effect of electromagnetic stimulation on patients suffering from non-union. a retrospective study...

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JOURNAL OF BIOELECTRICITY, 10(1&2), 101-117 (1991) EFFECT OF ELECTROMAGNETIC STIMULATION ON PATIENTS SUFFERING FROM NON-UNION. A RETROSPECTIVE STUDY WITH A CONTROL GROUP. Traina G.C.*, Fontanesi G.**, Costa P.***, Mammi G.I.§, Pisano F.§§, Giancecchi F.***, Adravanti P. * Istituto Clinica Ortopedica, Universita' di Ferrara. ** Istituto Ortopedico Rizzoli, I Divisione, Bologna. *** Divisione di Ortopedia e Traumatologia, Arcispedale 5 Divisiolne di Ortopedia e Traumatologia, Ospedale C. S. Maria Nuova, Reggio Emilia. Magati, Scandiano, Reggio Emilia. 59 Divisione di Ortopedia e Traumatologia, Ospedale Ugolino, Parma. SUMMARY In this study we have reviewed a group of patients suffering from non-union treated at the same hospitals Correspondance and reprint requests to: Prof. Giancarlo Traina Istituto Clinica Ortopedica Ospedale S. Anna Universita' di Ferrara Ferrara Italy 101 Copyright 0 199 1 by Marcel Dekker, Inc. Electromagn Biol Med Downloaded from informahealthcare.com by McMaster University on 12/02/14 For personal use only.

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Page 1: Effect of Electromagnetic Stimulation on Patients Suffering from Non-Union. A Retrospective Study with a Control Group

JOURNAL OF BIOELECTRICITY, 10(1&2), 101-117 (1991)

EFFECT OF ELECTROMAGNETIC STIMULATION ON PATIENTS SUFFERING FROM NON-UNION. A RETROSPECTIVE STUDY WITH A CONTROL GROUP.

Traina G.C.*, Fontanesi G.**, Costa P.***, Mammi G.I.§, Pisano F.§§, Giancecchi F.***, Adravanti P.

* Istituto Clinica Ortopedica, Universita' di Ferrara. * * Istituto Ortopedico Rizzoli, I Divisione, Bologna. * * * Divisione di Ortopedia e Traumatologia, Arcispedale

5 Divisiolne di Ortopedia e Traumatologia, Ospedale C. S. Maria Nuova, Reggio Emilia.

Magati, Scandiano, Reggio Emilia. 59 Divisione di Ortopedia e Traumatologia, Ospedale

Ugolino, Parma.

SUMMARY

In this study we have reviewed a group of patients suffering from non-union treated at the same hospitals

Correspondance and reprint requests to: Prof. Giancarlo Traina Istituto Clinica Ortopedica Ospedale S. Anna Universita' di Ferrara Ferrara Italy

101

Copyright 0 199 1 by Marcel Dekker, Inc.

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102 TEUINA ET AL.

by the same surgeons. Twenty six patients (control group) received an orthopaedic treatment aimed at promoting bone healing, fourty one patients (experimental group) were stimulated with an electromagnetic field generator without any further change in the orthopaedic management of the non-union. Eighteen patients healed in the control group and thirty six in the experimental group. The average healing time was shorter among patients stimulated. No difference was observed in the success rate between the 2 groups of patients for non infected non-unions. Infection proved to be detrimental for the success of the treatment in the control group, while it did not negatively influence the outcome of stimulation. Provided that the orthopaedic treatment of the non-union is considered satisfactory, electromagnetic stimulation is a valid option in the treatment of non-unions.

INTRODUCTION

Electrical stimulation of osteogenesis with low frequency pulsating electromagnetic waves (PEMF's) has been under research since early seventies. There are now in the literature numerous clinical studies that confirm the efficacy of the treatment of patients with delayed unions or pseudarthrosis (1-8). Usually researchers, once having defined the pathology and the criteria for admission to the study, started stimulation with PEMF's and later described the results and compared them to their own previous experience. The conclusions drawn were inevitably subject to personal

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ELECTROMAGNETIC STIMULATION OF NON-UNIONS 103

judgement. Attempts have been made to evaluate the effect of PEMF in congenital pseudarthrosis by prospective controlled studies (8). This type of approach has been widely criticised. The need for double blind research has been underlined (9,lO). What is principally under consideration is the difficult in quantifying the efficacy of electro-bone stimulation (EBS) in the context of its use with standard immobilization or indeed by itself (6). Now are available studies in double blind for patients with delayed unions (111, osteotomies (12,131, tendinitis (14), prosthesis (15) spinal fusion (16) and soft tissue (17). All are statistically significant for bioeffects of PEMFs The problem becomes more complex when considering pseudarthrosis. To our knowledge the only study in double blind carried out to date on patients suffering from non-union was in the U.K. (18). Patient recruitment was extremely difficult (the group comprised only 16 patients), in addition the study has been criticized as control patients received a magnetic field stimulation although very small (19); no definitive conclusion can be drawn from the study ( 2 0 ) .

