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Global Regenerative Trade

ORTHOPLASTY

Subchondral bone plasty

ORTHOPLASTY is a disposable device for treating subchondral bone lesions.

The subchondral bone plasty procedure is a minimally-invasive, fluoroscopically-assisted procedure that identifies and repairs subchondral bone defects, also named Bone Marrow Lesions (BMLs)The procedure is carried out with a minimally-invasive approach under fluoroscopy guidance along with arthroscopy, to target and manage of findings inside the joint.

The pathology is classified as a SIFK (Subchondral Insufficiency Fracture of the Knee) and in the initial stages of SONK (Spontaneous Osteonecrosis of the Knee). The patient that presents with this pathology, suffers from relatively early osteoarthritis and consults the clinical specialist as a result of intense pain that does not correspond to a significantly compromised radiographic scenario.

In fact, these lesions are not visible under X-Ray and only a diagnostic confirmation using MRI reveals a hyper-intense uptake signal in sequences sensitive to T2 fluids (hydrogen) and in STIR sequences.

The objective of the method is to reinforce subchondral bone lesions using the same principal as vertebroplasty and involves the percutaneous insertion into the bone rarefaction site, of an appropriate bone substitute or of an autologous bone graft enhanced with a concentrate of mesenchymal stromal cells.

ORTHOPLASTY BENEFITS

FIELDS OF APPLICATION

about the product

MEDICAL PROFESSIONALS

ORTHOPLASTY The subchondral bone plasty procedure is a minimally-invasive, fluoroscopically-assisted procedure that identifies and repairs subchondral bone defects, also named Bone Marrow Lesions (BMLs).

Reduced risk of infections

  • Ready-to-use bone substitute
  • no preparation needed
  • Hardening in wet environment only: no time pressure during application
  • Truly biologic: composed by a micro-crystalline, calcium deficient hydroxyapatite – major bone constituent
  • High load sharing properties (up to 45 MPa)
  • Radio-opaque paste: clearly visible under fluoroscopy and X-rays
  • Bioresorbable during bone remodeling

SURGICAL TECHNIQUE​

COMPONENTS

– WORKING CANNULA with trocar tip stylet

made by an external cannula with ultrasharp crown tip used as working channel and an internal stylet with trocar tip to access the subchondral bone. The needle has a plastic handle.

 

– DRILL STYLET

composed by a metal part with distal bone drill (screwed terminal portion) and a plastic handle. This device is used to dig into the bone to target the area to be treated.

– DIRECTABLE BONE FILLER 

is a cement infusion cannula (often referred to as the “filler” cannula) and consists of a steel cannula with a plastic handle, equipped with a pusher stylet. The lateral holes in the cannula allow a directable injection of the bone cement in the area to be treated. The plastic handle has a universal luer lock connection for filling the cannula with bone cement. Also dedicated injection syringes with luer lock connection are present in the kit.

– BIOLOGICAL CEMENT (optional)

  • truly biological
  • ready-to-use: “tooth paste” consistence
  • no time pressure: “infinite” working time
  • hardening in wet environment only
  • radio-opaque
  • bioresorbable

SURGICAL TECHNIQUE

  1. Identify the Bone Marrow Lesion (BML) using a fat-suppressed MRI (T2) and choose the optimal approach and trajectory.

  2. Through intraoperative fluoroscopy, target the defect associated with Bone Marrow Lesion (BML) linked to the MRI results.

  3. Access the bone defect using Orthoplasty access tools kit.

  4. Fill bone defect with bone substitute under fluoroscopic guidance.

  5. Alternatively, BML defects can be filled with Marrow-Stem kit, using the creeping substitution technique and marrow mesenchymal stem cells instead of a bone substitute.

DOWNLOAD LITERATURE!

Subchondral bone plasty

ORTHOPLASTY

ORTHOPLASTY is a disposable device for treating subchondral bone lesions.

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SUPPORTING EVIDENCE

ORTHO & SPORT MEDICINE APPLICATIONS

 

Adipose-Derived Mesenchymal Stem Cells for the Treatment of Articular Cartilage: A Systematic Review on Preclinical and Clinical Evidence

Francesco Perdisa, Natalia GostyNska, Alice Roffi,2 Giuseppe Filardo, Maurilio Marcacci and Elizaveta Kon – Hindawi Publishing

Corporation Stem Cells International Volume 2015, Article ID 597652, 13 pages http://dx.doi.org/10.1155/2015/597652

 

Adipose-derived stem cells in orthopaedic pathologies

Federico Giuseppe Usuelli, Riccardo D’Ambrosi, Camilla Maccario, Cristian Indino, Luigi Manzi and Nicola Maffulli – British Medical

Bulletin, 2017, 1–24 doi: 10.1093/bmb/ldx030

  

 

Mesenchymal Stem Cells injection in hip osteoarthritis: preliminary results

Carlo Dall’Oca, Stefano Breda, Nicholas Elena, Roberto Valentini, Elena Manuela Samaila, Bruno Magnan – Acta Biomed 2019; Vol.

90, Supplement 1: 75-80 DOI: 10.23750/abm.v90i1-S.8084

 

 

Intra-Articular Administration of Autologous Micro-Fragmented Adipose Tissue in Dogs with Spontaneous Osteoarthritis: Safety, Feasibility and Clinical Outcomes

Offer Zeira, Simone Scaccia, Letizia Pettinari, Erica Ghezzi, Nimrod Asiag, Laura Martinelli, Daniele Zahirpour, Maria P. Dumas, Martin Konar, Davide M. Lupi, Laurence Fiette, Luisa Pascucci, Leonardo Leonardi, Alistair Cliff, Giulio Alessandri, Augusto Pessina,

Daniele Spaziante, Marina Aralla – Stem Cells Translational Medicine 2018;00:1–10

 

 

Micro-fragmented adipose tissue injection associated with arthroscopic procedures in patients with symptomatic knee osteoarthritis

G. Cattaneo, A. De Caro, F. Napoli, D. Chiapale, P. Trada and A. Camera – Cattaneo et al. BMC Musculoskeletal Disorders (2018)

19:176 https://doi.org/10.1186/s12891-018-2105-8

 

 

The Effect of Intra-articular Injection of Autologous Microfragmented Fat Tissue on Proteoglycan Synthesis in Patients with Knee Osteoarthritis

Damir Hudetz, Igor Borić, Eduard Rod, Željko Jeleč , Andrej Radić, Trpimir Vrdoljak, Andrea Skelin, Gordan Lauc, Irena Trbojević-

Akmačić, Mihovil Plečko, Ozren Polašek and Dragan Primorac – Genes 2017, 8, 270; doi: 10.3390/genes8100270

 

 

Autologous and micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis

A. Russo, V. Condello, V. Madonna, M. Guerriero and C. Zorzi – Russo et al. Journal of Experimental Orthopaedics (2017) 4:33

DOI 10.1186/s40634-017-0108-2

 

 

Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance

R.D. Striano, H. Chen, N. Bilbool, K. Azatullah, J. Hilado, K. Horan – CellR4 2015; 3 (5): e1690

 

 

Non-Responding Knee Pain with Osteoarthritis, Meniscus and Ligament Tears Treated with Ultrasound Guided Autologous, Micro-Fragmented and Minimally Manipulated Adipose Tissue

Richard David Striano, Valeria Battista, Norma Bilboo – Open Journal of Regenerative Medicine, 2017, 6, 17-26

http://www.scirp.org/journal/ojrm

 

 

Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees

Jay Panchal, MD Gerard Malanga, MD Mitchell Sheinkop, MD – Am J Orthop. 2018;47(11)

 

 

Microfragmented adipose injections in the treatment of knee osteoarthritis

Gerard A. Malanga, Sean Bemanian – Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.10.021

 

 

Autologous micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis: an update at 3 year follow-up

Russo, D. Screpis, S. L. Di Donato, S. Bonetti, G. Piovan and C. Zorzi – Russo et al. Journal of Experimental Orthopaedics (2018) 5:52

https://doi.org/10.1186/s40634-018-0169-x

 

Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response

Alfredo Schiavone Panni & Michele Vasso & Adriano Braile & Giuseppe Toro & Annalisa De Cicco & Davide Viggiano & Federica

Lepore – International Orthopaedics (SICOT) (2019) 43:7–13

 

Refractory Shoulder Pain with Osteoarthritis and Rotator Cuff Tear Treated With Micro-Fragmented Adipose Tissue

Richard D Striano, Gerard A Malanga, Norma Bilbool, Khatira Azatullah – BIBLIOTICS JOURNALS Orthop Spine Sports Med (2018) 2:1 014 

 

Injection of autologous micro-fragmented adipose tissue for the treatment of post-traumatic degenerative lesion of knee cartilage: a case report

M. Franceschini, C. Castellaneta, G. Mineo – CellR4 2016; 4 (1): e1768

 

Video Article Autologous Microfractured and Purified Adipose Tissue for Arthroscopic Management of Osteochondral Lesions of the Talus

Riccardo D’Ambrosi, Cristian Indino1, Camilla Maccario, Luigi Manzi, Federico Giuseppe Usuelli –

URL: https://www.jove.com/video/56395

DOI: doi:10.3791/56395

 

BASIC SCIENCE

 

Long-Lasting Anti-Inflammatory Activity of Human Microfragmented Adipose Tissue

Sara Nava, Valeria Sordi, Luisa Pascucci, Carlo Tremolada, Emilio Ciusani, Offer Zeira, Moris Cadei, Gianni Soldati, Augusto Pessina,
Eugenio Parati, Mark Slevin and Giulio Alessandri
Hindawi
Stem Cells International
Volume 2019, Article ID 5901479, 13 pages
https://doi.org/10.1155/2019/5901479

A New Nonenzymatic Method and Device to Obtain a Fat Tissue Derivative Highly Enriched in Pericyte-Like Elements by Mild Mechanical Forces from Human Lipoaspirates
Francesca Bianchi, Margherita Maioli, Erika Leonardi,§ Elena Olivi, Gianandrea Pasquinelli, Sabrina Valente, Armando J. Mendez,
Camillo Ricordi, Mirco Raffaini, Carlo Tremolada and Carlo Ventura
Cell Transplantation, Vol. 22, pp. 2063–2077, 2013

Lipogems, a New Modality of Fat Tissue Handling to Enhance Tissue Repair in Chronic Hind Limb Ischemia
F. Bianchi, E. Olivi, M. Baldassarre, F.A. Giannone, M. Lagge-a, S. Valente, C. Cavallini, R. Tassinari, S. Canaider, G. Pasquinelli, C.
Tremolada, C. Ventura
CellR4 2014; 2 (6): e1289

Human Lipoaspirate as Autologous Injectable Active Scaffold for One-Step Repair of Cartilage Defects
Michela Bosetti, Alessia Borrone, Antonia Follenzi, Fanuel Messaggio, Carlo Tremolada and Mario Cannas
Cell Transplantation, Vol. 25, pp. 1043–1056, 2016

Characteristics and Properties of Mesenchymal Stem Cells Derived from Microfragmented Adipose Tissue
Stephana Carelli, Fanuel Messaggio, Alessandra Canazza, Danuta Maria Hebda, Filippo Caremoli, Elisa Latorre, Maria Grazia
Grimoldi, Mattia Colli, Gaetano Bulfamante, Carlo Tremolada, Anna Maria Di Giulio and Alfredo Gorio
Cell Transplantation, Vol. 24, pp. 1233–1252, 2015

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THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS: