survivorship of pinnacle ceramic-on-ceramic … · survivorship of pinnacle® ceramic-on-ceramic...

SURVIVORSHIP OF PINNACLE CERAMIC-ON-CERAMIC BEARINGS IN NATIONAL JOINT REPLACEMENT REGISTRIESPaul E. Voorhorst, MS, MBA, Vice President, Worldwide Clinical Research | DePuy Synthes Joint Reconstruction*John Leopold, MS, Biostatistician | DePuy Synthes Joint Reconstruction

Implant selection, patient characteristics, and surgical technique during primary THA may have a direct impact on the procedures outcome. Some hip systems have a long clinical history, and the effects these variables have on device safety and performance are established. For newer systems with less clinical history, the impact of variables that affect hip survival is multifactorial and stillemerging.

National joint registries provide valuable information on the revision rates/survivorship of newer and older implants alike. Typically they include large cohorts with contributions from all surgeons, irrespective of experience level as well as variations in standard of care and hospital processes. These data sources include the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the National Joint Registry for England, Wales and Northern Ireland (NJR). Different hip systems may be combined into a single broad category (e.g. hip replacement) for evaluation. Primary total hip replacement is a well-established and efficacious procedure, as demonstrated by the 2014 annual reports from AOANJRR (Table HT18 shown on page 4) and the NJR (Table 3.7) which observed 7-year cementless THA cumulative percent revision rates of 4.1% (95% Cl: 4.0% - 4.3%) and 5.50% (95% Cl: 5.35% - 5.66%), respectively.1,2

To evaluate the effect of different variables on device performance more carefully, it is useful to look at data available for specific product configurations.

National Joint Registry for England, Wales and Northern Ireland Data for PINNACLE Ceramic-on-Ceramic Bearings

The 2014 annual report from the NJR (Table 3.10) reported a 7-year cumulative percent revision rate of

3.24% (95% CI 2.86%3.66% for a cohort of 27,920 PINNACLE Cups with Ceramic-on-Ceramic bearings implanted with CORAIL stems.2 This was the only stem construct reported with this cup.

Based on data supplied for post-marketing surveillance by the National Joint Registry Centre on 10 September 2014, DePuy Synthes Joint Reconstruction conducted a Kaplan-Meier analysis on the PINNACLE with CERAMAX Ceramic-on-Ceramic System for primary THA, encompassing 31,340 cementless hips.3 This analysis examined the survival of CERAMAX Ceramic-on-Ceramic Bearings in combination with CORAIL, SUMMIT and S-ROM Cementless Stems. Subject mean age was 59.4 years (range 12-94) and 53.3% were female.3

PINNACLE Ceramic-on-Ceramic Survivorship by Cementless Hip Stem with Revision for Any Reason as the Endpoint (September 20143), (95% CI), n with Later Follow-up

Hip Stem 5 Years 7 Years 9 Years

CORAIL Hip Stem (N=30,109)

2.32% (2.12, 2.55)

n=6,431

3.00% (2.68, 3.36)

n=1,683

3.77% (3.05, 4.67)

n=195

SUMMIT Hip Stem (N=700)1.51%

(0.72, 3.16)n=261

1.97% (0.95, 4.07)

n=87

Data available

2015

S-ROM Hip Stem (N=531)4.95%

(3.21, 7.59) n=193

4.95% (3.21, 7.59)

n=89

Data available

2015

The 9-year cumulative percent revision rate across these three uncemented DePuy Synthes Joint Reconstruction stems in this series was 3.83%. These results are consistent with the guidelines set forth by the UK National Institute for Health and Care Excellence (NICE).4

All references to survivorship estimates discussed were calculated according to the Kaplan-Meier method. Cumulative percent revision rate is defined as 100 x [1-Survivorship].All procedures using metal/metal prostheses with head size larger than 32mm have been excluded.

A difference in outcome related to femoral head size has been reported by the AOANJRR for the class of Ceramic-on-Ceramic bearings, with 28 mm bearings having a higher rate of revision compared to 32 mm (Figure HT33 shown on page 4).5 Accordingly, NJR data specific to the three femoral head sizes in PINNACLE Ceramic-on-Ceramic bearings was also stratified and analysed. Risk of revision for any reason with a 28 mm bearing was not statistically different from either 32 mm or 36 mm (HR=0.91 and 1.23 respectively, p>0.05), adjusting for age and gender. Bearings with a 32 mm head did have a statistically significant higher risk of revision compared to 36 mm (HR=1.35, p=0.032).

