Stimulation of osteogenesis

Pulsed Electromagnetic Fields (Biostim and Biostim SPT devices)

Stimulation by inductive technology (PEMF) is used in the United States and Europe as a safe, non-invasive therapy for the following clinical applications:

• Fractures
• Fresh fractures at risk of non-union^{7, 8}
• Osteotomies^{9, 10}
• Delayed union and pseudarthrosis^{11, 12}
• Osteonecrosis^{13, 14}
• Revision of prosthetic implants¹⁵
• Painful arthroprothesis
• Complex regional pain syndrome

CLINICAL CASES BIOSTIM^® and BIOSTIM® SPT

Risk Fractures

• Exposed distal tibia fracture
  Clinical case study: Dr Giuseppe Caff, Dr Alessandro Pietropaolo, Dr Alessandro Famoso, Dr Giovanni Restuccia - Orthopaedics and Traumatology Unit ARNAS Garibaldi Catania
• Tibial Pilon Fracture
  Clinical case study: Dr A. Ambrosone - A. Perrino Hospital - Brindisi

Pseudarthrosis

• Pseudarthrosis of the femur
  Clinical case study: Dr Nino Emilio Rinaldi - Genoa
• Pseudarthrosis of the radius
  Clinical case study: Prof. Valerio Ioli, Dr Roberto Savica, Dr Domenico Fenga, A.O.U. University Hospital G. Martino, Messina

Capacitive Coupling Electric Field technique (Osteobit and Osteospine devices)

Stimulation by CCEF opens voltage-dependent calcium (Ca²⁺) channels.¹⁶ The increase in intracellular Ca²⁺ levels initiates the same cascade of events as the inductive method and, through the calmodulin metabolic pathway, leads to the release of growth factors and osteoblast proliferation.^{17, 18}

Clinical applications:

• Fractures
• Fresh operated and unoperated fractures at risk of non-union
• Delayed union and pseudarthrosis¹⁹
• Stress fractures²⁰
• Osteoporotic vertebral fractures²¹
• Bone Marrow Edema and pain^{21, 22}
• Post arthrodesis surgery²³

CLINICAL CASES OSTEOBIT^®

Delayed union

• Distal radius fracture
  Clinical case study: Dr P.P. Borelli - Brescia

Pseudarthrosis

• Clavicle fracture
  Clinical case study: Dr L. Memè – Azienda Ospedaliera Ospedali Riuniti Marche Nord (Pesaro and Fano).

CLINICAL CASES OSTEOSPINE^®

Osteoporotic fractures

• Vertebral fracture
  Clinical case study: Dr V. Piccinni - Celio Military Hospital - Rome
• Vertebral fracture
  Clinical case study: Dr A. Piazzolla - University Hospital - Bari
• Vertebral fracture
  Clinical case study: Dr M. Ferraro - Gaetano Pini Orthopaedic Institute - Milan

Post-surgical treatment

• Vertebral fracture
  Clinical case study: Dr E. Piovan - University Hospital - Verona
• Vertebral fracture
  Clinical case study: Dr A. Piazzolla - University Hospital - Bari

Low-Intensity Pulsed Ultrasound, LIPUS (FAST device)

The operating principle of FAST® Therapy is based on the generation, by means of a special transducer, of an ultrasound beam with an acoustic intensity of SATA (Spatial average-temporal average) of 30mW/cm².

FAST® Therapy delivers a signal consisting of 200 µs burst of 1.5 MHz sine waves, repeating at 1 kHz and delivering 30 mW/cm2 SATA intensity.

Stimulation by low-intensity pulsed ultrasound (LIPUS) acts through the stimulation of membrane mechanoreceptors that induce the formation of focal adhesion plaques on the cell surface and the subsequent activation of FAK kinase.²⁴ Stimulation by LIPUS promotes the activation of the enzyme cyclooxygenase-2 (COX-2), which, through the synthesis of prostaglandin E2 (PGE2)²⁵ promotes the expression of osteogenic genes, stimulating mineralisation and endochondral ossification.

Stimulation with LIPUS is a rapid, non-invasive treatment that promotes osteogenesis while reducing recovery time.

Unlike other methods that require treatment times of several hours per day (8 hours/day), the LIPUS technique requires only 20 minutes per day. The ultrasound beam is, however, rather collimated and is therefore suitable for the treatment of circumscribed areas (not exceeding 5 cm²) that must be precisely identified by means of anatomical findings. While inductive and capacitive technologies can always be used in the presence of internal fixation devices (plates, screws, nails), ultrasounds require precise identification of the direction of the ultrasound beam. If the patient has a plaque in the lateral region, the ultrasound beam needs to be directed in a mid-lateral or anteroposterior direction in order to avoid it being reflected, thus cancelling out the therapeutic benefit.

Clinical applications:

• Fractures^{26, 27}
• Fresh fractures at risk of non-union²⁸
• Delayed union and pseudarthrosis²⁹
• Stress fractures

PDF casi clinici FAST

Control of the articular environment (I-ONE and I-ONE TPC devices)

The administration of biophysical stimuli dedicated to joint wellbeing involves the use of electromagnetic energy applied using coils (inductive technique, Pulsed Electromagnetic Fields or PEMF).

Through multiple preclinical studies both in-vivo and in-vitro, it was possible to identify the mechanism of action of PEMF stimulation with joint-specific signal.

The following effects were observed:

• Up-regulation of adenosine A_2A receptors expressed on the surface of chondrocytes, synoviocytes and osteoblasts resulting in a strong anti-inflammatory effect;³⁰
• Inhibition of the catabolic action of pro-inflammatory cytokines;^{31, 32}
• Increased chondrocyte anabolic activities and proteoglycan synthesis;³³
• Prevention of osteoarthritic degeneration: limitation of articular cartilage fissuring phenomena, maintenance of cartilage thickness and prevention of sclerosis phenomena in subchondral bone;^{34, 35}
• Repair of tissue damage following osteochondral transplantation,³⁶ inhibition of pro-inflammatory cytokine release (IL-1ß and TNFa) and increased TGFß1 synthesis.

Clinical applications:

• Degenerative joint diseases: early osteoarthritis,³⁷ inflammatory joint processes.³⁸
• Post-surgical treatment after restorative or regenerative medicine procedures: microfractures, cartilage abrasions, osteocartilage transplants, mesenchymal cell transplants.^39-42
• Bone Marrow Edema
• Complex regional pain syndrome
• Spontaneous osteonecrosis of the knee.⁴³
• Post-arthroplasty treatment to inhibit inflammatory processes and chronic pain.^{44, 45}

CLINICAL CASES I-ONE^® and I-ONE® TPC

Complex regional pain syndrome

• Medial femoral condyle
  Clinical case study: Prof. F. Franceschi - University Hospital Biomedical Campus - Rome

Bone Marrow Edema

• Tibial plateau
  Clinical case study: Prof. F. Franceschi - University Hospital Biomedical Campus - Rome

Spontaneous osteonecrosis of the knee

• Medial femoral condyle
  Clinical case study: Dr G.M. Marcheggiani Muccioli - Rizzoli Orthopaedic Institute - Bologna

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