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Proxima




  Francesco Saverio Santori, Nicola Santori
         Orthopaedics & Traumatology
Hospital S. Pietro Fatebenefratelli - Rome - Italy
WHY CREATE A NEW HIP IMPLANT?

             THR survivorship
81% at 25 year follow-up (revision of any
component as endpoint)
                    Bury D et al JBJS 2002


88% at 30 year follow-up or to the time of death
(original prothesis intact)
                    Callaghan J et al JBJS 2004
WHY CREATE A NEW HIP IMPLANT?


CONVENTIONAL IMPLANTS GIVE VERY GOOD RESULT
AND THEY HAVE WIDE INCIDATIONS HOWEVER THEY
HAVE THE FOLLOWING PROBLEMS:

             1. STRESS SHIELDING
             2. THIGH PAIN
             3. SOFT TISSUE PAIN
             4. LOOSENING
STRESS SHIELDING




Proximal load transfer is never gauranteed with a
           traditional stemmed implant
DIAPHESEAL FIXATION




  stress shielding !!!!!
THIGH PAIN
DAMAGE TO TENDON INSERTION POINTS
LOOSENING
Bone ingrowth occurs only if the implant is very near to bone:
• 1 mm between implant and bone
  (2 mm with Ha)
Therefore it's very important to have as much bone contact as
possible, i.e. circumferential contact
CONSERVE BONE STOCK


               The next
               operation!



CONSERVATIVE
 PHILOSPHY
Conservative implants


CONSERVATION OF THE FEMORAL NECK




               ?
          RESURFACING
Hip resurfacing


Smith Petersen developed a CoCr
resurfacing head in the 1930s
Charnley used a resurfacing design in the
1960s
   •teflon-on-teflon bearing
   •very low friction
   •very high wear!!
Hip resurfacing

    • FEMORAL NECK FRACTURES – AN IMPORTANT
       COMPLICATION OF SURFACE HIP REPLACEMENT 
    • 3497 surface replacement hips of the Birmingham
      model.
    • 50 fractures of the femoral neck
    • (1.9%) in female patients
    • (1.0%) in male patients
    • … surgeon’s experience was thus without influence
A. J. Shimmin and D. Back, BSc : Femoral neck fractures following Birmingham hip
resurfacing. A NATIONAL REVIEW OF 50 CASES.
Journal of Bone and Joint Surgery - British Volume 2005; Vol 87-B: 463-464.
Hip resurfacing
Ø 37 femoral surface replacement (FSR)
Ø 24 failures (64.8%)




 Failure of femoral surface replacement for femoral head
 avascular necrosis.
 Squire M, Fehring TK, Odum S, Griffin WL, Bohannon Mason J. - J
 Arthroplasty 2005
Hip resurfacing
The initial experience of Birmingham
resurfacing replacement in USA :
          540 cases
          37 complications (7%)
          10 early fractures




  1 mo     Malchau SICOT 2008
Hip resurfacing



• Difficult procedure
• Long learning curve
• Insufficient respect of soft tissues
• More bone is removed from the acetabulum in hip
  resurfacing than during hybrid total hip arthroplasty,
  a difference which is most marked in larger patients.
CONSERVATION OF THE NECK

         1938
NECK SPARING PROSTHESIS




          SILENT
                                ESKA




PROXIMA                 CFP            FRIENDLY S
NECK SPARING PROSTHESIS




   NANOS                TWO STEP




METHA         MODULUS              MAYO
3 PHILOSPHIES



 a   Conserve all of the neck
                                            b
                                Sub Capitale (or
                                lower) neck cut with
         c                      distal support

 Horizontal neck cut
 with metafisis 360°
 contact.
a
Conserve all of the neck
a
    Conserve all of the neck




            SILENT




                               TWO STEP
a   Conserve all of the neck




Failed conservative prosthesis can be replaced using a
    primary prosthesis
b
Sub Capitale (or
lower) neck cut with
distal support
CFP


MAYO                                  ESKA




          METHA               b   Sub Capitale (or
                                  lower) neck cut with
                                  distal support


  NANOS

                  MODULUS
b
Sub Capitale (or
lower) neck cut with
distal support
Observe the difficulty in
removing a stem with distal
fixation.
Observe the
difficulty in
removing a
stem with
distal
fixation.
TYPE B CONSERVATIVE IMPLANTS


