National Joint Replacement Registry. Metal on Metal Bearing Surface Total Conventional Hip Arthroplasty

Transcription

1 ational Joint Replacement Registry Metal on Metal Bearing Surface Total Conventional Hip Arthroplasty SUPPLEMETARY REPORT 2015

2 COTETS ITRODUCTIO... 1 METAL O METAL... 2 Demographics... 2 Outcome... 2 LIST OF TABLES Outcome... 2 Table MM1 umber of Revisions of Metal/Metal Primary Total Conventional Hip Replacement by Year of Implant... 3 Table MM2 CPR of Metal/Metal Primary Total Conventional Hip Replacement... 3 Table MM3 Type of Revision of Metal/Metal Primary Total Conventional Hip Replacement... 3 Table MM4 Revision Diagnosis of Metal/Metal Primary Total Conventional Hip Replacement... 4 Table MM5 CPR of M/M Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA)... 5 Table MM6 CPR of M/M Primary Total Conventional Hip Replacement by Age (Primary Diagnosis OA)... 6 Table MM7 CPR of M/M Primary Total Conventional Hip Replacement by Head Size and Age (Primary Diagnosis OA)... 7 Table MM8 CPR of M/M Primary Total Conventional Hip Replacement by Gender and Head Size (Primary Diagnosis OA)... 8 Table MM9 CPR of M/M Primary Total Conventional Hip Replacement Head Size >32mm by Head and Acetabular Surface LIST OF FIGURES Outcome... 2 Figure MM1 Cumulative Incidence Revision Diagnosis of Metal/Metal Primary Total Conventional Hip Replacement... 4 Figure MM2 CPR of Metal/Metal Primary Total Conventional Hip Replacement by Head Size... 5 Figure MM3 CPR of Metal/Metal Primary Total Conventional Hip Replacement by Age... 6 Figure MM4 CPR of Metal/Metal Primary Total Conventional Hip Replacement by Age and Head Size... 7 Figure MM6 CPR of Metal/Metal Primary Total Conventional Hip Replacement by Gender and Head Size... 8 Figure MM7 Cumulative Incidence Revision Diagnosis of M/M and M/P Primary Total Conventional Hip Replacement... 9 Figure MM8 Cumulative Incidence Revision Diagnosis of M/M and M/P Primary Total Conventional Hip by Head Size... 9

3 ITRODUCTIO Data presented in this report have been submitted to the Registry by both public and private hospitals. Currently this involves 305 hospitals nationally but varies from time to time due to hospital closures, new hospitals or changes to services within hospitals. The Registry was implemented in a staged manner on a state-by-state basis. Implementation was completed nationally by mid 2002; therefore 2003 was the first year of complete national data. All hip replacement procedures recorded by the Registry from the commencement date to the 31 December 2014 have been included in this report. The table below shows the commencement date for each state/territory. Commencement Date of Hip Replacement by State/Territory State/Territory Commencement Date South Australia September 1999 Queensland April 2000 Western Australia April 2000 Victoria July 2000 Tasmania September 2000 orthern Territory October 2000 Australian Capital Territory May 2001 ew South Wales June 2001 End Data Period: 31 December 2014 Page 1

