Ultrasonido en Fracturas

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INGENIERIA DE REHABILITACIÓN

IngenieríaEleclrónica. Automática y Comunicaciones, Vol. .\.XHI. No. 1. 2002

Acceleration of osseous fracture repair by low-intensity pulsed ultrasound therapy: a preliminary study
O. Rodriguez' & R. MonreaP

'In.s/iiiito de Cibernélica, Matemática y Física (ICIMAf), CITMA, Ciudad de La Habana. Cuba. •Hospital Comandante Manuel Fajardo. Ciudad de La Habana, Cuba.

RESUMEN I ABSTRACT
Ultrasound ti-eatinerit has been shown to stimulate osseous fracture repair in many clinical studies. Tliis paper presents the resitlts obtained in a .study effected in a total of fifteen imunited fractures, including new fractures, delayed unions and no-unions were treated dailv for twenty »limites with a pulsed ultrasound signal of 30 m W/cm- (SATA), and pulse bursts width of 400 s repeated, with a frequency of 0,5 kHz. llie treatments were applied until the fractures were clinically and radiographicallv healed. Many of these patients had multiple attempts to achieve union, which failed. Metal fixation was present in nine of them. Radiographie evidence oj healing M'as the bridging by callus of three cortices, and patients were clinically heated when they could bear weights without pain. None of the treatments failed. In the study it wxis used a Tlierawed 10 IF, an advanced inicroprocessor-controlled apparatus for the generation of therapeutic ultrasound, designed in compliance with the lEC (International Zlect)r/technicaI Commission) Standards. %•• wonis: iiltrasowul therapy, fnictinv repair, non-nnion.
Enmuchos estudios clínicos se tía demostrado que el tratamiento por ultrasonido estimula la reparación de las fracuras óseas. Este articulo presenta los resultados obtenidos en un total de quince fracturas no unidas.incluyendo nueas fracturas, uniones demoradas y no-imiones que fueron tratadas diariamente durante veinte minutos con piilsis de ultrasonido de 30 mW/cni- (SATA) y pulsos estrechos de 400 s de duración y una frecuencia de 0.5 kHz. Los ratamientos se mantuvieron hasta que las fracturas, clínica y radiográficamente, sanaron. Muchos de estos pacieites habían intentado curarse sin é.\ito. En nueve de ellos había fijadores metálicos presentes. La e\ idencia de cura p r radiografía ñie la presencia de puentes callosos de tres cortezas, y clínicamente se consideraron curados cuaiidi pudieron soportar pesos sin dolor. Ninguno de los tratamientos fracasó. En este estudio se utilizó el Theramed 101F. un equipo de tecnología avanzada controlado por microprocesador para la generación de ultrasonido terapéutico que cumple las nonnas de la IEC (International Electrotechnícal Commission). Pahbrds clave:ta~<jpiade ulüíisonido, reparación de fracturas, no-uiiión. Recibido; diciembre 2001 Aprobado: diciembre 2001

Acceleration iil...

INTRODUCTION

.:

Even though tlie use of tlie ultrasound in medical application is better known for its results in diagnostic imaging, the employment of tins technique with therapeutic purposes is currently, receiving an increased interest in the research community related witli these topics. Tlie best example of tliis is the quantity and quality of papers devoted to this subject that are appearhig in the recent literature, as well in sessions of national and international meetings on ultrasonics. Tlie first effect of ultra sound in tissue is mechanical vibrations,, which causes compressions and expansions of tlie medium, witli tlie samefrequencyand with amplitude proportional to tíie applied stimulus. This is what is called micromassage or mechanical therapy. In second place. Üie propagation of the vibrations in the tissue generates heat for friction. The combination of Üiese two effects produces a group of physical''^ and biochemical' e\'ents, which in turn michains specific biological and physiologic respond ' It is found, among other effects, the following reactions: increase of local sanguine circulation and increase of permeabilitN' in tlie cellular membrmie, reduction of pain, muscular relaxation, increase of the regeneration of tissues and the expression of the activity of certain genes as well the stimulation to the production of specific enzymes tliat are related \vith healing processes. Depending on tlie mode of the ultrasonic application being continuous or pulsed, it is possible to mmiage tlie increment of üie temperature in certain areas, especially important in the bony tissue. One of the most promise application of ultrasound for therapeutic purposes is for the acceleration of osseous fracture repair, despite the specific mechanism by which ultrasound can stimulated fracture healing remain imknowii. HoweA er. different paths of action have been reported, studies in vitro ha\ e indicated responses to low-intensity ultrasound, which include, elevated levels of tlie messages IGF mRNAs. oslecalcin and bone sialoprotein mRNAs.' ParA izi el o/.** reported in tlie evaluation of the effects of low intensity-pulsed ultrasound on rat chondroc)1es in vitro, the increment in level of aggrecan niRNA ¿md in proteoglycan swithesis after three and five treatment of 10 min a day. Kokubu et al. ' using an analogous ultrasound signal 20 niin, examined the regulation of prostaglandin E2 (PGE2) production by ultrasound exposure in mouse osteoblastic cell line. MCiT.l-El. The production of PGE2 in osteoblasts was augmented by ultiasound, which was threefold at 60 min in comparison with luiexposed samples. They evaluated the e.xpression of q cIooxygenase-2 (COX-2) niRNA, which is a critical enzyme for PGE2 production, and found that ultrasound rapidly up-regulated tlie expression of COX-2 niRNA in a time dq)endent manner. In addition, PGE2 production by ultrasound was drastically suppressed by a selective inhibitor of COX-2. They postulated that this results provide a strong evidence that PGE2 production in osteoblast is dependent upon the induction of COX-2 mRNA expression byulfrasound and offer a mechan istic insight how ultrasound accelerates fracture repairs. 69

Other studies have reported a modification of calcium incorporation by low-intensity ultrasound in cartilage and bone cell (in vitro), and a vinculum between physical stress and prostaglandin E2 in tlie remodeling of bone.'*' Anyway, in 1983 Duarte reported in a model of rabbits, that low-intensity pulsed ulfrasound can accelerate the healing of the fracture at tlie site of bilateral osteotomy of fibula and at bilateral drill holes on the cortex of femur, by radiological ^ind histological evaluations, in a placebo controlled study.'" Xavier and Duarte demonsfrated acceleration of normal fracture healing in humans nsing this technique. Tliey also iiidiaited that low-intensity ultrasound can induce bone repair of ununited diaphyseal fractures." Pilla showed in a controlled rabbit model on lnidshaft fibular osteotomies and in prospective double-blind, randomized human clinical trials in groups of patients suffering Colles's and tibia diaphyseal fractures, that low-intensity pulsed ultrasound significantly accelerates fresh fracture repair. In addition, he reported that maximal effects occurs at 30 mW/cnr with an ultrasound signal of 1,5 MHz, 200 ms sine wave burst vvidtli. rqDeatingat 1 kHz.'Wang eio/.'Reported in highly controlled model of rats on closed femoral shaft fractures, that low-intensity ulfrasound stimulation at 0,5 and 1,5 MHz significantly Increased the mechiuiical parameters of tlie healing fracture aillus. when tested to failure in torsion. Moreover, they pointed out that there was not a significant difference in Üie effects obtained b> these two difFerent ultrasound frequencies on the mechanical properties of tlie callus. In a multicenter. prospective, randomized, double-blind, placebo-confrolled study, Heckman et al. '•" reported a significant acceleration (38 % approximately) of fracture healing in patients who received active low-intensity pulsed ultrasound for the treatment of tibia diaphyseal fracture. In tlie same manner Kristiensen et al. ''shown that this type of ultrasound therapy can significantly shortening the time to radiographie healing of dorsally angulated fracture of the distal aspect of the radius that had been treated with manipulation and caster. The time to union was significaitly shorter for the fracture tliat were treated with ultrasound tliat it was for those that were treated with placebo 63 ± 3 d compared witli 98 ± 5 d. Many otliers clinical investigations VNÍÜI tlie use of low-intensity pulsed ultrasound ha\'e been shown sticcessfi.il healing of fresh fractures delayed unions aid nonunions, which include fractures, fixed witli metallic implants.'*^"^Taken into account tlie reported results about Uie use of lowintensity pulsed ultrasound in the treatment of bone fractures. and Hie possibility of implementing, for this propose, an equipmentfor clinical investigation at hospital, tlie goals of this study were: l.To use tliis tlierapy for patients affected firstly of delayed imion and nonunions. 2. To evaluate by ourselves, the utility of tliis technique. Then, this paper presents tlie results obtained in a study effected in the hospital Comandante Manuel Fajardo in Ha\ mía. Cuba, between April 1999 and June 2000 with the use of this technique. The equipment used, a Theramed lOlF ulfrasound tlierapy generator, is an advanced niicroprocessor-confrolled apparatus, designed in compliance witli the lEC Standards.

Ingeniería Electrónica, Automática y Comunicaciones, 1/2002

MATERIALS AND METHODS
The principal characteristics of the Theramed 10 IF are the following: Ultrasovmd transducer 25 nun piezoceramic (PZT) disc with an aluminun front plate. Frequency lMHz. Ullrasound intensiUfrom 30 to 40 mW/cm-, selec. téd in steps of 10 mW/cni^ ' (SATA)* Treatment time from Ito30iuin. Application mode pulsed. 400 us cofitaining Pulse burst width approximately 400 sinewave pressure pulses. Pulse repetition rates 0.5kHz.

There were a total of fifteen patients in the study. All of them were consulted before of the ultrasound applications, obtaining a written permission. Tlie patients were treated daily for twenty minutes with a pulsed ultrasound signal of 30 mW/cm' (SATA) and pulse bursts widtli of 400 ms repeated vvitli a frequency of 15 kHz. Ultrasound water based coupling gel was used between the device transducer and the skin to obtain effective ultrasound transmission to tlie fracture.

RESULTS
Table 1 presents data from tlie time offractiu"edate, to the sttirt of ultrasound tlierapy. for each fractured bone. The time from tlie start of ultrasound therapy to healed fracture, is given in table 2. Table 3 shows and ovaall sununar>' of fracture locations, and table 4 other procedures combined with ultrasound therapy.

Table 1 Time from fracture date to the start of ultrasound tlierap)' 0-90 (d) 0 0 0 0 2 2 91-150 (d) 0 2 0 1 0
J

.

Bone Scaphoid Himiems Tibia Radius Meta carpal Total

Subtotal 6 3 3 1 2 - . . 15

151-270 (d)' 2 1 0 0 0 3

No-iuiions 4 0 3 0 0 7

Table 2 Tune for tlie start of ultrasound therapy to healed fractures 0-90 (d) 6 3 I 1 2 13 7« 91-150 (d) 0 0 2 0 0 2151-270 (d) 0 0 0 0 0 0

Bone Scaphoid Hiunerus. Tibia Radius Metacaipal TotaKno Med)

Subtotal 6 3 3 1 2 15

No-unbns
• 0

0 0 0 0 0

Accelcratiuii of...

Table 3 Overall siinmiirv- by fracture locations Scaphoid PatieiUs (No) Male Fenialc Healed Faüed 6 6
0 6 0 0 I 2

Theprocess of fracture repair follows tree overlapping phases; 1. Inflammation 2. Reparation Radius Meta carpal 3. Remodeling. Taking into account the knowledge of tlie interaction of ultrasound with the tissues it tiiay be postulated that ultrasound has its most prominent effects during the first and the second phases. For example, because the high mismatch between the acoustical impedance of bone relative to tliat of tlie siuTounding soft tissues.approximately 25-40 % of Üie ultrasound energy is reflected at the bone-tissues interfaces in an intact bone.-' Furtliermore about 80 % of the energy that does penetrate the cortex is adsorbed within the first millimeter of propagation.-*^ In the otlier hand, during the inflammatorx' aiid repcirative phases of repair, tlie integrity of tlie outer cortex of bone is lost, consequently this allow a fracture gap or and entr) point to ultrasound into the injured area. Finally it may be said that Uie variation of temperature in tissue due to tlie absorption of energy in tlie range used by lovv-iiitensit\ pulsed ultrasound (50mW/cnr), is negligible (0,01"C) and insufficient to generate biological responses.

