Prosthetic Foot Task Force

Report

Tom DiBello, COJonathan Naft, CPO

Mitchell Dobson, CPO

Project Introduction• SADMERC asked for AOPA’s input• AOPA BOD

– Coding and reimbursement committee • Prosthetic foot sub committee

• Members of the subcommittee include– Tom DiBello CO Chairman– Jonathan Naft CPO– Mitchell Dobson CPO– Al Kritter CPO– Joe McTernan AOPA Staff– Kathy Dodson AOPA Staff

Project Introduction• Goal of the project was to develop a set of

coding guidelines that would be used to differentiate prosthetic feet

• These guidelines would be defined through a cooperative effort of all of the current prosthetic foot manufacturers

• The first meeting was convened in July of 2007 in Alexandria Virginia

Project Introduction• The intention of the project was to develop

guidelines that could be used to determine whether the mechanical characteristics of a particular foot met the criteria described by the wording of a particular code

• These guidelines are not intended to correlate or describe the functional characteristics of the foot but rather the mechanical attributes of the foot

Project Introduction• Once these guidelines were established they would

permit the SADMERC, now the PDAC to classify feet into a new set of L Codes designed for this project

• Thirty-eight (38) months and eleven (11) meetings later the project is moving forward nicely

• The body of work is impressive by any standard• Hat’s off to the engineers that did the hard work of this

task force and to their superiors who appreciated the importance of the project and provided funding for it

Project Introduction• Through an unprecedented spirit of cooperation these

men and women spent countless hours working on this project

• This historic project is remarkable in its scope and unique in that it is neither government funded nor government mandated

• Thirteen (13) manufacturers were invited and ten (10) choose to become active members of the group

Manufacturer MembersIn alphabetical order:

– American• Michael Curtis

– BioQuest• Byron Claudino• Monty Moshier• Barry Townsend

– College Park Industries• Chris Johnson• Mike Leydet• Mike Link

Manufacturer Members– Endolite

• Alan Kercher• Saeed Zahedi

– Freedom• Roland Christensen• Kurt Collier• Danielle Taylor

– Kingsley• Jeff Kingsley

Manufacturer Members• Ohio Willow Wood

– Jim Colvin– Ben Elliott– Lonnie Nolt

• Ossur– Ian Fothergill– Grimur Jonsson– Dave McGill

• Otto Bock– Sarah McCarvill– Jim Remley– Greg Schneider

Manufacturer Members– Trulife

• David Adams• Chris DeHart• David Hensley• Jay Humphries

Review Of The Process• Several face to face meetings around the US

• Round robin preliminary testing

• Ongoing Email discussions

• Independent testing for inclusion in final report

SADMERC Proposed Coding (2007)

• Reduced Number of Codes– 4 “base” codes + 2 “addition” codes

• Effectively combines:– All dynamic response feet into a single code

• L5976 & L5981 – All ankle motion into single code

• Uni-axial (1 plane of motion) • Multiaxial-torsion units (3 planes of motion)

• Code vs. Functional Level Concerns

AOPA Proposed Coding - Goals• Similar Structure

– “Base” foot codes– “Addition” codes

• Functional or Attribute Descriptive Code Verbiage – No Brand Names

• Independently Testable and/or Verifiable Features

AOPA Proposed Coding - Goals• Accurately Represent Feet and/or other

Components on the Market• Allow for Future

Development/Classification• Maintain Functional Level Classification

Meeting with SADMERC (2008)

• Very promising• Liked direction• Eagerly anticipated “standards”• Encouraged further work

Meeting with PDAC (2009)

• Rejected proposed code set• Welcomed industry input for consistency• Still liked direction• Encouraged continued work

Context Based Code Descriptors

• Similar to a “definition”• Attempts to identify key terms (approx 10) within existing

code descriptor verbiage– Such as “pylon” or “axial torque absorbing”

• Further explains the term within the prosthetic foot arena (context)– “Rigid” for a prosthetic foot is different than “rigid” for

a spinal device– “Flexible” for a prosthetic foot is different than

“flexible” for a spinal device

How To Recommend an L-Code?

• Can now answer this question with regard to many prosthetic feet.

• Beyond our scope to answer what is the best product.

Re-Flex VSP

L5987

Freedom Renegade

What code?

OWW Fusion Bock Advantage

Test Procedures

•  Test Procedure: Dynamic Keel Test• Scope: This test procedure defines test

setup and method for evaluating a foot design for keel/toe dynamics. The results of this test define whether the keel is rigid, flexible or dynamic.

Test Procedures

Keel Type Displacement @ 1230N % Return

Rigid 25mm NA

Flexible ≥25mm <75%

Dynamic ≥25mm ≥75%

Compare Results to Keel Classification Criteria

Test ProceduresTest Procedure: Dynamic Heel Test

Scope: This test procedure defines test setup and method for evaluating a foot design for heel dynamics. The results of this test define whether the heel is dynamic or cushioned. This test is only done on foot designs that have qualified as “dynamic keel”.

Test Procedure

Heel Type Displacement @ 1230N % Return

Dynamic ≥13mm or pass % Return at heel

≥82% or pass displacement at heel

Cushioned Does not meet Displacement and/or % Return criteria for dynamic heel.

Compare Results to Heel Classification Criteria

Test ProcedureSingle Axis Test -800 N Loading

Multiaxial

Plane(s)of Motion Saggital Saggital Coronal

Multiaxial: 8° α Dorsiflexion 1230N @ 200 N/s

8° α Plantarflexion 1230N @ 200 N/s Inversion

≥ Heel Contact ≥ Toe Contact ≥ 8°

Second Loading Fail < Heel Contact < Toe Contact < 8°

Test Order:• Saggital Dorsiflexion• If Pass then Saggital Plantarflexion• If Pass then Coronal Inversion• If Pass then Foot Complies with Multiaxial

Axial Torque

Overall Angular Range

Qualifies for Axial Torque

≥16° yes

<16° no

Scope: This test procedure defines test setup and method for evaluating a foot and/or adapter designed for axial torque absorption.

Vertical Loading

Addition to lower extremity prosthesis, Vertical Loading FeatureThis feature is described as: “The ability of a prosthetic component to

compress along its longitudinal axis under axial load.”

Scope: This protocol describes:

• A test setup to evaluate vertical loading properties of a prosthetic foot.

• A test setup to evaluate vertical loading properties of an endoskeletal component..

Vertical Loading

Vertical LoadingResults

a) Prosthetic foot

Vertical Displacement < 10mm

Does Not Meet Vertical Loading

Vertical Displacement >= 10mm

Meets Vertical Loading

a) Endo component

Vertical Displacement < 6mm

Does Not Meet Vertical Loading

Vertical Displacement >= 6mm

Meets Vertical Loading

Dynamic Pylon Scope: This test procedure defines the test setup and method for all pylons without foot assembly and foot assemblies that have qualified as dynamic keel and dynamic heel. The maximum length from fixture to loadpoint that can be used for these tests is 250mm.

Pylons attaining a net displacement of >10mm qualify for the code.

Horizontal DisplacementTest Procedure: Keel and Heel Horizontal Displacement Test

This test procedure defines test setup and method for evaluating a foot design for keel and heel horizontal displacement performance.

Horizontal

• The passing criterion for the horizontal toe keel motion is >= 25 mm.• The passing criterion for the horizontal heel motion is > = 5 mm.

Test Assignment:• L5970, L5971 requires demonstrating features

below the Keel and Heel threshold test.• L5972 requires demonstrating features above

the Keel threshold test for flexible keel.• L5974 requires demonstrating features above

the Single Axis Test threshold.

Test Assignment:• L5975 requires demonstrating features above the Single

Axis Test threshold as well as above the Keel threshold test.

• L5976 requires demonstrating features above the threshold of the Dynamic Keel test.

• L5978 requires demonstrating features above the threshold for the Multiaxial test

• L5979 requires demonstrating features above the threshold of the Dynamic Keel test and the Multiaxial test.

Test Assignment:• L5980 requires demonstrating features above

the threshold for the Dynamic Keel, Dynamic Heel, and Dynamic Pylon tests.

• L5981 requires demonstrating features above the threshold for the Dynamic Keel and Dynamic Heel tests as well as meeting AOPA’s interpretation of independent design criteria for the deflecting heel

Test Assignment:L5982 requires demonstrating features above the Axial Torque test.L5984 requires demonstrating features above the Axial Torque testL5985 requires demonstrating features above the threshold for the Dynamic Pylon test.L5986 requires demonstrating features above the threshold for the Multiaxial test.

Test Assignment• L5987 requires demonstrating features above the

threshold for the Dynamic Keel and Dynamic Heel tests along with the Vertical Loading test, or, demonstrating features above the threshold for the Dynamic Keel and Dynamic Heel tests along with the Horizontal Displacement test

• L5988 requires demonstrating features above the threshold of the Vertical Loading test.

AmericanDuroFlex L5981

BioQuestPerfect Stride X3 L5987

BockOB 1S49 SACH L5971OB 1H38 Single Axis Foot L5974OB 1A30 Greissinger Plus L5972OB 1D10 Dynamic Foot L5976OB 1D35 Dynamic Motion L5981,L5986OB 1C20 ProSymes L5981OB 1E57 LoRider L5981OB 1E44 Journey L5981OB 1C31 Trias Plus L5981,L5986OB 1E50 Advantage DP2 L5980OB 1C40 C-Walk L5981,L5986OB 1E56 Axtion L5981OB 1E58 AxtionDP L5980, L5986OB HarmonyP2 L5984,L5988

EndoliteElite VT L5987,L5986Elite2 L5987,L5986Muliflex L5986Dynamic Response 2 L5979Navigator L5972,L5986Echelon L5981,L5986,L5968,L5999Esprit L5981Senior L5972Stellar L5972Epirus L5981,L5986TT Pro L5988,L5984

FreedomRenegade (RS1) L5987LP Renegade L5987Silhouette (RS4) L5980,L5986LP Silhouette L5980,L5986Senator (VS1) L5976Renegade MX L5987,L5986Sierra (FS1) L5986,L5981Pacifica (FS2) L5981Highlander (FS3) L5981,L5986Renegade LP MX L5987,L5986

OssurElation L5976,L5990LP Veriflex L5981Mod III L5980VSP L5987Sure Flex L5976Ceterus L5987,L5984Talux L5987,L5986

OWWCC2 L5976CCHP L5976DuraLite L5980Fusion L5987, L5986Impulse L5976Magnum L5976SACH L5971Single Axis L5974Trailblazer L5981

TrulifeCadence L5980,L5986Catalyst L5987,L5986Seattle Lightfoot L5976

The Future

• Where do we go from here?

Thank You!

• Jonathan Naft, CPO• Mitch Dobson, CPO• Tom DiBello, CO