Excellent result but:
• When compared to conventional prosthesis
  • Limited indications: ”you must have good
    bone quality”
  • In some types of prosthesis the level of
    complications was embarissing.
• Often they don't have enough clinical history.
c
Horizontal neck cut
with metafisis 360°
contact.
De Puy PROXIMATM Hip
                   1991-2006

The story of a conservative implant created as a
result of the most recent biomecchanical
principals.
 • PRESERVING BONE STOCK
 • AVOID THIGH PAIN AND SOFT TISSUE PAIN
 • LOWER THE PERCENTAGE OF
   COMPLICATIONS
 • HAVE LARGER INDICATIONS
THE LATERAL LOAD TRANSFER
DYNAMIC BIOMECHANICS OF FEMORAL
STRESS TRANSFER
• One must consider also the involvment of
  muscles. In particolar ileo-tibial band exerts
  compression forces on the lateral cortex.
• The classic model of Koch is not adeguate as
  it didn't take into account muscle action and
  so predicted compression forces only on the
  medial femor.                                                 ITB

• The ideal prosthesis should transmit forces
  laterally.
  Fetto, J.F., Bettinger P., Austin K., Re-examination of Hip
  Biomechanics During Unilateral Stance.
  Am J Orthop., 605-612, August 1995
FORCE TRANSFER ON THE LATERAL FLARE




 Walker PS et al, Hip International, 1999
WHY NO STEM?



• The biomecchanics show that
  in a prosthesis with a lateral
  flare the forces are only
  applied proximally.
• The stem is therefore not




                                              X
                                              Contact Stress
                                                 (MPa)

  necessary for stability



                                          X
  Walker PS et al., Hip International, 1999
PRESERVATION OF THE NECK

The preservation of the femoral neck increases the resistence of
the implant to rotational forces - because the neck becomes
more rectangular shaped proximally
     Torsional load (Nm)
60
50
40
30
                    `
20
10                                             Proxima
0
     0%       15%       50%    100%
                        Neck preservation

          Pipino 1983 ,Freeman 1986
          Whiteside et al, Am J Orthop, 1995
CONSERVATION OF THE FEMORAL NECK
PROXIMAL CONTACT AREA



                          44 cm²
                          DePuy Proxima size 3




          39cm²                         18cm²            39 cm²

                                                       Stryker Accolade TMZF,
S&N: Synergy Stem         Stryker Osteonics Omnifit,            size 4
size 14(roughtest area)            size 4
PROXIMA DOESN'T DAMAGE TENDON INSERTION POINTS
CLINICAL EXPERIENCE


                   1995-2004
            140 PROXIMA custom-made
                                      type1
• Conservative neck recsection
• Forces distributed to the
  lateral cortex                 type 2
 (circumferential loading)
• Stem-less
         2005-2008
     260 PROXIMA std.
PROXIMA CUSTOM-MADE PROSTHESIS
                    (1995)
           System Design – Implant Features

• Titanium (Ti-6Al-4V)
• Short stem
  (metaphyseal loading)
• Ha coating
• Lateral flare
• Conservative neck
  resection
• Contact with load
  bearing cancellous bone
  (M, L, A, P)
PROXIMA CUSTOM-MADE TYPE 1




      7Y          8Y
STRESS SHIELDING
                ESKA
                          CFP
MAYO
PROXIMA CUSTOM-MADE TYPE 2 - 1999




                 12 y         7y


type1                                       type2
TYPICAL CASES
FINITE ELEMENT ANALYSIS

OBJECTIVE
  Examine the effects of a lateral flare on the
  stability of a short stem with metafisis loading

CONCLUSIONS
•   In a prosthesis with a lateral flare a distal
    stem does not improve primary stability
•   No difference in stability between a large and
    small lateral flare
•   A High Friction porous coating auments the
    prothesis' stability.


