attune knee system · depuy synthes companies created an extensive portfolio with 10 femoral and...

UNMET NEEDS IN TOTAL KNEE ARTHROPLASTY Data shows that as recently as 2009, between 10% and 20% of total knee arthroplasty patients were dissatisfied with their results.4

What Impacts Patient Satisfaction:

• Anterior Knee Pain: One of the most common complaints after total knee replacement is anterior knee pain. Data has shown that up to 50% of patients experience anterior knee pain.5,13

• Instability: Data has shown that activities which cause a greater force on the knee after total knee arthroplasty lead to increased problems. This has been attributed to design factors, procedure related challenges, and inadequate soft tissue stability.6 Patient dissatisfaction increases to 28% when patients perform high demand activities like going up or down stairs.4

• Implant Fit: Tibial base overhang on the posterior medial side of the resected tibial bone can cause irritation of the Medial Collateral Ligament (MCL). Overhang on the posterior lateral side can result in impingement with the popliteal tendon. Femoral component overhang of 3 mm is associated with an almost twofold increased risk of knee pain more severe than occasional or mild at 2 years after surgery.7 A study with some commonly used knee designs has shown that 40% of men and 68% of women have at least one area of the implant with 3 mm or more of overhang.7

2017 VALUE BASED PURCHASING DOMAINS AND PERCENTAGE OF REIMBURSEMENT

ATTUNE® KNEE SYSTEMVALUE ANALYSIS BRIEF

25%

25% 25%

25%

Efficiency and Cost Reduction

Safety

ClinicalCare

Person and Community Engagement

VALUE BASED PURCHASING

Comprehensive Care for Joint Replacement (CJR Model)

CJR is a mandatory bundled payment for Medicare fee-for-service knee and hip replacement in 67 selected geographical areas. Hospitals are held accountable for the quality and cost of care for lower extremity joint replacements. This includes the cost during the hospital stay and for 90 days after discharge. The hospital may set up gainsharing or division of risk with partners in their system.8

VALUE SUMMARYThe ATTUNE® Knee System is designed to reduce pain and improve patient satisfaction around the world. Extensive research and science has gone into the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers.

Since the commercial launch in 2013, the ATTUNE Knee System has shown statistically significant improvements in multiple Patient Reported Outcome Measures (PROMs) compared to certain leading knee brands.1 Additional studies have demonstrated significant improvements in patellofemoral outcomes, including reduced anterior knee pain, compared to another leading knee brand.2,5,12,14 DePuy Synthes was granted over 60 patents based on proprietary ATTUNE Knee System technology.3

Value Analysis Brief ATTUNE® Knee System DePuy Synthes 1

ATTUNE Knee features address unmet needs for hospitals, patients, and surgeons. Each of these technologies was designed to provide function for surgeons in the operating room and for patients after surgery, resulting in over 60 patents granted for the ATTUNE Knee System.3

Extensive Size Offering for Diverse Population:

To address sizing challenges, the ATTUNE Knee System sizing is based on extensive research using a global database of patients.11 Based on these data, DePuy Synthes Companies created an extensive portfolio with 10 femoral and tibial component sizes, plus 4 additional narrow femoral component sizes, to meet the needs of the diverse worldwide population.11

The chart below from Fitzpatrick et al.11 depicts the ATTUNE Knee femoral sizing line overlaid on the measurements of patients studied. The femoral sizes were developed to minimize instances of component overhang (i.e. greater number of patients above the line rather than below).

• Standard: The standard sizing line (purple) shows coverage without overhang is achieved for approximately 70% of patients.11

• Narrow: The narrow femoral sizes (green line) show coverage without overhang is achieved for approximately 30% of patients beyond the standard sizing.11

Subject DataATTUNE® Knee - StandardATTUNE® Knee - Narrow

40 45 50 55 60 65 70 75 50

55

60

65

70

75

80

85

90

Fem

oral

Med

ial/L

ater

al M

easu

rem

ent (

mm

)

Femoral Anterior/Posterior Measurement (mm)

THE ATTUNE KNEE SYSTEM IS DESIGNED TO REDUCE PAIN, INCREASE STABILITY, AND ADDRESS IMPLANT FIT

The ATTUNE Knee is Designed for Motion and Stability:

The chart below contains data from a study looking at the ATTUNE Knee and the other named TKA designs in relation to constraint at various degrees of flexion. This data supports that the ATTUNE Knee offers more stability than the other named TKA designs while still allowing rotational freedom in deeper flexion.9 This is accomplished through a gradually reducing radius (ATTUNE GRADIUS™ Curve) on the femoral component paired with a mating tibial insert. The result is a balanced level of motion and stability that more closely matches that found in the native knee.10 This aids in patient performance during dynamic activities such as going up and down stairs.9 The study concluded the other manufacturers’ TKA implants named in the chart below have abrupt* changes during the gait cycle (highlighted by the purple arrows in the chart from Fitzpatrick et al.9).

