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PATIENT SPECIFIC
INSTRUMENTATION – When
to TRUST them & When to
DITCH them?
DR VAIBHAV BAGARIA
CARE HOSPITAL
NAGPUR
1
What Drives Human Innovation?

I don't think necessity is the mother of invention - invention, in my o
Agatha Christie (1890 - 1976), An Autobiography, 1977
2
THE WISH LIST
SURGEON: M THE BEST, HAVE THE
BEST RESULTS, QUICK IN AND QUICK
OUT WITHOUT COMPROMISING.
HOSPITAL/ STAFF: LESS INVENTORY,
QUICK TURN AROUND TIME.
PATIENT: OPERATION TO LAST
LIFETIME!; good pain relief, excellent
Function!
3
CONVENTIONAL Instruments
Each company has its own set of
instrumentation – overload hospital
inventory, hospital sterilisation dept,
nurses learning curve, OR turn around
time -> adds to the cost.
Issue with use of IM alignment rod: Fat
embolism, bleeding, fractures, infection.
Repeated use of conventional Jigs ->
theoretical risk of contamination
4
Computer NAVIGATION
Not what computers are meant to do: Decrease
time, cut cost and inventory!
Still require the use of conventional instruments
– and to it adds some more inventory making it
more complex.
prolonged operative time
Complications assoc with pin insertion.
Requires continuous line of sight – can be
annoying!
Sizing also based on avg bone geometry & is ?
5
Pro vs Anti: Time 2 move on?

6
Story behind PSI

7
STEPS IN Designing PSI
3-D reconstruction of CT/MRI scan data.
Surgical Simulation
Sizing & Alignment of the prosthesis.
Creation of templates using CAD
software.
Using Rapid prototyping technology –
virtual templates are converted to physical
templates or jigs.
8
Planning for PSI

9
Full Length X- rays

10
MRI planning

11
11
Femoral Planning

12
Tibial Side planning

13
Jigs

14
Intraoperative Use of JIGS

15
CAD & RAPID PROTOTYPING

16
Other uses of Rapid Prototyping

17
COMMERCIAL AVALIABLITY
SIGNATURE: Biomet
VISIONAIRE: Smith & Nephew
TRU MATCH: Depuy
PSI: Zimmer
ConforMIS: Patient specific implants.

18
19
Nagpur Simulation Experience
Based on surgical simulation done using
the software ( MIMICS).
Team comprised of Orthopaedic Surgeon ,
radiologist and Engineers who routinely
did surgical simulation planning and Rapid
prototyping.
Although experienced – the study could
be potentially biased and be treated as
opinion!
20
Potential flaws in universal
application of PSI

21
ERROR: SOURCE CODE?
Plain radiographs: 10 degree flexion & 25
rotation -> significant alteration in axis
calculation.( good system use
combination of long film x rays & CT/MRI)
Thickness of Slice of CT scan/ MRI
Who is doing the surgical simulation.
How has the programme been validated?
Lonner JH, Laird MT, Stuchin SA (1996) Effect of rotation and knee
flexion on radiographic alignment in total knee arthroplasties.
Clin Orthop Relat Res 331: 102–106
22
ERROR: STATIC
Treats any deformity as fixed deformity.
Contrary to well founded principle: ‘ TKR
is a soft tissue surgery’
Especially inaccurate for large mobile
deformities.
Robs surgeon of opportunity to make the
knee tight or slightly loose depending on
patient profile.
23
ERROR: Bone always
Simulation & Planning is largely based on bony
landmarks.
ER rotation is based on two fixed criteria – an
additional info that surgeon often use intraoperatively.
Mal positioned or externally rotated Tibial
Tuberosity significantly reduced accuracy.
Similarly in the cases where there were large
osteophytes which were ossified – the program
did not distinguish it from true bone.
24
Over all
Accuracy is similar to conventional jigs,
not as accurate as CAS.
Not good- When there were extensive
oseophytes.
- When tibial torsion was beyond
standard.
- When the deformities are mobile.
However relatively accurate when the
deformity was extra articular.
25
So! When to trust them?
Straight forward, simple cases
only. @ the moment!

