The Use of Bone Stimulators With Athletes. James Sullivan DPM, ATC EATA Symposium 2006 Philadelphia, Pennsylvania

Transcription

1 The Use of Bone Stimulators With Athletes James Sullivan DPM, ATC EATA Symposium 2006 Philadelphia, Pennsylvania

2 Bone Anatomical Structure Physiological Organ

3 Bone Anatomical Structure Provides rigid framework Serves as a lever system for movement Provides protection to vulnerable viscera

4 Physiological Organ Contains hemopoetic tissue Production of Erythrocytes Production of Leukocytes Production of Platelets

5 Physiological Organ of Storage Calcium Phosphorus Magnesium Sodium

6 Bone Cells Osteoblasts Osteoclasts Osteocytes Bone Morphogenic Protein

7 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.

8 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.

9 Bone Morphogenic Protien Bone Morphogenic Protien, (BMP), is responsible for differentiation of the mesenchymal cells to osteoblasts.

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11 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.

12 Blood Supply to Bone Efferent vascular system that conveys venous blood

13 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

14 Cortical Bone Internal and external callus formation occurs Stage of Clinical Union Stage of consolidation or radiographic union

15 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

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17 Fracture Demographics >6,000,000 Fractures Annually 3% - 5% Non-Healing 200, ,000 Non - Healing

18 Stages of Fracture Healing Hematoma Formation and Inflammation Cartilage Formation Cartilage Calcification and Angiogenesis Bone Formation Remodeling of Fracture Callus

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20 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 Shamos and Lavine 1967 Piezoelectric Properties of Biological Tissues Anderson and Eriksson 1968 Electrical Properties of Hydrated Collagen Bassett and Pawluk; Lotke, Black, Richardson; Grodzinsky, Lipshitz, Glimcher 1972, 1974, 1978 Electromechanical Properties of Articular Cartilage

21 History of Bone Stimulators FDA approves PEMF technology for treatment of non-unions Brighton and Pollack report on the treatment of non-unions with direct current FDA approves the use of capacitive coupling technology for treatment of nonunions

22 History of Bone Stimulators FDA approves the use of CMF technology in the treatment of non-unions FDA approves the use of ultrasound technology in the use of fresh fractures

23 The Bone Formation Cycle 1. Matrix: Osteoconduction Nutrition 2. Biological Stimulants Osteopromotion Osteoinduction 3. Cells Osteogenicity

24 Biophysical Stimulation 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

25 Biochemical Mechanisms CCEF CMF PEMF At the cell/tissue level, consider these different techniques to be similar to biophysical stimuli What might be the common mechanism(s) underlying the cell/tissue level response?

26 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)

27 Biological Stimulants in Bone Formation Growth factor effect on bone formation Chemotaxis: Growth factors attract progenitors 2. Biological Stimulants Osteoprogenitors Pre-osteoblast Osteoblast Osteocyte Proliferation phase Differen tiation phase Matrix formation phase Proliferation: Growth factors enhance proliferation rates Differentiation: Growth factors increase differentiation rates Bone formation: Growth factors enhance bone ECM formation

28 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

29 Growth Factor Studies Magnetic Field 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 3) Increased Cell Proliferation IGF-II Amplification Cascade IGF-II IGF-II

30 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

31 Growth Factor Model Growth Factors (i.e. IGFs) GF Receptors Educational Purposes Only. Do Not Copy or Distribute.

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33 CMF Signal Differentiation ITS DIFFERENT!!! 20 Ma g ne tic Fie ld (Ga us s ) 0 Ma g ne tic Fie ld (Ga us s ) 20 Ma gnetic Field T s OrthoLogic Technology CMF ( Combined Magnetic Field) Educational Purposes Only. Do Not Copy or Distribute.

34 Pulsed Magnetic Fields Improve Osteoblast Activity During the Repair of an Experimental Osseous Defect Cane et al. (1993) J. Orthop. Res. 11: 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.

35 Pulsed Magnetic Fields Improve Osteoblast Activity During the Repair of an Experimental Osseous Defect Cane et al. (1993) J. Orthop. Res. 11: Educational Purposes Only. Do Not Copy or Distribute.

