Derek Amanatullah, MD, UC Davis - California Orthopaedic ...

Comparison of Surgical Outcomes andImplant Wear between Ceramic-on-Ceramicand Ceramic-on-Polyethylene BearingSurfaces in Total Hip ArthroplastyDerek F. Amanatullah, M.D., Ph.D.Orthopaedic Research LaboratoryDepartment of Orthopaedic SurgeryUniversity of California at Davis

DisclosureFood and Drug AdministrationInvestigational Device Exemption (IDE)Reflection® Ceramic-Ceramic Hip System(IDE Number: G980027)Funding for data collection was provided by Smith and Nephewunder the FDA guidelines for an IDE. This secondary data analysiswas conducted without contract or direct funding from any sponsor.

Background• Wear Debris Stimulates Osteolysis• Ceramic-on-Ceramic Couplings- low linear wear rate- low rate of osteolysis- audible component related noise- ceramic implant fracture• A Linear Wear Rate

HypothesisCeramic-on-Polyethylene bearingsmay offer a low linear wear ratewhile avoiding the Ceramic-specific complicationsof Ceramic-on-Ceramic articulations

Randomization and AttritionReflection Ceramic-Ceramic Hip SystemBetween 1999 and 200114 Orthopaedic Surgeons, 9 InstitutionsFollow-up for over 5 yearsPatients = 312Hips = 357THA for osteoarthritis or rheumatoid arthritis21 to 80 years of age; Harris Hip Score (HHS) 60n196187183182176131125Patients were lost tofollow-up as a resultof missed appointments,death, and withdrawalfrom the studyn1611541471441379995

Statistically Random Patient CharacteristicsCeramic-on-CeramicCeramic-on-Polyethylenep-valuePatientsTotal Hip Arthroplasty (THA)Bilateral THA (%)Men (%)Mean Age (years) ± SDMean Height (cm) ± SDMean Weight (kg) ± SDMean BMI (kg/m 2 ) ± SDContralateral Hip Involvement (%)Joint Involvement Other than Hip (%)16619630 (15.3%)106 (63.9%)50.4 ± 12.8173.2 ± 10.186.9 ± 20.029.6 ± 12.464 (38.6%)47 (28.3%)14616115 (9.3%)84 (57.5%)54.7 ± 12.9172.3 ± 9.783.7 ± 18.528.0 ± 5.157 (39.0%)46 (31.5%)--0.0610.1520.003 *0.3570.1160.1331.0000.621Physical Activity Prior to SurgeryNone (%)Light (%)Moderate (%)Intense (%)14 (7.1%)123 (62.8%)54 (27.6%)5 (2.6%)5 (3.1%)111 (68.9%)38 (23.6%)6 (3.7%)0.245Operative Blood Loss (ml) ± SD527 ± 371510 ± 3960.822Operative Time (minutes) ± SD110 ± 52114 ± 640.534Hospital Stay (days) ± SD4.4 ± 2.04.4 ± 1.70.675

No Significant Change in Patient ReportedOutcome Scores at Any Time Interval*Patient Reported Outcome Score10090807060504030Preoperative 3 6 12 24 48 >60Ceramic-on-PolyethyleneCeramic-on-CeramicPostoperative (months)

Higher Radiographic Wear Rateswith Ceramic-on-Polyethylene BearingsLinear Wear RateVolumetric Wear Rate250150200125μm/year150100mm 3 /year100755050*25*0Ceramic-on-Polyethylene Ceramic-on-Ceramic0Ceramic-on-Polyethylene Ceramic-on-CeramicCeramic-on-PolyethyleneCeramic-on-CeramicLivermore, et al. (1990) JBJS 72: 518.Dumbleton, et al. (2002) J Arthroplasty 17:649.Yoo, et al. (2005) JBJS 87: 530.D’Antonio, et al. (2005) CORR 436: 164.

Head Size and Wear RateCeramic-on-Polyethylene(28 mm, 100%)Wear rate22 μm/year70 μm/year100 μm/year156 μm/yearHead Size22.225 mm32 mmVariable28 mmCeramic-on-Ceramic(28 mm, 31%, or 32 mm, 69%)2.1 μm/year4 μm/year6 μm/year16 μm/yearVariable28 mmVariableVariableKichner and Willert (1992) CORR 282: 86.Tanaka, et al. (2003) JBJS Br. 85: 655.Hernigou, et al. (2003) JBJS Br. 85: 504.Wroblewski , et al. (1996) JBJS Br. 78: 280.Livermore, et al. (1990) JBJS 72: 518.Walter (1992) CORR 282: 31.Jazrawi, et al. (1999) J Arthrplasty 14: 781.Clarke, et al. (2000) Proc. Inst. Mech. Engr. 214: 331.