In an attempt to quantify the effect of PEMF we have reviewed a group of patients treated at 4 different centers and diagnosis of non-union. Among these, those with satisfactory biomechanical conditions, who had not been operated on during the three preceding months, whose immobilization had not been changed and had shown no signs of progression toward healing were PEMF stimulated, not modifying the immobilization technique. We think that stimulation

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104 TRAINA ET AL.

with PEMF could be identified as the most important or sole promoter of osteogenetic activity in these patients (5). In the same period of time, at the same centers, other patients with a non-union were treated on to create satisfactory biomechanical conditions: any defect in the orthopaedic treatment (i.e. : bone loss over 1 cm, inadequate immobilization, non-alignement of bone stumps) which could account for the lack of healing was corrected by the most appropriate orthopaedic technique. These non-unions should consolidate as result of the orthopaedic treatment. In this study we compare the success rate of the two groups of patients. Even though the study was carried out retrospectively it compares two individual groups treated simultaneously by the same teams of surgeons.

MATERIALS AND METHODS

Under considerations are patients suffering from non-union after at least nine months from the trauma. Sixty seven patients diagnosed to have a non-union were reviewed. The minimum follow-up for all patients was 2 years. 26 patients (control group) had undergone the orthopaedic treatment. The average age of the control group was 4 6 . 21 were male and 5 female. Ten pseudarthroses (39%) were infected. The fracture sites are indicated on table I. The average age of lesions was 26 months (extremes 9 - 180). The average number of previous surgical intervention was 1.4 (extremes 0 -

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ELECTROMAGNETIC STIMULATION OF NON-UNIONS 105

TABLE I

Femur 3 11,5% 11 26 .8%

Forearm 3 11.5% 8 1 9 . 5 %

Humerus 2 7 . 6 % 1 2 . 4 %

Metatarsal 1 3 . 8 % 1 2.4%

3 1 , 3 patients had neveI been operated on before. Plating was performed in 9 patients and, in 5 of these, autologous bone graft was performed. Six patients underwent endomedullary nailing, in 2 cases autologous bone graft was used. Five patients were treated with bone graft alone. Two patients were put in external fixators, in 1 case a bone graft was used. One patient was treated with an osteotomy ( 2 1 ) . Finally, 3 patients were casted, since inadequate immobilization was considered to be responsible for the lack of healing. 41 patients (experimental group) were treated with PEMF's without changing the immobilization. The average

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106 TRAINA ET AL.

age in this group was 38 years; 36 were male, 5 female. 18 non-unions (43%) were infected. The fracture sites are shown on table I. The average age of the lesion was 21 months (extremes 9-192). The average number of previous surgical interventions was 1.6 (0-3). Five patients had been operated 3 months before stimulation and in the other cases more than 3 months. Three patients had never been operated on. When the patients began the stimulation immobilization was not changed. In 17 patients it was a cast, in 10 a nail, in 7 an external fixator, in 5 plate and screws, and 2 used a brace. Patients were treated with an electromagnetic field generator (IGEAstimulator, Igea, Carpi, Italy) with the following technical specifications: 75 Hz frequency, impulse width 1.3 msec induced voltage in a coil probe 3.5+/lmv (fig 1). Patients were instructed to use the stimulator 8 hours per day until they healed. In both groups infection was always treated with proper antibiotic treatment. Patients were considered healed when both radiographic and clinical criteria were met. From a radiographic stand point, the patient was judged healed when in at least 3 out of 4 cortices by bone callus or cortices bridging was present. In addition, a follow-up X-ray was evaluated to confirm the healed status for all patients, and that the patient had not had further surgery. The minimum follow-up has been 2 years, maximum 6 years. Clinical evaluation was based on the patient records maintained in the hospital, describing the fracture site as solid and the patient weight bearing, without pain, or protection.

