Bibliography - Bone Stimulators - Jeff Anglen, MD
Brighton CT, Black J, Friedenberg ZB, Esterhai JL, Day LJ, and ConnollyJF. A multicenter study of the treatment of nonunion with constant directcurrent. JBJS 63-A(1): 2-13, 1981
A prospective, multicenter study without control or comparisons of theuse of semi-invasive technique of constant direct current ( 4 cathodes with20 microamperes of current for 12 weeks) for nonunion. In the 178 NU (175patients) treated at University of Pennsylvania, 149 (83.7%) healed; thosewith a history of osteomyelitis had a 74.4% heal rate. In 80 NU (79 pts)treated at other institutions, 58 (72.5%) healed.
Paterson DC, Lewis GN, Cass CA. Treatment of delayed union and nonunionwith an implanted direct current stimulator. Clin. Orthop. 148:117-128,1980
Eighty four patients treated by 30 Australian surgeons using an implantedDC stimulator supplying 20 microamperes through a single cathode for 20-26weeks. Fracture healing occurred in 72/84 (86%) with an average time tounion of 16 weeks. Forty four of the patients had 1 or more previous operation,15 were infected. Eleven had concurrent bone graft surgery. Five requireda second stimulator implantation to achieve union.
Cundy PJ, Paterson DC. A ten-year review of treatment of delayed unionand nonunion with an implanted bone growth stimulator. Clin Orthop. 259:216-222,1990
A ten year follow-up of the patients from the study above, in which38 of 81 known living patients were located and reviewed. All were completelyhealed, one had had a refracture, six of the original 12 treatment failureshad subsequently healed with further treatment. No clinical or radiographicadverse effects of cathode, no insertion site complications, normal remodeling.
Day L. Electrical stimulation in the treatment of ununited fractures. Clin. Orthop. 161:54-7, 1981.
Sixteen patients with nonunion of average duration 2 years were treatedwith semi-invasive electrical stimulation. Eleven healed and returned tofull activities without external immobilization. Complications includedone late deep infection and one recurrence of osteomyelitis. Of the 5 failuresìstability increased markedly in all casesî. One failure wasthought to be clearly due to excessive motion (30-40 degrees), ìwhichwe now know is not compatible with healing by this methodî.
Bodamyali T, Bhatt B, Hughes JF, et al.: Pulsed electromagnetic fieldssimultaneously induce osteogenesis and upregulate transcription of BoneMorphogenic Proteins 2 and 4 in rat osteoblasts in vitro. Biochemical andBiophysical Research Communications 250:458-61, 1998
Title sort of speaks for itself.
McLeod KJ, and Rubin JT. The effect of low frequency electrical fieldson osteogenesis. JBJS 74-A(7): 920-9, 1992
The use of PEMF on functionally isolated turkey ulnae not only preventeddisuse osteopenia seen in controls and with inactive coils, but actuallyincreased bone mass. Lower frequency pulses (15 Hz) were more effectivethan higher frequency (75 or 150 Hz), suggesting that osseous tissue isfrequency sensitive.
Sharrard WJW. A double-blind trial of pulsed electromagnetic fieldsfor delayed union of tibial fractures. JBJS 72-B:347-55, 1990
Twenty patients with active stimulators compared to 25 with dummy boxeswere treated for 12 weeks; outcome evaluated clinically and radiographicallyby blinded orthopaedist and independently by blinded radiologist. Radiographichealing was increased by the active unit, p=.002 (radiologist) and p=.02(orthopaedist). No significant difference in clinical criteria: pain, tenderness,motion.
Parnell EJ and Simonis RB. The effect of electrical stimulation in thetreatment of Nonunion of the tibia. JBJS 73-B: S178, 1991
PEMF had a significant effect in increasing healing in a double blindstudy of 34 tibial nonunions which were also treated with external fixationand fibular osteotomy, p=.03.
Bassett CAL, Mitchell SN, Gaston SR. Pulsing Electromagnetic Field Treatmentin ununited fractures and failed arthrodesis. JAMA 247(5):623-628, 1982
Retrospective review of treatment results in >1000 ununited fracturesand 71 failed arthrodeses. Overall success rate of 81% for 220 patientstreated at the authorsí institution, 76% for 625 patients treatedat other US sites, and 79% for 233 patients treated at international sites. In 657 tibias, the sucress rate was 82%. Infection, previous surgery,presence of metal did not affect success rate. Addition of bone graft surgerywith electrical stimulation seemed to increase the rate of success to 92%. The authors believe that NWB and immobilization is required for success.
Bassett CAL, Mitchell SN, Gaston SR. Treatment of ununited tibial diaphysealfractures with pulsing electromagnetic fields. JBJS 63A:511-523, 1981
PEMF for 10 hrs/day resulted in healing in 87% of 127 fractures whichhad shown no evident of healing progress for 3 months prior to treatmentwith a median healing time of 5.2 months.
Bassett CAL. Development and application of PEMFs for ununited fracturesand arthrodeses. Clinics in Plastic Surgery 12(2):259-277, 1985
Borsalino G, Bagnacani M, Bettati E, et al. Electrical stimulation ofhuman femoral intertrochanteric osteotomies. Double-blind study. Clin.Orthop. 237:256-63, 1988
31 intertrochanteric osteotomies fixed with blade plate and treatedwith active or dummy stimulators, evaluated by 3 blinded orthopaedic surgeons. Statistically significant improvement in healing was seen with active stimulators.
Mammi GI, Rocchi R, Cadossi R, Traina GC. Effect of PEMF on the healingof human tibial osteotomies: a double-blind trial. Clin. Orthop. 288:246-253,1993
40 tibial osteotomies for arthrosis fixed with a staple, evaluated by4 blinded independent orthopaedic surgeons showed significantly higher levelof healing with active stimulator, p<.006.
Gossling HR, Bernstein RA, and Abbott J. Treatment of ununited tibialfractures: comparison of surgery and pulsed electromagnetic fields. Orthopaedics15(6):711-9, 1992
This is a meta-analysis of the English literature form 1977-1987 whichreviewed 14 articles on surgical treatment and 28 on PEMF. Overall successrate was 82% (range 70-100) for surgery and 81% (range 63-100) for PEMF. Success rate for surgery drops dramatically with successive operations,while number of surgeries does not seem to effect results of PEMF. In 5controlled, comparison studies, PEMF was better in 4; PEMF seemed to havea better success rate in infected cases.
Peltier LF. A brief historical note on the use of electricity in thetreatment of fractures. Clin. Orthop. 161:4-7, 1981
Zamora-Navas P, Borras Verdera A, Antelo Lorenzo R, Saras Ayusa JR, andPena Reina MC. Electrical stimulation of bone nonunion with the presenceof a gap. Acta Orthopaedica Belgica 61(3):169-76, 1995
A total of 22 established NU Rxíd with capacitively coupled stimulatorresulted in solid union in 73% of cases in average 26 weeks. A gap of .5cm or more was present in all, before treatment. Results were better withmetaphyseal gaps, results were not affected by presence on infection.
Pienkowski D, Pollack SR, Brighton CT, and Griffith NJ. Comparison ofasymmetrical and symmetrical pulse waveforms in electromagnetic stimulation. J. Ortho. Res. 10(2):247-55, 1992
Rabbit fibular osteotomy model used to compare PEMF with symmetric waveformto assymetric waveform. The significance is that assymetric waveform, thoughtto be necessary for efficacy, requires significantly more electrical energyand constrains delivery systems. Results suggest that assymetry is notnecessary and that a narrow pulse width, symmetrical square wave signalcan also stimulate stiffness increase, and that the high-amplitude, narrowpulse portion of the assymetric PEMF signal is the component responsiblefor clinical effectiveness.
Brighton CT, Pollack SR. Treatment of recalcitrant nonunion with a capacitivelycoupled electric field. JBJS 67A:577-585, 1985
The first report of a patient treated was by Brighton and Pollack in1984, and in the next year they reported a series of 22 nonunions witha 77% success rate. Mean time to healing 23 weeks. The study included17 previously treated fx (grafting or e-stim)
Scott G, and King JB. A prospective, double-blind trial of electricalcapacitive coupling in the treatment of nonunion of the long bones. JBJS76A(6):820-826, 1994
23 patients entered, 2 failed to comply. All had 9 months with no signof healing progress and had no other previous RX for 3 months other thanimmobilization. 6 of 10 with active stimulators healed, while 0 of 11 withdummy stimulators were successful. Mean duration of treatment for healingwas 21 weeks. P=.004 Of the placebo patients, 6 later had treatment withan active unit; 2 healed rapidly.
A comment letter by Dr. Tim Bray in JBJS 77(5):809, 1995 noted thatthe sample size was small, and that there were differences between the twogroups in type of nonunion, presence of infection, previous treatment andlocation of nonunion.
Abeed RI, Naseer M, Abel EW. Capacitively coupled electrical stimulationtreatment: results from patients with failed long bone fracture unions. J. Ort. Trauma 12(7):510-3, 1998
A retrospective review of 16 patients with nonunions of 9-77 monthsduration which were treated for 30 weeks or until healing. Eleven of the16 healed with average time of 15 weeks. All patients with a plate-platedistance less than 80 mm healed, suggesting a relationship of healing tosufficient current.
