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AMIC® Chondro-Gide® nel ginocchio

AMIC® Chondro-Gide® è una procedura minimamente invasiva a singolo step che usa la Condrogenesi Autologa Indotta da Matrice (AMIC®) combinata con Chondro-Gide® nella riparazione dei difetti cartilaginei. Supportata da più di 10 ani di successi clinici, AMIC® Chondro-Gide®  è un trattamento efficace e economico1-3 per la riparazione della cartilagine danneggiata del ginocchio, alleviando o prevenendo il dolore e rallentando la progressione del danno.

AMIC® Chondro-Gide® combina le Microfratture (MFx) con l’uso di Chondro-Gide® che copre e protegge sia il coagulo proveniente dalle MFX che la riparazione tissutale4.  Può essere fatta sia in chirurgia mini-open che in artroscopia. Biocompatibile e completamente riassorbibile, Chondro-Gide® supporta il potenziale fisiologico di guarigione.

Vantaggi

Con la sua speciale stuttura doppio strato, Chondro-Gide® fornisce un ambiente protettivo che favorisce la crescita di nuovo tessuto5,6.

  • Membrana di collagene naturale I/III doppio strato5
  • Biocompatibile e naturalmente riassorbibile5
  • Facile da maneggiare: flessibile e resistente alle lacerazioni5
  • Può essere stabilizzata con colla di fibrina in situ5
  • Compatibile con varie tecniche di rigenerazione tissutale7
  • Procedura one-step5
  • Pronta per l’uso5

References

  1. SCHIAVONE PANNI, A., et al. Good clinical results with autologous matrix-induced chondrogenesis (Amic) technique in large knee chondral defects. Knee Surg Sports Traumatol Arthrosc, 2018 Apr 26(4):1130-36 (Clinical study)
  2. WALTHER, M., et al. Scaffold based reconstruction of focal full thickness talar cartilage defects. Clinical Research on Foot & Ankle, 2013, 1-5. (Clinical study)
  3. KAISER, N., et al. Clinical results 10 years after AMIC in the knee. Swiss Med Wkly, 2015, 145 (Suppl 210), 43S. (Clinical study)
  4. VOLZ, M., et al. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  5. Geistlich Pharma AG data on file (Bench test)
  6. GILLE, J., et al. Cell-Laden and Cell-Free Matrix-Induced-Chondrogenesis versus Microfracture for the Treatment of Articular Cartilage Defects: A Histological and Biomechanical Study in Sheep. Cartilage OnlineFirst, January 7, 2010, doi:10.1177/1947603509358721 (Pre-clinical study)
  7. KRAMER, J., et al. In vivo matrix-guided human mesenchymal stem cells. Cell Mol Life Sci, Mar 2006, 63(5), 616-626. (Clinical study)
  8. MITHOEFER, K., et al. The microfracture technique for the sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  9. GOYAL, D., et al. Evidence-based status of microfracture technique: a systematic review of level I and II studies. Arthroscopy, Sep 2013, 29(9), 1579-1588. (Review of clinical studies)
  10. FONTANA, A., et al. Sustained five-year benefit of autologous matrix-induced chondrogenesis for femoral acetabular impingement-induced chondral lesions compared with microfracture treatment. Bone Joint J, May 2015, 97-B(5), 628-635. (Clinical study)
  11. GAO, L., et al. Early loss of subchondral bone following microfracture is counteracted by bone marrow aspirate in a translational model of osteochondral repair.  Nature Scientif-ic Reports, 2017, 7:45189, DOI: 10.1038/srep45189 (Pre-clinical study)
  12. FRANK, R.M., et al., Failure of Bone Marrow Stimulation Techniques, Sports Med Arthrosc Rev, 2017, 25 (1) (Review of clinical studies)
  13. STEADMAN, J.R., Microfracture Technique for Full-Thickness Chondral Defects: Technique and Clinical Results. Operative Techniques in Orthopaedics. 1997. 7(4), 300-304. (Clinical study)
  14. KAISER, N., et al. Clinical results 10 years after AMIC in the knee. Swiss Med Wkly, 2015, 145 (Suppl 210), 43S. (Clinical study)
  15. VOLZ, M., et al. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  16. SCHAGEMANN, J., et al. Mid-term outcome of arthroscopic AMIC for the treatment of articular cartilage defects in the knee joint is equivalent to mini-open procedures. Arch Orthop Trauma Surg, Jan 22 2018. (Clinical study)
  17. STEINWACHS, M.R.,et al. Systematic Review and Meta-Analysis of the Clinical Evidence on the Use of Autologous Matrix-Induced Chondrogenesis in the Knee. Cartilage. 2019:1947603519870846. https://www.ncbi.nlm.nih.gov/ pubmed/31508990 (Review of clinical studies)
  18. FOSSUM, V., et al. Collagen-Covered Autologous Chondrocyte Implantation Versus  Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. Orthopaedic Journal of Sports Medicine. 019;7(9):2325967119868212. doi.org/10.1177/2325967119868212 (Clinical study)