             Dep Bioeng University Southampton G.B.
After 2,5y   After 6,5y
INDICATIONS
  ARTHRITIS
INDICATIONS
    AVN
INDICATIONS
OSTEOPOROUS
OSTEOPOROUS




Reumatoid arthritis


         61y
BONE CHANGES IN OSTEOPOROSIS




Bone remodeling modifies bone structure
Age-related changes in bone geometry make a
correct fit and fill more difficult




                        Seeman. Lancet 2002; 359: 1841-50
                        Seeman. N Engl J Med. 2003; 349:320-3
OSTEOPOROUS




84 y
81 y
91y
      After 18 m
PROXIMATM Hip

   HOW HAVE MY INDICATIONS CHANGED


   CEMENTED         NON-CEMENTED
   PROSTHESIS        PROSTHESIS
2004   45,4%           54,6%

2007   9,4 %           90,6%
84 y
SERIOUS OSTEOPOROSUS
• CEMENTED PROSTHESIS
UNUSUAL INDICATIONS
UNUSUAL INDICATIONS
UNUSUAL INDICATIONS
UNUSUAL INDICATIONS
UNUSUAL INDICATIONS
UNUSUAL INDICATIONS




    75 y
 Furlong 9 y
TKR same side
    CVD
CONTRO-INDICATIONS


• Excessive antiversion o valgus
  femoral neck
• Serious Osteoporosus
• Metafisis Osteosclerosus
RESULTS

                International Experience
          4748 implantations (up to June 08)
              27 revisions (8 – trial, 19 – markets)
          0.59% revision rate
In all cases, revisins were performed with primary or
conservative prosthesis

                     personal update
            402 implantations (1995-2008)
               0 revisions
Complications with traditional prosthesis
INTRAOPERATORY FRACTURES   EARLY LOOSENING




                                 After 2 m
Complications with Proxima




1mo
                      2y
MIGRATION




After 7y
SUBSIDENCE INTO VARUS
SUBSIDENCE INTO VARUS
SUBSIDENCE INTO VARUS
     -THIGH PAIN
SUBSIDENCE INTO VARUS
+ HIGH OFF-SET + LONG HEAD OFFSET




         LOOSENING
IS PROXIMA INVASIVE?




74 y




                     TIGH PAIN
                 -STRESS SHIELDING
IS PROXIMA INVASIVE?




                          TIGH PAIN
                       STRESS SHIELDING
After 2,5y   After 6,5y
De Puy PROXIMATM Hip

     CONCLUSIONS




WHAT IS THE DIFFERENCE
De Puy PROXIMATM Hip

             CONCLUSIONS




ANATOMICA CIRCUMFERENZIAL DISTRIBUTION OF
            IMPLANT STRESSES
CONSERVATIVE PROSTHESIS
                CONCLUSIONS
  The other conservative solutions (resurfacing or
  normal neck preserving prosthesis) have
  normally restricted indications, both because
  they are not appropriate for a non-normal
  femoral morphology and because they have a
  need of good bone quality.
• For some of these implants the number of
  complications is very high
• Often times they don't have a long follow-up
De Puy PROXIMATM Hip

                   CONCLUSIONS

PROXIMA, after a short learning curve may be used with the
same indications as a normal non-cemented prosthesis.


     • Wide indications
     • Improvement of the Peri-Prosthetic
       bone quality
     • Low percentage of complications
De Puy PROXIMATM Hip