FLEXION ANGLE

0º 15º 30º 60º 90º 120ºAbrupt

Change*

ATTUNE CR FB Knee Conformity

0.88 0.83 0.77 0.66 0.67 0.35 None

ATTUNE CR RP Knee Conformity

0.99 0.93 0.87 0.74 0.76 0.40 None

Smith & Nephew® Genesis® II CR FB Conformity

0.59 0.32 0.32 0.32 0.21 0.21 11º

Biomet® Vanguard® CR FB Conformity

0.47 0.47 0.30 0.30 0.21 0.21 25º

Zimmer® NexGen® CR FB Conformity

0.54 0.54 0.54 0.31 0.31 0.31 37º

Stryker® Triathlon™ CR FB Conformity

0.38 0.22 0.22 0.22 0.22 0.11 10º

*An abrupt change occurs when the geometry of the TKA implant changes from a large load-bearing distal radius to a smaller posterior radius.29

2 DePuy Synthes ATTUNE® Knee System Value Analysis Brief

Literature has shown that up to 50% of TKA patients experience anterior knee pain,5,13 one of the most common complaints after total knee arthroplasty. When compared to a leading knee brand, two studies demonstrated statistically significant reductions in anterior knee pain for patients implanted with ATTUNE Posterior Stabilized Knee at 2 year follow-up,2-5 with one study showing as few as 2% of patients experienced post-operative anterior knee pain.2 Other recent studies have observed less incidence of symptomatic crepitus for ATTUNE PS Knees compared to a leading knee brand.2,5,12,14

ATTUNE KNEE PATIENTS HAVE BEEN SHOWN TO EXPERIENCE STATISTICALLY SIGNIFICANT IMPROVEMENTS IN PATELLOFEMORAL OUTCOMES COMPARED TO ANOTHER LEADING KNEE BRAND 2,5,12,14

THE ATTUNE KNEE SYSTEM OFFERS A WIDE VARIETY OF CHOICES FOR EVERY SURGICAL WORKFLOW

ATTUNE KNEE US CLASS III PREMARKET APPROVALS† (PMA):

• PS & CR Femoral Components• Medialized Dome and Medialized Anatomic Patella

Components• PS & CR Rotating Platform Tibial Inserts with AOX™

Antioxidant Polyethylene• Rotating Platform Tibial Base† PMA approval P830055.

ATTUNE KNEE SYSTEM OVERVIEW

The ATTUNE Knee System is designed to deliver a high level of stability and motion. DePuy Synthes Companies has applied for extensive patent protection in countries throughout the world for the ATTUNE System implants, instruments, and surgical methods. In the U.S. alone, there are over 60 patents granted for key inventions related to ATTUNE Knee implants and instruments.3

• Available in Rotating Platform (RP) and Fixed Bearing (FB)

• CR and PS implant variants designed to accommodate Posterior Stabilized (PS), Cruciate Retaining (CR) and Cruciate Sacrificing (CS) techniques

• 14 Left and Right Femoral Sizes (includes Standard and Narrow options)

• 10 Tibial Sizes• 1 mm Tibial Insert Increments for most commonly

used thicknesses and 2 mm for remainder• 0.5 mm Patella Thickness Increments• Medialized Dome and Medialized Anatomic

Patella Options• Gap Balancing & Measured Resection Techniques• Advanced materials: AOX Antioxidant Polyethylene for

all Patella Components and Tibial Inserts• Options include stemmed tibia in primary TKA

The ATTUNE Knee accommodates patient variation by currently offering a wider breadth of sizes compared with certain other leading knee systems in the market, as outlined in the table below.

Femoral Sizes

Tibial Sizes

Insert Thickness

Increments

ATTUNE Knee 14 101-2 mm

increments

Zimmer® Persona®15 21 9

1-2 mm increments

Stryker® Triathlon™16 8 8

2-3 mm increments

Biomet® Vanguard®17 10 9

1-2 mm increments

Smith & Nephew® Journey 2™18 10 8

1-4 mm increments

The patella components within the ATTUNE System are designed with a dome that is offset medially. This offset is designed to reflect the natural patella shape and enhance patellofemoral function. The chart below shows that the ATTUNE Knee System is one of the few leading TKA systems currently in the market (mentioned below) with both dome and medially offset patella options.

Knee Systems with a Medialized Patella

ATTUNE Knee Yes

Zimmer® Persona®15 No

Stryker® Triathlon™16 Yes

Biomet® Vanguard®17 No

Smith & Nephew® Journey 2™18 No


THE ATTUNE KNEE SYSTEM HAS SHOWN IMPROVED PATIENT REPORTED OUTCOMES COMPARED TO CERTAIN OTHER LEADING KNEE BRANDS1 AND PERFORMED FAVORABLY TO THE CLASS OF TKR IN TWO NATIONAL JOINT REGISTRIES

Patient Reported Outcome Measures (PROMs) are pre- and post-operative questionnaires that measure outcomes from the patient’s perspective. The Oxford Knee Score (OKS) is a widely used PROM that measures pain and functional outcomes. The Oxford Knee Score is graded on a scale of 0-48, with 48 being the highest score.20

Interim results of two worldwide, multi-center prospective studies demonstrated four PROMs that favored the ATTUNE Knee System. OKS data is shown in the table below.1

Results from 18,262 ATTUNE Knee System implants have been recorded in two large national joint registries. The National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man (NJR), and the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) both demonstrate real world evidence with the ATTUNE Knee System.

Per the 2017 NJR, in which 9,878 knees are being tracked, the ATTUNE Knee estimated cumulative percent revision was 1.00% at three years (99.00 % survivorship), comparing favorably to the overall class of all Cemented TKA that has an estimated cumulative percent revision of 1.49% at three years.21

Per the 2017 AOANJRR report, in which 8,384 ATTUNE Knees are being tracked (N=5,691 CR, N=2,693 PS), the ATTUNE Knee estimated cumulative percent revision was 2.1% (1.4, 3.1) for ATTUNE Cruciate Retaining Knee, 1.1% (0.6, 1.9) for ATTUNE Posterior Stabilized Knee at three years.22