4 METAL O METAL Demographics Metal on Metal (M/M) bearing surface has been used in 22,088 primary total conventional hip replacements. The use of M/M has continued to decline with 59 procedures undertaken in 2014 (Table MM1). M/M has a 14 year cumulative percent revision of 19.8% (Table MM2). There have been 3115 revisions of M/M primary total conventional hip replacement. The majority of revisions involve the acetabular only (59.8%), followed by revision to both the femoral and acetabular components (15.4%) (Table MM3). The main reasons for revision are metal related pathology (41.2%), loosening/lysis (27.3%) and infection (10.9%) (Table MM4 and Figure MM1). Outcome Since 2008, the Registry has identified that M/M bearing surface has a higher rate of revision compared to Metal on Polyethylene (M/P). In 2010, M/M was identified as having a higher rate of revision compared to all other bearing surfaces. It was also in that year that the Registry first identified the important relationship between head size and revision of M/M prostheses. To further evaluate the effect of head size with M/M bearing surface, analysis was undertaken comparing four head size groups ( 28, 30-32, 36-40, >40mm). There is no difference in the rate of revision between head sizes 28mm or less and 30-32mm. The two larger head size groups were associated with an increased rate of revision compared to head sizes 32mm or less. In particular there has been an increasing rate of revision for head sizes greater than 40mm (Table MM5 and Figure MM2). The Registry continues to report a difference in the rate of revision with regard to age. Patients aged less than 75 years of age have a higher rate of revision compared to patients 75 years or older after 4.5 years. (Table MM6 and Figure MM3). difference for head sizes 32mm or less (Table MM8 and Figure MM6). There are differences in the reasons for revision when M/M and M/P bearing surfaces are compared. The cumulative incidence of reason for revision demonstrates a higher incidence of revision for metal related pathology, loosening/lysis and infection for the M/M group. The cumulative incidence for these three revision diagnoses for M/M at 14 years is, 4.9% and 1.9% respectively compared to MoP, 2.5% and 0.9% respectively (Figure MM7). It is uncertain why there is a higher incidence of reported infection. The diagnosis of infection is reported to the Registry at the time of surgery and has not been confirmed by linking to results of microbiological investigation. The differences in the reasons for revision between M/M and M/P are more evident in the M/M prostheses with a head size greater than 32mm. Metal related pathology is largely confined to head sizes greater than 32mm. The cumulative incidence of metal related pathology at 10 years is 9.9% for head sizes greater than 32mm and 0.4% for head sizes 32mm or less. The incidence of metal related pathology is potentially higher as it is possible that undiagnosed metal related pathology contributes to the increased rate of loosening/lysis and infection reported in M/M articulations with larger head sizes (Figure MM8). The Registry has also identified that lysis, as the sole diagnosis for revision, is reported with the highest frequency in metal on metal articulations. In order to determine if the higher revision rate of M/M articulations with greater than 32mm head sizes is prosthesis specific, the Registry has analysed all prosthesis head/acetabular combinations with head size greater than 32mm with more than 200 procedures. There are 13 combinations that meet these criteria. The cumulative percent revision ranges from 4.3% to 36.7% at seven years (Table MM9). There continues to be a relationship between age and head size. The rate of revision for head sizes greater than 32mm is higher regardless of age. When using head sizes greater than 32mm, those aged less than 65 years have a higher rate of revision than those aged 65 years or older (Table MM7 and Figure MM4). Females have a higher rate of revision for M/M (Table MM8 and Figure MM5). This difference is related to head size. For head sizes greater than 32mm, both males and females have a higher rate of revision, with females having the highest rate. There is no gender End Data Period: 31 December 2014 Page 2

5 Table MM1 umber of Revisions of Metal/Metal Primary Total Conventional Hip Replacement by Year of Implant Year of Implant umber Revised Total umber TOTAL Table MM2 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement Bearing Surface Revised Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Metal/Metal (1.6, 2.0) 5.0 (4.8, 5.3) 9.7 (9.3, 10.1) 14.1 (13.6, 14.6) 17.4 (16.8, 18.1) 19.8 (18.8, 20.7) TOTAL Table MM3 Type of Revision of Metal/Metal Primary Total Conventional Hip Replacement Metal/Metal Type of Revision umber % Primaries Revised % Revisions Acetabular Component THR (Femoral/Acetabular) Femoral Component Head/Insert Cement Spacer Head Only Head/eck/Insert Minor Components Head/eck Insert Only Removal of Prostheses Bipolar Only eck Only Reinsertion of Components Saddle Revision Primary End Data Period: 31 December 2014 Page 3

6 Cumulative Incidence Table MM4 Revision Diagnosis of Metal/Metal Primary Total Conventional Hip Replacement Metal/Metal Revision Diagnosis umber % Primaries Revised % Revisions Pain Leg Length Discrepancy Implant Breakage Stem Incorrect Sizing Implant Breakage Acetabular Wear Acetabulum Malposition Tumour Instability Synovitis Wear Acetabular Insert Implant Breakage Acetabular Insert Osteonecrosis Heterotopic Bone Other Revision Primary Figure MM1 Cumulative Incidence Revision Diagnosis of Metal/Metal Primary Total Conventional Hip Replacement (Primary Diagnosis OA) Metal/Metal End Data Period: 31 December 2014 Page 4

