in 87 patients were available for review at five years . Two hips had been revised , one for infection and one for peri-prosthetic fracture . At the final follow-up there were no significant differences between the groups for the mean Western Ontario and McMaster Universities osteoarthritis index ( pain , p = 0.543 ; function , p = 0.10 ; stiffness , p = 0.99 ) , Short Form-12 ( physical component , p = 0.878 ; mental component , p = 0.818 ) or Harris hip scores ( p = 0.22 ) . Radiological outcomes revealed no significant wear in the ceramic group . Comparison of st and ard and highly cross-linked polyethylene , however , revealed an almost threefold difference in the mean annual linear wear rates ( 0.151 mm/year versus 0.059 mm/year , respectively ) ( p < 0.001 ) Purpose The purpose of this study was to assess the midterm results of total knee arthroplasty ( TKA ) implanted with  a specific computer navigation system in a group of patients ( NAV ) and to assess the same prosthesis implanted with the conventional technique in another group ( CON ) ; we hypothesized that computer navigation surgery would improve implant alignment , functional scores and survival of the implant compared to the conventional technique . Methods From 2008 to 2009 , 225 patients were enrolled in the study and r and omly assigned in CON and NAV groups ; 240 consecutive mobile-bearing ultra-congruent score ( Amplitude , Valence , France ) TKAs were performed by a single surgeon , 117 using the conventional method and 123 using the computer-navigated approach .  Clinical outcome assessment was based on the Knee Society Score ( KSS ) , the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score . Component survival was calculated by Kaplan – Meier analysis . Results Median follow-up was 6.4 years ( range 6–7 years ) . Two patients were lost to follow-up . No differences were seen between the two groups in age , sex , BMI and side of implantation . Three patients of CON group referred feelings of instability during walking , but clinical tests were all negative . NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis , lateral distal femoral angle , medial proximal tibial angle and tibial slope in post-operative radiographic assessment . There was one case of early post-operative superficial infection ( caused by Staph . Aureus ) successfully treated with antibiotics . No mechanical loosening , mobile-bearing dislocation or patellofemoral complication was seen . At 7 years of follow-up , component survival in relation to the risk of aseptic loosening or other complications was 100 % . There were no implant revisions . Conclusion This study demonstrates superior accuracy in implant positioning and statistical significant better functional outcomes of computer-navigated TKA . Computer navigation for TKAs should be used routinely in primary implants . Level of evidence II Although the published studies on the outcomes of  total hip arthroplasty (  THA ) performed with currently available ceramic components show high survivorship and low bearing wear at midterm followup , concern over ceramic fracture and squeaking persist . For these reasons , the use of ceramic is limited . Recently , a new alumina matrix composite material ( Delta ceramic ) with improved material properties was developed to address these concerns . We report the early outcomes and complications of a prospect i ve , r and omized , multicenter trial of 263 patients ( 264 hips ) at eight centers , comparing a Delta ceramic-on-ceramic ( COC ) articulation with a Delta ceramic head-crosslinked polyethylene bearing combination ( COP ) . There were 177 COC hips and 87 COP hips . Complications  were reported for all patients , whereas  clinical and radiographic results were provided for the 233 patients with minimum 2-year followup ( average , 31.2 months ; range , 21–49 months ) . The Harris hip scores and clinical , radiographic , and survivorship outcomes were similar in both groups . There were four ( 2 % ) revisions in the COC group and two ( 2 % ) in the COP group . We encountered three intraoperative ceramic liner-related events . In addition , one patient receiving the COC underwent revision for chipping of the ceramic liner , and a second had ceramic fragmentation on followup radiographs but has not undergone revision . These liner related complications remain a concern . No patient reported squeaking in either group ; this leaves us hopeful the new material will lessen the frequency of squeaking . In the short term , the Delta COC articulation provided similar functional scores and survivorship and complication rates with the