Hiunenis
3

1

2

3 0 3 0

1 0 1

2 0 2

0

'

0

Table 4 Otliers proccdiccs combined uitli iilù'asoiaid therapy External lutenial fix + lk + p epic tiled External iittenial SubtOtill bone craft livitiort li\ + Ititemal fixCaster 6 6 (J 0 I 2 (,) 0 0 0 0 0
Ü

Bone bcaphoid Humeras libia
EladiiLs

CONCLUSIONS
The results obtained in the continuation of the realization of the study, about the use of low-intensit)- pulsed ultrasound in the treatment of bone fractures, point to confirm the international reports as a ^alid and useful therapy for this subject, and encourage us to continue employing this technique to clinical appliaition. There were a total of fifteen patients in the study. All of tliem vyere consuhed before of the ultrasound applications, obtaining a written permission. The patients were treated daily for tvyenty minutes with a pulsed ultrasound signal of 3t) mW/cnr(SATA) and pulse bursts \yidth of 400 ms repeated vyitli a frequency of 0.5 kHz. Ultrasound water based coupling gel vyas used between the device transducer and the skin to obtain effective ultrasound transmission to the fracture.

0 1 0 1 0

0

0 2
1 ¿.

t) 1
0 -)

0

Metacaipal Total Healed :i5) Failed ( 0 ) ,

0

15

6

0

2

4

DISCUSSION
Despite the current limitation in determining how ultrasound can induce a healing process for acceleration of bony fractures the following considerations may^ be done. Frequency seems not to be and decisive factor as reported by Duarte'" and Wang et al}^ Nevertlieless, the absorption of ultrasound energy depends on the frequency; and tliis could be an important factor when tlie ultrasor:ic beam has to pass trough difíerent type of tissue, taking into accoimt the coefficients of absorption of each one to ultrasound. Moreo^ er, this could be an important factor determining tlie deep of penetration of the ultrasound in the bone tissue, because of its high absorption coefficient.
71

REFERENCES
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iúi Electi'únk'ii, Autoniiitica > Comunicaciones, I/2U02

4. REDJSKE, A. IM. et ai: "Ultrasonic Enhancement Action on Escheiichia Coli Biofilms; an in Vivo Model". Antimicrob Agent.'iChenwther.Wo\.43{5lpp. 121 !-4. 1999. 5. NARUSE, K. ef ai "Anabolic Response of Mouse BoneManow-Derived Stromal Cell Clone ST2 Cells to Lowintensity Pulsed Ultrasound". Biochetn Biophys Res Com/mm. Vol. 5.286( 1 ), pp. 216-20. Februar^'. 2000. 6. PARVIZI, J.: •"Low-Intensity Ultrasound Stimulates Proteoglycan S\nthesis in Rat Chondrocytes by Increasing . Aggrecan Gene Expression". JOrthop Res. 17(4). pp. 488-94.
.luh. 1999.. •

18. FRANKEL, V. H.: "Results of Prescription Use of Pulse Ultrasound Terapy in Fracture Management". Surgical Technolog}' International VIL pp. 389-93. 1998. 19. GLAZER, P. A. et. ai: "Use of Ultrasound in Spinal Arthrodesis. a Rabbit Model", Spine, Vol. 23( 10), pp. 1142-48. 1998. 20. HADJIARGYROU, IM.: "Enhancement of Fracture Healing by Low Intensity Ultrasound". Clin Orthop (355 SuppI ) : S, pp. 216-29. October. 1998. 21. M AYR, E. et al. : "Ultrasound Therapy for No-Unions.Three Case Reports", Unfallchirurg. Vol. 102(3), pp. 191-196. 1999. 22. SATO, W.; T. MATSUSHITA « K. NAKAIMURA.: & "Acceleration of Increase in Bone Mineral Content b\ Low-Intensity Ultrasound Energy in Leg Lengthening". .1 Ultrasound in Med Vol. 18(10). pp. 699-702. 1999. 23. TÄNZER, M. étal.: "Effects of Non-Invasive Low-lntensit\ Ultrasound on Bone Growth into Porous-Coated Implants". .JOrthop Resyo\. 14, pp. 901-06. 1996. 24. WU, C. C. et al.: "Exposure to Low-Intensity Ultrasound Stimulate Aggrecan Gene Expresión b\ Cultured Chondrocytes". 42nd Annual Meeting. Orthopedic Research Societ}-Atlanta, G A. 1996. 25. WARDEN, S. J. et al.: "Can Conventional Therapeutic Ultrasound Units be Used to Accelerate Fracture Repair'.'". Phys Ther Rev. 4:117-126. 1999. 26. WARDEN, S. J. et al.: "Acceleration of Fresh Fracture Repair Using the Sonic Accelerated Fracture Healing System (SAFHS): A Review", Calcif Tissue Int. 66:157-63.2000.

