Hips using Palacos Antibiotic Cement - Heraeus

2

3

4

12

17

Appendix A lists details of all Palacos Antibiotic Cement products included in this report.

This report has been produced by the National Joint Registry of England, Wales and Northern Ireland (NJR). It

summarises usage and outcomes associated with the Hips using Palacos Antibiotic Cement up to the specified

dates. This analysis is based on data collected by the NJR and PROMs data collected by NHS Digital for the

following combinations of products:

This report is made available to Heraeus Medical under licence. Under this licence, Heraeus Medical is free to

distribute this document, subject to the restrictions specified in the National Joint Registry Supplier Feedback

Data Access and Use Code of Practice.

Cemented Components

Hips using Palacos Antibiotic Cement

APPENDIX A – Component List

Produced on:

Licensed for use until:

18 May 2021

18 May 2022

ContentsRecorded Usage in NJR

Patient and Procedure Details

Revision and Survivorship

Patient Reported Outcome Measures

Implant Summary Report for: Heraeus Medical


NJR Database extract:

Comprising PRIMARY hips implanted up to: 07 March 2021

06 May 2021

Ref: Summary.Report.HP_Cement_Palacos Antibiotic.20/05/2021.16:58

©2021 Northgate Public Services (UK) Limited

Summary Report for:

Implant Usage

Date of first recorded usage in the NJR:

Date of last recorded usage in this dataset:

Maximum implantation time: 15.5 years

Mean implantation time: 5.4 years

Current

Outcome

Pre-

20102010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Total %

Death 24358 6641 6637 6556 6145 5582 4757 3892 2897 1982 1180 272 9 70908 17.2%

Revised 2185 508 517 566 553 573 607 574 521 432 364 143 8 7551 1.8%

Unrevised 30480 12275 15135 18728 22523 26503 29640 33763 36153 38848 42038 23990 3508 333584 81.0%

Total 57023 19424 22289 25850 29221 32658 35004 38229 39571 41262 43582 24405 3525 412043 100%

06 September 2005

07 March 2021

Totals Recorded in NJR

Procedures


NJR Recorded Usage

Year of implantation

Cumulative Total

412,043

434

2,950

5,070

Consultants

Implanting Surgeons

Centres

Patients 367,751

0

50000

100000

150000

200000

250000

300000

350000

400000

450000

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

20

15

20

16

20

17

20

18

20

19

20

20

20

21

20

22

Cumulative Procedures

Procedures

0

1000

2000

3000

4000

5000

6000

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

20

15

20

16

20

17

20

18

20

19

20

20

20

21

20

22

Cumulative Surgeons and Centres

Centres Consultants Implanting Surgeons



Summary Report for:

Patient Details

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJR

All NJR hip

replacement

Total Procedures 412,043 324,344 1,285,207

Total Patients 367,751 290,394 1,082,079

Demographics

Mean age 71.6 70.2 68.6

< 50 3.1% 5.0% 5.9%

50 – 59 8.8% 11.3% 13.8%

60 – 69 24.8% 25.2% 28.9%

70 – 79 40.6% 37.7% 34.7%

≥ 80 22.7% 20.7% 16.6%

Median BMI 28 28 28

% BMI information available 70.3% 57.4% 62.7%

Underweight ( BMI < 18.5) 1.0% 1.1% 0.9%

Normal (18.5 ≤ BMI < 25) 21.5% 22.4% 20.8%

Overweight (25 ≤ BMI < 30) 39.7% 40.2% 39.6%

Obese I (30 ≤ BMI < 35) 25.4% 24.6% 25.8%

Obese II (35 ≤ BMI < 40) 9.3% 8.8% 9.7%

Obese III (BMI ≥ 40) 3.1% 2.9% 3.3%

% Male 35.8% 38.6% 40.2%

ASA Grades

P1 - Fit and healthy 10.8% 15.9% 15.6%

P2 - Mild disease not incapacitating 68.9% 65.1% 67.7%

P3 - Incapacitating systemic disease 19.6% 18.3% 16.2%

P4 / P5 0.7% 0.7% 0.6%

Indications

Osteoarthritis 89.91% 90.06% 91.26%

Rheumatoid Arthritis 1.42% 1.41% 1.32%

Avascular Necrosis 2.47% 2.46% 2.53%

Fractured Neck of Femur 5.36% 4.62% 3.69%

CDH/DDH 1.08% 1.33% 1.58%

Other 2.14% 2.54% 2.12%

Total of indications may exceed total number of implants, since more than one indication can be listed per

case.