26
Why PSI for simple Cases?
COST Time -> COST ( reduces surgical time by
upto 2o min, and more vs CAS)
EASY: cuts 22 surgical step.
Can be overridden
Possibly less chance of infection
Other advantages that navigation has
over conventional instruments
27
When to ditch them?
Complex intra articular deformities.
Correctable deformities or significantly lax
knees.
Significant tibial torsion.
Intra operatively – esp when the external
rotation set by jig does not match up with
other parameters like parallel to tibial cuts.

28
In Conclusion
Non of the three available tech - conventional,
CAS, PSI are panacea yet they have their own
advantages.
Surgeons should not be dogmatic about any
one of them , rather should have all three in
armamentarium.
Future is out there some where.. And in our view
perhaps a combination of all three and also
another dimension of Remote surgeries.
29
COMPARISON
PARAME ACCURA COST
TERS
CY

EASE
TIME
OF USE

CI

OK

OK

OK

OK

CAS

GOOD

BAD

BAD

BAD

PSI

NOT
OK
KNOWN

GOOD

GOOD

30
Treat Like Driving experience!
PSI is like having a chauffer driving you around:
good for simple chores and most importantly
should follow your commands!
Navigation for complex situations, and for the
places where you never have been! But do you
really need it to drive home?
But You would like to keep the steering when
you are in deep mess! Or on a racing track! Till
the time you find a Schumaker!
31
Acknowledgements
Team Members: Dr Shirish Deshpande (CIIMS, Nagpur), Dr Kuthe
(VNIT), Dr Chaware, Dr Darshna Rasalkar (PCWH, Hong Kong), Dr
Jami Ilyas ( Royal Perth Hospital, Australia), Mr C Mazumdar
( ISRO), Dr Shalini Bagaria (CARE Nagpur) & Dr Amit Nemade
( CARE, Nagpur)
VNIT Nagpur
IIT Powai & Prof Ravi
Royal Perth Hospital, Perth, Australia.
Sir Charles Gardiner Hospital, Perth, Australia.
SPORTSMED SA Adelaide, Australia.

32
Publications on RP: Journey So
far

Text

Patents: Indian & International Pending
33
Text
Text
Text
Text
Text

www.drbagaria.com
34

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Patient Specific Instrumentation in Total Knee Replacement

