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.
FIELDS OF APPLICATION
about the product
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
– 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
Identify the Bone Marrow Lesion (BML) using a fat-suppressed MRI (T2) and choose the optimal approach and trajectory.
Through intraoperative fluoroscopy, target the defect associated with Bone Marrow Lesion (BML) linked to the MRI results.
Access the bone defect using Orthoplasty access tools kit.
Fill bone defect with bone substitute under fluoroscopic guidance.
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.
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)
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
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
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
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 –
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
Stem Cells International
Volume 2019, Article ID 5901479, 13 pages
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