The Use of Bone Stimulators With Athletes James Sullivan DPM, ATC EATA Symposium 2006 Philadelphia, Pennsylvania
Bone • Anatomical Structure • Physiological Organ
Bone • Anatomical Structure • Provides rigid framework • Serves as a lever system for movement • Provides protection to vulnerable viscera
Physiological Organ • Contains hemopoetic tissue • Production of Erythrocytes • Production of Leukocytes • Production of Platelets
Physiological Organ of Storage • Calcium • Phosphorus • Magnesium • Sodium
Bone Cells • Osteoblasts • Osteoclasts • Osteocytes • Bone Morphogenic Protein
Osteoblasts • Essential for osteogenesis or ossification, since they produce the matrix in which calcification will occur. Once calcification occurs in the matrix, the tissue is bone.
Osteocytes • An osteoblast once surrounded by the organic intercelluar substance, (or matrix), that it forms, it is then within the lacuna. It is now an osteocyte. Each osteocyte extends cytoplasmic processes or canuliculi to connect to neighboring osteocytes.
Bone Morphogenic Protien • Bone Morphogenic Protien, (BMP), is responsible for differentiation of the mesenchymal cells to osteoblasts.
Blood Supply to Bone • Afferent vascular system involving nutrient and metaphyseal arteries that combine to supply the inner two thirds of the cortex and the periosteal arteries that supply the outer one third.
Blood Supply to Bone • Efferent vascular system that conveys venous blood
Cortical Bone • Initial bleeding followed by clotting of vessels at fracture sight and a few millimeters away from the fracture sight. • Fracture hematoma gives a medium for early stages of healing
Cortical Bone • Internal and external callus formation occurs • Stage of Clinical Union • Stage of consolidation or radiographic union
Cancellous Bone • Healing primarily occurs through an internal or endosteal callus formation, within the fracture hematoma • Woven or non-lemellar bone quickly forms within the endosteal callus • Woven bone is replaced with lemellar bone which creates a clinical union, remodeling and consolidation follows
Fracture Demographics • >6,000,000 Fractures Annually • 3% - 5% Non-Healing • 200,000 - 300,000 Non - Healing
Stages of Fracture Healing • Hematoma Formation and Inflammation • Cartilage Formation • Cartilage Calcification and Angiogenesis • Bone Formation • Remodeling of Fracture Callus
Historical Background Historical Background Authors Publication Date Topic Fukada and Yasuda 1954, 1957 Piezoelectric Properties of Dry Bone Bassett and Becker 1962 Electrical Properties of Hydrated Bone Friedenberg and Brighton 1966 Electrical Properties of Hydrated Bone Sham os and Lavine 1967 Piezoelectric Properties of Biological Tissues Anderson and Eriksson 1968 Electrical Properties of Hydrated Collagen Bassett and Pawluk; Lotke, Black, 1972, 1974, Electrom echanical Properties of Richardson; Grodzinsky, Lipshitz, 1978 Articular Cartilage Glim cher
History of Bone Stimulators • 1979 - FDA approves PEMF technology for treatment of non-unions • 1985 - Brighton and Pollack report on the treatment of non-unions with direct current • 1986 - FDA approves the use of capacitive coupling technology for treatment of non- unions
History of Bone Stimulators • 1994 - FDA approves the use of CMF technology in the treatment of non-unions • 1994 - FDA approves the use of ultrasound technology in the use of fresh fractures
The Bone Formation Cycle The Bone Formation Cycle 2. Biological 1. Matrix: Stimulants Osteoconduction Osteopromotion Osteoinduction Nutrition Nutrition 3. Cells Osteogenicity
Biophysical Stimulation Biophysical Stimulation of Bone Formation of Bone Formation � Electrical and Electromagnetic Field – CCEF, CMF, DC, PEMF � Ultrasound – SAFHS, Lithotripter fields � Laser – Invasive, experimental � Mechanical – Dynamic loading of external fixation, vibration
Biochemical Mechanisms Biochemical Mechanisms � At the cell/tissue level, consider � CCEF these different techniques to be � CMF similar to biophysical stimuli � PEMF � What might be the common mechanism(s) underlying the cell/tissue level response?