7. KOKUBU. T. et ai: -Low Intensity Pulsed Ultrasound Exposure Increases Prostaglandin E2 Production Via the Induction of Cycloo.\ygenase-2 mRNA in Mouse Osteoblasts". Biocheni Biophy.<i Res Commun. 16;256 (2):284-7. March. 1999. 8. RYABY, J. T. et al.: "Low-Intensity Pulsed Ultrasound Increases Calcium Incorporation in Both Differentiating Cartilage and Bone Cell Cultures". Trans Orthop Res Soc, 14:15.1989. 9. SOIMJEN, D.: "Bone Remodeling Induced by Physical Stress is Prosteglandin E2 Mediated". Bioehem Biophys Acta. Vol. 627. pp. 91-100.1980. 1(1. DUARTE. L. R.: "The Stimulation of Bone Growth by Ultriisoiind". Arch Orthop Trauma .Siirg, Vol. 101. pp. 53-59, 1983. 11. XAVIER. C. A.M. & L. M. DUARTE: "Treatment of NonUnions by Utrasound Stimulation: First Clinical Applications". Read ¡ the Meeting of the Latin-American Orthopedic U Association, at the Annual Meeting of the American Academy of Orthopaedic Surgeons. San Francisco. California. January 25. 1987. 12. PILLA, A. A. ci al.: "Acceleration Bone Repair by Pulsed Sine Wave Ultrasound: Animal. Clinical and Mechanistic Studies". Electromagnetics in Medicine and Biology. Edited by C T. Brighton & S.R. Pollack. San Francisco Press. 331-41, San Francisco, 1991. 13. WANG, S. J.: "Low Intensity Ultrasound Treatment Ihcreases Strength in a Rat Femoral Fracture Model"../ Orihop Res. Vol. 12(1). pp. 40-47. 1994. 14. HECKMAN, J. D.: "Acceleration of Tibia Fracture-Healing b\ Non-Invasive. Low-Intensity Pulsed Ultrasound",./ßo/7if ./o/;7/5í//xA'-^«)7.Vol.76(l).pp. 26-34. 1994. 15. KRIST1ANSEN,T. K. eial.: "Accelerated Healing of Distal Fracture with the Use of Specific, Low-Intensity Ultrasound", ./ Bone .Joint Siirg. Vol. 79A( 1 ). No. 7. pp. 961 -73. 1997. 16. COOK, S.D. e/iv/.: ".Acceleration of Tibia and Distal Radius Fracture Healing in Patients who Smoke". Clin Orthop. 337, pp. 198-207. April. 1997. 17. DUARTE, L.R.& ¡M. CHOFFLE: "Low Intensity Pulsed Ultrasound and Effects on Ununited Fractures". Ptesent at the Orthopaedic Health Conference. University Hospital, University of Sao Paulo. Brazil. June. 1994.
72

AUTHORS
Orlando Rey Rodríguez Rúa Licenciado en Fisica. Master en Ciencias Fisicas. Labora cotiio Investigador Agregado en el Instituto de Cibernética Matemática y Física, desempeñando la función de J' de Proyecto de Ultrasonido Terapéutico. Su principal campo de trabajo es el diseño de equipos para terapia por ultrasonidos, diseño \ simulación de transductores ultrasónicos y estudio de la interacción del ultrasonido con el medio biológico y sus respuestas. Correo electrónico: re> HIÍIÍ/ eiclet.icmf.inr.cii Ricardo Monreal González Especialista en Ortopedia y Traumatología. Profesor Auxiliar Desempeña el cargo de Especialista en Ortopedia y Trautnatoloiiia.

Vol. XXIII.No. 1.2002

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