Patient / Procedure Details



Summary Report for:

Reasons for Revision - all bearing types

Reasons for revision of primary procedures in which the implant was used.

Reason for Revision Revised†

Expected Revisions* p value

Unexplained Pain 554 644.04 <0.001

Dislocation / Subluxation 1887 1874.52 0.689

Adverse Soft Tissue Reaction 342 447.56 <0.001

Infection 1657 1681.64 0.388

Aseptic Loosening - Stem 570 662.84 <0.001

Aseptic Loosening - Socket 1053 1082.01 0.273

Periprosthetic Fracture Stem 1455 1505.57 0.065

Periprosthetic Fracture Socket 134 141.19 0.403

Malalignment Stem 174 186.87 0.206

Malalignment Socket 371 345.27 0.063

Wear Of Acetabular Component 258 239.83 0.149

Lysis Stem 153 171.39 0.099

Lysis Socket 227 226.47 0.968

Implant Fracture Stem 126 127.73 0.865

Implant Fracture Socket 33 34.19 0.818

Implant Fracture Head 33 36.74 0.449

Dissociation of Liner 90 79.15 0.092

Other / reason not recorded 284 311.64 0.044

Total Revised 7551 7885.00 <0.001

† multiple reasons may be listed for one revision procedure

Significantly better, p < 0.001


Significantly worse p < 0.05


Components RevisedNumber of

procedures

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJR

Femoral only 1789 24% 18%

Acetabular only 1628 22% 17%

Both femoral and acetabular 3244 43% 60%

Neither femoral nor acetabular

revision recorded *890 12% 5%

* includes isolated head and/or liner exchange



* Based on All NJR Hips with Cement, adjusted for agegroup,

gender, indications, and implantation year



Summary Report for:

Reasons for Revision - excluding Metal on Metal

Reasons for revision of non-MoM primary procedures in which the implant was used.

Reason for Revision Revised†

Expected

Revisions* p value

Unexplained Pain 423 419.98 0.844

Dislocation / Subluxation 1868 1880.41 0.684

Adverse Soft Tissue Reaction 112 101.78 0.175

Infection 1628 1679.08 0.063

Aseptic Loosening - Stem 509 597.33 <0.001

Aseptic Loosening - Socket 1007 1039.21 0.194

Periprosthetic Fracture Stem 1393 1412.68 0.442

Periprosthetic Fracture Socket 133 136.33 0.703

Malalignment Stem 167 175.25 0.374

Malalignment Socket 344 317.41 0.033

Wear Of Acetabular Component 250 235.80 0.245

Lysis Stem 121 132.53 0.235

Lysis Socket 192 186.97 0.642

Implant Fracture Stem 117 123.63 0.432

Implant Fracture Socket 33 33.13 1

Implant Fracture Head 29 32.56 0.367

Dissociation of Liner 90 76.64 0.028

Other / reason not recorded 232 227.83 0.697

Total Revised 6989 7145.03 0.008

† multiple reasons may be listed for one revision procedure





Components RevisedNumber of

procedures

Hips using

Palacos Antibiotic

Cement

All other cement brands in

NJR

Femoral only 1740 25% 22%

Acetabular only 1575 23% 23%

Both femoral and acetabular 2792 40% 48%

Neither femoral nor acetabular

revision recorded *882 13% 7%

* includes isolated head and/or liner exchange



* Based on All NJR Hips with Cement (excluding metal on

metal), adjusted for agegroup, gender, indications, and

implantation year



Summary Report for:

Cumulative Revision Rate

AdjustmentHazard Ratio

(95% CI)p- value

0.78 ‡

(0.76 - 0.80)

0.91

(0.88 - 0.94)

‡ Hazard ratio varies with time

All bearings. Adjusted for age, gender,

year cohort and indications.<0.001

Endpoint: All reasons for revision. All Bearing types



Cox Proportional Hazards model for revision risk ratio of Hips using Palacos Antibiotic Cement / All

other cement brands in NJR, with endpoint as any revision.