7 Cumulative Percent Revision Table MM5 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA) Bearing Surface Head Size Revised Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Metal/Metal 28mm (1.1, 1.9) 3.1 (2.5, 3.7) 3.8 (3.2, 4.6) 4.8 (4.0, 5.6) 5.9 (5.0, 6.8) 7.3 (6.3, 8.6) Metal/Metal 30-32mm (1.2, 2.4) 3.5 (2.8, 4.4) 5.0 (4.1, 6.0) 5.4 (4.5, 6.5) 7.2 (5.8, 8.8) Metal/Metal 36-40mm (1.7, 2.6) 4.6 (4.0, 5.4) 7.2 (6.4, 8.1) 9.7 (8.7, 10.8) 12.9 (11.6, 14.3) Metal/Metal >40mm (1.3, 1.8) 6.1 (5.6, 6.5) 13.2 (12.6, 13.9) 20.2 (19.4, 21.0) 26.4 (25.0, 27.8) TOTAL Figure MM2 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA) 35% 30% 25% 20% 15% 10% 5% Metal/Metal 28mm Metal/Metal 30-32mm Metal/Metal 36-40mm Metal/Metal >40mm HR - adjusted for age and gender Metal/Metal 30-32mm vs Metal/Metal 28mm Entire Period: HR=1.24 (0.98, 1.56),p=0.079 Metal/Metal 36-40mm vs Metal/Metal 28mm 0-4.5Yr: HR=1.75 (1.41, 2.17),p< Yr+: HR=3.48 (2.66, 4.56),p<0.001 Metal/Metal >40mm vs Metal/Metal 28mm 0-1.5Yr: HR=1.40 (1.10, 1.77),p= Yr - 2Yr: HR=2.67 (1.83, 3.90),p< Yr - 2.5Yr: HR=4.06 (2.78, 5.94),p< Yr - 3Yr: HR=3.96 (2.74, 5.74),p< Yr - 4.5Yr: HR=6.72 (5.19, 8.71),p< Yr+: HR=9.78 (7.72, 12.38),p< % umber at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Metal/Metal 28mm Metal/Metal 30-32mm Metal/Metal 36-40mm Metal/Metal >40mm End Data Period: 31 December 2014 Page 5

8 Cumulative Percent Revision Table MM6 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Age (Primary Diagnosis OA) Bearing Surface Age Revised Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Metal/Metal < (1.2, 2.0) 5.3 (4.6, 6.0) 9.9 (9.0, 10.9) 15.2 (14.0, 16.4) 18.6 (17.2, 20.2) 22.8 (20.6, 25.2) Metal/Metal (1.1, 1.7) 5.2 (4.6, 5.7) 10.2 (9.5, 11.0) 14.9 (14.0, 15.8) 18.4 (17.3, 19.6) 20.3 (18.7, 22.1) Metal/Metal (1.5, 2.2) 5.0 (4.5, 5.6) 9.8 (9.1, 10.6) 13.8 (13.0, 14.8) 17.3 (16.2, 18.5) Metal/Metal (1.6, 2.6) 4.7 (4.0, 5.5) 8.4 (7.5, 9.5) 11.8 (10.6, 13.1) 13.5 (12.1, 15.1) TOTAL Figure MM3 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Age (Primary Diagnosis OA) 35% 30% 25% 20% 15% 10% 5% Metal/Metal <55 Metal/Metal Metal/Metal Metal/Metal 75 HR - adjusted for gender Metal/Metal <55 vs Metal/Metal Yr: HR=1.15 (0.97, 1.36),p= Yr+: HR=1.92 (1.53, 2.41),p<0.001 Metal/Metal vs Metal/Metal Mth: HR=0.79 (0.57, 1.09),p= Mth - 1.5Yr: HR=1.13 (0.84, 1.51),p= Yr - 2Yr: HR=1.58 (1.12, 2.23),p= Yr - 2.5Yr: HR=1.14 (0.82, 1.58),p= Yr - 3Yr: HR=1.21 (0.88, 1.67),p= Yr - 4.5Yr: HR=1.19 (0.98, 1.45),p= Yr+: HR=1.71 (1.37, 2.12),p<0.001 Metal/Metal vs Metal/Metal Yr: HR=1.11 (0.95, 1.29),p= Yr+: HR=1.53 (1.23, 1.91),p< % umber at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Metal/Metal < Metal/Metal Metal/Metal Metal/Metal End Data Period: 31 December 2014 Page 6

