SyCap: A novel implant to address the treatment gap for ... · SyCap: A novel implant to address...
Transcript of SyCap: A novel implant to address the treatment gap for ... · SyCap: A novel implant to address...
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SyCap: A novel implant to address
the treatment gap for middle-aged
patients with focal cartilage defects
Maria Pastrama, TU/e
October 9th, 2019
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Focal knee cartilage defects (FCD)
0
50,000
100,000
150,000
Total 40y - 60y
FCD incidence per year (US & Europe)Femur
Tibia
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FCDs: Treatment gap for middle-aged patients
?
Regenerative
therapy
Total knee
replacement
40-60 years > 60 years< 40 years
Resurfacing
metal implants
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Resurfacing metal implants: Drawbacks
No MRI monitoring Damage to opposing tissue
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FCDs: Treatment gap for middle-aged patients
?
Regenerative
therapy
Total knee
replacement
40-60 years > 60 years< 40 years
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SyCap: Objective
Develop a non-resorbable implant for the treatment of cartilage
defects in middle aged patients
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SyCap: Design
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SyCap: Mechanical properties
CartilageSyCap top
layer *
Trabecular
bone
SyCap bottom
layer *
(Apparent)
Modulus [MPa]2–25 10–37 390–650 450–598
T.A. Burgers et al. J Biomech. 41: 1077–1085, 2008; D. Shepherd and B. B. Seedhom, Ann. Rheum. Dis., 58(1): 27–34, 1999; D. Shepherd, Rheumatology,
38(2): 124–132, 2002.
* in water at 37º C
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Spray coating method
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SyCap: Benefits & unique selling points
◆ Biomechanics closely mimics cartilage biomechanics
◆ Allows for postoperative MRI (no substantial metal)
◆ Off-the-shelf, minorly invasive procedure
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SyCap: Animal studies
2017
In vivo 1A
2018
In vivo 1B
2019
In vivo 2
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Evaluation methods
MRI
X-Ray
Micro-CT
Histology
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SyCap: Animal studies
2017
In vivo 1A
2018
In vivo 1B
2019
In vivo 2
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Animal Study 1A
◆ 20 skeletally mature Dutch milk goats (3.2±0.5 years, 82.6±9.4 kg)
◆ BCP-coated/uncoated PCU implants vs. metal implants inserted
bilaterally into medial femoral condyle
◆ 12 week follow-up
◆ Primary outcome measure: Implant osseointegration
bone-implant contact (BIC) [%] on histology
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Preclinical in vivo data: Excellent osseointegration &
cartilage preservation
Patent Application
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Conclusions Animal Study 1A
◆ Coating is effective in stimulating osseointegration for solid PCU
implants
◆ Surgical technique can be further improved
– Pre-drilling
– Press-fit
◆ Modify implant shape in order to improve translation from goat implant
design to human implant design
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Implant shape: Finite Element Analysis
Horizontal strain (εxx)
Heuijerjans 2018
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Conclusions Animal Study 1A: Design update
Shape
Press-fit
Surgical procedure
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SyCap: Animal studies
2018
In vivo 1B
2017
In vivo 1A
2019
In vivo 2
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Animal Study 1B: Osseointegration
◆ 16 skeletally mature Dutch milk goats (2-3 years, 60-80 kg)
◆ Implants inserted bilaterally into medial femoral condyle
◆ 12 week follow-up
◆ Primary outcome measure: Implant osseointegration
bone-implant contact (BIC) [%] on histology
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Animal Study 1B: Osseointegration
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SyCap: Animal studies
2019
In vivo 2
2017
In vivo 1A
2018
In vivo 1B
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Animal Study 2: Long term adjacent & opposing cartilage
assessment
◆ 32 skeletally mature Dutch milk goats (2-3 years, 60-80 kg)
– PCU implant 1 (Bionate)
– PCU implant 2 (Bionate composite)
– Sham
– Metal implant
◆ Implants inserted bilaterally into medial femoral condyle
◆ 26 & 52 week follow-up (n=8 knees per group)
◆ Primary outcome measure: histological scoring of opposing cartilage
OOCHAS score
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Animal Study 2: Preliminary results
Metal implant SyCap
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Optical profiling Ultrasound imaging
Animal Study 2: Roughness measurements
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Outlook: Human implant design
Human
implant
design
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Human implant design: Full knee FE analysis
van de Wetering 2019
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Effect of implant curvature and placement depth
van de Wetering 2019
Perfect curvature
Flat implant
’’Good’’ placement
Flat implant
’’Bad’’ placement
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Thank you!
SyCap project
René van Donkelaar
Pieter Emans
Frank Everaerts
Jessica Gerards
Pieter van Hugten
Ralph Jeuken
Filip Maes
Henk Oevering
Alex Roth
Jens Thies