Our experience in the treatment of chondropathies with Bioseed -C
Transcript of Our experience in the treatment of chondropathies with Bioseed -C
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Our experience in the treatment ofchondropathies with Bioseed ®-C and
chondrotissue®
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Our Experience
• Autologus Chondrocyte Implantation
(ACI)
• Application of innovative
scaffolds (like substitutive
biological prostheses)
combined with microfractures
BioSeed -C
chondrotissue
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BioSeed-C
3d stable polymeric scaffold ( 30X20X2mm)
Innovative stable fixation
ideal primary graft stability and biocompatibility
cell culture with autologous serum
transplantation possible 21 days after prior biopsy
cryopreservation possible
logistic assistance in whole Europe
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Clinical Application BioSeed-C
- Debridement- Measuring- Sizing
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Clinical Application BioSeed-C- Fixation with transosseous knots (Erggelet technique)
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Clinical Application BioSeed-C
- Fixation withresorbable pins(SmartNail)
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OUR EXPERIENCEFrom September 2006 until today
we have recruited 155 patients
122 transplantations; 14 biopsies with no transplantation (refusal/indecisiveness); 18 patients are waiting for a transplantation; 1 failed cell culture (*); 80 M - 42 F ( average age 38 years ); femoral condyle defects ( average size 3.5 cm2 ); current clinical follow-up: 36 months; traumatic (64 pts), degenerative (58 pts), OCD (2 pts) etiology; 15 pts. had already received other orthopaedic treatments; 120 cases by mini-arthrotomy and 2 by arthroscopy
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OUR EXPERIENCE Diagnosis on the basis of attentive anamnesis,
objective examination and MRI
15 pts. treated with associated surgery procedures(3 LCA pro LARS – various meniscectomies)
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MRI3-6-9 months
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MRI3-6-9 months
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MRI3-6-9 months
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MRI3-6-9 months (PTE)
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Rehabilitation program Very important for the therapeutical success: because of the new tissue
formation it is not possible to immediately return to sport activity;
Rehabilitation paths from the first post-OP day (CMP), different initial programs
according to the lesion site ( F/P, F/T, T/T )
FEMORO-TIBIAL LESIONS : without loading for 4 weeks and progressive
loading from the 5th to the 12th week (to full body weight). CMP (immediately 0°-
40° with weekly 30° increase). Immediate off-load muscular isometric
reinforcement ( with contractions). Return to low-medium contact sports after 6
months, to more intensive contact sports after 8-12 months.
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Outcomes
Positive and encouraging
Clinical prospective study (C.Erggelet) – Surgery Dep. Freiburg University(November 2001- November 2004)
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Outcomes
MRIs 6 months after surgery showed a good defect filling in all patients
Arthroscopic second-looks with biopsy 9 months after surgery showed hyaline-like cartilage tissue, with integration into the surrounding cartilage and bone.
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OutcomesEVALUATION
24 months follow-up (80 patients)
IKDS score KOOS score CINCINNATI KNEE score
92% no or slightest pain when feeling the joint line of treated condyle; 77% improvement of pain symptomatology compared to pre-OP
evaluation; 82% return to full joint mobility.
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chondrotissue “intelligent” scaffold, to be used
in combination with Pridie/Boeck
drilling or microfractures. For the
haemostasis and protection of the
underlying tissue in traumatic and
degenerative joint cartilage
defects
We have already performed 40
implantations
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Regeneration of articular cartilage
In association with microfractures
One-step procedure
Easy application
Easy logistics
100% biological and absorbable
in 40-60 days
chondrotissue
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Traditional marrow stimulating techniques
Traditional marrow stimulating techniques to treat traumatic or degenerative cartilage defects
Drilling or microfractures of subchondral bone
Articular bleeding Regeneration of a low quality tissue
(fibrocartilage)
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Drilling or microfracture
Covering with intelligent scaffold
Haemostasis and protection-
Ideal 3d environment for
tissue regeneration
Optimal differentiation-formation of hyaline-like
cartilage
Protection of subchondral bone and surrounding cartilage
Traditional marrow stimulating techniques with application of a scaffold
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size: 20 x 30 x 1.1 mm
Composed by:
Resorbable matrixpure polyglycolic acid (PGA), CE marked, class III
Hyaluronic acid, CE marked, class III
chondrotissue
scaffold
rehydratation: serum or physiologic solution
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PGA matrix with mechanical stability
Protection of underlying tissue haemostasis 3D scaffold> stimulates cell distribution> differentiation high cell biocompatibility easy to use
Max traction force Fmax
1
10
100
Soft PGA Felt chondrotissue
New
ton
(N)
P = 0,751
chondrotissue
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chondrotissueHyaluronic Acid
Natural biopolymer
Important for cartilage structure and function (organizes proteoglicans in joint cartilage)
Viscoelastic
sudden loading: shock absorber action of shear stress: lubrificant
Molecular filter: erythrocytes, leucocytes, oxygen free radicals
Chondrogenic differentiation
High cell biocompatibility
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Preclinical studiesin vitro studies with horse stem cells
Hyaluronic acid helps tissue regeneration derived from stem cells!