             CONCLUSIONS


THE SURGICAL TECHNIQUE IS NOT
 DIFFICULT...IT'S JUST DIFFERENT


Can be used with any type of surgical access
De Puy PROXIMATM Hip

        CONCLUSIONS




13 YEARS OF CLINICAL EXPERIENCE
GRAZIE

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Corato

  • 1. Proxima Francesco Saverio Santori, Nicola Santori Orthopaedics & Traumatology Hospital S. Pietro Fatebenefratelli - Rome - Italy
  • 2. WHY CREATE A NEW HIP IMPLANT? THR survivorship 81% at 25 year follow-up (revision of any component as endpoint) Bury D et al JBJS 2002 88% at 30 year follow-up or to the time of death (original prothesis intact) Callaghan J et al JBJS 2004
  • 3. WHY CREATE A NEW HIP IMPLANT? CONVENTIONAL IMPLANTS GIVE VERY GOOD RESULT AND THEY HAVE WIDE INCIDATIONS HOWEVER THEY HAVE THE FOLLOWING PROBLEMS: 1. STRESS SHIELDING 2. THIGH PAIN 3. SOFT TISSUE PAIN 4. LOOSENING
  • 4. STRESS SHIELDING Proximal load transfer is never gauranteed with a traditional stemmed implant
  • 5. DIAPHESEAL FIXATION stress shielding !!!!!
  • 7. DAMAGE TO TENDON INSERTION POINTS
  • 9. Bone ingrowth occurs only if the implant is very near to bone: • 1 mm between implant and bone (2 mm with Ha) Therefore it's very important to have as much bone contact as possible, i.e. circumferential contact
  • 10. CONSERVE BONE STOCK The next operation! CONSERVATIVE PHILOSPHY
  • 11. Conservative implants CONSERVATION OF THE FEMORAL NECK ? RESURFACING
  • 12. Hip resurfacing Smith Petersen developed a CoCr resurfacing head in the 1930s Charnley used a resurfacing design in the 1960s •teflon-on-teflon bearing •very low friction •very high wear!!
  • 13. Hip resurfacing • FEMORAL NECK FRACTURES – AN IMPORTANT COMPLICATION OF SURFACE HIP REPLACEMENT  • 3497 surface replacement hips of the Birmingham model. • 50 fractures of the femoral neck • (1.9%) in female patients • (1.0%) in male patients • … surgeon’s experience was thus without influence A. J. Shimmin and D. Back, BSc : Femoral neck fractures following Birmingham hip resurfacing. A NATIONAL REVIEW OF 50 CASES. Journal of Bone and Joint Surgery - British Volume 2005; Vol 87-B: 463-464.
  • 14. Hip resurfacing Ø 37 femoral surface replacement (FSR) Ø 24 failures (64.8%) Failure of femoral surface replacement for femoral head avascular necrosis. Squire M, Fehring TK, Odum S, Griffin WL, Bohannon Mason J. - J Arthroplasty 2005
  • 15. Hip resurfacing The initial experience of Birmingham resurfacing replacement in USA : 540 cases 37 complications (7%) 10 early fractures 1 mo Malchau SICOT 2008
  • 16. Hip resurfacing • Difficult procedure • Long learning curve • Insufficient respect of soft tissues • More bone is removed from the acetabulum in hip resurfacing than during hybrid total hip arthroplasty, a difference which is most marked in larger patients.
  • 17. CONSERVATION OF THE NECK 1938
  • 18. NECK SPARING PROSTHESIS SILENT ESKA PROXIMA CFP FRIENDLY S
  • 19. NECK SPARING PROSTHESIS NANOS TWO STEP METHA MODULUS MAYO
  • 20. 3 PHILOSPHIES a Conserve all of the neck b Sub Capitale (or lower) neck cut with c distal support Horizontal neck cut with metafisis 360° contact.
  • 21. a Conserve all of the neck
  • 22. a Conserve all of the neck SILENT TWO STEP
  • 23. a Conserve all of the neck Failed conservative prosthesis can be replaced using a primary prosthesis
  • 24. b Sub Capitale (or lower) neck cut with distal support
  • 25. CFP MAYO ESKA METHA b Sub Capitale (or lower) neck cut with distal support NANOS MODULUS
  • 26. b Sub Capitale (or lower) neck cut with distal support
  • 27. Observe the difficulty in removing a stem with distal fixation.
  • 28. Observe the difficulty in removing a stem with distal fixation.
  • 29. TYPE B CONSERVATIVE IMPLANTS Excellent result but: • When compared to conventional prosthesis • Limited indications: ”you must have good bone quality” • In some types of prosthesis the level of complications was embarissing. • Often they don't have enough clinical history.
  • 30. c Horizontal neck cut with metafisis 360° contact.
  • 31. De Puy PROXIMATM Hip 1991-2006 The story of a conservative implant created as a result of the most recent biomecchanical principals. • PRESERVING BONE STOCK • AVOID THIGH PAIN AND SOFT TISSUE PAIN • LOWER THE PERCENTAGE OF COMPLICATIONS • HAVE LARGER INDICATIONS
