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.

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Presentation transcript:

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 Total Hip Replacement

James A. D’Antonio, M.D. ICJR 1/29/ yr female Now 25yrs p/o

James A. D’Antonio, M.D. ICJR 1/29/2010 Extreme hardness / Scratch resistant Extreme hardness / Scratch resistant Hydrophilic = improved lubrication Hydrophilic = improved lubrication No metal ion release No metal ion release Debri – far less volume Debri – far less volume Superior wear resistance Superior wear resistance Major Advantages

James A. D’Antonio, M.D. ICJR 1/29/ st 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 16 centers

James A. D’Antonio, M.D. ICJR 1/29/ Surgeons - Benjamin Bierbaum, M.D. - William Capello, M.D. - James D’Antonio, M.D. - James Roberson, M.D. - Robert Zann, M.D. 5 Surgeons - Benjamin Bierbaum, M.D. - William Capello, M.D. - James D’Antonio, M.D. - James Roberson, M.D. - Robert Zann, M.D. # hips = 475 (380 C/C) # hips = 475 (380 C/C) US IDE Ceramic Study Design: 12 th Year CORR July, 2005 CORR December, 2005 control

James A. D’Antonio, M.D. ICJR 1/29/ st Stage Patients – 8-12 yrs 1 st Stage Patients – 8-12 yrs System I 99 hips System II 95 hips System III 95 hips Ti Sleeve – 7-10 yrs System III 95 hips 2 nd Stage 186 hips

James A. D’Antonio, M.D. ICJR 1/29/2010 DemographicsMale% Mean Age (yrs.)Diagnosis Mean Wt. (lbs.)F/U(yrs.)System I c/c 66%53OA88% System II c/c 67%55OA82% System III poly 60%54OA82% nd Stage c/c69%51.882% No Difference

James A. D’Antonio, M.D. ICJR 1/29/2010 Clinical Data 7 to 12 yearsPainNone/SlLimp None/ Mild Mean HHS Harris % G/E Pt.Sat.System I c/c 96%99%96.996%99% System II c/c 95%99%97.094%99% System III poly III poly92%96%96.896%99% 2nd Stage c/c92%98%96.395%99% No Difference

James A. D’Antonio, M.D. ICJR 1/29/2010 All ceramic = 96.8% Poly control = 91.3%

James A. D’Antonio, M.D. ICJR 1/29/ % Survivorship End Point Bearing Surface Failure  380 ceramic cases = 2 revisions = 0.5% - 1 fracture at 6yrs - 1 chip at 9yrs  No revisions for lysis or wear in the 3 Al / Al patients groups (system 1, 2, and Trident)

James A. D’Antonio, M.D. ICJR 1/29/2010  All implants boney stable  Osteolysis Metal /Poly (control) = 19.4% Ceramic/Ceramic = 1.7% Radiographic (8 – 12yrs year) P < yrs4yrs

James A. D’Antonio, M.D. ICJR 1/29/ yr old male 6ft. 3in. 235lbs Tight end UColo Now 12 yrs p/o In gym 4-5days Asymptomatic 6 of 380 ceramic cases - evidence of lysis

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

James A. D’Antonio, M.D. ICJR 1/29/2010 Ceramic Concerns  Fracture  Squeaking

James A. D’Antonio, M.D. ICJR 1/29/2010 Realistic Fracture Risk 2008  If Major technical errors are avoided (head/socket mismatch, failure to seat implant, autoclaving, interposed debri etc.) - 1 in 1,500 to 1 in 5,000 head > socket 28mm > 32+mm - 1 in 1,500 to 1 in 5,000 head > socket 28mm > 32+mm

James A. D’Antonio, M.D. ICJR 1/29/2010 Poster Presented at 2009 AAOS, Paper submitted for publication Ceramic on Ceramic hip outcome at a 5-10 year interval Arthroplasty: Ceramic on Ceramic hip outcome at a 5-10 year interval Arthroplasty: Has it lived up to its expectations? J. Wesley Mesko, MD, James A. D’Antonio MD, William N. Capello MD, Marybeth Naughton BS

James A. D’Antonio, M.D. ICJR 1/29/2010 Patients (930 C/C hips) in IDE ABC/Trident studies plus continued access patients follow/up required by FDA follow/up required by FDA Data gathered included: DislocationsInfections Aseptic femoral loosening Aseptic acetabular loosening Noise (describe) Other (describe)

James A. D’Antonio, M.D. ICJR 1/29/2010 C/C Patients (930 hips)- Omnifit® HA stem and one of three acetabular components C/C Patients (930 hips)- Omnifit® HA stem and one of three acetabular components Ti Alloy CP Ti