PROMs favor ATTUNE Knee1

PROM Scale Brand 1 year 2 years

Oxford Knee Score

0-48ATTUNE Knee 41.5 ± 6.2 42.3 ± 6.3

Leading Knee Brands (non-ATTUNE Knee)*

40.2 ± 7.4 41.4 ± 6.9

* Leading brands included SIGMA® Knee, NexGen®, and Triathlon®, n=845

Adapted from tables 3.25(a), 3.29

Cumulative Percentage Probability of a First Revision (95% CI) if Time Elapsed Since Primary Operation is:

Brand Number of Knee Joints

1 year 3 years 5 years 7 years 10 years

ATTUNE Knee (Table 3.29)

9,878 0.30 (0.20-0.46)

1.00 (0.66-1.52)

ALL Cemented Knee (Table 3.25(a)

828,573 0.39 (0.38-0.41)

1.49 (1.46-1.52)

2.13 (2.10-2.17)

2.63 (2.59-2.67)

3.35 (3.29-3.42)

The PS ATTUNE Knee compares favorably with the overall class of

posterior stabilized cemented TKA at three years which has an estimated

cumulative percent revision of 2.9% (2.8, 3.0).22

The CR ATTUNE Knee performs in line with the overall class of cemented,

minimally stabilized TKA at three years which has an estimated cumulative percent

revision of 2.2% (2.1, 2.3).22

1.1% 2.1%


THE ATTUNE KNEE SYSTEM MAY HELP YOU ACHIEVE THE TRIPLE AIM GOALS: IMPROVED PATIENT EXPERIENCE, IMPROVED OUTCOMES, AND REDUCED COSTS

DePuy Synthes Companies queried the Premier Perspective™ Database in late 2015. The Premier Perspective™ Database, which includes billing, cost, device, medication, diagnosis, and procedure data from more than 670 hospitals in the United States, was analyzed to identify trends in TKA. The data were analyzed for the ATTUNE Knee’s performance (single-arm) and a comparison of the ATTUNE Knee compared to the Triathlon™ Knee (comparative arm).24

The objective of the single-arm analysis was to evaluate hospital length of stay (LOS) and discharge status for patients who received TKA with the ATTUNE Knee. 1,766 patients received the ATTUNE Knee within a total of 55 hospitals over the observation period. The study concluded that 85% of ATTUNE Knee patients in the study were discharged in 3 days or less.23

Using the same Premier Perspective™ data, a retrospective, comparative review of real world claims demonstrated that patients in the study who received a TKA with the ATTUNE Knee had statistically shorter length of stay (2.94 vs. 3.13; p<0.001) compared to the patients in the study implanted with Triathlon™ Knee.24 The comparative study included 38 hospitals in the U.S., representing 1,178 primary, unilateral TKAs with the ATTUNE Knee System and 5,707 primary, unilateral TKAs

with Triathlon™. Small improvements in hospital length of stay and reduced total hospital costs are becoming increasingly relevant, as the shift to value based care places more financial burden on providers for the episode of care.24

Patients in the study who received TKA with the ATTUNE Knee had a slightly shorter Length of Stay (LOS) and were less likely to be discharged to a skilled nursing facility (SNF) and more likely to be discharged home versus patients in the study who received a Triathlon™ Knee.24 Sensitivity analyses suggest that these effects could not be explained by patient factors including age, insurance or marital status.24

Seventy-nine percent of patients (1,387/1,766) were discharged to home

Eighty-five percent of patients (1,506/1,766) were discharged in three days or less

79%

16%5%

Home or Home Health Care

SNF

Other Facility1 2 3 4 5 6+

Days in Hospital

1000

900

800

700

600

500

400

300

200

100

0

Nu

mb

er o

f H

osp

ital

Ad

mis

sio

ns

ATTUNE Knee

Dis

char

ged

to

SN

F(%

)

Triathlon™

40%

30%

20%

10%

0%

24%(20.09%–29.04%)

34%(30.01%–38.95%)

Adjusted Proportion of Patients Discharged Home,

Mean (95% Confidence Interval)

ATTUNE Knee

Dis

char

ged

Ho

me(

%)

Triathlon™

100%

80%

60%

40%

20%

0%

76%(71%–80%) 66%

(61%–70%)

Adjusted Hospital Length of Stay,


ATTUNE Knee

Ave

rag

e H

osp

ital

LO

S

Triathlon™

3

2

1

0

2.94(2.84–3.06)

3.13(3.03–3.22)

Odds Ratio (95% Confidence Interval): 0.61 (0.50-0.75) p < .001

Odds Ratio (95% Confidence Interval):1.63 (1.34-1.98) p < .001

Mean Diff: .19 days p < .001

Adjusted Proportion of Patients Discharged to

Skilled Nursing Facility (SNF), Mean (95% Confidence Interval)

ATTUNE Knee

Dis

char

ged

to

SN

F(%

)

Triathlon™

40%

30%

20%

10%

0%

24%(20.09%–29.04%)

34%(30.01%–38.95%)

Adjusted Proportion of Patients Discharged Home,


ATTUNE KneeD

isch

arg

ed H

om

e(%

)Triathlon™

100%

80%

60%

40%

20%

0%

76%(71%–80%) 66%

(61%–70%)

Adjusted Hospital Length of Stay,


ATTUNE Knee

Ave

rag

e H

osp

ital

LO

S

Triathlon™

3

2

1

0

2.94(2.84–3.06)

3.13(3.03–3.22)

Odds Ratio (95% Confidence Interval): 0.61 (0.50-0.75) p < .001

Odds Ratio (95% Confidence Interval):1.63 (1.34-1.98) p < .001

Mean Diff: .19 days p < .001

Adjusted Proportion of Patients Discharged to

Skilled Nursing Facility (SNF), Mean (95% Confidence Interval)


ATTUNE Knee features address unmet needs for hospitals, patients, and surgeons. Each of these technologies was designed to provide function for surgeons in the operating room and for patients after surgery, resulting in over 60 patents granted for the ATTUNE Knee System.3

ATTUNE GRADIUS™ Curve

The patented ATTUNE GRADIUS™ Curve is designed with a gradually reducing femoral radius. This curve potentially creates a smooth transition during knee bending and produces high stability of the knee by reducing unnatural sliding of the femur on the tibia.25

GLIDERIGHT™ Articulation

The patellofemoral interaction is one of the more challenging aspects of total knee arthroplasty.27 The GLIDERIGHT™ Articulation encompasses a trochlear groove designed to accommodate patient variation and soft tissue interaction, and patella components designed to optimize patella tracking while maintaining bone coverage.

INNOVATIVE DESIGN PROVIDES INCREASED STABILITY AND IMPROVED PATELLOFEMORAL FUNCTION COMPARED TO ANOTHER LEADING KNEE BRAND

2,5,12,14

SOFCAM™ Contact

The proprietary s-curve design of the SOFCAM™ Contact is designed to provide a smooth engagement for gradual femoral rollback and stability in flexion, while reducing the forces transferred to the tibial spine.26

LOGICLOCK™ Tibial Base

The LOGICLOCK™ Tibial Base is designed to allow for a tibial base that can be upsized or downsized two sizes versus the insert,achieving the highest conformity and optimized stability in early flexion.9 The ATTUNE Knee is differentiated from Fixed Bearing competitive designs (Persona®, Vanguard®, Triathlon™, NexGen®) which currently do not provide this insert to femur matching in every case.15-18

INTUITION™ Instruments

The INTUITION™ Instruments were developed to deliver efficiencies for all stakeholders and an intuitive surgical process. Advanced composite materials and modular designs allow lighter instruments, less trials, and less instrument trays while providing intra-operative flexibility for the surgeon.28

AOX™ Antioxidant Polyethylene

AOX Antioxidant Polyethylene has an advanced blend of polyethylene resin and a proprietary COVERNOX™ Antioxidant. AOX Polyethylene is designed to deliver optimal wear resistance and long term oxidative stability.


COMBINED WITH OTHER DEPUY SYNTHES COMPANIES PROGRAMS, THE ATTUNE KNEE SYSTEM MAY REDUCE COSTS AND INCREASE EFFICIENCIES

Efficiency

Digital Templating: Digital Templating is a pre-operative templating tool that can help size the implant and potentially reduce the number of instruments needed in the operating room on the day of surgery.

TRUMATCH® Personalized Solutions:

TRUMATCH® Personalized Solutions is the DePuy Synthes Companies Patient Specific Instrumentation System. TRUMATCH Personalized Solutions delivers personalized patient cutting blocks or pin guides based on CT scans of a patient’s knee.

ATTUNE Knee Primary Size Specific Trays

The ATTUNE Knee features Size Specific trays that can help potentially reduce the number of trays from eight to two full & two half trays. Combined with digital templating, significant efficiencies may be realized with reduced sterilization costs, reduced set up and tear down time, and less space required to store instruments in the facility.

DATA Tracker App

This tablet based application can be used to record start and stop times for set up, anaesthesia, surgery, and room turn over. These data are compiled into charts to demonstrate where efficiencies are being realized and lost.

Health Partner for Knees

The Health Partner for Knees patient app is a 24/7 personal coach that is designed to help prepare patients for surgery and recovery, from 4 weeks pre-operatively up to 12 weeks post-operatively. Using proven behavioral science and energy management techniques along with relevant health information, the app aims to motivate patients on their path to recovery, while potentially reducing readmissions and post-surgical complications.


For more information, contact your DePuy Synthes Companies Sales Consultant today.

The third party trademarks used herein are the trademarks of their respective owners.

References1. Hamilton, W. G., Brenkel, I., Clatworthy, M., Dwyer, K., Himden, S., Lesko, J., Kantor,

S. (2016). Early Patient Reported Outcomes With New Primary vs. Contemporary Total Knee Arthroplasty: A Comparison of Two, Worldwide, Multi-Center Prospective Studies. American Academy of Orthopaedic Surgeons Annual Meeting, Poster Number 106, San Diego, CA. Study comparators included the SIGMA Knee (89%), Triathlon™ (7%), NexGen® (3%), and Other (1%).

2. Indelli, P. F., Gennaro, P., Johnson, P., Graceffa, A., Massimiliano, M. (2016). Posterior-stabilized total knee arthroplasty: a matched pair analysis of a classic and its evolutional design. Arthroplasty Today 2(4), 193-198. This study compared the PS ATTUNE Knee to the PS SIGMA Knee.

3. DePuy Synthes Companies. (April, 2017). Data on File: ATTUNE Patent Review. Warsaw, IN.

4. Bourne, R. B., Chesworth, B., Davis, A., Mahomed, N., & Charron, K. (2010). Comparing patient outcomes after THA and TKA: is there a difference? Clinical Orthopaedics and Related Research, 468(2), 542-6.

5. Ranawat, C. S., White, P. B., West, S., Ranawat, A. S. (2016). Clinical and Radiographic Results of Attune and PFC Sigma Knee Designs at 2-Year Follow-Up: A Prospective Matched-Pair Analysis. Journal of Arthroplasty, 32(2), 431-436. This study compared the PS ATTUNE Knee to the PS SIGMA Knee.

6. Noble, P. C., Gordon, M. J., Weiss, J. M., Reddix, R. N., Conditt, M. A., & Mathis, K. B. (2005). Does total knee replacement restore normal knee function? Clinical Orthopaedics and Related Research, 431, 157-165.

