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Prosthetic Foot Task Force

Prosthetic Foot Task Force. Report. Tom DiBello, CO Jonathan 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

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Prosthetic Foot Task Force

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  1. Prosthetic Foot Task Force Report Tom DiBello, CO Jonathan Naft, CPO Mitchell Dobson, CPO

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Manufacturer Members In alphabetical order: • American • Michael Curtis • BioQuest • Byron Claudino • Monty Moshier • Barry Townsend • College Park Industries • Chris Johnson • Mike Leydet • Mike Link

  8. Manufacturer Members • Endolite • Alan Kercher • Saeed Zahedi • Freedom • Roland Christensen • Kurt Collier • Danielle Taylor • Kingsley • Jeff Kingsley

  9. 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

  10. Manufacturer Members • Trulife • David Adams • Chris DeHart • David Hensley • Jay Humphries

  11. 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

  12. 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

  13. 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

  14. AOPA Proposed Coding - Goals • Accurately Represent Feet and/or other Components on the Market • Allow for Future Development/Classification • Maintain Functional Level Classification

  15. Meeting with SADMERC (2008) • Very promising • Liked direction • Eagerly anticipated “standards” • Encouraged further work

  16. Meeting with PDAC (2009) Rejected proposed code set Welcomed industry input for consistency Still liked direction Encouraged continued work

  17. 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

  18. 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.

  19. Re-Flex VSPL5987

  20. Freedom RenegadeWhat code?

  21. OWW Fusion Bock Advantage

  22. 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.

  23. Test Procedures Compare Results to Keel Classification Criteria

  24. Test Procedures

  25. Test Procedure Compare Results to Heel Classification Criteria

  26. Test ProcedureSingle Axis Test -800 N Loading

  27. Multiaxial

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

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

  30. Vertical Loading • Addition to lower extremity prosthesis, Vertical Loading Feature • This 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..

  31. Vertical Loading

  32. Vertical Loading

  33. 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 load point that can be used for these tests is 250mm.

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

  35. Horizontal Displacement Test 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.

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

  37. Test Assignment: • L5970, L5971 requires demonstrating features below the Keel and Heel threshold test. • L5972 requires demonstrating featuresabove the Keel threshold test for flexible keel. • L5974 requires demonstrating features above the Single Axis Test threshold.

  38. 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.

  39. 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

  40. Test Assignment: L5982 requires demonstrating features above the Axial Torque test. L5984 requires demonstrating features above the Axial Torque test L5985 requires demonstrating features above the threshold for the Dynamic Pylon test. L5986 requires demonstrating features above the threshold for the Multiaxial test.

  41. 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.

  42. The Future • Where do we go from here?

  43. Thank You! • Jonathan Naft, CPO • Mitch Dobson, CPO • Tom DiBello, CO

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