James A. D’Antonio, M.D. ICJR 1/29/2010 James A. D’Antonio, M.D My disclosures: Stryker...
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Transcript of James A. D’Antonio, M.D. ICJR 1/29/2010 James A. D’Antonio, M.D My disclosures: Stryker...
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
• 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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
• 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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
All ceramic = 96.8%All ceramic = 96.8%Poly control = 91.3%Poly control = 91.3%
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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)
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
Ceramic Concerns
FractureFracture SqueakingSqueaking
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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)
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
Now 10 yrs p/o
Cycles 3000mi/yrSnow skier
Hockey playerAsymptomatic
no lysis
38 yr old male
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
45 yr old MD’s wife5’ 3” 120lbsMarathon runner
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
Ceramic / C32mm
Now 8yrs p/o 15-20miles/wkand 5-10K’s
Asymptomaticno Lysis
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
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
James A. D’Antonio, M.D.James A. D’Antonio, M.D.ICJR 1/29/2010
My indication for C/C bearings
Young and active The high energy athletic
patient