James A. D’Antonio, M.D. ICJR 1/29/2010 ABC® N=325 Trident ® N=605 TotalN=930 Squeaking5(1.5%)4(0.7%)9(0.97%) Clicking2(0.6%)8(1.3%)10(1.1%) Popping02(0.3%)2(0.2%) Creaking02(1pt)(0.3%)2(0,2%) Noise

James A. D’Antonio, M.D. ICJR 1/29/2010 Capello Squeaking Scale 1- Occurs rarely, not reproducible 8 hips, 7 patients 2- Occasionally, reproducible 0 hips 3- Frequently, reproducible 1 hip (0.1%) (0.1%) 4- Occurs with every step/position change 0 hips JOA 23 #7 Suppl

James A. D’Antonio, M.D. ICJR 1/29/2010  At 12+ yrs experience with ceramic bearings mated with a TAlV alloy and a variety of cup designs squeaking has not been a problem

James A. D’Antonio, M.D. ICJR 1/29/2010 Now 10 yrs p/o Cycles 3000mi/yr Snow skier Hockey player Asymptomatic no lysis 38 yr old male

James A. D’Antonio, M.D. ICJR 1/29/ yr old MD’s wife 5’ 3” 120lbs Marathon runner

James A. D’Antonio, M.D. ICJR 1/29/2010 Ceramic / C 32mm Now 8yrs p/o 15-20miles/wk and 5-10K’s Asymptomatic no Lysis

James A. D’Antonio, M.D. ICJR 1/29/2010 Summary – Ceramic/Ceramic  Superior Wear  Rare (minor) lysis at 12yrs  Survivorship high – younger pts.  Fx risk low with good surg. tech.  Squeaking – rare and not an issue

James A. D’Antonio, M.D. ICJR 1/29/2010 My indication for C/C bearings Young and active The high energy athletic patient

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

James A. D’Antonio, M.D. ICJR 1/29/2010 My indication for C/C bearings Young and active – the high energy athlete Superior wear resistance

James A. D’Antonio, M.D. ICJR 1/29/2010 Bearing Surface Related Failures  ceramic (380 hips) = 5 = 1.3% - 1 liner fx at 6 yrs - 1 anterior chip at 9yrs - 3 recurrent dislo.  poly control (95hips) = 5 = 5.3% - 2 for osteolysis - 3 recurrent dislo.

James A. D’Antonio, M.D. ICJR 1/29/2010 Bearing Surface Related Failures  ceramic (380 hips) = 5 = 1.3% - 1 liner fx at 6 yrs - 1 anterior chip at 9yrs - 3 recurrent dislo.  poly control (95hips) = 5 = 5.3% - 2 for osteolysis - 3 recurrent dislo. 0.5% 2.1%

James A. D’Antonio, M.D. ICJR 1/29/2010 Squeaking Reports titanium-molybdenum-zirconium-iron TMZF and V- 40 taper TMZF and V- 40 taper - Restrepo (JOA 08) = 3% (had high version) - Keurentjes (CORR 08) = 20% (aimed for 0º version) - Jarrett (JBJS 09) = 10.7%

James A. D’Antonio, M.D. ICJR 1/29/2010 Squeaking Reports titanium-aluminum-vanadium  TAlV with C-taper - Lusty (JBJS) = 0.3% - Mesko (AAOS 09) = 0.97% in 930 consecutive cases ` - D’Antonio ( # 411) = 1.2% 5 pts. admit to a rare event 5 pts. admit to a rare event none can reproduce not an issue none can reproduce not an issue

James A. D’Antonio, M.D. ICJR 1/29/2010 Squeaking Report  Restrepo, Hozack (pending JBJS) same surgeon, same approach 152 TMZF with V40 = 18.4% (6 revised) 152 TAlV with C-taper = 2.6% 152 TAlV with C-taper = 2.6% (0 revised)

James A. D’Antonio, M.D. ICJR 1/29/2010 Noise – Vibration from Stem?  Ceramics resonate at 20,000hz above upper limit of human hearing  In - vivo range sq. hips is 400 to 7500hz  TMZF implants % lower MOE than TAlV TMZF = smaller AP dimension -  ’d flex V-40 taper geometry smaller than C-taper  Metallurgy and geometry play a significant part in incidence and severity of squeaking

James A. D’Antonio, M.D. ICJR 1/29/2010 Ceramics  Wide spread industrial use  30 + yrs - THA bearing world wide

James A. D’Antonio, M.D. ICJR 1/29/ nd Stage US IDE Study Ti Acetabular Component Sleeve Study period:10/ Study period:10/ ProspectiveProspective Control ABC lllControl ABC lll Multi-center trial 5 centersMulti-center trial 5 centers

James A. D’Antonio, M.D. ICJR 1/29/2010 Time Line – In Vivo Failures  50% within 12 months  70% within 24 months  83% within 36 months  28mm >> 32mm