Ceramic Fracture and Component Related NoiseAre Risks of Ceramic-on-Ceramic ArticulationsLiner FractureSciatic Nerve InjuryGreater Trochanter FractureDifficulty Implanting Cup or LinerHeterotopic Ossification (HO)DislocationTrochanteric BursitisComponent Related NoiseDeep Venous ThrombosisPulmonary EmbolusInfection, superficialInfection, deepImplant Fracture: linerImplant Fracture: headLeg Length DiscrepancySubluxation or SubsidenceComponent MigrationWear Debris or OsteolysisRevision SurgeryCeramic-on-Ceramic (%)(n = 196)2 (1.0%)1 (0.5%)1 (0.5%)2 (1.0%)59 (30.1%)10 (5.1%)8 (4.1%)6 (3.1%)3 (1.5%)2 (1.0%)6 (3.1%)1 (0.5%)2 (1.0%)1 (0.5%)2 (1.0%)3 (1.5%)4 (2.0%)1 (0.5%)11 (5.6%)Ceramic-on-Polyethylene (%)(n = 161)IntraoperativePostoperative0 (0.0%)0 (0.0%)1 (0.6%)2 (1.2%)41 (25.5%)9 (5.6%)5 (3.1%)0 (0.0%)2 (1.2%)1 (0.6%)3 (1.9%)2 (1.2%)0 (0.0%)0 (0.0%)1 (0.6%)2 (1.2%)2 (1.2%)1 (0.6%)3 (1.9%)p-value0.3010.5490.7970.7580.1970.6720.4220.026 *0.5920.5730.3570.9090.3010.5490.5730.5920.4390.7970.059Cumulative Fracture Risk 5 (2.6%)0 (0.00%)0.049 *

Conclusions• Prospective, multi-center, randomized clinical trail• No difference in patient reported outcome measures• The mean linear wear rate of ceramic-on-ceramic articulations isconsistent with protection from osteolysis• The mean linear wear rate of ceramic-on-polyethylene articulations isinconsistent with protection from osteolysis• Ceramic-on-ceramic specific complications-2.6%rate of ceramic implant fracture-3.1%rate of audible component related noiseThe use of ceramic-on-ceramic or ceramic-on-polyethylenebearing surfaces in THA remains a compromise between the longtermramifications of wear debris and short-term ceramic-specificcomplicationsDumbleton, et al. (2002) J Arthroplasty 17:649.Toni, et al. (2006) JBJS S4: 55.Park, et al. (2006) JBJS 88: 780.Willmann (2000) CORR 379: 22.Jazrawi, et al. (1999) J Arthrplasty 14: 781.

AcknowledgementsCo-AuthorsJoshua Landa, M.D.Eric J. Strauss, M.D.Gregg Jarit, M.D.Jonathan P. Garino, M.D.Norman E. Walter, M.D.Sunny Kim, Ph.D.Paul E. Di Cesare, M.D.Smith and NephewOther Participating SurgeonsScott Corpe, M.D.Michael Grecula, M.D.James Howe, M.D.Kristaps Keggi, M.D.Michael Lynch, M.D.Blake Ragsdale, M.D.David Randall, M.D.Thomas Russell, M.D.Richard Sanders, M.D.Sean Scully, M.D.Joseph Zuckerman, M.D.Thank you to the California Orthopaedic Associationfor recognizing this work!

Reasons of RevisionInitial TreatmentIntervalComponents RevisedReason for Revision3 MonthsLiner, HeadRecurrent Dislocations3 MonthsAll ComponentsInfection6 MonthsCup, Liner, HeadRecurrent Anterior Dislocations1 YearHead, StemStem SubsidenceCeramic-on-Ceramic(n = 11)1 Year2 YearsCup, Liner, HeadLiner, HeadRecurrent Anterior DislocationsAudible Component Related NoiseCeramic Head Fracture3 YearsCup, Liner, HeadCeramic Liner Fracture3 YearsHead, StemLoose Femoral Component4 YearsCup, Liner, HeadRecurrent Dislocations5 YearsCup, Liner, HeadCeramic Liner Fracture6 YearsHead, StemLoose Femoral ComponentCeramic-on-Polyethylene(n=3)BeforeDischarge3 MonthsLiner, HeadAll ComponentsInstability of the HipInfection5 YearsLiner, HeadRecurrent Dislocations