7. Mahoney, O. M., Kinsey, T. (2010). Overhang of the femoral component in total knee arthroplasty: risk factors and clinical consequences. The Journal of Bone and Joint Surgery, 92(5), 1115-21.

8. Centers for Medicare and Medicaid Services. Comprehensive Care for Joint Replacement (CJR) model. November 19, 2015. https://innovation.cms.gov/Files/slides/cjr-finalruleintro-slides.pdf. Accessed November 30, 2015.

9. Fitzpatrick, C. K., Clary, C. W., & Rullkoetter, P. J. (2012). The influence of design on TKR mechanics during activities of daily living. Orthopaedic Research Society, 58th Annual Meeting, Poster Number 2034, San Francisco, CA.

10. Sathasivam, S., Walker, P. S. (1999). The conflicting requirements of laxity and conformity in total knee replacement. Journal of Biomechanics, 32, 239-47.

11. Fitzpatrick C.K., Wright A.W. (2012). Verification Summary EN-023. Femoral Size Analysis Using CT Scans. University of College Dublin & DePuy Synthes Joint Reconstruction. Data on File.

12. Toomey SE, Daccach JA, Shah JC, Himden SE, Lesko JP, Hamilton WG. Comparative Incidence of Patellofemoral Complications Between 2 Total Knee Arthroplasty Systems in a Multicenter, Prospective Clinical Study. Journal of Arhtroplasty; 2017: 1-6. This study compared the PS ATTUNE Knee to the PS SIGMA Knee.

13. van Jonbergen, H-P. W., Reuver, J., Mutsaerts, E. L., Poolman, R, W. (2014). Determinants of anterior knee pain following total knee replacement: a systematic review. Knee Surg Sports Traumatol Arthrocs, 22, 478-499.

14. Martin, J., Jennings, J., Watters, T., Levy, D., McNabb, D., Dennis, D. (2016). Femoral Implant Design Modification Decreases the Incidence of Patellar Crepitus in Total Knee Arthroplasty. Journal of Arthroplasty, 32(4) 1310-1313. This study compared the PS ATTUNE Knee to the PS SIGMA Knee.

15. Zimmer, Inc. (2012). Persona: The Personalized Knee System Product Profiler. Warsaw, IN.

16. Stryker, Inc. (2015). Triathlon Knee System MIS Surgical Protocol. Mahwah, NJ.

17. Zimmer Biomet, Inc. (2016). Vanguard Complete Knee System Design Rationale. Warsaw, IN.

18. Smith & Nephew, Inc. (2013). Journey II Surgical Technique. Memphis, TN.

19. US Food and Drug Administration. Learn if a Medical Device has been Cleared by FDA for Marketing. June 2014. Available from: http://www.fda. gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm

20. Murray, D. W., Fitzpatrick, R., Rogers, K., et al. (2007). The use of the Oxford hip and knee scores. Journal of Bone and Joint Surgery, 89-B, 1010-1014.

21. 14th Annual Report 2017: National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, Surgical Data to 31 December 2016, table 3.25(a), table 3.28. Retrieved from: http://www.njrreports.org.uk/Portals/0/PDFdownloads/NJR%2014th%20Annual%20Report%202017.pdf

22. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2017). Tables KT7, KT22, KT 23. Full summary of all data is available from: https://aoanjrr.sahmri.com/annual-reports-2017

23. Etter K, Lerner J, de Moor C, Yoo A, Kalsekar I, Danielson V. Hospital Length of Stay and Discharge Disposition after Primary Total Knee Arthroplasty: Real-world Analysis of 1,766 Patients who Received the ATTUNE Knee System. 2016; DePuy Synthes Companies White Paper DSUS/JRC/0116/1336(1).

24. Etter K, Lerner J, de Moor C, Yoo A, Kalsekar I. Comparative Analysis of Hospital Length of Stay and Discharge Status of Two Contemporary Primary Total Knee Systems. Journal of Knee Surgery. 2017; 193: 1-33.

25. Clary, C. W., Fitzpatrick, C. K., Maletsky, L. P., & Rullkoetter, P. J. (2012). Improving dynamic mid-stance stability: an experimental and finite element study. Orthopaedic Research Society, 58th Annual Meeting, Poster Number 1044, San Francisco, CA.

26. Fitzpatrick, C. K., Clary, C. W., & Rullkoetter, P. J. (2012). Post-cam engagement during dynamic activity with current posterior stabilized TKR. 18th European Society of Biomechanics, Presentation Number 1700, Lisbon, Portugal.

27. Amis, A. A., Senavongse, W., Bull, A. M. J. (2006). Patellofemoral kinematics during knee flexion-extension: an in vitro study. Journal of Orthopaedic Research, 24, 2201-2211.

28. DePuy Synthes Companies. (Oct 2012). Data on File: ATTUNE Reduction in Tray Weight. Warsaw, IN.

29. Clary C, Fitzpatrick CK, Maletsky LP, Rullkoetter PJ. The influence of total knee arthroplasty geometry on mid-flexion stability: An experimental and finite element study. J Biomech. 2013; 46: 1351-7.