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ELECTROMAGNETIC STIMULATION OF NON-UNIONS 10 7

A

FIGURE 1. Top: waveform of the magnetic field recorded by a Hall probe (912 Gaussmeter, RFL, Boonton, N.J.). Bottom: waveform of the electric field recorded with a coil probe made of 50 turns ( 0 . 5 cm i.d.1 of copper wire ( 0 . 2 0 mm $1, connected to an oscilloscope.

Healing time was measured from the day of start of stimulation or surgery to reach the above mentioned criteria. Patients were considered to be failures if the above mentioned criteria were not met within 12 months from stimulation start or surgery, or if any further surgery was required to promote bone healing.

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108 TRAINA ET AL.

Time in months 7.8 (+-3.5) 5.7 ( + - 2 . 5 )

Non infected 14 (87%) 20 (87%) non-unions

Statistical analysis are made using the Student's t test and the Fisher's exact test.

RESULTS

18 patients in the control group healed due to surgery. 36 patients healed due to PEMF stimulation. Average healing times were respectively 7.8 months (+/ - 3.5) in the control group and 5.7 months (+/- 2.5) in the stimulated group (p < 0.01). Table 11. Of the 8 patients in the control group classified as failures 2 had been treated with cast, two with bone graft, one with a nail, one with plate, one with osteotomy and one with external fixators. At follow-up

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ELECTROMAGNETIC STIMULATION OF NON-UNIONS 109

4 of these 8 patients had not been re-operated, and were not healed yet. Two re-operated with nails did not heal, 1 operated with an osteotomy and 1 plated healed. Five patients in the experimental stimulated group did not heal. They had been stimulated an average of 7.2 months (1-16 extremes). At follow-up three were never operated and did not heal, 2 were operated (bone graft in one case, intermedullary nail in the other) and healed in 6 and 5 months respectively. The healing rate for non-infected non-unions was the same in both groups (87%), however the healing time was 7.6 months (+/-3.7) in the control group and 5.5 months (+/-1.8) in the experimental one (p<0.03). In the control group, 6 out of 10, (60%), infected non-unions did not heal and in the experimental group 2

out of 18, (12%), did not heal (p<0.05, Fisher's exact test). Infec+.ed non unions healed in 9.7 months (+/-1.7) in the control group and in 6 months ( + / - 3 . 2 )

in the experimental group (p<0.04). In the PEMF stimulated group, we were able to observe effects of stimulation are usually evident in the first 3 months (figure 2 ) . If, after 90 days, no modification of the bone healing is observed, our experience suggests that a change of treatment be recommended.

DISCUSSION

We have conducted a retrospective study that has allowed us to compare 2 groups of patients treated in @the same orthopaedic environment by the same group of surgeons during the same period of time. All patients suffered from a non-union; severe and long lasting

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110 TRAINA ET AL.

FIGURE 2A.

G.M. male aged 35. Infected non-union 10 months after the trauma, immobilization in cast: start of stimulation.

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ELECTROMAGNETIC STIMULATION OF NON-UNIONS 111

FIGURE 2B. 3.5 months later the patient healed: end of stimulation.

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FIGURE 2C. Follow-up X-rays 2.5 years after the end stimulation.

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cases, who already had experienced repeated surgical procedures which decreases the chances of success (22). The control group healed as result of the orthopaedic procedure performed, the experimental group as result of PEMF stimulation. The results in the control group are not as satisfactory as those of the experimental group. This is particularly true for infected non-unions in the control group; the presence of infection is still a difficult problem to be solved. It negatively affects the healing ( 2 3 ) . In the experimental group the presence of infection did not influence the effectiveness of the stimulation, this observation has been reported also by other authors (3-7). For non-infected non-unions, the success rate is the same in both groups, however in the experimental group the healing time is shorter. In this study we have considered only those patients in which the immobilization technique was satisfactory and expected to be able to heal the patients. Provided these conditions are present, our results indicate that PEMF stimulation can even be preferable to the alternative of further surgery. Finally, we would underline the necessity, at all times, for solving the mechanical problem. After this has been solved PEMF's should be considered immediately, or after a few months if little progression has been observed. This integrated view of the use of surgery and stimulation in the treatment of non-unions helps solve both the biomechanical and biological problems that often are at the root of ununited fractures.

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TRAINA ET AL.

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