The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 88, Issue suppl 2

Femoral Head Bone-Preserving Procedures | November 01, 2006

Biophysical Stimulation with Pulsed Electromagnetic Fields in Osteonecrosis of the Femoral Head

Leo Massari, MD; Milena Fini, MD; Ruggero Cadossi, MD; Stefania Setti, MSc; Gian Carlo Traina, MD

The authors did not receive grants or outside funding in support of their research for or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2006 Nov 01;88(suppl 2):56-60. doi: 10.2106/JBJS.F.00536

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Abstract

Background: Osteonecrosis of the femoral head is the end point of a disease process that results in bone necrosis, joint edema, and cartilage damage. It leads to joint arthritis that necessitates total hip arthroplasty in many patients. Because of its positive effects on osteogenesis and its chondroprotective effect of articular cartilage, pulsed electromagnetic field stimulation has been proposed as a method to prevent or delay the progression of osteonecrosis.

Methods: A retrospective analysis of the results of treatment with pulsed electromagnetic field stimulation of seventy-six hips in sixty-six patients with osteonecrosis of the femoral head was performed. Patients with Ficat stage I, II, or III osteonecrosis of the femoral head were treated with pulsed electromagnetic field stimulation for eight hours per day for an average of five months. Clinical and diagnostic imaging information was collected at the start of the treatment and at the time of follow-up. The primary end point analyzed was the avoidance of hip surgery, and the secondary end point was limiting the radiographic progression (according to Ficat stage) of osteonecrosis of the femoral head.

Results: Fifteen hips required a total hip arthroplasty; twelve of these hips were in patients with Ficat stage-III disease. The need for total hip arthroplasty was significantly higher in patients with Ficat stage-III disease than in patients with Ficat stage-I (p < 0.0001) or II (p < 0.01) disease at the beginning of treatment. Pulsed electromagnetic fields preserved 94% of Ficat stage-I or II hips. Furthermore, radiographic progression (according to Ficat stage) occurred in twenty hips (26%). Pain, present in all patients at the start of the treatment, disappeared after sixty days of stimulation in thirty-five patients (53%) and was of moderate intensity in seventeen patients (26%).

Conclusions: The results of this study confirm that pulsed electromagnetic field treatment may be indicated in the early stages of osteonecrosis of the femoral head (Ficat stages I and II). Pulsed electromagnetic field stimulation may be able to either preserve the hip or delay the time until surgery. The authors hypothesize that the short-term effect of pulsed electromagnetic field stimulation may be to protect the articular cartilage from the catabolic effect of inflammation and subchondral bone-marrow edema. The long-term effect of pulsed electromagnetic field stimulation may be to promote osteogenic activity at the necrotic area and prevent trabecular fracture and subchondral bone collapse.

Level of Evidence: Therapeutic Level IV. See Instructions to Authors on jbjs.org for a complete description of levels of evidence.

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Osteonecrosis of the femoral head is the end point of a disease process that results in insufficient blood flow and bone-tissue necrosis, which often leads to destruction of the hip joint. The disease is observed more frequently among men in the second through the fourth decades of life. In the United States, approximately 20,000 new cases are diagnosed each year¹. The clinical and radiographic evolution of the disease often culminates in joint instability, arthritis, and the need for a total hip replacement². The etiology and pathogenesis of and the therapy for osteonecrosis of the femoral head have yet to be clearly identified and defined³. The importance of trying to save hips of patients with this disease underscores the need to introduce suitable protocols for early diagnosis and therapy^4,5.

Both bone tissue and cartilage suffer when osteonecrosis of the femoral head develops; in bone, death of the osteocytes is followed by trabecular fracture and collapse of the subchondral bone of the femoral head, leading to arthritis of the hip joint, while joint inflammation and subchondral bone-marrow edema can severely affect the articular cartilage^6-8.

Treatment of osteonecrosis of the femoral head often requires total hip arthroplasty; however, the mean age of the patients is approximately forty years and the long-term results of joint replacement in these young patients are not always satisfactory. Because of the above considerations, much attention has been given to treatments and procedures aimed at preserving the hip and avoiding or delaying replacement. Recent studies in which improved technology was used have shown similar results after total hip replacement in patients with osteonecrosis of the femoral head as compared with patients with osteoarthritis. Despite these findings, due to the relatively young age of patients with osteonecrosis of the femoral head, a total hip replacement would most likely need to be revised at some point in time.