© DePuy Synthes 2015, 2018. All rights reserved.DSUS/JRC/0514/0188(3) 05/18

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46582USATel: +1 (800) 366-8143Fax: +1 (800) 669-2530

www.depuysynthes.com

DePuy (Ireland)Loughbeg, RingaskiddyCo. Cork, IrelandTel: + 353 21 4914 000Fax: + 353 21 4914 199

DePuy International, Ltd.St Anthony’s Road Leeds LS11 8DT EnglandTel: +44 (0) 113 270 0461 0086

Additional resources:

http://knees.thehealthpartner.com/

http://www.ATTUNEevidence.com (U.S.)

www.provingthepromise.com (EMEA)

Australian Orthopedic Association National Joint Replacement Registry 2017 Annual Report

Extracted from Table KT7 Cumulative Percent Revision of Cemented Primary Total Knee Replacement by Prosthesis Combination

AOANJRR | 2017 ANNUAL REPORT

192 aoa.org.au Data Per iod 1 September 1999 – 31 December 2016

PROSTHESIS TYPES

There have been 516 femoral and tibial prosthesis combinations used in primary total knee replacement reported to the Registry. In 2016, 119 femoral and tibial combinations were used. This is eight less than in 2015. The cumulative percent revision of the 144 combinations with more than 400 procedures per combination are listed in Tables KT7 to KT9. Although the listed combinations are a small proportion of all possible combinations, they represent 96.4% of all primary total knee replacement. The ‘Other’ group is the combined outcome of the remaining 372 prosthesis combinations with less than 400 procedures reported per combination. There are 63 cemented femoral and tibial prosthesis combinations with more than 400 procedures. Of those with a 16 year cumulative percent revision, the Nexgen CR/Nexgen is the

lowest at 5.1% (Table KT7). There are 39 cementless femoral and tibial prosthesis combinations with more than 400 procedures. Of those with a 16 year cumulative percent revision, the Nexgen CR/Nexgen is the lowest at 4.4% (Table KT8).

There are 42 combinations of primary total knee replacement using hybrid fixation and with more than 400 procedures. The PFC Sigma CR/PFC Sigma has the lowest 16 year cumulative percent revision (4.8%) (Table KT9).

Table KT7 Cumulative Percent Revision of Cemented Primary Total Knee Replacement by Prosthesis Combination

Femoral Component

Tibial Component

N Revised

N Total 1 Yr 3 Yrs 5 Yrs 10 Yrs 15 Yrs 16 Yrs

ACS ACS Mobile 12 533 1.0 (0.4, 2.4) 1.9 (0.9, 3.9) AGC AGC 195 3497 0.5 (0.3, 0.9) 2.5 (2.0, 3.0) 3.6 (3.0, 4.3) 5.6 (4.8, 6.5) 8.8 (7.4, 10.4) 9.6 (7.6, 12.1) Active Knee Active Knee 48 1698 0.9 (0.5, 1.5) 2.4 (1.7, 3.4) 3.7 (2.7, 5.0) 4.8 (3.4, 6.6) Advance Advance II 56 918 1.5 (0.9, 2.6) 4.2 (3.1, 5.7) 4.8 (3.6, 6.4) 7.1 (5.4, 9.4) Apex Knee CR Apex Knee 3 1016 0.1 (0.0, 0.7) 0.7 (0.2, 2.2) Apex Knee PS Apex Knee 25 1953 0.7 (0.4, 1.2) 3.4 (1.9, 5.9) Attune CR Attune 49 5691 0.6 (0.4, 0.9) 2.1 (1.4, 3.1) Attune PS Attune 18 2693 0.4 (0.2, 0.8) 1.1 (0.6, 1.9) BalanSys BalanSys 27 1636 0.3 (0.1, 0.7) 1.6 (1.0, 2.5) 2.1 (1.3, 3.2) 4.2 (2.5, 7.0) Columbus Columbus 8 403 0.8 (0.3, 2.5) 2.5 (1.2, 5.4) 2.5 (1.2, 5.4) Duracon Duracon* 453 8968 1.0 (0.8, 1.2) 2.4 (2.1, 2.8) 3.3 (2.9, 3.7) 4.9 (4.4, 5.4) 7.0 (6.3, 7.9) 7.2 (6.4, 8.2) E.Motion E.Motion 23 519 2.0 (1.1, 3.7) 4.9 (3.2, 7.4) 5.4 (3.6, 8.1) Evolis Evolis 14 797 0.3 (0.1, 1.1) 1.0 (0.5, 2.1) 1.6 (0.9, 3.0) Evolution Evolution 32 3107 0.7 (0.4, 1.2) 2.3 (1.5, 3.5) GMK Primary GMK Primary 17 587 1.1 (0.5, 2.3) 2.8 (1.7, 4.7) 5.1 (2.6, 9.8) GMK Sphere Primary GMK Primary 49 3417 1.2 (0.8, 1.7) 2.7 (2.0, 3.7)

Genesis II CR Genesis II 466 13669 0.9 (0.8, 1.1) 2.4 (2.1, 2.7) 3.1 (2.8, 3.4) 4.3 (3.9, 4.7) 5.6 (4.9, 6.5) 6.0 (5.0, 7.1) Genesis II CR Profix Mobile* 35 490 1.7 (0.8, 3.3) 3.4 (2.1, 5.4) 5.4 (3.7, 8.0) 9.0 (6.3, 12.9) Genesis II Oxinium CR Genesis II 347 7488 1.0 (0.8, 1.3) 2.8 (2.4, 3.2) 3.7 (3.2, 4.2) 6.1 (5.5, 6.9) 10.9 (8.3, 14.2)

Genesis II Oxinium PS Genesis II 785 15823 1.5 (1.3, 1.7) 3.8 (3.5, 4.1) 5.2 (4.8, 5.6) 7.5 (6.9, 8.1)

Genesis II PS Genesis II 571 15816 1.2 (1.1, 1.4) 2.8 (2.6, 3.1) 3.7 (3.4, 4.0) 5.0 (4.5, 5.5) 6.2 (5.2, 7.3) Journey Oxinium Journey* 245 3032 1.4 (1.0, 1.9) 4.6 (3.9, 5.4) 6.4 (5.6, 7.4) 10.9 (9.4, 12.7)

Kinemax Plus Kinemax Plus* 111 1826 0.9 (0.6, 1.5) 2.4 (1.8, 3.3) 3.1 (2.4, 4.0) 4.6 (3.7, 5.7) 8.5 (6.9, 10.4) 9.3 (7.2, 12.0) LCS CR LCS 299 3939 1.0 (0.7, 1.4) 3.8 (3.2, 4.4) 5.0 (4.4, 5.8) 7.2 (6.4, 8.1) 9.1 (8.1, 10.2) 9.4 (8.2, 10.8)

516 different femoral and tibial prosthesis combinations have been reported to the Registry. Outcomes at 16 years are being

reported for the first time.



