International Consortium of Orthopaedic(ICOR) Registries Implant LibraryMDEpiNet February 24, 2015

Liz Paxton, Director, National Implant Registries and co-lead, ICOR Coordinating CenterArt Sedrakyan, MD, Co-lead, ICOR Coordinating CenterSteve Graves, MD, DPhilMaria Inacio, PhD, Epidemiologist

Presenter: Rebecca Love, Senior ConsultantNATIONAL IMPLANT REGISTRIES

American Joint Replacement Registry Australian Orthopaedic Assoc. RegistryAustrian Arthroplasty Register California Joint Replacement RegistryCanadian Joint Replacement Registry England & Wales National Joint RegistryHealthEast Joint Registry Hip and Knee Registry of the NetherlandsHospital for Special Surgery Italian Register of Orthopaedic Implants

Kaiser Permanente Massachusetts General HospitalMayo Clinic New England Baptist Hospital RegistryNew Zealand Joint Register Norwegian Arthroplasty RegisterOrthoCarolina Portuguese Arthroplasty RegisterRush University Med. Ctr. Joint Registry Slovakian Arthroplasty Register

ScFCOT THA Registry Swedish Hip and Knee RegistersScottish Arthroplasty Project UMass FORCE RegistryVirginia State Registry Western Slope Study Group

>3,000,000 Patients Worldwide

ICOR Global Standardization Database

Develop global, standardized classification system of hip and knee implantable devices based on their clinical attributes and characteristics to advance the implementation of UDI and FDA postmarket surveillance

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ICOR Global Standardization Database

Each existing registry develops and maintains own clinical attributes reference database: No standardization Standardization of international registries implant

reference databases and clinical attributes with linkage to UDI based on catalog number

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Complexity of Implant Evaluation Historically:

– Implants named after inventors (Charnley’s low friction arthroplasty1 or the Freeman-Swanson knee2)

– Modifications led to more detailed information (e.g. Mark II, Mark III)– Eventually very detailed information became available in the prosthesis

descriptions DEPUY catalog number 960225, catalog description:

PFC* SIGMA PLI TIBIAL INSERT 20MM SIZE 2 64MM M/L 43MM A/P

Current issues with implant evaluation:– Non-uniformity of implant catalog numbers (within and between companies)

– Names changed without catalog numbers changing: Depuy’s PFC PFC-Sigma Sigma

– Implant attribute categorization

Complexity of Implant Evaluation

If based solely on implant catalog numbers, at KP for knees there are: 10833 inserts* (2500 femoral/trays/patella) *340 cement =

~9,000,000,000 combinations To be meaningful, groups of implants with similar

attributes are necessary for studying/evaluating implants

Optetrak PS (Exactech) -125 different parts

StrykerScorpio PS

87 different parts

Zimmer NexGen CR301 different parts

Zimmer NexGen LCCK(constrained) – 194 different

parts

Each part will have a different number assigned by company

Classification Challenges: Tibial Inserts

Permutations of NexGen CR insert- 13 “footprints” (i.e. width and length)- 5 thicknesses: 10, 12, 14, 17, 20mm- With & without inflection (2 options)- With cross-linked poly (2 options)

13 footprints x 5 sizes x 2 degrees x 2 polys = 260 unique catalog #s for this variation

19,354 tibial inserts for all manufacturers and designs.

Each has a unique catalog # - link to UDI

Millions of possible combinations based on catalog #/UDI

Implant Clinical Classification: Important?

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Approach to Implant Classification

Registries obtain company catalogs yearly – Catalogs usually contain alphanumeric product identifications and

descriptions of implants e.g.: 962023 PFC SIGMARP CVTBIN S2.5 15.0

Programmers build comprehensive database with assembled listing

– Implant name, component type, sizes

Surgeons identify important attributes and classification system using published literature and reports/alerts on specific attributes/implant features

Approach to Implant Classification

Quality control/logic checks– Data rules applied (combinations, exceptions, ranges, etc)– Implant features according to the classification are compared

against other registry information If procedure was reported as a UKA are the components uni? If cancer diagnosis is reported have cancer-specific prostheses been

used? If procedure reported was a hip resurface are stems used?

Comparison of final classification/harmonization with other registries for each feature

ICOR Catalog Framework: Knees

Component Identification

Femoral Component(Unicompartmental,Trochlea, Total)

Tibial Component

Baseplate(Unicompartmental, Total)

Knee Insert(Unicompartmental, Total)

Non-Modular (Monoblock)(Unicompartmental, Total)

Patella

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Insert

Material

Conventional Polyethylene

Highly-CrosslinkedPolyethylene

Vitamin E Infused Highly-Crosslinked Polyethylene

Thickness

XXXmm x XXXmm

Size

XXmm or S/M/L

Stability

Cruciate Retaining

Posterior Stabilized

Constrained/Hinged

Mobility

Fixed

Rotating

Sliding

Total Knee Implants: Insert

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Complexity of Implant Evaluation: Combinations Insert dictates stability

– E.g. CR femoral component + PS insert= PS stability

Insert dictates mobility– E.g. mobile rotating platform tibial tray + fixed insert= fixed

Bearing surface– Insert material + femoral material

Modularity dictates bearing surface– Monoblock implants have no inserts (mostly metal on conventional poly)

Fixation depends on implant combination– Hybrid/Cemented

ICOR Global Standardized Library: Knees MANUFACTURER CTLGNUMB JOINTTYPE COMPTYPE TRADENAME MODNAME CTLGDESC CEMENT_FIXATION BONE_FIXATION ROUGHNESS SIZE SIDE PMAT MMAT CMAT

COATING DIAM THICK LENGTH AP ML STABILITY MOBILITY MODULARITY SET REV OTHER LOCATION PMAN1

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Fixed Posterior Stabilized (PS) vs. Non-PS Total Knee Arthroplasty Survival Across Registries

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Linking Clinical Attributes to UDI

Patient safety – Are total hip MOM implants failing?– Does a specific knee have a high revision rate?

Post market surveillance of devices when new device features are added to market Comparative effectiveness research

– Which has a lower survival function: modular or monoblock MOM hips?

– Do fixed or mobile total knees have best performance over time?

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Future Recommendations

A global implant classification system enhances the UDI for comparative effectiveness research Linkage of UDI to implant libraries with clinical attributes of

devices translates the UDI into clinically meaningful information Physician societies need to be involved Ownership, funding and governance need to be established Catalog numbers are essential for transition to UDI and

historical implants

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