All bearings. Unadjusted. <0.001 ‡

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

0 2 4 6 8 10 12 14 16

Cu

mu

lati

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evis

ion

Rat

e

Implantation time / years

All other cement brands in NJR

All other cement brands in NJR (adjusted)




Summary Report for:



(95% CI)p- value

0.93 ‡

(0.90 - 0.96)

0.95

(0.91 - 0.98)


Excluding MoM. Adjusted for age,

gender, year cohort and indications.0.004



Endpoint: All reasons for revision. Excluding Metal-on-Metal



Excluding MoM, Unadjusted. <0.001 ‡

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

0 2 4 6 8 10 12 14 16

Cu

mu

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ion

Rat

e







Summary Report for:



(95% CI)p- value

0.71 ‡

(0.68 - 0.73)

0.85

(0.82 - 0.89)


All bearings. Adjusted for age, gender,

year cohort and indications.<0.001



Endpoint: Cemented Component Revision. All Bearing types



All bearings. Unadjusted. <0.001 ‡

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

0 2 4 6 8 10 12 14 16

Cu

mu

lati

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evis

ion

Rat

e







Summary Report for:



(95% CI)p- value

0.87 ‡

(0.84 - 0.91)

0.91

(0.87 - 0.95)


Excluding MoM. Adjusted for age,

gender, year cohort and indications.<0.001



Endpoint: Cemented Component Revision. Excluding Metal-on-Metal



Excluding MoM. Unadjusted. <0.001 ‡

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

0 2 4 6 8 10 12 14 16

Cu

mu

lati

ve R

evis

ion

Rat

e







Summary Report for:

Endpoint: All revisions

Period

/yearsAt Risk

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJRAll THR At Risk

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJRAll THR

0 412,043 - - - 407,178 - - -

1 382,669 0.7% (0.7% - 0.7%) 0.7% (0.6% - 0.7%) 0.8% (0.8% - 0.8%) 377,920 0.7% (0.7% - 0.7%) 0.6% (0.6% - 0.7%) 0.8% (0.8% - 0.8%)

2 332,652 1.0% (0.9% - 1.0%) 1.0% (1.0% - 1.0%) 1.1% (1.1% - 1.2%) 328,061 1.0% (0.9% - 1.0%) 0.9% (0.9% - 1.0%) 1.1% (1.1% - 1.1%)

3 284,508 1.2% (1.2% - 1.3%) 1.3% (1.3% - 1.4%) 1.5% (1.4% - 1.5%) 280,059 1.2% (1.2% - 1.2%) 1.2% (1.1% - 1.2%) 1.3% (1.3% - 1.4%)

4 240,296 1.4% (1.4% - 1.5%) 1.6% (1.6% - 1.7%) 1.8% (1.7% - 1.8%) 236,006 1.4% (1.4% - 1.4%) 1.4% (1.3% - 1.4%) 1.6% (1.5% - 1.6%)

5 198,266 1.7% (1.6% - 1.7%) 2.0% (1.9% - 2.1%) 2.1% (2.1% - 2.1%) 194,151 1.6% (1.5% - 1.6%) 1.6% (1.6% - 1.7%) 1.8% (1.8% - 1.8%)

6 160,433 1.9% (1.8% - 1.9%) 2.4% (2.3% - 2.4%) 2.5% (2.5% - 2.5%) 156,494 1.8% (1.7% - 1.8%) 1.9% (1.8% - 1.9%) 2.0% (2.0% - 2.0%)