Tecnica chirurgica in Mini-Open, Dr. M. Steinwachs

Tecnica chirurgia in artroscopia, prof. Dr. Justus Gille

Evidenza clinica su AMIC® nel ginocchio

AMIC® Chondro-Gide® si è dimostrata essere un trattamento efficace nella riparazione di lesioni cartilaginea nel ginocchio. Studi clinici mostrano il successo del trattamento con AMIC® Chondro-Gide® sia con chirurgia mini-open che con tecniche artroscopiche per oltre 10 anni14.

Migliore performance rispetto alle sole Microfratture (MFx), dopo 2 anni

In uno studio controllato randomizzato a 3 gruppi con 47 pazienti in due centri15, è stata visto un significativo peggioramento del risultato dopo 2 anni dal trattamento con solo MicroFratture (MFx) (senza Chondro-Gide®). Sia il dolore che i valori funzionali (ICRS e Valori di Cincinnati modificati) rimanevano stabili o addirittura miglioravano con AMIC®, mentre dolore e valori funzionali peggioravano per il gruppo MFx.

References

  1. SCHIAVONE PANNI, A., et al. Good clinical results with autologous matrix-induced chondrogenesis (Amic) technique in large knee chondral defects. Knee Surg Sports Traumatol Arthrosc, 2018 Apr 26(4):1130-36 (Clinical study)
  2. WALTHER, M., et al. Scaffold based reconstruction of focal full thickness talar cartilage defects. Clinical Research on Foot & Ankle, 2013, 1-5. (Clinical study)
  3. KAISER, N., et al. Clinical results 10 years after AMIC in the knee. Swiss Med Wkly, 2015, 145 (Suppl 210), 43S. (Clinical study)
  4. VOLZ, M., et al. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  5. Geistlich Pharma AG data on file (Bench test)
  6. GILLE, J., et al. Cell-Laden and Cell-Free Matrix-Induced-Chondrogenesis versus Microfracture for the Treatment of Articular Cartilage Defects: A Histological and Biomechanical Study in Sheep. Cartilage OnlineFirst, January 7, 2010, doi:10.1177/1947603509358721 (Pre-clinical study)
  7. KRAMER, J., et al. In vivo matrix-guided human mesenchymal stem cells. Cell Mol Life Sci, Mar 2006, 63(5), 616-626. (Clinical study)
  8. MITHOEFER, K., et al. The microfracture technique for the sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  9. GOYAL, D., et al. Evidence-based status of microfracture technique: a systematic review of level I and II studies. Arthroscopy, Sep 2013, 29(9), 1579-1588. (Review of clinical studies)
  10. FONTANA, A., et al. Sustained five-year benefit of autologous matrix-induced chondrogenesis for femoral acetabular impingement-induced chondral lesions compared with microfracture treatment. Bone Joint J, May 2015, 97-B(5), 628-635. (Clinical study)
  11. GAO, L., et al. Early loss of subchondral bone following microfracture is counteracted by bone marrow aspirate in a translational model of osteochondral repair.  Nature Scientif-ic Reports, 2017, 7:45189, DOI: 10.1038/srep45189 (Pre-clinical study)
  12. FRANK, R.M., et al., Failure of Bone Marrow Stimulation Techniques, Sports Med Arthrosc Rev, 2017, 25 (1) (Review of clinical studies)