Whereas nonoperative treatment (non-weight-bearing and pharmacological measures) has not definitely been proven to alter the course of osteonecrosis of the femoral head, surgical treatment can prevent disease or slow down the progression of disease⁹. The main surgical treatment methods for early stage osteonecrosis of the femoral head include osteotomy, core decompression, and the application of bone grafts; recently, the use of growth factors has also been added to the list¹⁰. Pulsed electromagnetic field stimulation—a noninvasive treatment— has been proposed as a treatment method⁹. Electrical stimulation has been shown to be clinically useful for enhancing bone repair in nonunions following fracture, incorporation of bone graft, osteotomy, and arthrodesis^11-14. Furthermore, recent experimental evidence demonstrated a chondroprotective effect of pulsed electromagnetic fields^15,16. The biophysical treatment of osteonecrosis of the femoral head with pulsed electromagnetic fields to limit the progression of the disease was first reported by Bassett et al.^17,18. The rationale for the use of pulsed electromagnetic fields in the treatment of osteonecrosis of the femoral head rests on two fundamental mechanisms of action: (1) pulsed electromagnetic fields can play an important role in the local control of inflammation and, in particular, the prevention of articular cartilage degeneration^15,16,19,20; and (2) pulsed electromagnetic fields favor the repair activity that has been observed in osteonecrotic areas of the femoral head and can potentiate the healing process by stimulating neovascularization and new bone formation^21,22.

These combined effects might result in effective pain control, chondroprotection, and optimization of the healing process with consequent conservation of the femoral head. Since 1989, patients with this condition have been treated with pulsed electromagnetic fields. This study analyzes the collective experience concerning the efficacy of stimulation with pulsed electromagnetic fields for the treatment of osteonecrosis of the femoral head. An effort was made to define the radiographic stages at which treatment of the disease is indicated.

Materials and Methods

Materials and Methods | Results | Discussion | References

The protocol for this retrospective review of medical records and radiographs was approved by our institutional review boards. We reviewed the medical records of sixty-six consecutive patients (seventy-six hips) who received pulsed electromagnetic field stimulation for the treatment of Ficat stage I, II, or III osteonecrosis of the femoral head²³. The patients included forty-nine men and seventeen women (mean age, forty-four years). Ten patients had bilateral involvement. There were no identifiable associated risk factors in fifty-one patients (77%), whereas a predisposing factor could be identified in fifteen patients (23%). The primary end point analyzed in this study was the avoidance of hip surgery, and the secondary end point was limiting the radiographic progression of osteonecrosis of the femoral head.

Information was collected regarding gender, age, and hip pain at the time of onset of osteonecrosis of the femoral head. Data concerning recommended weight-bearing status at the time of diagnosis was also sought. In all cases, the presence of osteonecrosis was confirmed by diagnostic imaging. Standard radiographs were available for the purpose of Ficat staging²³, and magnetic resonance images, computed tomo-graphic scans, and scintigrams were acquired to confirm the diagnosis. Clinical and diagnostic imaging information was collected for all available follow-up examinations. To evaluate the efficacy of treatment, the authors analyzed whether the patient had total joint replacement and/or whether the Ficat and Arlet staging had remained unchanged.

To control pain, which at the start of stimulation had been present for a mean of 4 ± 3 months, nonsteroidal antiinflammatory drug therapy was utilized in most patients. Non-weight-bearing was advised for all patients.

Treatment with pulsed electromagnetic fields was started at the time of the initial diagnosis. Patients were instructed to use the stimulator for eight hours per day for six months. The treatment could be performed in multiple sessions, with each session lasting at least two hours. The electromagnetic stimulation device did not include a clock to monitor patient compliance.

A circular coil positioned on the lateral surface of the thigh was kept in place by a Velcro strap (Velcro, Manchester, New Hampshire). The pulse generator (BIOSTIM; IGEA, Carpi, Italy) supplied the coil with single-voltage pulses at 75 Hz, with each pulse lasting 1.3 msec. The voltage of the pulse was set so that, at the level of the femoral head, the electric field and tolerance that was induced in a standard coil probe was 2 ± 0.5 mV¹⁴ (Fig. 1). The mean duration of treatment was 5 ± 2 months.

Radiographic signs of progression of osteonecrosis of the femoral head at the time of follow-up were separately evaluated according to the Ficat stage of disease that had been identified at the beginning of treatment. Statistical analyses were performed with use of the chi-square test, and the level of significance was set at p = 0.01.

Results

Materials and Methods | Results | Discussion | References

Patients returned periodically for examination after the end of pulsed electromagnetic field stimulation. The mean duration of follow-up was twenty-eight months (minimum, twelve months; maximum, 108 months). All hips that were judged to be at Ficat stage I or II had computed tomographic confirmation of the diagnosis.

Although non-weight-bearing had been advised for all patients, only thirty-four patients (52%) had actually spent a period (three to five months) without loading the joint. The other patients had commenced loading as soon as the pain symptoms had lessened enough to make this possible.

At the final follow-up, fifteen of the seventy-six hips (20%) had progression of osteonecrosis of the femoral head that led to the onset of a severe degenerative osteoarthritis and required surgery. Of these fifteen hips, twelve had Ficat stage-III disease at the beginning of treatment, whereas the remaining three hips had Ficat stage-II disease at the beginning of treatment. The frequency with which surgical intervention was necessary was significantly higher in hips with Ficat stage-III disease than in hips with Ficat stage-II disease (p < 0.01) or Ficat stage-I disease (p < 0.0001). No significant differences were observed between the hips with Ficat stage-I disease and the hips with Ficat stage-II disease (Table I). Pulsed electromagnetic fields preserved fifty (94%) of the fifty-three Ficat stage-I or II hips.

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TABLE I Need for Hip Replacement by Ficat Stage

Ficat Stage at Start of Treament	Number of Hips	Number of Hip Replacements
I	31	0
II	22	3
III	23	12

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TABLE I Need for Hip Replacement by Ficat Stage

Ficat Stage at Start of Treament	Number of Hips	Number of Hip Replacements
I	31	0
II	22	3
III	23	12

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Fig. 1: A: Waveform of the magnetic field. B: Waveform of the electric field induced in the standard coil probe. (Reprinted, with permission, from: Borsalino G, Bagnacani M, Bettati E, Fornaciari F, Rocchi R, Uluhogian S, Ceccherelli G, Cadossi R. Electrical stimulation of human femoral intertrochanteric osteotomies: double-blind study. Clin Orthop Relat Res. 1988;237:258.)

On the basis of the radiographic evaluation at the time of the final follow-up, it was determined that twenty hips (26%) had advanced in Ficat stage: three hips with Ficat stage-I disease had progressed to Ficat stage-II disease; five hips with Ficat stage-II disease had progressed to Ficat stage-III disease, necessitating total hip arthroplasty in three; and twelve hips with Ficat stage-III disease had progressed to Ficat stage-IV disease, necessitating total hip arthroplasty in all twelve. Among non-weight-bearing patients, eight patients underwent hip arthroplasty and three patients (four hips) had osteonecrotic progression according to Ficat stage.

In the majority of patients, at thirty to sixty days from the beginning of stimulation, a considerable improvement was observed in pain symptoms, such that by the time of the two-month follow-up, the pain was absent in thirty-five patients (53%) and moderate in seventeen patients (26%).

Discussion

Materials and Methods | Results | Discussion | References

In the present study, patients with Ficat stage I or II osteonecrosis of the femoral head responded well to treatment with pulsed electromagnetic fields and, in most cases, the treatment prevented disease progression. Overall, 94% of the hips that were at Ficat stage I or II and received treatment with pulsed electromagnetic field stimulation had joint preservation.

Our findings confirmed the results of other studies of pulsed electromagnetic fields as reported in the literature ^9,18,24-26. Other studies used a different pulsed electromagnetic field generator for the treatment of osteonecrosis of the femoral head. The characteristics of the stimulation parameters in the present study, as compared with those from the literature, were: an induced electric field of 2 mV versus 15 mV, and an impulse width of 1.3 msec (a frequency of 75 Hz) versus 0.38 msec (a frequency of 72 Hz). The signal employed by us and these other authors were all single-pulse signals, which have been described in detail by Bassett²⁷. Single-pulse signals have also been used to enhance bone-healing^14,28 and, in our experience, to prevent osteoarthritis¹⁶. In addition to single-pulse signals, burst signals have been shown to be effective in the prevention of osteoarthritis¹⁵ and are utilized in clinical settings for the purpose of bone-healing¹¹. Both single-pulse and burst signals display the square shape that is necessary to induce a large electric field into the tissue.

The treatment method for Ficat stage-III disease must always be carefully decided on a per-patient basis. Pulsed electromagnetic field stimulation may be advisable only for younger, stage-III patients. This treatment method may not offer any beneficial effects to a patient whose hip has already collapsed or is biomechanically compromised. It is possible that such patients may benefit from removal of the necrotic bone combined with local insertion of bone grafts followed by pulsed electromagnetic field stimulation, as reported by Santori et al.²⁹. Furthermore, it has been reported by some authors that hip survival is significantly higher in patients who are managed with core decompression plus pulsed electromagnetic field stimulation compared with patients who are managed with core decompression alone (p = 0.01)^1-9. Thus, pulsed electromagnetic field stimulation should be considered as an ancillary adjunctive treatment to surgical treatment for both early and later stages of osteonecrosis of the femoral head.

Whether or not weight-bearing is allowed does not appear to affect the results with regard to the need for arthroplasty or to osteonecrotic progression according to Ficat stage. The lack of influence of non-weight-bearing on progression of osteonecrosis has also been reported in the study by Steinberg et al.². An important effect of this treatment is pain relief, accompanied by recovery of joint function, which was observed in most patients (53%) after sixty days of treatment.

The initial stages of osteonecrosis of the femoral head are associated with an ischemic and inflammatory component; the latter is believed to be partly responsible for joint pain and edema. The effect of pulsed electromagnetic fields on joint and bone-marrow edema has always been viewed as an ancillary effect by researchers who traditionally have focused on bone-tissue healing. It has been shown that pulsed electromagnetic field biophysical stimulation (1) increases the availability of the A_2A adenosine receptors situated on the cell membrane of the neutrophils and exerts a strong antiinflammatory effect accompanied by a decreased production of free radicals^20,30; (2) inhibits the catabolic effects of the inflammatory cytokines on the joint cartilage and stimulates the synthesis of proteoglycans²⁰; and (3) halts the progression of osteoarthritis in vivo, favoring the expression of cytokine with anabolic effects on cartilage and down-regulating the expression of cytokines with catabolic effects on cartilage^15,16. These effects of pulsed electromagnetic fields may play a fundamental role in the treatment of osteonecrosis of the femoral head by limiting the damage induced by inflammation and preserving cartilage and subchondral bone. Thus, the use of pulsed electromagnetic fields in the treatment of osteonecrosis of the femoral head, specifically during the early Ficat stages of the disease, can be expected to lead, in the short term (thirty to sixty days), to pain control and cartilage integrity through an antiinflammatory A_2A adenosine agonist effect.

In the long term, the effects of the treatment may allow for the recovery of the ischemic bone tissue through: (1) stimulation of local production of growth factors as well as the osteogenic activity of osteoblasts^31-33; (2) promotion of new vessel formation and containment of extension of the necrotic area resulting from ischemia^21,34; and (3) reduction of bone reabsorption by interfering with the activation of the parathyroid hormone receptor, thus decreasing the recruitment and differentiation of osteoclasts^35,36.

Treatment with pulsed electromagnetic fields may be a viable alternative to surgical treatment of osteonecrosis of the femoral head in hips with Ficat stage-I or II disease. Nevertheless, the time commitment required from the patient should not be underestimated. Daily treatment is both lengthy and demanding, and some patients find the coil positioning to be uncomfortable. Patients may find it preferable to perform the treatment during the night. Magnetic resonance imaging enables early diagnosis and intervention at the onset of the disorder with the immediate use of pulsed electromagnetic field stimulation. This modality represents an important therapeutic opportunity to resolve the disease or at least to delay the time until joint replacement becomes necessary. ?

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Topics

biophysics ; electromagnetic fields ; femur head necrosis ; hip region ; osteonecrosis

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Leo Massari, Milena Fini, Ruggero Cadossi, Stefania Setti, Gian Carlo Traina; Biophysical Stimulation with Pulsed Electromagnetic Fields in Osteonecrosis of the Femoral Head. The Journal of Bone & Joint Surgery. 2006 Nov;88(suppl_2):56-60.

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