7 126,918 2.1% (2.1% - 2.2%) 2.8% (2.7% - 2.8%) 2.9% (2.8% - 2.9%) 123,162 2.0% (1.9% - 2.0%) 2.1% (2.1% - 2.2%) 2.3% (2.2% - 2.3%)

8 97,805 2.4% (2.3% - 2.4%) 3.2% (3.1% - 3.2%) 3.3% (3.3% - 3.3%) 94,215 2.2% (2.1% - 2.3%) 2.4% (2.3% - 2.5%) 2.5% (2.5% - 2.6%)

9 73,529 2.7% (2.6% - 2.7%) 3.6% (3.5% - 3.7%) 3.7% (3.7% - 3.8%) 70,133 2.5% (2.4% - 2.5%) 2.7% (2.6% - 2.8%) 2.8% (2.8% - 2.9%)

10 53,292 3.0% (2.9% - 3.0%) 4.0% (4.0% - 4.1%) 4.2% (4.1% - 4.2%) 50,250 2.7% (2.7% - 2.8%) 3.1% (3.0% - 3.1%) 3.1% (3.1% - 3.2%)

11 37,292 3.3% (3.2% - 3.4%) 4.5% (4.4% - 4.6%) 4.7% (4.6% - 4.7%) 34,653 3.1% (3.0% - 3.2%) 3.5% (3.4% - 3.6%) 3.5% (3.4% - 3.5%)

12 24,252 3.8% (3.6% - 3.9%) 5.1% (5.0% - 5.2%) 5.2% (5.2% - 5.3%) 22,203 3.5% (3.3% - 3.6%) 4.0% (3.9% - 4.1%) 3.9% (3.9% - 4.0%)

13 13,306 4.1% (3.9% - 4.2%) 5.6% (5.5% - 5.7%) 5.7% (5.7% - 5.8%) 12,133 3.7% (3.6% - 3.9%) 4.4% (4.3% - 4.5%) 4.3% (4.3% - 4.4%)

14 5,013 4.4% (4.2% - 4.6%) 6.1% (6.0% - 6.2%) 6.2% (6.1% - 6.3%) 4,650 4.0% (3.8% - 4.2%) 4.8% (4.7% - 5.0%) 4.7% (4.7% - 4.8%)

15 ( - ) 6.6% (6.5% - 6.8%) 6.7% (6.6% - 6.8%) ( - ) 5.4% (5.2% - 5.5%) 5.2% (5.1% - 5.3%)

Cumulative revision rate with 95% confidence intervals Rate is only reported for times where more than 40 remain at risk

Excluding Metal on Metal BearingsAll Bearing types






Summary Report for:

Endpoint: Cemented Component Revision

Period

/yearsAt Risk

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJRAll THR At Risk

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJRAll THR

0 412,043 - - - 407,178 - - -

1 382,669 0.5% (0.4% - 0.5%) 0.5% (0.5% - 0.5%) ( - ) 377,920 0.5% (0.4% - 0.5%) 0.4% (0.4% - 0.5%) ( - )

2 332,652 0.7% (0.7% - 0.7%) 0.8% (0.8% - 0.8%) ( - ) 328,061 0.7% (0.6% - 0.7%) 0.7% (0.7% - 0.7%) ( - )

3 284,508 0.9% (0.9% - 0.9%) 1.1% (1.0% - 1.1%) ( - ) 280,059 0.9% (0.8% - 0.9%) 0.9% (0.9% - 0.9%) ( - )

4 240,296 1.1% (1.0% - 1.1%) 1.3% (1.3% - 1.4%) ( - ) 236,006 1.0% (1.0% - 1.1%) 1.1% (1.0% - 1.1%) ( - )

5 198,266 1.3% (1.2% - 1.3%) 1.7% (1.6% - 1.7%) ( - ) 194,151 1.2% (1.2% - 1.2%) 1.3% (1.3% - 1.3%) ( - )

6 160,433 1.5% (1.4% - 1.5%) 2.0% (2.0% - 2.1%) ( - ) 156,494 1.4% (1.3% - 1.4%) 1.5% (1.5% - 1.6%) ( - )