PINNACLE Ceramic-on-Ceramic Survivorship by Head Size with Revision for Any Reason as the Endpoint (September 20143), (95% CI), n with Later Follow-up

Head Size 3 Years 5 Years 7 Years 9 Years

All sizes (N= 31,340)

1.74% (1.59, 1.91) n=16,590

2.36% (2.16, 2.59)

n=6,885

3.01% (2.70, 3.35)

n=1,859

3.83% (3.13, 4.67)

n=226

28 mm (N=4,548)

1.91% (1.53, 2.39)

n=3,136

2.46% (1.99, 3.02)

n=1,815

3.11% (2.51, 3.85)

n=813

4.04% (3.04, 5.37)

n=178

32 mm (N=4,651)

1.75% (1.35, 2.26)

n=1,493

2.59% (1.96, 3.42)

n=243

Available 2016

Available 2019

36 mm (N=22,141)

1.69% (1.51, 1.89) n=11,961

2.30% (2.07, 2.57)

n=4,827

2.95% (2.58, 3.36)

n=1,045

3.64% (2.65, 5.00)

n=48

The incidence of revision related to the modularity or bearing type for wear, liner disassociation, osteolysis and liner fracture are as follows:

PINNACLE Ceramic-on-Ceramic Reasons for Revision (September 20143)

PINNACLE Ceramic Liners Implanted (N=31,340)

Reason for Revision Crude Revision Rate

Wear 0.04%

Liner Dissociation 0.03%

Lysis 0.02%

Liner Fracture 0.18%

Australian Orthopaedic Association National Joint Replacement Registry Data for Ceramic Bearings

According to the 2014 AOANJRR annual report (Table HT13 shown on page 5)6, the PINNACLE Acetabular Cup System used in combination with CORAIL and SUMMIT Cementless Stems had 10-year cumulative percent revision rates of 4.8% and 2.2%, respectively.6 AOANJRR does not report survivorship or revision reasons for any specific stem, cup, bearing combination (e.g. SUMMIT stem, PINNACLE Acetabular cup, Ceramic-on-Ceramic bearing, other than selected Metal-on-Metal combinations).

The AOANJRR has reported percent revision for the class of Ceramic-on-Ceramic bearings by head size, which can be compared to the class of cross-linked polyethylene and to metal-on-cross-linked polyethylene bearings in an OA population.

2

Cumulative Percent Revision of Ceramic-on- Ceramic Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA) (2014 AOANJRR Table HT277 shown on page 5)

Bearing Class

Head Size 3 Years 5 Years 10 Years 13 Years

Ceramic-on- Ceramic

28 mm (N=6,405)

3.4% 4.3% 6.6% 7.7%

32 mm (N=22,826)

2.4% 3.0% 4.8% 5.9%

36-38 mm (N=24,414)

2.4% 3.3% 5.3%

40 mm (N=4,183)

1.8%

Note: represents data that is not yet available.

Cumulative Percent Revision of Primary Total Conventional Hip Replacement for Cross-Linked Polyethylene and Head Size (Primary Diagnosis OA) (2014 AOANJRR Table HT258 shown on page5)

Bearing Class Head Size 3 Years 5 Years 10 Years 13 Years

Cross-Linked Polyethylene

32 mm (N=38,111)

2.3% 3.0% 4.6%

Note: represents data that is not yet available.

For the OA population, there was a statistically significant difference between Ceramic-on-Ceramic bearings and metal-on-cross-linked polyethylene bearings (Table HT21 shown on page 6)9 after adjusting for age and gender (HR=1.10 [1.03, 1.17], p=0.004).

Conclusion

The DePuy Synthes Joint Reconstruction PINNACLE Acetabular Cup System remains one of the most widely implanted cups across the world. With approaching a decade of clinical application, the reported success rates with this implant system and its Ceramic-on-Ceramic options are well documented in the NJR. As the utilization of Ceramic-on-Ceramic articulations continues to grow, this data suggest that the PINNACLE Acetabular Cup System is one of the most widely implanted and clinically robust Ceramic-on-Ceramic acetabular systems in themarketplace.