PROSTHESIS TYPES

There have been 516 femoral and tibial prosthesis combinations used in primary total knee replacement reported to the Registry. In 2016, 119 femoral and tibial combinations were used. This is eight less than in 2015. The cumulative percent revision of the 144 combinations with more than 400 procedures per combination are listed in Tables KT7 to KT9. Although the listed combinations are a small proportion of all possible combinations, they represent 96.4% of all primary total knee replacement. The ‘Other’ group is the combined outcome of the remaining 372 prosthesis combinations with less than 400 procedures reported per combination. There are 63 cemented femoral and tibial prosthesis combinations with more than 400 procedures. Of those with a 16 year cumulative percent revision, the Nexgen CR/Nexgen is the

lowest at 5.1% (Table KT7). There are 39 cementless femoral and tibial prosthesis combinations with more than 400 procedures. Of those with a 16 year cumulative percent revision, the Nexgen CR/Nexgen is the lowest at 4.4% (Table KT8).

There are 42 combinations of primary total knee replacement using hybrid fixation and with more than 400 procedures. The PFC Sigma CR/PFC Sigma has the lowest 16 year cumulative percent revision (4.8%) (Table KT9).

Table KT7 Cumulative Percent Revision of Cemented Primary Total Knee Replacement by Prosthesis Combination

Femoral Component

Tibial Component

N Revised


ACS ACS Mobile 12 533 1.0 (0.4, 2.4) 1.9 (0.9, 3.9) AGC AGC 195 3497 0.5 (0.3, 0.9) 2.5 (2.0, 3.0) 3.6 (3.0, 4.3) 5.6 (4.8, 6.5) 8.8 (7.4, 10.4) 9.6 (7.6, 12.1) Active Knee Active Knee 48 1698 0.9 (0.5, 1.5) 2.4 (1.7, 3.4) 3.7 (2.7, 5.0) 4.8 (3.4, 6.6) Advance Advance II 56 918 1.5 (0.9, 2.6) 4.2 (3.1, 5.7) 4.8 (3.6, 6.4) 7.1 (5.4, 9.4) Apex Knee CR Apex Knee 3 1016 0.1 (0.0, 0.7) 0.7 (0.2, 2.2) Apex Knee PS Apex Knee 25 1953 0.7 (0.4, 1.2) 3.4 (1.9, 5.9) Attune CR Attune 49 5691 0.6 (0.4, 0.9) 2.1 (1.4, 3.1) Attune PS Attune 18 2693 0.4 (0.2, 0.8) 1.1 (0.6, 1.9) BalanSys BalanSys 27 1636 0.3 (0.1, 0.7) 1.6 (1.0, 2.5) 2.1 (1.3, 3.2) 4.2 (2.5, 7.0) Columbus Columbus 8 403 0.8 (0.3, 2.5) 2.5 (1.2, 5.4) 2.5 (1.2, 5.4) Duracon Duracon* 453 8968 1.0 (0.8, 1.2) 2.4 (2.1, 2.8) 3.3 (2.9, 3.7) 4.9 (4.4, 5.4) 7.0 (6.3, 7.9) 7.2 (6.4, 8.2) E.Motion E.Motion 23 519 2.0 (1.1, 3.7) 4.9 (3.2, 7.4) 5.4 (3.6, 8.1) Evolis Evolis 14 797 0.3 (0.1, 1.1) 1.0 (0.5, 2.1) 1.6 (0.9, 3.0) Evolution Evolution 32 3107 0.7 (0.4, 1.2) 2.3 (1.5, 3.5) GMK Primary GMK Primary 17 587 1.1 (0.5, 2.3) 2.8 (1.7, 4.7) 5.1 (2.6, 9.8) GMK Sphere Primary GMK Primary 49 3417 1.2 (0.8, 1.7) 2.7 (2.0, 3.7)

Genesis II CR Genesis II 466 13669 0.9 (0.8, 1.1) 2.4 (2.1, 2.7) 3.1 (2.8, 3.4) 4.3 (3.9, 4.7) 5.6 (4.9, 6.5) 6.0 (5.0, 7.1) Genesis II CR Profix Mobile* 35 490 1.7 (0.8, 3.3) 3.4 (2.1, 5.4) 5.4 (3.7, 8.0) 9.0 (6.3, 12.9) Genesis II Oxinium CR Genesis II 347 7488 1.0 (0.8, 1.3) 2.8 (2.4, 3.2) 3.7 (3.2, 4.2) 6.1 (5.5, 6.9) 10.9 (8.3, 14.2)

Genesis II Oxinium PS Genesis II 785 15823 1.5 (1.3, 1.7) 3.8 (3.5, 4.1) 5.2 (4.8, 5.6) 7.5 (6.9, 8.1)

Genesis II PS Genesis II 571 15816 1.2 (1.1, 1.4) 2.8 (2.6, 3.1) 3.7 (3.4, 4.0) 5.0 (4.5, 5.5) 6.2 (5.2, 7.3) Journey Oxinium Journey* 245 3032 1.4 (1.0, 1.9) 4.6 (3.9, 5.4) 6.4 (5.6, 7.4) 10.9 (9.4, 12.7)