9 Cumulative Percent Revision Table MM7 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Head Size and Age (Primary Diagnosis OA) Head Size Age Revised Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs 32mm < (0.9, 1.7) 2.8 (2.2, 3.5) 3.7 (3.1, 4.5) 4.5 (3.7, 5.4) 5.8 (4.9, 6.8) 7.8 (6.5, 9.4) 32mm (1.4, 2.5) 3.8 (3.1, 4.7) 5.0 (4.2, 6.0) 5.7 (4.8, 6.7) 6.8 (5.8, 8.0) >32mm < (1.3, 1.8) 6.0 (5.5, 6.6) 12.3 (11.6, 13.1) 18.8 (17.9, 19.8) 24.2 (22.9, 25.6) >32mm (1.6, 2.3) 5.3 (4.8, 5.9) 10.9 (10.2, 11.7) 16.0 (15.1, 17.0) 20.5 (19.2, 21.9) TOTAL Figure MM4 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Age and Head Size (Primary Diagnosis OA) 35% 30% 25% 20% 15% 10% <65 32mm <65 >32mm 65 32mm 65 >32mm HR - adjusted for gender <65 32mm vs <65 >32mm 0-2Wk: HR=0.57 (0.24, 1.32),p= Wk - 2Yr: HR=0.60 (0.45, 0.80),p< Yr - 5Yr: HR=0.15 (0.11, 0.21),p< Yr - 5.5Yr: HR=0.04 (0.01, 0.15),p< Yr+: HR=0.18 (0.13, 0.24),p<0.001 <65 >32mm vs 65 >32mm Entire Period: HR=1.21 (1.12, 1.31),p<0.001 <65 32mm vs 65 32mm 0-5.5Yr: HR=0.71 (0.54, 0.92),p= Yr+: HR=1.74 (1.07, 2.84),p= % 0% mm vs 65 >32mm 0-2Yr: HR=0.94 (0.73, 1.20),p= Yr - 3Yr: HR=0.39 (0.27, 0.58),p< Yr - 5.5Yr: HR=0.20 (0.15, 0.27),p< Yr+: HR=0.13 (0.08, 0.20),p<0.001 umber at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs <65 32mm <65 >32mm mm >32mm End Data Period: 31 December 2014 Page 7

10 Cumulative Percent Revision Cumulative Percent Revision Table MM8 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Gender and Head Size (Primary Diagnosis OA) Gender Head Size Revised Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Male (1.3, 1.7) 4.4 (4.0, 4.8) 8.7 (8.1, 9.2) 12.6 (12.0, 13.3) 15.7 (14.9, 16.6) 17.7 (16.4, 19.1) Male 32mm (1.2, 2.2) 3.1 (2.5, 3.9) 4.0 (3.3, 4.8) 4.6 (3.9, 5.6) 5.5 (4.6, 6.5) 6.7 (5.4, 8.2) Male >32mm (1.2, 1.7) 4.8 (4.4, 5.3) 10.1 (9.5, 10.8) 15.3 (14.5, 16.2) 20.1 (18.8, 21.4) Female (1.6, 2.2) 5.9 (5.4, 6.4) 11.2 (10.5, 11.9) 16.1 (15.3, 16.9) 19.7 (18.7, 20.8) 22.0 (20.6, 23.6) Female 32mm (1.1, 2.0) 3.4 (2.7, 4.2) 4.7 (3.9, 5.6) 5.5 (4.6, 6.5) 7.1 (6.1, 8.3) Female >32mm (1.7, 2.5) 6.9 (6.3, 7.6) 13.8 (13.0, 14.8) 20.5 (19.5, 21.7) 25.9 (24.4, 27.4) TOTAL Figure MM5 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Gender (Primary Diagnosis OA) 35% 30% Metal/Metal Male Metal/Metal Female HR - adjusted for age Metal/Metal Female vs Metal/Metal Male Entire Period: HR=1.32 (1.23, 1.42),p< % 20% 15% 10% 5% 0% Figure MM6 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement by Gender and Head Size (Primary Diagnosis OA) 35% 30% 25% 20% 15% 10% 5% Male 32mm Male >32mm Female 32mm Female >32mm 0% HR - adjusted for age Male 32mm vs Male >32mm 0-1.5Yr: HR=1.06 (0.80, 1.40),p= Yr - 3Yr: HR=0.33 (0.22, 0.50),p< Yr+: HR=0.14 (0.11, 0.19),p<0.001 Male >32mm vs Female >32mm Entire Period: HR=0.71 (0.66, 0.77),p<0.001 Male 32mm vs Female 32mm Entire Period: HR=0.77 (0.62, 0.97),p=0.026 Female 32mm vs Female >32mm 0-2.5Yr: HR=0.60 (0.48, 0.75),p< Yr - 3Yr: HR=0.28 (0.19, 0.40),p< Yr - 6.5Yr: HR=0.14 (0.11, 0.18),p< Yr - 7Yr: HR=0.12 (0.08, 0.20),p< Yr+: HR=0.18 (0.13, 0.25),p<0.001 umber at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs Male 32mm Male >32mm Female 32mm Female >32mm End Data Period: 31 December 2014 Page 8