  13. STEADMAN, J.R., Microfracture Technique for Full-Thickness Chondral Defects: Technique and Clinical Results. Operative Techniques in Orthopaedics. 1997. 7(4), 300-304. (Clinical study)
  14. KAISER, N., et al. Clinical results 10 years after AMIC in the knee. Swiss Med Wkly, 2015, 145 (Suppl 210), 43S. (Clinical study)
  15. VOLZ, M., et al. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  16. SCHAGEMANN, J., et al. Mid-term outcome of arthroscopic AMIC for the treatment of articular cartilage defects in the knee joint is equivalent to mini-open procedures. Arch Orthop Trauma Surg, Jan 22 2018. (Clinical study)
  17. STEINWACHS, M.R.,et al. Systematic Review and Meta-Analysis of the Clinical Evidence on the Use of Autologous Matrix-Induced Chondrogenesis in the Knee. Cartilage. 2019:1947603519870846. https://www.ncbi.nlm.nih.gov/ pubmed/31508990 (Review of clinical studies)
  18. FOSSUM, V., et al. Collagen-Covered Autologous Chondrocyte Implantation Versus  Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. Orthopaedic Journal of Sports Medicine. 019;7(9):2325967119868212. doi.org/10.1177/2325967119868212 (Clinical study)
Stato funzionale nel tempo
AMIC® mostra una performance migliore rispetto alle sole MFx dopo 2 anni.

Artroscopia o mini-artrotomia, entrambe danno buoni risultati

In uno studio retrospettivo, Schagemann et al.16 hanno confrontato i risultati clinici delle procedure di AMIC® Chondro-Gide® eseguite in artroscopia o chirurgia mini-open, in pazienti seguiti fino a 2 anni. In base alla ’ Visual Analog Scale' (VAS) dei pazienti, Lysholm scores, e Knee injury and Osteoarthrithis Outcome Scores (KOOS), entrambi gli approcci chirurgici hanno permesso di ottenere buoni risultati.

Prima Meta-analisi di 12 studi su AMIC® Chondro-Gide® su 375 pazienti

Recentemente (2019) in una revisione sistematica e meta-analisi sui risultati ottenuti con AMIC®, gli autori hanno valutato lesioni condrali e osteocondrali di grado III/IV nel ginocchio con una dimensione del difetto media di 4.24 cm2 con più di 7 anni di follow-up.

L’uso della AMIC® Chondro-Gide® per difetti di dimensione tale che siano sopra la soglia raccomandata per le MFx, riduce significativamente il dolore e migliora la funzione dal baseline al follow-up. La meta-analisi documenta che la procedura AMIC® Chondro-Gide® migliora significativamente i risultati relativi a dolore e funzionalità nelle articolazioni del ginocchio con lesioni condrali o osteocondrali. I risultati inoltre dimostrano che il miglioramento è stato mantenuto per più di 5 anni, a conferma del successo a lungo termine della procedura AMIC® Chondro-Gide® nelle lesioni maggiori di grado III (> 4 cm2) e di grado IV17.

ACI-C e AMIC® Chondro-Gide® forniscono buoni risultati dopo 2 anni 

Fossum et al. (2019) hanno condotto uno studio prospettico controllato randomizzato per valutare i risultati delle tecniche ACI-C e AMIC® nei difetti condrali e osteocondrali del femore distale e patella. Non ci sono differenze significative tra i risultati ottenuti con ACI-C e AMIC® a 1 e 2 anni.