  • 32. THE LATERAL LOAD TRANSFER DYNAMIC BIOMECHANICS OF FEMORAL STRESS TRANSFER • One must consider also the involvment of muscles. In particolar ileo-tibial band exerts compression forces on the lateral cortex. • The classic model of Koch is not adeguate as it didn't take into account muscle action and so predicted compression forces only on the medial femor. ITB • The ideal prosthesis should transmit forces laterally. Fetto, J.F., Bettinger P., Austin K., Re-examination of Hip Biomechanics During Unilateral Stance. Am J Orthop., 605-612, August 1995
  • 33. FORCE TRANSFER ON THE LATERAL FLARE Walker PS et al, Hip International, 1999
  • 34. WHY NO STEM? • The biomecchanics show that in a prosthesis with a lateral flare the forces are only applied proximally. • The stem is therefore not X Contact Stress (MPa) necessary for stability X Walker PS et al., Hip International, 1999
  • 35. PRESERVATION OF THE NECK The preservation of the femoral neck increases the resistence of the implant to rotational forces - because the neck becomes more rectangular shaped proximally Torsional load (Nm) 60 50 40 30 ` 20 10 Proxima 0 0% 15% 50% 100% Neck preservation Pipino 1983 ,Freeman 1986 Whiteside et al, Am J Orthop, 1995
  • 36. CONSERVATION OF THE FEMORAL NECK
  • 37. PROXIMAL CONTACT AREA 44 cm² DePuy Proxima size 3 39cm² 18cm² 39 cm² Stryker Accolade TMZF, S&N: Synergy Stem Stryker Osteonics Omnifit, size 4 size 14(roughtest area) size 4
  • 38. PROXIMA DOESN'T DAMAGE TENDON INSERTION POINTS
  • 39. CLINICAL EXPERIENCE 1995-2004 140 PROXIMA custom-made type1 • Conservative neck recsection • Forces distributed to the lateral cortex type 2 (circumferential loading) • Stem-less 2005-2008 260 PROXIMA std.
  • 40. PROXIMA CUSTOM-MADE PROSTHESIS (1995) System Design – Implant Features • Titanium (Ti-6Al-4V) • Short stem (metaphyseal loading) • Ha coating • Lateral flare • Conservative neck resection • Contact with load bearing cancellous bone (M, L, A, P)
  • 42. STRESS SHIELDING ESKA CFP MAYO
  • 43. PROXIMA CUSTOM-MADE TYPE 2 - 1999 12 y 7y type1 type2
  • 45. FINITE ELEMENT ANALYSIS OBJECTIVE Examine the effects of a lateral flare on the stability of a short stem with metafisis loading CONCLUSIONS • In a prosthesis with a lateral flare a distal stem does not improve primary stability • No difference in stability between a large and small lateral flare • A High Friction porous coating auments the prothesis' stability. Dep Bioeng University Southampton G.B.
  • 46. After 2,5y After 6,5y
  • 47.
  • 48.
  • 50. INDICATIONS AVN
  • 53. BONE CHANGES IN OSTEOPOROSIS Bone remodeling modifies bone structure
  • 54. Age-related changes in bone geometry make a correct fit and fill more difficult Seeman. Lancet 2002; 359: 1841-50 Seeman. N Engl J Med. 2003; 349:320-3
  • 56. 81 y
  • 57. 91y After 18 m
  • 58. PROXIMATM Hip HOW HAVE MY INDICATIONS CHANGED CEMENTED NON-CEMENTED PROSTHESIS PROSTHESIS 2004 45,4% 54,6% 2007 9,4 % 90,6%
  • 59. 84 y
  • 66. UNUSUAL INDICATIONS 75 y Furlong 9 y TKR same side CVD
  • 67. CONTRO-INDICATIONS • Excessive antiversion o valgus femoral neck • Serious Osteoporosus • Metafisis Osteosclerosus
  • 68. RESULTS International Experience 4748 implantations (up to June 08) 27 revisions (8 – trial, 19 – markets) 0.59% revision rate In all cases, revisins were performed with primary or conservative prosthesis personal update 402 implantations (1995-2008) 0 revisions
  • 70. INTRAOPERATORY FRACTURES EARLY LOOSENING After 2 m
  • 75. SUBSIDENCE INTO VARUS -THIGH PAIN
  • 76. SUBSIDENCE INTO VARUS + HIGH OFF-SET + LONG HEAD OFFSET LOOSENING
  • 77. IS PROXIMA INVASIVE? 74 y TIGH PAIN -STRESS SHIELDING
  • 78. IS PROXIMA INVASIVE? TIGH PAIN STRESS SHIELDING
  • 79. After 2,5y After 6,5y
  • 80. De Puy PROXIMATM Hip CONCLUSIONS WHAT IS THE DIFFERENCE
  • 81. De Puy PROXIMATM Hip CONCLUSIONS ANATOMICA CIRCUMFERENZIAL DISTRIBUTION OF IMPLANT STRESSES
  • 82. CONSERVATIVE PROSTHESIS CONCLUSIONS The other conservative solutions (resurfacing or normal neck preserving prosthesis) have normally restricted indications, both because they are not appropriate for a non-normal femoral morphology and because they have a need of good bone quality. • For some of these implants the number of complications is very high • Often times they don't have a long follow-up
  • 83. De Puy PROXIMATM Hip CONCLUSIONS PROXIMA, after a short learning curve may be used with the same indications as a normal non-cemented prosthesis. • Wide indications • Improvement of the Peri-Prosthetic bone quality • Low percentage of complications
  • 84. De Puy PROXIMATM Hip CONCLUSIONS THE SURGICAL TECHNIQUE IS NOT DIFFICULT...IT'S JUST DIFFERENT Can be used with any type of surgical access
  • 85. De Puy PROXIMATM Hip CONCLUSIONS 13 YEARS OF CLINICAL EXPERIENCE

