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Global Regenerative Trade

OSTEOPLASTY

Tibial plateau, calcaneus and metaphyseal fracture balloon augmentation
 

OSTEOPLASTY kit is a minimally invasive system for the reduction of metaphyseal fractures and bone height restoration, reducing related pain.

The procedure is intended to be used for tibial plateau, calcaneus and distal radius injuries.

The procedure described is indicated for the treatment of patients who have been diagnosed with a tibial plateau depression fracture, according to the Schatzker classification system, corresponding to:

  • TYPE II fractures
  • TYPE III fractures

The system, depending on the fracture type and bone quality, can be used with or without additional plates and/or screws.

why us

MEDICAL PROFESSIONALS

OSTEOPLASTY kit is a minimally invasive system for the reduction of metaphyseal fractures and bone height restoration, reducing related pain.

  • Totally minimally invasive solution
  • Bone height restoration: gradual and controlled elevation of the area to be treated.
  • Reduced risk of infections
  • Preservation of physiological anatomy and protection of the treated area for any subsequent revisions
  • Fast recovery after treatment
  • 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.

– 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

– 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.

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.

VIDEOS FOR YOU!

DOWNLOAD LITERATURE!

Tibial plateau, calcaneus and metaphyseal fracture balloon augmentation

OSTEOPLASTY

OSTEOPLASTY kit is a minimally invasive system for the reduction of metaphyseal fractures and bone height restoration, reducing related pain.

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SUPPORTING EVIDENCE

 

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: