SURVIVORSHIP OF PINNACLE CERAMIC-ON-CERAMIC .SURVIVORSHIP OF PINNACLE® CERAMIC-ON-CERAMIC BEARINGS

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  • 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

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