Kinemax Plus Kinemax Plus* 111 1826 0.9 (0.6, 1.5) 2.4 (1.8, 3.3) 3.1 (2.4, 4.0) 4.6 (3.7, 5.7) 8.5 (6.9, 10.4) 9.3 (7.2, 12.0) LCS CR LCS 299 3939 1.0 (0.7, 1.4) 3.8 (3.2, 4.4) 5.0 (4.4, 5.8) 7.2 (6.4, 8.1) 9.1 (8.1, 10.2) 9.4 (8.2, 10.8)

516 different femoral and tibial prosthesis combinations have been reported to the Registry. Outcomes at 16 years are being

reported for the first time. AOANJRR | 2017 ANNUAL REPORT

aoa.org.au 213Data Per iod 1 September 1999 – 31 December 2016

Fixation

The effect of fixation varies depending on implant stability. With a minimally stabilised prosthesis, there is no difference between cemented and hybrid fixation and both have a lower rate of revision compared to cementless fixation (Table KT22 and Figure KT24). When a posterior stabilised knee is used, cemented fixation has a lower rate of revision compared to hybrid fixation and when compared to cementless fixation within the first 1.5 years. Hybrid fixation has a higher rate of revision compared to both cemented and cementless fixation (Table KT23 and Figure KT25).

When a medial pivot prosthesis is used there is a similar outcome to minimally stabilised prostheses with respect to fixation. There is no difference between cemented and hybrid fixation and both have a lower rate of revision compared to cementless fixation (Table KT24 and Figure KT26).

Table KT22 Cumulative Percent Revision of Minimally Stabilised Primary Total Knee Replacement by Fixation (Primary

Diagnosis OA)

Fixation N Revised


Cemented 4712 157680 0.8 (0.8, 0.9) 2.2 (2.1, 2.3) 2.9 (2.9, 3.0) 4.5 (4.3, 4.6) 6.5 (6.2, 6.9) 6.9 (6.5, 7.3) Cementless 4795 102625 1.2 (1.1, 1.2) 3.2 (3.0, 3.3) 4.2 (4.1, 4.4) 6.1 (5.9, 6.3) 8.5 (8.1, 8.9) 9.6 (8.9, 10.3) Hybrid 3804 118721 0.8 (0.8, 0.9) 2.3 (2.2, 2.4) 3.1 (3.0, 3.2) 4.6 (4.4, 4.7) 6.4 (6.1, 6.7) 7.0 (6.4, 7.6) TOTAL 13311 379026

Note: Excluding cementless Genesis Oxinium and Profix Oxinium femoral prostheses Figure KT24 Cumulative Percent Revision of Minimally Stabilised Primary Total Knee Replacement by Fixation (Primary

Diagnosis OA)

Number at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 10 Yrs 15 Yrs 16 Yrs Cemented 157680 137324 102690 75175 27902 2835 658 Cementless 102625 95177 78385 60395 22089 1754 451 Hybrid 118721 106395 81421 59789 23799 2381 546

Cum

ulat

ive

Perc

ent R

evisi

on

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

22%

24%

Years Since Primary Procedure0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Cementless vs CementedEntire Period: HR=1.26 (1.21, 1.32),p<0.001

Hybrid vs CementedEntire Period: HR=0.99 (0.95, 1.04),p=0.775

Cementless vs HybridEntire Period: HR=1.27 (1.22, 1.33),p<0.001

HR - adjusted for age and genderCementedCementlessHybrid

Cementing the tibial component gives the best outcome for minimally stabilised and medial pivot prostheses. Cementing both tibial and femoral components gives the

best outcome for posterior stabilised prostheses.



Table KT23 Cumulative Percent Revision of Posterior Stabilised Primary Total Knee Replacement by Fixation (Primary Diagnosis OA)

Fixation N Revised


Cemented 4774 124375 1.1 (1.1, 1.2) 2.9 (2.8, 3.0) 3.9 (3.8, 4.1) 5.9 (5.8, 6.1) 7.8 (7.3, 8.3) 8.0 (7.3, 8.8) Cementless 337 6947 1.9 (1.6, 2.2) 4.0 (3.5, 4.5) 5.0 (4.5, 5.6) 6.3 (5.6, 7.1) Hybrid 675 11458 1.6 (1.4, 1.8) 4.2 (3.8, 4.6) 5.5 (5.1, 6.0) 7.3 (6.7, 7.9) 10.3 (9.0, 11.8) 10.9 (9.3, 12.8) TOTAL 5786 142780

Figure KT25 Cumulative Percent Revision of Posterior Stabilised Primary Total Knee Replacement by Fixation (Primary Diagnosis

OA)

Number at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 10 Yrs 15 Yrs 16 Yrs Cemented 124375 110276 83217 59991 15594 689 140 Cementless 6947 6351 5132 3930 769 12 2 Hybrid 11458 10570 8814 7016 2276 174 54

Cum

ulat

ive

Perc

ent R

evisi

on

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

22%

24%

Years Since Primary Procedure0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Cementless vs Cemented0 - 1.5Yr: HR=1.36 (1.17, 1.59),p<0.001

1.5Yr+: HR=0.89 (0.76, 1.05),p=0.163

Hybrid vs CementedEntire Period: HR=1.28 (1.18, 1.39),p<0.001

Hybrid vs CementlessEntire Period: HR=1.20 (1.05, 1.36),p=0.007

HR - adjusted for age and genderCementedCementlessHybrid

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