Common Biologic Stimulants Common Biologic Stimulants � Insulin-like growth factor (IGF) � Transforming growth factor-beta (TGF- B ) � Platelet-derived growth factor (PDGF) � Fibroblast growth factor (FGF) � Bone morphogenic protein 2 (BMP-2) � Bone morphogenic protein 7 (BMP-7)
Biological Stimulants in Bone Formation Biological Stimulants in Bone Formation Growth factor effect on bone formation Chemotaxis: Growth Chemotaxis: Growth factors attract progenitors factors attract progenitors Osteocyte 2. Biological Osteoprogenitors Pre-osteoblast Osteoblast Stimulants Proliferation Differentiation Matrix formation phase phase phase Bone formation: Proliferation: Differentiation: Bone formation: Proliferation: Differentiation: Growth factors Growth factors Growth factors Growth factors Growth factors Growth factors enhance increase enhance bone enhance increase enhance bone differentiation ECM formation proliferation rates differentiation ECM formation proliferation rates rates rates
Osteocytes • REMEMBER - Once and osteoblast surrounds itself with that organic substance called the matrix it becomes and osteocyte. The osteocytes then extend cytoplasmic processes to connect to neighboring osteocytes. BONE FORMATION
Growth Factor Studies Growth Factor Studies IGF-II Magnetic Field IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II 1) Increased IGF-II Production 2) Increased IGF-II Receptor Expression Amplification 3) Increased Cell Proliferation Cascade
CMF Effects on Osteoblasts • Fitzsimmons, et al, 1995 ^IGF-II • Fitzsimmons, et al, 1995 ^IGF-II • Fitzsimmons, et al, 1994 ^Ca Flux • Ryaby, et al, 1994 ^IGF-II in Fx • Callus
Growth Factor Model Growth Factors (i.e. IGFs) GF Receptors Educational Purposes Only. Do Not Copy or Distribute.
CMF Signal Differentiation CMF Signal Differentiation ITS DIFFERENT!!! T 20 d l e i F c i t Ma g ne tic Fie ld Ma g ne tic Fie ld e n g (Ga us s ) (Ga us s ) a M 0 20 0 1990’s OrthoLogic Technology CMF ( ombined agnetic ield) C M F Educational Purposes Only. Do Not Copy or Distribute.
Pulsed Magnetic Fields Improve Osteoblast Activity Pulsed Magnetic Fields Improve Osteoblast Activity During the Repair of an Experimental Osseous Defect During the Repair of an Experimental Osseous Defect Cane et al. (1993) Cane et al. (1993) J. Orthop. Res. J. Orthop. Res. 11:664-670 11:664-670 • Transcortical holes in horses • 75 Hz PEMF continuous for 30 days • Histomorphometric analysis (BV% and MAR) • > 2-fold increase in TBV (p<.01) and MAR (p<.001) with PEMF exposure Educational Purposes Only. Do Not Copy or Distribute.
Pulsed Magnetic Fields Improve Osteoblast Activity Pulsed Magnetic Fields Improve Osteoblast Activity During the Repair of an Experimental Osseous Defect During the Repair of an Experimental Osseous Defect Cane et al. (1993) Cane et al. (1993) J. Orthop. Res. J. Orthop. Res. 11:664-670 11:664-670 Educational Purposes Only. Do Not Copy or Distribute.
PEMF – PMA Study (EBI) PEMF – PMA Study (EBI) • 146 nonunions • > 9 months post injury • 2.3 average number of prior surgeries • 63.5% efficacy in 115 patients @ long term (4 year) follow-up • 8 – 10 hours/day Educational Purposes Only. Do Not Copy or Distribute.
CMF Technology CMF Technology � Frequency within the optimal range for bone stimulation (<150 Hz) – AC (Sine Wave) • Frequency: 76.6 Hz • .2-.4 gauss – DC (Static Field) • .2 gauss
CMF Reversal of OVX-osteopenia CMF Reversal of OVX-osteopenia • Direct calculation of trabecular bone • Synchrotron-based x-ray compressive tomographic microscopy modulus by FEM XTM Tibial Analysis Site
CMF Effect on Growth Factor Production CMF Effect on Growth Factor Production Rat Spine Fusion Model Rat Spine Fusion Model 40 PCR Products (ng) 30 20 10 0 IGF-1 IGF-1 CMF BMP-7 BMP-7 CMF BMP-2 BMP-2 CMF CONT CONT CONT
OL1000 Clinical Study OL1000 Clinical Study � The “Gold Standard” Clinical Study – Strict entrance criteria – Rigorous endpoint – Independent radiographic verification – No forced adjunctive treatment
OL1000 Clinical Study OL1000 Clinical Study � Entrance Criteria – Nonunion (trauma) – >9 months post-injury – No surgery prior 3 months – No radiographic evidence of healing for prior 3 months • Independent, blinded panel verification � Study Participants – 112 patients with 116 nonunions – 29.3 months mean time since initial injury • Range from 8.5 months to 256.0 months – 2.5 mean number of prior surgeries • Range from 0 to 11
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