  • 1. PATIENT SPECIFIC INSTRUMENTATION – When to TRUST them & When to DITCH them? DR VAIBHAV BAGARIA CARE HOSPITAL NAGPUR 1
  • 2. What Drives Human Innovation? I don't think necessity is the mother of invention - invention, in my o Agatha Christie (1890 - 1976), An Autobiography, 1977 2
  • 3. THE WISH LIST SURGEON: M THE BEST, HAVE THE BEST RESULTS, QUICK IN AND QUICK OUT WITHOUT COMPROMISING. HOSPITAL/ STAFF: LESS INVENTORY, QUICK TURN AROUND TIME. PATIENT: OPERATION TO LAST LIFETIME!; good pain relief, excellent Function! 3
  • 4. CONVENTIONAL Instruments Each company has its own set of instrumentation – overload hospital inventory, hospital sterilisation dept, nurses learning curve, OR turn around time -> adds to the cost. Issue with use of IM alignment rod: Fat embolism, bleeding, fractures, infection. Repeated use of conventional Jigs -> theoretical risk of contamination 4
  • 5. Computer NAVIGATION Not what computers are meant to do: Decrease time, cut cost and inventory! Still require the use of conventional instruments – and to it adds some more inventory making it more complex. prolonged operative time Complications assoc with pin insertion. Requires continuous line of sight – can be annoying! Sizing also based on avg bone geometry & is ? 5
  • 6. Pro vs Anti: Time 2 move on? 6
  • 8. STEPS IN Designing PSI 3-D reconstruction of CT/MRI scan data. Surgical Simulation Sizing & Alignment of the prosthesis. Creation of templates using CAD software. Using Rapid prototyping technology – virtual templates are converted to physical templates or jigs. 8
  • 10. Full Length X- rays 10
  • 16. CAD & RAPID PROTOTYPING 16
  • 17. Other uses of Rapid Prototyping 17
  • 18. COMMERCIAL AVALIABLITY SIGNATURE: Biomet VISIONAIRE: Smith & Nephew TRU MATCH: Depuy PSI: Zimmer ConforMIS: Patient specific implants. 18
  • 19. 19
  • 20. Nagpur Simulation Experience Based on surgical simulation done using the software ( MIMICS). Team comprised of Orthopaedic Surgeon , radiologist and Engineers who routinely did surgical simulation planning and Rapid prototyping. Although experienced – the study could be potentially biased and be treated as opinion! 20
  • 21. Potential flaws in universal application of PSI 21
  • 22. ERROR: SOURCE CODE? Plain radiographs: 10 degree flexion & 25 rotation -> significant alteration in axis calculation.( good system use combination of long film x rays & CT/MRI) Thickness of Slice of CT scan/ MRI Who is doing the surgical simulation. How has the programme been validated? Lonner JH, Laird MT, Stuchin SA (1996) Effect of rotation and knee flexion on radiographic alignment in total knee arthroplasties. Clin Orthop Relat Res 331: 102–106 22
  • 23. ERROR: STATIC Treats any deformity as fixed deformity. Contrary to well founded principle: ‘ TKR is a soft tissue surgery’ Especially inaccurate for large mobile deformities. Robs surgeon of opportunity to make the knee tight or slightly loose depending on patient profile. 23
  • 24. ERROR: Bone always Simulation & Planning is largely based on bony landmarks. ER rotation is based on two fixed criteria – an additional info that surgeon often use intraoperatively. Mal positioned or externally rotated Tibial Tuberosity significantly reduced accuracy. Similarly in the cases where there were large osteophytes which were ossified – the program did not distinguish it from true bone. 24
  • 25. Over all Accuracy is similar to conventional jigs, not as accurate as CAS. Not good- When there were extensive oseophytes. - When tibial torsion was beyond standard. - When the deformities are mobile. However relatively accurate when the deformity was extra articular. 25
  • 26. So! When to trust them? Straight forward, simple cases only. @ the moment! 26
  • 27. Why PSI for simple Cases? COST Time -> COST ( reduces surgical time by upto 2o min, and more vs CAS) EASY: cuts 22 surgical step. Can be overridden Possibly less chance of infection Other advantages that navigation has over conventional instruments 27
  • 28. When to ditch them? Complex intra articular deformities. Correctable deformities or significantly lax knees. Significant tibial torsion. Intra operatively – esp when the external rotation set by jig does not match up with other parameters like parallel to tibial cuts. 28
  • 29. In Conclusion Non of the three available tech - conventional, CAS, PSI are panacea yet they have their own advantages. Surgeons should not be dogmatic about any one of them , rather should have all three in armamentarium. Future is out there some where.. And in our view perhaps a combination of all three and also another dimension of Remote surgeries. 29
  • 30. COMPARISON PARAME ACCURA COST TERS CY EASE TIME OF USE CI OK OK OK OK CAS GOOD BAD BAD BAD PSI NOT OK KNOWN GOOD GOOD 30
  • 31. Treat Like Driving experience! PSI is like having a chauffer driving you around: good for simple chores and most importantly should follow your commands! Navigation for complex situations, and for the places where you never have been! But do you really need it to drive home? But You would like to keep the steering when you are in deep mess! Or on a racing track! Till the time you find a Schumaker! 31
  • 32. Acknowledgements Team Members: Dr Shirish Deshpande (CIIMS, Nagpur), Dr Kuthe (VNIT), Dr Chaware, Dr Darshna Rasalkar (PCWH, Hong Kong), Dr Jami Ilyas ( Royal Perth Hospital, Australia), Mr C Mazumdar ( ISRO), Dr Shalini Bagaria (CARE Nagpur) & Dr Amit Nemade ( CARE, Nagpur) VNIT Nagpur IIT Powai & Prof Ravi Royal Perth Hospital, Perth, Australia. Sir Charles Gardiner Hospital, Perth, Australia. SPORTSMED SA Adelaide, Australia. 32
  • 33. Publications on RP: Journey So far Text Patents: Indian & International Pending 33