FXA Demo Presentation

1
Preface
This presentation and pilot study was conducted
for a customer to assess the in-vivo implant
performance and the effect of the implantation on
the adjacent segments over a follow-up time
between 12 and 60 months post-op. The
presentation summarizes a small study cohort of
10 patients and shows one sample analysis. In
order to protect the customers privacy, several
details and key findings were deleted. The goal
of this blinded presentation is to demonstrate
some of the capabilities of the FXA software and
to give an example of a presentation as it was
given to surgeons in order to show the
scientific, data driven and evidence based
company philosophy of this client. For a
dedicated presentation of the FXA method, or if
you have any further questions, please contact
us Frank Trautwein, ft_at_acesgmbh.de, orDr.
Frank Heuer, frank.heuer_at_acesgmbh.de, 49 711
34238223 (Director RD) ACES GmbH, Kanalstrasse
12/1, 73728 Esslingen, Germany
2
Introduction

• Q What is Functional X-Ray Analysis?
• A A scientific software tool, based on
  radiographic images, to
• Analyze spinal kinematics
• Investigate patient pathologies and different
  treatment options
• Evaluate and document safety and efficacy in
  clinical trials, studies and post-market
  surveillance

3
Introduction

• Q How does it work?
• Radiographic images are feed into the analysis
  software
• Software detects and precisely measures relative
  motion
• Rates instability, degeneration, Range of Motion
  (ROM), Center of Rotation (COR/ICR), Subsidence,
  Migration
• Generates report with relevant information and
  analysis confidence
• Static measurements also available Disc Height,
  Foraminal Height, Spinal Canal Cross Section,
  Cobb Angle

4
Introduction

• Q What is the difference to other methods, such
  as RSA?
• The FXA software does not need any Tantalum or
  other markers
• Lower x-ray exposure works with standard
  flexion/extension images as they are routinely
  taken for diagnosis and follow/up
• Software uses a unique, patent pending matching
  algorithm which does not rely on edge
  identification like some other research or
  commercial projects. The algorithm is
  operator-independent.
• Advantage Superior accuracy, built-in
  out-of-plane compensation and 100 reproducible
  measurements.

5
Validation (Synthetic Images)
Validation Example Pre-defined rotation centers
on synthetic images

• Goal and Method
• Software shall locate Centers of Rotation (COR)
• They should match the centers that were used to
  create the synthetic images
• Difference between actual and measured location
  is recorded

Actual COR
6
Validation (Synthetic Images)

• Variation of intersegmental angles on synthetic
  images
• CAD model with defined angular rotations and COR
  locations was generated
• Synthetic Flexion and Extension images generated
• Images were processed and analyzed by the FXA
  software exactly the same way as X-ray images
• Measured results were compared with actual values

7
Validation (Synthetic Images)
Example Result
Deviation of the measured COR (center of
rotation) from the actual COR location
Note Synthetic images are ideal for algorithms
utilizing edge detection, but rather challenging
for our algorithm
8
Results (Synthetic Images)
Mean values of the measured ROM
Deviation of the measured COR from the actual COR
location
30.7 mm 36.8 mm 1.6 mm 0.7 mm 0.9 mm 0.7
mm 0.6 mm 0.3 mm 0.3 mm 0.1 mm 0.2 mm
0.1 mm
0.10 0.03 0.50 0.03 1.00 0.01 2.00
0.02 3.00 0.02 5.00 0.01
9
Results (Synthetic Images)

• Real World accuracy depends alsoon image
  quality
• Clarity and Contrast
• Visibility of object to be evaluated
• Out-of plane deviation
• In-Vitro experiments conducted to assess FXA
  accuracy on actual x-ray images.

Biomech. Lab at the University of Münster
10
Functional X-Ray Analysisof the sample Implant
An analysis of 9 patients (12 months
follow-up)1 patient (5 years follow-up)
Frank Trautwein, Dr. Frank Heuer, ACES Ing.-GmbH
11
FXA - Study of the Sample Implant
08-Jun-2010
Date of Evaluation
Version
Functional X-Ray Analysis (FXA) V.1.5
Parameters
Range of Motion (ROM)
Center of Rotation (COR)
Subjects
10 Patients
12 Implants (2 Patients with 2 Implants)
Time Points
Pre-OP Post-OP 0, 3, 6, 12 2 additional index
levels with 18, 36 and 60 months
12
FXA - Study Summary
13
FXA - Study Summary
2 Implants, 1 Pat.
14
FXA - Study Summary
Comments
At Pre-OP, the index level has a smaller ROM when
compared to the adjacent levels. The adjacent
level below the index level tends to yield a
slightly larger ROM compared to the adjacent
level above the index level. After implantation
the overall ROM decreased, which might be caused
by the patient maintaining a pain relieving
posture during x-ray assessment. The adjacent
levels show a nearly symmetrical ROM. Starting
at 3 month Post-OP, the ROM of the index level is
increasing up to a mean value of 5.4 (12
months).
15
FXA - Study Summary
2 Implants, 1 Pat.
16
FXA - Study Summary
Comments
Pre-OP, the index level has 90 of ROM in
relation to the adjacent level above. After
implantation, it can be seen that the motion
sharing (independent from the overall ROM in
absolute values) remained in a similar range over
time. The index level ROM was between 40 and
60 for all time points.
17
FXA - Study Case Examples
Pre-OP
s
s
s
ROM 5.7
ROM 9.2
ROM 11.5
C4-5
C5-6
C6-7
18
FXA - Study Case Examples
Post-OP (0 months)
s
s
s
ROM 7.9
ROM 1.8
ROM 7.2
C4-5
C5-6
C6-7
19
FXA - Study Case Examples
Post-OP (3 months)
s
s
s
ROM 8.8
ROM 4.3
ROM 15.2
C4-5
C5-6
C6-7
20
FXA - Study Case Examples
Post-OP (6 months)
s
s
s
ROM 10.5
ROM 4.8
ROM 12.1
C4-5
C5-6
C6-7
21
FXA - Study Case Examples
Post-OP (12 months)
s
s
s
ROM 10.8
ROM 6.7
ROM 14.2
C4-5
C5-6
C6-7
22
FXA - Study Case Examples
Change of COR over Time on Adjacent Level
(different patient)
s
s
s
s
Post-OP
12 months
6 months
Pre-OP
23
FXA - Study Summary
General Comments and Limitations

• Patients need to get identical instructions in
  preparation for the x-ray taking
• Different x-ray exposure settings were used for
  flexion and extension movements, which should be
  avoided
• Most of the time the visibility of C7 was limited
• In a few cases the x-ray images of various time
  points were incomplete
• For long term follow-up (18 months) only one
  patient was available

24
FXA - Study Summary
Further suggestions and ideas

• Definition of an Surveillance Protocol, mainly
  for improving consistency of x-rays
• Defining parameters to detect the adjacent
  segment degeneration, i.e. changes in
• ROM
• COR
• AP-Translation
• Disk Height
• Comparison to alternative treatment options like
  xxx or yyy

25
FXA - Study Summary
Analysis Result Summary

• Index Level remains mobile with a ROM of 40-60
  of the adjacent level over all time points
• The adjacent level ROM remains mostly unchanged
  over time (except directly Post-OP)
• The COR of the index level moves cranial and
  slightly posterior
• The COR of the adjacent level seems not to be
  influenced by the Implant and remains constant
  over time
• The ROM of the adjacent segments tends to slowly
  increase over time by a small amount (2-3)

26
With kind regards from Esslingen (Stuttgart,
Germany)
Thank You!