James A. D’Antonio, M.D. ICJR 1/29/2010 James A. D’Antonio, M.D My disclosures: Stryker -Consultant -Royalties -Research Support Ceramic on Ceramic Bearings

James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010

James A. D’Antonio, M.DJames A. D’Antonio, M.D

My disclosures: Stryker -Consultant -Royalties

-Research Support

Ceramic on Ceramic Bearings Ceramic on Ceramic Bearings Total Hip ReplacementTotal Hip Replacement


• Extreme hardnessExtreme hardness / Scratch resistant / Scratch resistant

• Hydrophilic = Hydrophilic = improved lubricationimproved lubrication

• No metal ion releaseNo metal ion release

• Debri – far less volume Debri – far less volume

• Superior wear resistanceSuperior wear resistance

Major AdvantagesMajor Advantages


11stst US IDE Study US IDE Study

• Study period:10/96 -10/98Study period:10/96 -10/98• ProspectiveProspective• ControlledControlled• RandomizedRandomized• Multi-center trialMulti-center trial

512 hip cases 512 hip cases 16 centers16 centers


• 5 Surgeons 5 Surgeons - - Benjamin Bierbaum, M.D.Benjamin Bierbaum, M.D. - - William Capello, M.D.William Capello, M.D. - - James D’Antonio, M.D.James D’Antonio, M.D. - - James Roberson, M.D.James Roberson, M.D. - -

Robert Zann, M.D.Robert Zann, M.D.

• # hips = 475# hips = 475(380 C/C)(380 C/C)

US IDE Ceramic Study Design: 12US IDE Ceramic Study Design: 12thth Year Year

CORR July, 2005CORR July, 2005CORR December, 2005CORR December, 2005

control


11stst Stage Patients – 8-12 yrs Stage Patients – 8-12 yrs

System ISystem I99 hips99 hips

System IISystem II95 hips95 hips

System IIISystem III95 hips95 hips

Ti Sleeve – 7-10 yrs

System IIISystem III95 hips95 hips

2nd Stage 186 hips


Demographics

MaleMale

%%

Mean Mean AgeAge

(yrs.)(yrs.)DiagnosisDiagnosis

Mean Mean Wt.Wt.

(lbs.)(lbs.)

F/UF/U

(yrs.)(yrs.)

SystemSystem

I c/cI c/c66%66% 5353

OAOA

88% 88% 186186 8-128-12

SystemSystem

II c/cII c/c67%67% 5555

OAOA

82% 82% 191191 8-128-12

SystemSystem

III polyIII poly60%60% 5454

OAOA

82% 82% 188188 8-128-12

22ndnd Stage Stage

c/cc/c69%69% 51.851.8 82%82% 189189 7-107-10

No Difference

No Difference


Clinical Data 7 to 12 years

PainPain

None/SlNone/Sl

LimpLimp

None/None/MildMild

Mean Mean HHSHHS

Harris % Harris % G/EG/E

Pt.Pt.

Sat.Sat.

SystemSystemI c/cI c/c

96%96% 99%99% 96.996.9 96%96% 99%99%

System System II c/cII c/c

95%95% 99%99% 97.097.0 94%94% 99%99%

SystemSystem III polyIII poly

92%92% 96%96% 96.896.8 96%96% 99%99%

2nd Stage2nd Stage

c/cc/c92%92% 98%98% 96.396.3 95%95% 99%99%

No Difference

No Difference


All ceramic = 96.8%All ceramic = 96.8%Poly control = 91.3%Poly control = 91.3%


99.5% Survivorship End Point Bearing Surface Failure

380 ceramic cases = 2 revisions = 0.5%380 ceramic cases = 2 revisions = 0.5%- 1 fracture at 6yrs- 1 fracture at 6yrs- 1 chip at 9yrs- 1 chip at 9yrs

No revisions for lysis or wearNo revisions for lysis or wear in the in the 3 3 Al / Al patients groups Al / Al patients groups (system 1, 2, and Trident)(system 1, 2, and Trident)


All implants boney stableAll implants boney stable OsteolysisOsteolysis

Metal /Poly (control) = 19.4%Metal /Poly (control) = 19.4%Ceramic/Ceramic = 1.7%Ceramic/Ceramic = 1.7%

Radiographic (8 – 12yrs year)

P < .001P < .001

12yrs12yrs4yrs4yrs


60 yr old male60 yr old male6ft. 3in. 235lbs6ft. 3in. 235lbs

Tight end UColoTight end UColoNow 12 yrs p/oNow 12 yrs p/oIn gym 4-5daysIn gym 4-5daysAsymptomaticAsymptomatic

6 of 380 ceramic cases - evidence of lysis 6 of 380 ceramic cases - evidence of lysis


AP same patient


Ceramic Concerns

FractureFracture SqueakingSqueaking


Realistic Fracture Risk 2008

If Major technical errors are If Major technical errors are avoided avoided (head/socket(head/socket mismatch,mismatch, failure to seat implant, autoclaving, failure to seat implant, autoclaving, interposed debri etc.)interposed debri etc.)