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chondrotissueCellular migration induced by serum and hyaluronic acid
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chondrotissueIndications
focal traumatic and degenerative chondral defects degree III to IV of Outerbridge scale, bigger than 1,5 cm2
femoral condyle, patella, trochlea, tibial plateau, talus, acetabulum…
chondral defects that may be treated with marrow stimulating techniques:
• microfracturing• Pridie drilling• etc.
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chondrotissueIndications
Microfracture, Pridie drilling
ACIProsthesis
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control group (7 sheep):
- defect size: 11mm x 8mm x 1,1mm
- microfracture
Implant group (7 sheep):
- defect size: 11mm x 8mm x 1,1mm
- microfracture
- covering with chondrotissue and transosseous fixation
histology:
- 14 days, 3 Months, 6 Months
chondrotissueanimal study
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chondrotissueanimal study
debridemant microfracture chondrotissue
winningthe serum
reconsti-tution
taking the blood sample
surgery
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chondrotissueanimal study
microfracture and bleeding microfracture and covering
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chondrotissueanimal study - after 3 months
inferior tissue formation
formation of hyaline like cartilage tissue
microfracture with chondrotissue®: 3 months after surgery
microfracture without covering: 3 months after surgery
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chondrotissueanimal study – after 6 months
still inferior tissue formation
advanced hyaline like tissue formation
microfracture with chondrotissue®: 6 months after surgery
microfracture without covering: 6 months after surgery
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chondrotissueanimal study – after 6 months
MicrofracturingBiopsy after 6 months
Bad quality regeneration tissue
chondrotissue®
Biopsy after 6 months
Hyaklin-like regeneration tissue
Collagene type II - coloration
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Dr. T. ZantopMRI 12 months
Case Report - 12 monthsm, 35, lat. femoral condyle - traumatic 4cm² - arthroscopy
dimension
microfracturing
pins
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Dr. T. Zantop
Case Report - 12 monthsf, 54, med. femoral condyle – degenerative 3cm² - arthroscopy
microfracturing
pins
dimension
MRI 12 months
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Dr. A. Bergmann
Case Report - 7 monthsm, 43, lateral talus – 0,7 cm² - arthrotomy
Imm. 1 deep cartilage lesion(outerbridge 4, white arrow)
Imm. 2 cartilage repair tissue after 7 months
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Smart Nail, PLA
How to fix BioSeed -C and chondrotissue ?
Erggelet knots Fibrin glue
* very stable* arthroscopy and arthrotomy* too long for patella (approx. 1.5 x 16 mm)
* with vycril 2-0* Not expensive* very stable* ideal for patella* possible only by arthroscopy
*arthroscopy and arthrotomy* appropriate for small defects, if possible not in weight-bearing areas
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chondrotissueWe used this cell-free technique to treat patients
older than 50 with internal and external femoral
chondropathies of 3rd – 4th Outerbridge grade,
with or without femoral-patellar-tibial
chondropahies of inferior grade.
We collected some cases in tibial- talar
chondropathies using fibrin glue to fix the
scaffold.
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chondrotissue
The surgical implantation technique, the
pre- and post-OP procedure as well as the
rehabilitation program are the same as for
autologous chondrocyte transplantations
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chondrotissue- technique
• Perform debridement and microfracturing of subchondralbone
• Soak the scaffold with the patient´s own serum (2-3 ml)
• Cut to size to fit the defect
• Fix using the afore mentioned techniques
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chondrotissue- Advantages
One-step procedure
Reduced costs
Relatively faster rehabilitation
Clinical short-term results are almost
overlapping to the ones obtained with the ACI
procedure
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ConclusionsThe ACI is an effective treatment for
cartilage pathologies with precise indications, e.g. in the so called motivated “young old patients”.
Literature about the ACI procedure shows that the repair tissue has typical characteristics of hyaline cartilage (after 24 months – cartilage and tidemark regeneration).
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Conclusions chondrotissue is though a valid alternative
considering clinical outcomes and costs.bioengineering opens new possibilities for
the treatment of complex tissue defects. The use of bioactive factors and genetic induction techniques will - hopefully –allow faster, high-quality, long-term solutions.
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THANKS