ceramic head mated with crosslinked polyethylene . Level of Evidence : Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence In a prospect i ve study , 194 knees undergoing total knee arthroplasty ( 110 knees with alumina ceramic prostheses ; 84 knees with Co – Cr alloy prostheses )  were clinical ly and radiologically evaluated . Average follow-up period was 66 months ( 36–124 months ) . Average age at the time of surgery was 66 years . In the ceramic prostheses , two revision surgeries were performed because of breakage of the tibial tray and late infection , whereas two revisions of the Co – Cr alloy prostheses were carried out due to loosening and late infection . In the other patients , there were no significant differences in clinical parameters ( HSS knee score and range of motion ) between the two prostheses . In radiological evaluation , we could not find any radiolucent lines around the femoral ceramic component while radiolucency was present in three knees ( 3.6 % ) around the Co – Cr femoral component . Beneath the tibial tray , three knees ( 2.7 % ) showed a radiolucent line around the former prosthesis while eight knees ( 9.5 % ) demonstrated a radiolucent line around the latter prosthesis . Chi-square tests showed a significant difference in the occurrence of radiolucent line around both of the femoral and tibial prosthesis . This study demonstrated that clinical results of the alumina ceramic PCL retaining total knee prosthesis are comparable to the st and ard Co – Cr alloy PCL retaining total knee prosthesis . Although we could not draw any conclusions regarding the superiority of the ceramic prosthesis with respect to UHMWPE wear and long-term survivorship , this report encouraged a long-term follow-up study on ceramic prostheses The higher failure rate of total hip arthroplasty ( THA ) in young , active patients remains a challenge for surgeons . Recently , larger-diameter femoral heads combined with an alumina matrix composite ceramic ( BIOLOX Delta ; CeramTec AG , Plochingen , Germany ) articulation was developed to improve implant longevity and meet patients ' activity dem and s while reducing the risk of component-related complications . The purpose of this study was to determine whether this new device may provide advantages for young , active patients . A prospect i ve , r and omized , controlled trial was conducted on 93 patients ( 113 THAs ) with more than 3 years of follow-up . Patients were r and omly divided into a study group ( 51 THAs ) with a 36-mm Delta ceramic-on-ceramic ( COC ) articulation and a control group ( 62 THAs ) with a common-sized alumina ceramic head on polyethylene liner ( COP ) articulation .  Clinical and radiographic results were collected to compare the outcomes and complications , including implant-related failures , osteolysis , and noises . The large-diameter Delta COC articulation provided greater range of motion improvement ( 6.1 ° more ) , similar Harris Hip Scores , and similar complication rates compared with the alumina COP articulation . This study suggests that in the short term , the large-diameter Delta COC articulation results in better range of motion with no higher complication rates ; however , mid-term ( 8 - 10 years ) or longer follow-up is necessary to determine its superiority in young , active patients
Overall , there was a notable enhancement of joint function after the procedure , with a satisfactory mid- and long-term survival of the ceramic components , which is comparable to that of the conventional alloy components reported previously .
However , revision due to aseptic loosening , wear , and component fracture appeared to be rare , demonstrating the safety of in vivo use of ceramic bearings in the TKA procedure .
Conclusions Ceramic TKA implants show similar post-operative clinical results and survival rate compared to their conventional metallic counterparts .
Our results confirmed the safety of in vivo use of ceramic bearings in TKA , with rare implant breakage and aseptic loosening .
Purpose Ceramic bearings have been widely used in total hip arthroplasty ( THA ) , which result ed in satisfactory clinical outcomes due to the excellent tribological characteristics of the implants .
However , ceramic components are not commonly used in total knee arthroplasty ( TKA ) because of brittleness .
This study aim ed to gather and analyze information regarding the clinical outcomes ( including survival without revision , causes of revision , functional outcome , and incidence of loosening ) and reach a definitive conclusion about the use of ceramic femoral components in total knee arthroplasty .