- 1 in 1,500 to 1 in 5,000- 1 in 1,500 to 1 in 5,000 head > sockethead > socket

28mm > 32+mm28mm > 32+mm


Poster Presented at 2009 AAOS, Poster Presented at 2009 AAOS, Paper submitted for publicationPaper submitted for publication

Ceramic on Ceramic hip outcome Ceramic on Ceramic hip outcome at a 5-10 year interval Arthroplasty:at a 5-10 year interval Arthroplasty:

Has it lived up to its expectations?Has it lived up to its expectations?

J. Wesley Mesko, MD, James A. D’Antonio MD, J. Wesley Mesko, MD, James A. D’Antonio MD, William N. Capello MD, Marybeth Naughton BSWilliam N. Capello MD, Marybeth Naughton BS


Patients (930 C/C hips) in IDE ABC/Trident studies Patients (930 C/C hips) in IDE ABC/Trident studies plus continued access patients plus continued access patients

follow/up required by FDAfollow/up required by FDA

Data gathered included:Data gathered included:

DislocationsDislocationsInfectionsInfections

Aseptic femoral looseningAseptic femoral looseningAseptic acetabular looseningAseptic acetabular loosening

Noise (describe)Noise (describe)Other (describe)Other (describe)


C/C Patients (930 hips)- Omnifit® HA stem C/C Patients (930 hips)- Omnifit® HA stem and one of three acetabular componentsand one of three acetabular components

Ti AlloyTi Alloy

CP TiCP Ti


ABC® ABC® N=325N=325

TridentTrident® ®

N=605N=605

TotalTotal

N=930N=930

SqueakingSqueaking 55

(1.5%)(1.5%)

44

(0.7%)(0.7%)

99

(0.97%)(0.97%)

ClickingClicking 22

(0.6%)(0.6%)

88

(1.3%)(1.3%)

1010

(1.1%)(1.1%)

PoppingPopping 00 2 2

(0.3%)(0.3%)

2 2

(0.2%) (0.2%)

CreakingCreaking 00 2(1pt)2(1pt)

(0.3%)(0.3%)

22

(0,2%)(0,2%)

NoiseNoise


Capello Squeaking ScaleCapello Squeaking Scale

1- Occurs rarely, not 1- Occurs rarely, not reproduciblereproducible

8 hips, 7 8 hips, 7 patientspatients

2- Occasionally, 2- Occasionally, reproduciblereproducible

0 hips0 hips

3- Frequently, 3- Frequently, reproduciblereproducible

1 hip1 hip

(0.1%)(0.1%)

4- Occurs with 4- Occurs with every step/position every step/position changechange

0 hips0 hips

JOA 23 #7 Suppl-1 2008JOA 23 #7 Suppl-1 2008


At 12+ yrs experience with ceramic At 12+ yrs experience with ceramic bearings mated with a TAlV bearings mated with a TAlV

alloy alloy and a variety of cup and a variety of cup designs designs squeaking squeaking has not been a has not been a problemproblem


Now 10 yrs p/o

Cycles 3000mi/yrSnow skier

Hockey playerAsymptomatic

no lysis

38 yr old male


45 yr old MD’s wife5’ 3” 120lbsMarathon runner


Ceramic / C32mm

Now 8yrs p/o 15-20miles/wkand 5-10K’s

Asymptomaticno Lysis


Summary – Ceramic/Ceramic

Superior Wear Superior Wear Rare (minor) lysis at 12yrsRare (minor) lysis at 12yrs Survivorship high – younger pts.Survivorship high – younger pts. Fx risk low with good surg. tech.Fx risk low with good surg. tech. Squeaking – rare and not an issue Squeaking – rare and not an issue


My indication for C/C bearings

Young and active The high energy athletic

patient


THANK THANK YOUYOU

Documents

James A. D’Antonio, M.D. ICJR 1/29/2010 James A. D’Antonio, M.D My disclosures: Stryker -Consultant -Royalties -Research Support Ceramic on Ceramic Bearings