11 Figure MM7 Cumulative Incidence Revision Diagnosis of Metal/Metal and Metal/Polyethylene Primary Total Conventional Hip Replacement (Primary Diagnosis OA) Metal/Metal Cumulative Incidence 1 Cumulative Incidence Metal/Polyethylene ote: Metal/Polyethylene includes both non cross-linked and cross-linked polyethylene Figure MM8 Cumulative Incidence Revision Diagnosis of Metal/Metal and Metal/Polyethylene Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA) Metal/Metal 32mm Cumulative Incidence 1 Cumulative Incidence Metal/Metal >32mm Metal/Polyethylene 32mm Cumulative Incidence Cumulative Incidence 1 5 Metal/Polyethylene >32mm ote: Metal/Polyethylene includes both non cross-linked and cross-linked polyethylene End Data Period: 31 December 2014 Page 9

12 Table MM9 Cumulative Percent Revision of Metal/Metal Primary Total Conventional Hip Replacement using Head Size >32mm by Head and Acetabular Surface (Primary Diagnosis OA) Head Surface Acetabular Surface Revised Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 14 Yrs ASR ASR (1.4, 2.2) 9.8 (8.9, 10.7) 24.4 (23.1, 25.8) 36.7 (35.2, 38.3) Articul/Eze Pinnacle (1.3, 2.6) 3.0 (2.3, 4.0) 4.8 (3.8, 6.0) 7.4 (6.1, 9.0) 9.9 (8.2, 12.0) BHR BHR (0.7, 1.5) 3.3 (2.6, 4.1) 6.1 (5.1, 7.2) 8.9 (7.8, 10.3) 12.3 (10.3, 14.5) BHR R (1.1, 3.7) 7.0 (5.1, 9.6) 11.1 (8.7, 14.1) BMHR BHR (0.8, 4.3) 3.7 (2.0, 6.8) 5.7 (3.3, 9.9) Bionik Bionik (2.2, 6.2) 8.1 (5.8, 11.4) 15.6 (12.2, 19.8) 22.0 (17.8, 27.1) Icon Icon (1.2, 4.7) 7.2 (4.9, 10.6) 12.4 (9.2, 16.5) 14.2 (10.7, 18.8) M2a M2a (1.1, 3.0) 4.3 (3.1, 6.0) 6.4 (4.9, 8.4) 8.2 (6.4, 10.4) 11.3 (9.1, 14.0) M2a Magnum Recap (0.9, 2.6) 2.5 (1.7, 3.8) 4.4 (3.2, 6.0) 7.0 (5.4, 9.0) Metasul Durom (0.7, 2.0) 3.9 (2.9, 5.2) 5.4 (4.2, 6.9) 8.7 (7.1, 10.7) 12.6 (9.3, 16.9) Mitch TRH Mitch TRH (0.9, 3.0) 5.1 (3.7, 7.1) 8.5 (6.6, 11.0) 11.5 (9.1, 14.6) Optimom Cormet (0.7, 2.5) 3.5 (2.3, 5.1) 5.0 (3.6, 7.0) 9.0 (6.9, 11.9) 15.1 (11.4, 19.9) S-Rom Pinnacle (1.0, 4.7) 3.6 (1.9, 6.5) 3.9 (2.2, 7.0) 4.3 (2.5, 7.5) 8.0 (5.0, 12.7) Other (24) (1.6, 4.2) 6.4 (4.7, 8.6) 9.5 (7.4, 12.2) 13.2 (10.5, 16.5) 17.0 (13.5, 21.2) TOTAL ote: Only combinations with over 200 procedures have been listed. End Data Period: 31 December 2014 Page 10