36 PEMF PMA Study (EBI) 146 nonunions > 9 months post injury 2.3 average number of prior surgeries 63.5% efficacy in 115 long term (4 year) follow-up 8 10 hours/day Educational Purposes Only. Do Not Copy or Distribute.

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38 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

39 CMF Reversal of OVX-osteopenia Synchrotron-based x-ray tomographic microscopy Direct calculation of trabecular bone compressive modulus by FEM XTM Tibial Analysis Site

40 CMF Effect on Growth Factor Production Rat Spine Fusion Model 40 PCR Products (ng) IGF-1 CONT IGF-1 CMF BMP-7 CONT BMP-7 CMF BMP-2 CONT BMP-2 CMF

41 OL1000 Clinical Study The Gold Standard Clinical Study Strict entrance criteria Rigorous endpoint Independent radiographic verification No forced adjunctive treatment

42 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 months 2.5 mean number of prior surgeries Range from 0 to 11

43 OL1000 Clinical Study Healed Criteria Clinically No pain or motion at the fracture site Radiographically 3 of 4 cortices bridged Independent, blinded panel verification

44 OL1000 Clinical Study Results Two Reference Points 1) Original Study 2) Original Long-term Follow-up

45 Original Study Results Percent Healed 80% 70% 60% 50% 40% 30% 20% 10% 0% 61% 76% 74% All Cases Tibiae <24 Months Post-Injury Healing Time 6.0 months Healing Time 5.8 months Healing Time 5.8 months

46 Long-Term Follow-up All patients (100%) remained healed at a minimum of two years post-treatment follow-up 10% drop-out OL1000 is the only BGS that did not have efficacy results downgraded at long-term follow-up

47 dj Ortho Regentek OL1000 CMF technology Combined Magnetic Field 30 minutes per day Lightweight Noninvasive One-button operation

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49 Bone Stimulators When do you use a Bone Stimulator on a fracture with an athlete??????

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51 Stress Fractures SIMPLY - Failure of the normal reparative process of bone to keep pace with the microtrauma or stresses of activity. Osteoblastic activity can not keep up with ostoclastic activity or the break down of bone due to some sort of trauma.

52 Stress Fractures TIBIA = The most common site of Stress Fractures in athletes accounting for up to 50% in some literature. Stress Fractures in the Athlete, Monteleone, G, Orthopedic Clinics of N America, 1995.

53 Fifth Metatarsal Jones Fracture - Fracture involving the metaphysial-diaphysial junction. Intraarticular involving 4th and 5th metatarsals. Avulsion Fractures - Lateral band of the Plantar Aponeurosis, Richi, WR, Rosenthal, DJ, Diaphysial Stress Fractures - Involves the proximal 1.5 cm of metatarsal.

54 Fifth Metatarsal The blood supply to the fifth metatarsal is identical to most other tubular bones. Nutrient artery to shaft. Metaphysial and epiphysial arteries to the base and tuberosity. Shereff, MJ., 1991 and Smith, JW., 1992

55 Fifth Metatarsal Periosteal plexus provides blood to the periosteum and the cortical bone. Large extraosseous vascular plexus is adjacent to the intermetatarsal articulation. Shereff, MJ., et al, Foot and Ankle, , 1991.

56 Treatment of Stress Fractures 1. Decrease or Stop Activity with or without immobilization 2. Treat the inflammatory condition 3. Correct the biomechanical etiology CAN WE DO MORE TO FACILITATE THE RETURN TO PLAY?

57 Calendar Year January to December Average 12 Months

58 College Athletics Football Season - August to January Hockey Season - September to March Track and Field Season - March to June Average Months

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60 Summary Physical stimulation affects bone repair in well controlled human clinical trials Cell/tissue level mechanism may be due to stimulation of local growth factor biosynthesis Many questions remain unanswered at the clinical level, specifically patient outcomes Educational Purposes Only. Do Not Copy or Distribute.

61 Summary Comparable efficacy for most of the EMF/US technologies Newer technologies (CMF and US) have: Improved patient compliance due to reduced daily treatment time Non-contact vs. contact mode Portability Educational Purposes Only. Do Not Copy or Distribute.

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