3

References

1. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report, Adelaide: AOA, 2014. Table HT18. Retrieved from: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2014

Page | 84 Data Period 1 September 1999 31 December 2013

Table HT18: Cumulative Percent Revision of Primary Total Conventional Hip Replacement by Fixation (Primary Diagnosis OA)

Fixation N

Revised N

Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

Cemented 824 19695 1.1 (1.0, 1.3) 2.1 (1.9, 2.3) 3.0 (2.8, 3.3) 4.0 (3.7, 4.4) 6.0 (5.5, 6.4) 9.0 (8.1, 9.9)

Cementless 4551 136311 1.7 (1.6, 1.8) 2.7 (2.6, 2.8) 3.4 (3.3, 3.5) 4.1 (4.0, 4.3) 5.4 (5.2, 5.6) 7.1 (6.7, 7.6)

Hybrid 2211 77768 1.2 (1.1, 1.3) 1.9 (1.8, 2.0) 2.6 (2.5, 2.7) 3.4 (3.2, 3.5) 4.8 (4.5, 5.0) 6.7 (6.1, 7.3)

TOTAL 7586 233774

Note: All procedures using metal/metal prostheses with head size larger than 32mm have been excluded

Figure HT11: Cumulative Percent Revision of Primary Total Conventional Hip Replacement by Fixation (Primary Diagnosis OA)

Number at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

Cemented 19695 18129 15104 12030 8969 4321 410

Cementless 136311 116379 82931 56072 37444 14938 839

Hybrid 77768 67968 51070 36475 24233 9968 817

Note: All procedures using metal/metal prostheses with head size larger than 32mm have been excluded

Cum

ulat

ive

Perc

ent R

evis

ion

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

Years Since Primary Procedure

0 1 2 3 4 5 6 7 8 9 10 11 12 13

CementedCementlessHybrid

HR adjusted for age and gender

Cemented vs Hybrid 0 - 1Mth: HR=0.61 (0.46, 0.81),p

6. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report, Adelaide: AOA, 2014 Table HT13. Retrieved from: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2014


Table HT13: Cumulative Percent Revision of Primary Total Conventional Hip Replacement with Cementless Fixation

Femoral Component

Acetabular Component

N Revised

N Total

1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

ABGII ABGII 189 2928 1.8 (1.4, 2.4) 3.1 (2.5, 3.8) 4.1 (3.4, 4.9) 5.3 (4.5, 6.2) 6.8 (5.8, 7.9) 10.1 (7.4, 13.7)

ABGII ABGII (Shell/Insert) 44 862 1.5 (0.9, 2.6) 2.4 (1.5, 3.7) 3.1 (2.1, 4.5) 4.2 (3.0, 5.9) 7.2 (5.2, 9.9)

ABGII Trident (Shell) 136 2313 2.4 (1.9, 3.1) 4.1 (3.3, 5.0) 5.0 (4.2, 6.0) 6.0 (5.0, 7.2) 7.9 (6.5, 9.6)

Accolade I Trident (Shell) 331 8746 1.6 (1.3, 1.9) 2.9 (2.5, 3.2) 3.8 (3.4, 4.2) 4.6 (4.1, 5.2) 5.9 (5.1, 6.9)

Accolade I Trident/Tritanium (Shell) 11 648 1.3 (0.6, 2.5) 1.9 (1.0, 3.4)

Alloclassic Allofit 187 5304 1.4 (1.1, 1.8) 2.3 (1.9, 2.7) 3.1 (2.6, 3.6) 3.6 (3.1, 4.2) 4.9 (4.2, 5.8)

Alloclassic Durom MoM 65 621 1.3 (0.7, 2.6) 5.0 (3.5, 7.0) 6.9 (5.1, 9.3) 11.3 (8.8, 14.5)

Alloclassic Fitmore 91 1695 2.8 (2.1, 3.7) 4.0 (3.2, 5.1) 5.0 (4.0, 6.2) 5.5 (4.5, 6.8) 6.4 (5.2, 7.9)

Alloclassic Trabecular Metal (Shell) 33 996 2.2 (1.4, 3.3) 3.0 (2.0, 4.3) 4.0 (2.8, 5.6) 4.0 (2.8, 5.6)

Alloclassic Trilogy 9 796 0.5 (0.2, 1.4) 0.7 (0.3, 1.6) 1.0 (0.5, 2.2) 2.0 (0.9, 4.5)

Anthology R3 57 3236 1.6 (1.2, 2.1) 1.9 (1.4, 2.4) 2.0 (1.5, 2.6)

Anthology Reflection (Shell) 17 887 1.4 (0.8, 2.4) 1.6 (1.0, 2.7) 1.9 (1.2, 3.1) 2.1 (1.3, 3.4)

Apex Fin II 29 940 1.8 (1.1, 2.9) 2.4 (1.6, 3.7) 3.7 (2.4, 5.5) 5.0 (3.3, 7.5)

CLS Allofit 38 780 1.4 (0.8, 2.6) 3.4 (2.3, 5.1) 3.8 (2.6, 5.5) 5.2 (3.7, 7.3) 5.9 (4.2, 8.2)

CLS Fitmore 31 646 1.9 (1.1, 3.3) 4.0 (2.7, 5.9) 4.4 (3.0, 6.4) 4.8 (3.4, 6.9) 5.1 (3.5, 7.3)

Citation Trident (Shell) 40 1147 1.7 (1.1, 2.7) 2.5 (1.7, 3.5) 3.0 (2.2, 4.2) 3.2 (2.3, 4.4) 3.9 (2.8, 5.3)

Citation Vitalock 32 555 0.5 (0.2, 1.7) 2.2 (1.2, 3.8) 2.8 (1.7, 4.5) 4.0 (2.6, 6.0) 6.5 (4.7, 9.2) 6.5 (4.7, 9.2)

Corail ASR MoM 976 2900 2.2 (1.7, 2.8) 11.1 (10.0, 12.4) 26.6 (25.0, 28.3) 39.2 (37.1, 41.3)

Corail DeltaMotion 7 587 0.8 (0.3, 2.1) 1.5 (0.6, 3.3)

Corail Duraloc 57 1433 1.4 (0.9, 2.2) 2.2 (1.6, 3.1) 2.8 (2.0, 3.8) 3.9 (2.9, 5.3) 5.6 (4.1, 7.5)

Corail Pinnacle 513 22250 1.6 (1.4, 1.7) 2.4 (2.2, 2.7) 3.1 (2.8, 3.4) 3.6 (3.2, 4.1) 4.8 (3.9, 5.9)

Corail Pinnacle MoM 68 966 2.2 (1.4, 3.3) 3.7 (2.6, 5.1) 6.1 (4.7, 7.9) 9.0 (6.8, 11.7)

Epoch Trilogy 40 1020 2.5 (1.7, 3.6) 3.4 (2.4, 4.7) 3.6 (2.6, 5.0) 4.1 (3.0, 5.6) 4.4 (3.2, 6.1)

F2L SPH-Blind 49 614 3.1 (2.0, 4.8) 4.9 (3.5, 7.0) 6.1 (4.5, 8.4) 6.8 (5.1, 9.2) 7.6 (5.7, 10.0)

H-Max Delta PF 12 598 2.1 (1.1, 3.7)

M/L Taper Continuum 13 570 2.0 (1.1, 3.6)

M/L Taper Trilogy 13 569 1.4 (0.7, 2.8) 1.7 (0.9, 3.2) 2.4 (1.3, 4.4) 3.3 (1.8, 6.0)

M/L Taper Kinectiv Continuum 36 1402 2.1 (1.5, 3.1) 3.0 (2.2, 4.2)

Mallory-Head Mallory-Head 133 2780 1.9 (1.4, 2.5) 2.4 (1.9, 3.0) 3.2 (2.5, 3.9) 4.0 (3.3, 4.9) 5.7 (4.7, 6.9) 9.4 (7.5, 11.8)

Metafix Trinity 16 679 2.0 (1.2, 3.4) 3.8 (2.0, 7.3)

Nanos R3 4 513 0.7 (0.2, 2.0) 1.0 (0.4, 2.8)

Natural Hip Fitmore 29 889 1.0 (0.5, 1.9) 1.6 (0.9, 2.7) 2.2 (1.4, 3.5) 2.7 (1.8, 4.0) 4.2 (2.9, 6.1)

Omnifit Secur-Fit 55 508 3.2 (1.9, 5.1) 5.0 (3.4, 7.3) 6.6 (4.7, 9.2) 8.0 (5.9, 10.7) 10.8 (8.2, 14.0)

Omnifit Trident (Shell) 58 1245 1.9 (1.2, 2.8) 3.1 (2.3, 4.3) 4.0 (3.0, 5.3) 4.7 (3.6, 6.1) 5.3 (4.1, 6.9)

Polarstem R3 36 2099 1.7 (1.2, 2.4) 2.3 (1.5, 3.4) 2.3 (1.5, 3.4)

Quadra-H Versafit 140 6314 1.9 (1.6, 2.3) 3.1 (2.6, 3.7) 3.2 (2.6, 3.8)

S-Rom Duraloc Option 31 666 1.5 (0.8, 2.8) 2.4 (1.5, 3.9) 3.4 (2.2, 5.0) 4.0 (2.7, 5.8) 4.7 (3.3, 6.7)

S-Rom Pinnacle 87 2582 2.1 (1.6, 2.7) 3.2 (2.6, 4.0) 3.5 (2.8, 4.4) 4.2 (3.3, 5.2) 4.4 (3.5, 5.5)

SL-Plus EPF-Plus 94 2256 1.7 (1.2, 2.3) 2.8 (2.2, 3.6) 3.6 (2.9, 4.5) 4.6 (3.7, 5.7) 6.6 (4.7, 9.3)

SL-Plus R3 37 1182 2.0 (1.3, 3.0) 3.4 (2.4, 4.8) 4.0 (2.9, 5.6)

Secur-Fit DeltaMotion 13 713 0.7 (0.3, 1.7) 2.1 (1.2, 3.7)

Secur-Fit Trident (Shell) 219 7580 1.5 (1.3, 1.8) 2.5 (2.2, 2.9) 3.1 (2.7, 3.6) 3.7 (3.2, 4.3) 4.0 (3.5, 4.7)

Secur-Fit Plus Trident (Shell) 150 5200 1.2 (0.9, 1.5) 1.9 (1.6, 2.3) 2.4 (2.0, 2.9) 2.7 (2.2, 3.2) 3.6 (3.1, 4.3) 4.7 (3.6, 6.2)

Summit ASR MoM 353 1118 1.2 (0.7, 2.0) 6.5 (5.2, 8.1) 19.8 (17.6, 22.3) 32.9 (30.0, 36.1)

Summit Pinnacle 50 3244 1.0 (0.7, 1.4) 1.4 (1.1, 2.0) 1.6 (1.2, 2.2) 2.2 (1.6, 3.1) 2.2 (1.6, 3.1)

Summit Pinnacle MoM 40 784 1.5 (0.9, 2.7) 2.2 (1.4, 3.5) 3.2 (2.2, 4.8) 4.9 (3.5, 6.8) 7.6 (5.4, 10.8)

Synergy BHR MoM 55 817 1.6 (0.9, 2.7) 3.1 (2.1, 4.5) 4.6 (3.4, 6.4) 7.5 (5.7, 9.9)

Synergy R3 70 3161 1.6 (1.2, 2.2) 2.4 (1.8, 3.0) 2.9 (2.2, 3.9)

Synergy Reflection (Shell) 265 7605 1.5 (1.3, 1.8) 2.3 (2.0, 2.7) 2.6 (2.3, 3.0) 3.1 (2.7, 3.5) 4.3 (3.7, 4.9) 5.4 (4.5, 6.4)

Taperloc Exceed 31 1653 1.1 (0.7, 1.8) 2.3 (1.6, 3.3) 2.5 (1.7, 3.8)

Taperloc M2a MoM 50 514 1.8 (0.9, 3.4) 4.3 (2.9, 6.5) 7.3 (5.3, 10.0) 8.7 (6.5, 11.7) 13.1 (9.8, 17.6)

Taperloc Mallory-Head 41 1230 1.7 (1.1, 2.6) 2.4 (1.7, 3.5) 2.8 (2.0, 4.1) 4.1 (2.9, 5.6) 4.3 (3.1, 5.9)

Taperloc Recap MoM 35 502 2.4 (1.4, 4.2) 4.1 (2.6, 6.2) 6.1 (4.3, 8.7) 8.1 (5.8, 11.2)



Femoral Component


N Revised

N Total


ABGII ABGII 189 2928 1.8 (1.4, 2.4) 3.1 (2.5, 3.8) 4.1 (3.4, 4.9) 5.3 (4.5, 6.2) 6.8 (5.8, 7.9) 10.1 (7.4, 13.7)










Anthology R3 57 3236 1.6 (1.2, 2.1) 1.9 (1.4, 2.4) 2.0 (1.5, 2.6)


Apex Fin II 29 940 1.8 (1.1, 2.9) 2.4 (1.6, 3.7) 3.7 (2.4, 5.5) 5.0 (3.3, 7.5)

CLS Allofit 38 780 1.4 (0.8, 2.6) 3.4 (2.3, 5.1) 3.8 (2.6, 5.5) 5.2 (3.7, 7.3) 5.9 (4.2, 8.2)

CLS Fitmore 31 646 1.9 (1.1, 3.3) 4.0 (2.7, 5.9) 4.4 (3.0, 6.4) 4.8 (3.4, 6.9) 5.1 (3.5, 7.3)



Corail ASR MoM 976 2900 2.2 (1.7, 2.8) 11.1 (10.0, 12.4) 26.6 (25.0, 28.3) 39.2 (37.1, 41.3)


Corail Duraloc 57 1433 1.4 (0.9, 2.2) 2.2 (1.6, 3.1) 2.8 (2.0, 3.8) 3.9 (2.9, 5.3) 5.6 (4.1, 7.5)

Corail Pinnacle 513 22250 1.6 (1.4, 1.7) 2.4 (2.2, 2.7) 3.1 (2.8, 3.4) 3.6 (3.2, 4.1) 4.8 (3.9, 5.9)


Epoch Trilogy 40 1020 2.5 (1.7, 3.6) 3.4 (2.4, 4.7) 3.6 (2.6, 5.0) 4.1 (3.0, 5.6) 4.4 (3.2, 6.1)

F2L SPH-Blind 49 614 3.1 (2.0, 4.8) 4.9 (3.5, 7.0) 6.1 (4.5, 8.4) 6.8 (5.1, 9.2) 7.6 (5.7, 10.0)

H-Max Delta PF 12 598 2.1 (1.1, 3.7)


M/L Taper Trilogy 13 569 1.4 (0.7, 2.8) 1.7 (0.9, 3.2) 2.4 (1.3, 4.4) 3.3 (1.8, 6.0)



Metafix Trinity 16 679 2.0 (1.2, 3.4) 3.8 (2.0, 7.3)

Nanos R3 4 513 0.7 (0.2, 2.0) 1.0 (0.4, 2.8)




Polarstem R3 36 2099 1.7 (1.2, 2.4) 2.3 (1.5, 3.4) 2.3 (1.5, 3.4)



S-Rom Pinnacle 87 2582 2.1 (1.6, 2.7) 3.2 (2.6, 4.0) 3.5 (2.8, 4.4) 4.2 (3.3, 5.2) 4.4 (3.5, 5.5)

SL-Plus EPF-Plus 94 2256 1.7 (1.2, 2.3) 2.8 (2.2, 3.6) 3.6 (2.9, 4.5) 4.6 (3.7, 5.7) 6.6 (4.7, 9.3)

SL-Plus R3 37 1182 2.0 (1.3, 3.0) 3.4 (2.4, 4.8) 4.0 (2.9, 5.6)




Summit ASR MoM 353 1118 1.2 (0.7, 2.0) 6.5 (5.2, 8.1) 19.8 (17.6, 22.3) 32.9 (30.0, 36.1)

Summit Pinnacle 50 3244 1.0 (0.7, 1.4) 1.4 (1.1, 2.0) 1.6 (1.2, 2.2) 2.2 (1.6, 3.1) 2.2 (1.6, 3.1)


Synergy BHR MoM 55 817 1.6 (0.9, 2.7) 3.1 (2.1, 4.5) 4.6 (3.4, 6.4) 7.5 (5.7, 9.9)

Synergy R3 70 3161 1.6 (1.2, 2.2) 2.4 (1.8, 3.0) 2.9 (2.2, 3.9)


Taperloc Exceed 31 1653 1.1 (0.7, 1.8) 2.3 (1.6, 3.3) 2.5 (1.7, 3.8)

Taperloc M2a MoM 50 514 1.8 (0.9, 3.4) 4.3 (2.9, 6.5) 7.3 (5.3, 10.0) 8.7 (6.5, 11.7) 13.1 (9.8, 17.6)





Femoral Component


N Revised

N Total


ABGII ABGII 189 2928 1.8 (1.4, 2.4) 3.1 (2.5, 3.8) 4.1 (3.4, 4.9) 5.3 (4.5, 6.2) 6.8 (5.8, 7.9) 10.1 (7.4, 13.7)










Anthology R3 57 3236 1.6 (1.2, 2.1) 1.9 (1.4, 2.4) 2.0 (1.5, 2.6)


Apex Fin II 29 940 1.8 (1.1, 2.9) 2.4 (1.6, 3.7) 3.7 (2.4, 5.5) 5.0 (3.3, 7.5)

CLS Allofit 38 780 1.4 (0.8, 2.6) 3.4 (2.3, 5.1) 3.8 (2.6, 5.5) 5.2 (3.7, 7.3) 5.9 (4.2, 8.2)

CLS Fitmore 31 646 1.9 (1.1, 3.3) 4.0 (2.7, 5.9) 4.4 (3.0, 6.4) 4.8 (3.4, 6.9) 5.1 (3.5, 7.3)



Corail ASR MoM 976 2900 2.2 (1.7, 2.8) 11.1 (10.0, 12.4) 26.6 (25.0, 28.3) 39.2 (37.1, 41.3)


Corail Duraloc 57 1433 1.4 (0.9, 2.2) 2.2 (1.6, 3.1) 2.8 (2.0, 3.8) 3.9 (2.9, 5.3) 5.6 (4.1, 7.5)

Corail Pinnacle 513 22250 1.6 (1.4, 1.7) 2.4 (2.2, 2.7) 3.1 (2.8, 3.4) 3.6 (3.2, 4.1) 4.8 (3.9, 5.9)


Epoch Trilogy 40 1020 2.5 (1.7, 3.6) 3.4 (2.4, 4.7) 3.6 (2.6, 5.0) 4.1 (3.0, 5.6) 4.4 (3.2, 6.1)

F2L SPH-Blind 49 614 3.1 (2.0, 4.8) 4.9 (3.5, 7.0) 6.1 (4.5, 8.4) 6.8 (5.1, 9.2) 7.6 (5.7, 10.0)

H-Max Delta PF 12 598 2.1 (1.1, 3.7)


M/L Taper Trilogy 13 569 1.4 (0.7, 2.8) 1.7 (0.9, 3.2) 2.4 (1.3, 4.4) 3.3 (1.8, 6.0)



Metafix Trinity 16 679 2.0 (1.2, 3.4) 3.8 (2.0, 7.3)

Nanos R3 4 513 0.7 (0.2, 2.0) 1.0 (0.4, 2.8)




Polarstem R3 36 2099 1.7 (1.2, 2.4) 2.3 (1.5, 3.4) 2.3 (1.5, 3.4)



S-Rom Pinnacle 87 2582 2.1 (1.6, 2.7) 3.2 (2.6, 4.0) 3.5 (2.8, 4.4) 4.2 (3.3, 5.2) 4.4 (3.5, 5.5)

SL-Plus EPF-Plus 94 2256 1.7 (1.2, 2.3) 2.8 (2.2, 3.6) 3.6 (2.9, 4.5) 4.6 (3.7, 5.7) 6.6 (4.7, 9.3)

SL-Plus R3 37 1182 2.0 (1.3, 3.0) 3.4 (2.4, 4.8) 4.0 (2.9, 5.6)




Summit ASR MoM 353 1118 1.2 (0.7, 2.0) 6.5 (5.2, 8.1) 19.8 (17.6, 22.3) 32.9 (30.0, 36.1)

Summit Pinnacle 50 3244 1.0 (0.7, 1.4) 1.4 (1.1, 2.0) 1.6 (1.2, 2.2) 2.2 (1.6, 3.1) 2.2 (1.6, 3.1)