7 126,918 1.6% (1.6% - 1.7%) 2.4% (2.3% - 2.4%) ( - ) 123,162 1.5% (1.5% - 1.6%) 1.7% (1.7% - 1.8%) ( - )

8 97,805 1.9% (1.8% - 1.9%) 2.7% (2.7% - 2.8%) ( - ) 94,215 1.7% (1.7% - 1.8%) 2.0% (1.9% - 2.0%) ( - )

9 73,529 2.1% (2.0% - 2.2%) 3.1% (3.1% - 3.2%) ( - ) 70,133 1.9% (1.9% - 2.0%) 2.3% (2.2% - 2.3%) ( - )

10 53,292 2.4% (2.3% - 2.5%) 3.6% (3.5% - 3.7%) ( - ) 50,250 2.2% (2.1% - 2.3%) 2.6% (2.5% - 2.7%) ( - )

11 37,292 2.7% (2.6% - 2.8%) 4.0% (3.9% - 4.1%) ( - ) 34,653 2.5% (2.4% - 2.6%) 3.0% (2.9% - 3.1%) ( - )

12 24,252 3.1% (3.0% - 3.2%) 4.6% (4.5% - 4.7%) ( - ) 22,203 2.8% (2.7% - 2.9%) 3.4% (3.3% - 3.5%) ( - )

13 13,306 3.4% (3.2% - 3.5%) 5.0% (4.9% - 5.1%) ( - ) 12,133 3.0% (2.9% - 3.2%) 3.8% (3.7% - 3.9%) ( - )

14 5,013 3.6% (3.4% - 3.8%) 5.5% (5.3% - 5.6%) ( - ) 4,650 3.3% (3.1% - 3.5%) 4.2% (4.1% - 4.4%) ( - )

15 ( - ) 6.0% (5.8% - 6.1%) ( - ) ( - ) 4.7% (4.5% - 4.9%) ( - )

Cumulative revision rate with 95% confidence intervals Rate is only reported for times where more than 40 remain at risk



All Bearing types Excluding Metal on Metal Bearings




Summary Report for:

Comprising PROMs data up to and including: 31/12/2019


Patient Reported Outcomes

PROMs Analysis

0

6

12

18

24

30

36

42

48

Mean Pre-op Mean 6 months post-op

Oxf

ord

Sco

re (

un

adju

sted

)



-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0.8

1

Mean Pre-op Mean 6 months post-op

EQ5

D S

core

(u

nad

just

ed)





Summary Report for:

PROMs Analysis Comprising PROMs data up to and including: 31/12/2019

Oxford Hip Score

(0 - 48)

Hips using Palacos

Antibiotic Cement

All other cement

brands in NJRAll THR in NJR

Paired Records 121,751 79,894 342,959

PreOp score 17.5 (17.5 - 17.6) 17.6 (17.5 - 17.6) 17.9 (17.9 - 18.0)

6 month score 39.2 (39.1 - 39.2) 38.9 (38.9 - 39.0) 39.5 (39.5 - 39.5)

6 month score (adjusted) 39.4 (39.4 - 39.5) 39.3 (39.3 - 39.4) 39.5 (39.5 - 39.5)

Health gain 21.6 (21.6 - 21.7) 21.3 (21.3 - 21.4) 21.6 (21.5 - 21.6)

Health gain (adjusted) 21.5 (21.5 - 21.6) 21.4 (21.3 - 21.5) 21.6 (21.5 - 21.6)

p value (adjusted health gain)

Score Improved 97.4% 97.2% 97.3%

EQ-5D Index

(-0.59 - 1.00)

Hips using Palacos

Antibiotic Cement

All other cement


Paired Records 111,587 73,322 315,677

PreOp score 0.340 (0.338 - 0.342) 0.339 (0.337 - 0.341) 0.353 (0.352 - 0.354)

6 month score 0.788 (0.787 - 0.790) 0.782 (0.781 - 0.784) 0.794 (0.794 - 0.795)