Brighton CT, Shaman P, Heppenstall RB, Esterhai JL, Pollack SR, FriedenbergZB. Tibial NU treated with direct current, capacitive coupling or bonegraft. Clin. Orthop. 321:223-4, 1995
Retrospective review using regression analysis of 271 tibial NU (minduration 9 months) treated by surgeon choice with one of three methods. Seven risk factors were identified: duration of the NU, prior bone graftsurgery, prior electrical treatment, open fracture, osteomyelitis, comminutedor oblique fracture pattern, atrophic NU type. If no risk factor existed,there was no significant difference in success rate in any of the methods,although capacitive coupling had the lowest heal rate. As more frisk factorsappeared the heal rate decreased regardless of treatment. In cases of previousbone graft failure, repeat grafting was less likely to be successful thanelectrical treatment. In atrophic nonunion, capacitive coupling had a worseheal rate.
Hadjiargyrou M, McLeod K, Ryaby JP, Rubin C. Enhancement of fracturehealing by low intensity ultrasound. Clin. Orthop. 355(supp):S216-229,1998
This is a review article that discusses what is known about ultrasoundstimulation of fracture healing, basic science, animal studies and clinicalstudies.
Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration oftibial fracture healing by non-invasive, low-intensity pulsed ultrasound. JBJS 76-A(1):26-34, 1994
Prospective, randomized, placebo controlled, double blind, multicenterstudy of 67 patients with closed or grade I open tibial shaft fracturesñ specific fracture criteria (transverse or short oblique, lengthof fx < 2X diaphysis, gap <.5 cm, displacement <50%) Active unitsgave a signal with 200 microsecond burst width, 1.5 mHz sine waves, 1 kHzrep rate average intensity 30 milliwatts/square cm. Active units produceda shorter time to clinical healing, to D/C cast, to cortical healing , andto clinical + radiographic healing, p=<.001-.01 No serious complicationswere seen.
Kristiansen, TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healingof distal radius fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective randomized, double-blind, placebo-controlledstudy. JBJS 79-A(7):961-73, 1997
60 patients with 61 fractures; 30 active units and 31 dummy boxes. Clinical and radiographic evaluation at specific time periods. Each stageof healing was significantly accelerated by active ultrasound, and the timeto union was shorter: 61(3 vs. 98(5 days, p<.0001. There was also smallerloss of reduction which stopped earlier in the active group.
Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Accelerationof tibial and distal radius fracture healing in patients who smoke. ClinOrthop. 337:198-207, 1997
Analysis of the data from the previous two studies with respect to smokingshowed an even greater improvement in healing times for smokers than fornon-smokers.
Emami A, Petren-Mallmin M, Larsson S. No effect of low intensity ultrasoundon healing time of intramedullary fixed tibia fractures. J. Orthop. Trauma13(4):252-7, 1999
Prospective, randomized, double-blind, placebo-controlled study of closedor grade 1 open tibial diaphyseal fx with severe comminution treated witha locked, reamed IM nail. Treatment started within 3 days, using same signalparameters as in Heckman et al. Radiographs assessed by blinded radiologistand traumatologist. No significant difference was found in healing time,appearance of first callus or time to FWB. In fact, the trends favored placebo. Authors speculated that the difference between their results and Heckmaníswere due to differences in mechanical environment at the fracture site ñrigidity, motion, loading differences or metal.
Zorlu U, Tercan M, Ozyazgan I, Taskan I, Kardas Y, Belkar F, Ozturk F. Comparative study of the effect of ultrasound and electrostimulation onbone healing in rats. Am. J. of PM&R 77(5):427-32, 1998
Fibular osteotomies were performed bilaterally on rats, with the rightside treated with semi invasive electrical stimulation (10 microamps, 30min/day, 15 days) or ultrasound (.1 watt/cm2, 2 min qod, 6d ñ 4 Rx)and the left side used as control with sham procedures. They were sacrificedfor histology, exam and Xray at day 7 and 14. Both treatments resultedin improved healing p<.05 at day 7 for e-stim and day 14 for US. Nodifference between the two treatments was seen.
Heckman JD, Sarasohn-Kahn J. The economics of treating tibia fracture: The cost of delayed unions. Bull Hosp Jt Dis 56:63-72, 1997
Three economic models used to evaluate the total cost of treating 1000pts in two treatment paths: operative and conservative included costs ofsurgery, recovery, outpatient costs, workerís compensation, emergencyroom and disability. Model 1 involved no use of ultrasound, Model 2 involveduse of ultrasound on only the conservative path, Model 3 used ultrasoundon both treatment paths. Comparison of conservative treatment in model2 to model 1 suggested a savings of $15,000 or 40% of treatment cost percase by the use of ultrasound on conservative treatment, by decreasing thenumber of secondary procedures and less workerís compensation. Comparisonof operative treatment in model 3 to model one suggested a savings of $13,000per case. Overall, the analysis suggested that use of ultrasound with bothtreatments could save $14.6 million.