The Use of Bone Stimulators With Athletes James Sullivan DPM, ATC - - PowerPoint PPT Presentation

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

• ccurs in the matrix, the tissue is bone.

Osteocytes

• An osteoblast once surrounded by the
• rganic 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

• ne 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
• ccurs
• 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

• s 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, Glim cher 1972, 1974, 1978 Electrom echanical Properties of Articular Cartilage

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

Nutrition Nutrition

• 3. Cells

Osteogenicity

• 1. Matrix:

Osteoconduction

• 2. Biological

Stimulants Osteopromotion Osteoinduction

Biophysical Stimulation

• f Bone Formation

Biophysical Stimulation

• f 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

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?

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)

Bone formation: Growth factors enhance bone ECM formation Bone formation: Growth factors enhance bone ECM formation

Biological Stimulants in Bone Formation Biological Stimulants in Bone Formation

• 2. Biological

Stimulants Growth factor effect on bone formation

Osteoprogenitors Pre-osteoblast Osteoblast Osteocyte Proliferation phase Differentiation phase Matrix formation phase Chemotaxis: Growth factors attract progenitors Chemotaxis: Growth factors attract progenitors Differentiation: Growth factors increase differentiation rates Differentiation: Growth factors increase differentiation rates Proliferation: Growth factors enhance proliferation rates Proliferation: Growth factors enhance proliferation 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

• steocytes. BONE FORMATION

IGF-II

IGF-II

Magnetic Field

1) Increased IGF-II Production 2) Increased IGF-II Receptor Expression 3) Increased Cell Proliferation

Amplification Cascade

IGF-II

IGF-II IGF-II IGF-II

IGF-II IGF-II

IGF-II IGF-II IGF-II IGF-II IGF-II IGF-II

Growth Factor Studies Growth Factor Studies

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

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GF Receptors Growth Factors (i.e. IGFs)

Growth Factor Model

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CMF Signal Differentiation CMF Signal Differentiation ITS DIFFERENT!!!

1990’s OrthoLogic Technology CMF ( ombined agnetic ield) C M F

Ma g ne tic Fie ld Ma g ne tic Fie ld

20 20 (Ga us s ) (Ga us s )

M a g n e t i c F i e l d T

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

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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

CMF Technology CMF Technology

Frequency within the

• ptimal range for bone

stimulation (<150 Hz)

– AC (Sine Wave)

• Frequency: 76.6 Hz
• .2-.4 gauss

– DC (Static Field)

• .2 gauss

XTM Tibial Analysis Site

• Synchrotron-based x-ray

tomographic microscopy

CMF Reversal of OVX-osteopenia CMF Reversal of OVX-osteopenia

• Direct calculation of

trabecular bone compressive modulus by FEM

CMF Effect on Growth Factor Production Rat Spine Fusion Model CMF Effect on Growth Factor Production Rat Spine Fusion Model

10 20 30 40 PCR Products (ng) IGF-1 CONT IGF-1 CMF BMP-7 CONT BMP-7 CMF BMP-2 CONT BMP-2 CMF

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

OL1000 Clinical Study OL1000 Clinical Study

Healed Criteria

– Clinically

• No pain or motion at the fracture site

– Radiographically

• 3 of 4 cortices bridged
• Independent, blinded panel verification

OL1000 Clinical Study Results OL1000 Clinical Study Results

Two Reference Points

1) Original Study 2) Original Long-term Follow-up

Original Study Results Original Study Results

0% 10% 20% 30% 40% 50% 60% 70% 80% All Cases Tibiae <24 Months Post-Injury

Percent Healed

61% 76% 74%

Healing Time 6.0 months Healing Time 5.8 months Healing Time 5.8 months

Long-Term Follow-up 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

dj Ortho Regentek™ OL1000 dj Ortho Regentek™ OL1000

CMF technology

– Combined Magnetic Field

30 minutes per day Lightweight Noninvasive One-button operation

Bone Stimulators

• When do you use a Bone Stimulator on a

fracture with an athlete??????

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
• stoclastic activity or the break down of

bone due to some sort of trauma.

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.

Fifth Metatarsal

• Jones Fracture - Fracture involving the

metaphysial-diaphysial junction. Intra- articular involving 4th and 5th metatarsals.

• Avulsion Fractures - Lateral band of the

Plantar Aponeurosis, Richi, WR, Rosenthal, DJ, 1984.

• Diaphysial Stress Fractures - Involves the

proximal 1.5 cm of metatarsal.

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

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, 350-

353, 1991.

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?

Calendar Year

• January to December
• Average 12 Months

College Athletics

• Football Season - August to January
• Hockey Season - September to March
• Track and Field Season - March to June
• Average - 5.6 Months

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Summary 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.

Summary 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