Editor's Notes

  1. <number>
  2. <number>
  3. galecki
  4. <number>
  5. <number>
  6. wiles londra 1938<number>
  7. <number>
  8. mainella 39aa two step e revisione con conus dopo 2 aa
  9. <number>
  10. The advantages of hip resurfacing include
  11. <number>
  12. In 1996, Fetto re-examined Koch’s model and found it to be inaccurate because it didn’t consider the effect of the lateral soft tissues known as the ilio-tibial band.The ilio-tibial band places the lateral aspect of the femur in compression.Fetto’s tension band model is consistent with studies of bone morphology. <number>
  13. nusca giovanna 2005 e corrisponde anche alle previsioni biomeccaniche<number>
  14. In a prosthesis with a lateral flare, stress is transferred proximo-medially and proximo-laterally. No stress is transferred distally and the distal stem is therfore not necessary to maintain stability.No distal stem also means no impngement and no thigh pain!This phenomenon has also been seen with the IPS system<number>
  15. Whiteside, in 1995, demonstrated in laboratory studies that preserving the femoral neck provides greater resistance to failure due to torsional load
  16. <number>
  17. bartole 1997SCARINGELLA 1999In qualche caso nel primo modello coche aveva un piccolo stelo
  18. <number>
  19. PERNAZZA 2003-6 61 AABILAT BELLI
  20. <number>
  21. MADDALENA LIVIANA<number>
  22. PARISELLA MARCO<number>
  23. E<number>
  24. MADDALENA LIVIANA 61 OP 2006 CASI BELLI INVASIVITA
  25. <number>
  26. <number>
  27. MADDALENA LIVIANA<number>
  28. AMBROSELLI GAETANO<number>
  29. Lodi luigia 1918
  30. <number>
  31. Bono patrizia<number>
  32. Corbara lidia84 aa grave op<number>
  33. LUCCHESI<number>
  34. gugliotta<number>
  35. ROSA FORTAREZZA
  36. <number><number>
  37. <number>
  38. <number>
  39. Fatiga migr fratt e var<number>
  40. D’ORAZOO MIGRAZIONE PROXIMA MAGGIO 2006 CONTROLLO 11 2006 GIUOCA A TENNIS E GOLF <number>
  41. Doria ver 61 op 2006 varo op<number>
  42. SEGATORE 72 VARO CASI BELLI 2006
  43. <number>
  44. MEREU AR 59 ZWEI 2004 PROX 2007 INVASIVIT
  45. MEREU AR 59 ZWEI 2004 PROX 2007 INVASIVIT
  46. PERNAZZA 2003-6 61 AABILAT BELLI
  47. <number>
  48. The advantages of hip resurfacing include