Synergy BHR MoM 55 817 1.6 (0.9, 2.7) 3.1 (2.1, 4.5) 4.6 (3.4, 6.4) 7.5 (5.7, 9.9)

Synergy R3 70 3161 1.6 (1.2, 2.2) 2.4 (1.8, 3.0) 2.9 (2.2, 3.9)


Taperloc Exceed 31 1653 1.1 (0.7, 1.8) 2.3 (1.6, 3.3) 2.5 (1.7, 3.8)

Taperloc M2a MoM 50 514 1.8 (0.9, 3.4) 4.3 (2.9, 6.5) 7.3 (5.3, 10.0) 8.7 (6.5, 11.7) 13.1 (9.8, 17.6)



7. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report, Adelaide: AOA, 2014 Table HT27. Retrieved from: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2014


Ceramic/Ceramic Bearing Ceramic/ceramic bearings have been used in 57,828 primary total conventional hip replacements undertaken for osteoarthritis. This is the second most common bearing reported to the Registry. This analysis includes outcome by head size and fixation.

Head Size

To evaluate the effect of head size an analysis was undertaken comparing four head size groups (28, 32, 36-38, and 40mm). The follow up period for the 40mm head size is four years compared to over 10 years follow up for the other three head sizes. Head sizes 32mm have a lower rate of revision compared to head sizes 28mm or less. There is no difference when head size 32mm is compared to the two larger head size groups (Table HT27 and Figure HT33). Head sizes 28mm or less have a higher rate of revision for prosthesis dislocation compared to the other head size groups (refer to chapter on dislocation). At one year, the cumulative incidence of dislocation is 0.9% for head sizes 28mm or less

compared to 0.4% for 32mm, 0.3% for 36-38mm and 0.1% for head sizes 40mm or larger (Figure HT34).

Fixation

The majority of procedures using ceramic/ceramic bearing surfaces are cementless (84.7%). Hybrid fixation accounts for 15.2%. Hybrid fixation has a lower rate of revision compared to cementless fixation over the entire period (Table HT28 and Figure HT35). When using cementless fixation, head size 40mm or larger has a lower rate of revision compared to 32mm. There remains a higher rate of revision for head sizes 28mm or less compared to 32mm (Table HT29 and Figure HT36). For hybrid fixation, head sizes 28mm or less have a higher rate of revision compared to 32mm over the entire period. Head size 32mm shows no significant difference compared to 36-38 and 40mm or greater head size groups (Table HT30 and Figure HT37).

Table HT27: Cumulative Percent Revision of Ceramic/Ceramic Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA)

Head Size N

Revised N

Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

28mm 380 6405 2.1 (1.7, 2.4) 3.4 (3.0, 3.9) 4.3 (3.8, 4.8) 5.2 (4.6, 5.8) 6.6 (6.0, 7.3) 7.7 (6.9, 8.6)

32mm 756 22826 1.4 (1.3, 1.6) 2.4 (2.2, 2.6) 3.0 (2.8, 3.3) 3.8 (3.5, 4.1) 4.8 (4.4, 5.2) 5.9 (5.1, 6.9)

36-38mm 619 24414 1.4 (1.3, 1.6) 2.4 (2.2, 2.7) 3.3 (3.0, 3.6) 4.0 (3.6, 4.4) 5.3 (4.6, 6.1)

40mm 63 4183 1.1 (0.8, 1.4) 1.8 (1.4, 2.3)

TOTAL 1818 57828

Figure HT33: Cumulative Percent Revision of Ceramic/Ceramic Primary Total Conventional Hip Replacement by Head Size (Primary Diagnosis OA)

Cum

ulat

ive

Perc

ent R

evis

ion

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

Years Since Primary Procedure

0 1 2 3 4 5 6 7 8 9 10 11 12 13

28mm vs 32mm

Entire Period: HR=1.40 (1.24, 1.59),p

9. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report, Adelaide: AOA, 2014 Figure HT21. Retrieved from: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2014


HR - adjusted for age and gender

Ceramic/Ceramic vs Metal/XL Entire Period: HR=1.10 (1.03, 1.17),p=0.004

Ceramic/Non XL vs Metal/XL Entire Period: HR=1.56 (1.38, 1.75),p

DSEM/JRC/1114/0208 06/15 Issued: 12/14

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