Gli autori concludono che AMIC® può essere considerata un’alternativa a ACI-C sovrapponibile dal punto di vista clinico ma meno costosa in quanto AMIC® è a singolo step e quindi molto meno dispensiosa in termini di risorse18.

References

  1. SCHIAVONE PANNI, A., et al. Good clinical results with autologous matrix-induced chondrogenesis (Amic) technique in large knee chondral defects. Knee Surg Sports Traumatol Arthrosc, 2018 Apr 26(4):1130-36 (Clinical study)
  2. WALTHER, M., et al. Scaffold based reconstruction of focal full thickness talar cartilage defects. Clinical Research on Foot & Ankle, 2013, 1-5. (Clinical study)
  3. KAISER, N., et al. Clinical results 10 years after AMIC in the knee. Swiss Med Wkly, 2015, 145 (Suppl 210), 43S. (Clinical study)
  4. VOLZ, M., et al. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  5. Geistlich Pharma AG data on file (Bench test)
  6. GILLE, J., et al. Cell-Laden and Cell-Free Matrix-Induced-Chondrogenesis versus Microfracture for the Treatment of Articular Cartilage Defects: A Histological and Biomechanical Study in Sheep. Cartilage OnlineFirst, January 7, 2010, doi:10.1177/1947603509358721 (Pre-clinical study)
  7. KRAMER, J., et al. In vivo matrix-guided human mesenchymal stem cells. Cell Mol Life Sci, Mar 2006, 63(5), 616-626. (Clinical study)
  8. MITHOEFER, K., et al. The microfracture technique for the sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  9. GOYAL, D., et al. Evidence-based status of microfracture technique: a systematic review of level I and II studies. Arthroscopy, Sep 2013, 29(9), 1579-1588. (Review of clinical studies)
  10. FONTANA, A., et al. Sustained five-year benefit of autologous matrix-induced chondrogenesis for femoral acetabular impingement-induced chondral lesions compared with microfracture treatment. Bone Joint J, May 2015, 97-B(5), 628-635. (Clinical study)
  11. GAO, L., et al. Early loss of subchondral bone following microfracture is counteracted by bone marrow aspirate in a translational model of osteochondral repair.  Nature Scientif-ic Reports, 2017, 7:45189, DOI: 10.1038/srep45189 (Pre-clinical study)
  12. FRANK, R.M., et al., Failure of Bone Marrow Stimulation Techniques, Sports Med Arthrosc Rev, 2017, 25 (1) (Review of clinical studies)
  13. STEADMAN, J.R., Microfracture Technique for Full-Thickness Chondral Defects: Technique and Clinical Results. Operative Techniques in Orthopaedics. 1997. 7(4), 300-304. (Clinical study)
  14. KAISER, N., et al. Clinical results 10 years after AMIC in the knee. Swiss Med Wkly, 2015, 145 (Suppl 210), 43S. (Clinical study)
  15. VOLZ, M., et al. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop, Apr 2017, 41(4), 797-804. (Clinical study)
  16. SCHAGEMANN, J., et al. Mid-term outcome of arthroscopic AMIC for the treatment of articular cartilage defects in the knee joint is equivalent to mini-open procedures. Arch Orthop Trauma Surg, Jan 22 2018. (Clinical study)
  17. STEINWACHS, M.R.,et al. Systematic Review and Meta-Analysis of the Clinical Evidence on the Use of Autologous Matrix-Induced Chondrogenesis in the Knee. Cartilage. 2019:1947603519870846. https://www.ncbi.nlm.nih.gov/ pubmed/31508990 (Review of clinical studies)
  18. FOSSUM, V., et al. Collagen-Covered Autologous Chondrocyte Implantation Versus  Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. Orthopaedic Journal of Sports Medicine. 019;7(9):2325967119868212. doi.org/10.1177/2325967119868212 (Clinical study)
Steven Kramer

International Product Manager Sports Medicine