Health gain 0.448 (0.446 - 0.450) 0.443 (0.441 - 0.446) 0.441 (0.440 - 0.442)




EQ-VAS

(0 - 100)

Hips using Palacos

Antibiotic Cement

All other cement


Paired Records 106,585 70,419 303,007

PreOp score 64.4 (64.3 - 64.6) 64.4 (64.2 - 64.5) 64.8 (64.7 - 64.9)

6 month score 76.5 (76.4 - 76.6) 76.0 (75.9 - 76.1) 77.0 (76.9 - 77.1)


Health gain 12.1 (12.0 - 12.2) 11.6 (11.4 - 11.8) 12.2 (12.1 - 12.3)




Figures in parentheses represent the 95% confidence interval for the mean

Adjusted scores correspond to the NHS Digital version 3 casemix-adjustment model. This includes patient

variables from PROMs, HES, and IMD data.



0.018

0.26

0.006



Summary Report for:

Responses are not case mix adjusted

Chi Squared p-value for difference: 0.271

Answer to 6-months general health question: Overall, how are your

problems now, compared to before your operation?

Chi Squared p-value for difference: 0.442

Answer to 6-months general health question: How would you describe

the results of your operation?



0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Hips using PalacosAntibiotic Cement

All other cementbrands in NJR

Success

Much worse

A little worse

About the same

A little better

Much better

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Hips using PalacosAntibiotic Cement

All other cementbrands in NJR

Satisfaction

Poor

Fair

Good

Very Good

Excellent



Summary Report for:

Success

ResponseHips using Palacos

Antibiotic Cement

All other cement

brands in NJR

Much better 107124 70021

A little better 10816 7227

About the same 2901 1998

A little worse 1660 1106

Much worse 1113 715

Satisfaction

ResponseHips using Palacos

Antibiotic Cement

All other cement

brands in NJR

Excellent 49747 32794

Very Good 43420 28180

Good 21338 13973

Fair 7022 4674

Poor 1912 1293

Answer to 6-months general health question:

"Overall, how are your problems now, compared to before your operation?"

Answer to 6-months general health question:

"How would you describe the results of your operation?"





Summary Report for:

Disclaimer

Disclaimer

The National Joint Registry (NJR) produces this report through its contractor, Northgate Public Services (UK)

Limited (NPS) using data collected, collated and provided by third parties. As a result, neither NJR or NPS takes

any responsibility for the accuracy, currency, reliability and correctness of any data used or referred to in this

report, and disclaims all warranties in relation to such data, in each case to the maximum extent permitted by

legislation.

To the maximum extent permitted by law, neither the NJR or NPS shall have any liability (including but not

limited to liability by reason of negligence) for any loss, damage, cost or expense incurred or arising by reason of

any person using or relying on the data within this report and whether caused by reason of any error, omission

or misrepresentation in the report or otherwise. This report is not to be taken as advice. Third parties using or

relying on the data in this report do so at their own risk and will be responsible for making their own

assessment and should verify all relevant representations, statements and information with their own

professional advisers.




Catalogue Number

Description

Number Implanted

66017569 Palacos R +G 2x40 g 357297

66017771 Palacos R +G 1x40 g 2753

66017772 Palacos R +G 1x60 g 5033

66017773 Palacos R +G 2x20 g 4457

66017776 Palacos R +G 2x10 g 6

66017783 Palamed G 1x20 g 1

66017787 Palacos LV +G 1x40 g 4448

66031993 PALACOS MV+G 1x40g 134

66031995 Palacos MV+G 2x40 g 1743

66031996 PALACOS MV+G 1x20g 2

66031998 Palacos MV+G 2x20 g 5

66032000 Palacos MV+G 1x60 g 1

66037894 PALACOS LV+G 1x20g 1

66044273 Palacos R+G Pro 55 cement 168

66044274 Palacos R+G Pro 75 cement 384

Multiple Found Multiple Found 35610



Hips using Palacos Antibiotic Cement - Heraeus

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