Patient Guide to Bone Growth Stimulation
Bone growth stimulation (BGS) is a therapy your surgeon may prescribe following a spinal fusion procedure. A bone growth stimulator is a supplemental device worn following cervical (neck) or lumbar (low back) spine surgery. BGS may be utilized to help spinal bone fuse after a fusion procedure or as a treatment for failed fusion. Bones create a mild electric field when they are healing or growing. A bone growth stimulator (BGS) sends more energy to the healing bone surface through either pulsed electromagnetic or ultrasound waves, which helps the bone heal more quickly. The Orthopaedic physicians at OSC only use external bone growth stimulators.
Aetna considers the use of an ultrasonic osteogenesis stimulator e. This system uses pulsed ultrasound to speed healing. Fractures on these sites are difficult to heal because of poor vascular supply. Aetna considers direct current electrical bone-growth stimulators, as well as inductive coupling or capacitive coupling non-invasive electrical stimulators medically necessary for any of the following nonspinal indications:.
Aetna considers direct current electrical bone-growth stimulators, as well as inductive coupling or capacitive coupling non-invasive electrical stimulators medically necessary for any of the following spinal indications:. Aetna considers electrical bone-growth stimulators experimental and investigational for the treatment of all other indications, including the following not an all-inclusive list because of a lack of adequate evidence of their effectiveness for these conditions:.
Aetna considers semi-invasive bone growth stimulators experimental how to attach reindeer antlers to car investigational for all indications including treatment of orthopedic and neurosurgical conditions e. An electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. Electrical stimulation can be applied either from the outside of the body noninvasive or from the inside of the body invasive.
A noninvasive electrical stimulator is characterized by an external power source which is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site.
An ultrasonic osteogenesis stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.
Ultrasonic fracture healing utilizes a signal generator and a transducer, which when placed over the fracture site on the skin, emits low intensity ultrasound signals that are emitted directly to the fracture. When applied over a fracture site, an ultrasonic accelerated fracture healing device produces an ultrasonic wave, which delivers mechanical pressure to the bone tissue at the fracture site. Although the mechanism by which the low-intensity pulsed ultrasound device accelerates bone healing is uncertain, it is thought to promote bone formation in a manner comparable to bone responses to mechanical stress.
West Caldwell, NJto accelerate the healing of new bone fractures in the tibial diaphysis and Colles' fractures of the distal radius in adults. The FDA approval of the device was based in part on its review of 2 multi-center randomized controlled trials of the device on tibial diaphyseal fractures and distal radius Colles' fractures. SAFHS low-intensity pulsed ultrasound has been demonstrated to significantly accelerate the time to clinical healing of fractures of the tibial diaphysis.
Tibial fractures are notorious for prolonged healing and a high incidence of delayed union and nonunion. The average fresh uncomplicated tibial fracture takes 4 months to heal, and a majority of cases of nonunion involve the tibia. A study by Heckman, et al. Thirteen fracture patients were lost to follow-up, and 17 fracture patients were excluded because of deviations from the study protocol the latter group of patients were included in an intention-to-treat analysisso that 66 patients with 67 fractures remained in the study to its conclusion.
Beginning 7 days after fracture, patients received one minute treatment each day either with ultrasound or with the placebo device for up to 20 weeks. Two clinical outcomes and two radiological outcomes were measured. The clinical outcomes examined were time to clinical healing defined as the time at which the physician thought that, on clinical examination, the fracture was stable and was not painful to palpation and the time to discontinuation of the cast defined as the time at which the physician what is the best thing for dry cracked lips the cast.
The radiological outcomes included cortical bridging the gradual disappearance of interruption of cortex at the fracture site as a result of callus formation and endosteal healing the gradual disappearance or obliteration of the fracture line and its replacement by a zone of increased density formed by endosteal callus. The time to radiographic healing was defined as the time to bridging of all four cortices.
A fifth outcome, time to complete healing, was defined as the time to complete radiographic and clinical healing. Given that clinical healing typically occurs before radiographic healing, the time to complete healing was primarily a reflection of the time to radiographic healing.
All patients were completely healed at the end of the study, regardless of whether they were treated with low-intensity pulsed ultrasound Heckman, et al. There was a statistically significant reduction in time to healing in the treatment group by each of the outcomes measured.
The reductions in time to healing measured clinically were smaller than the reductions in time to healing measured radiographically. In general, the magnitude of reductions in time to healing tended to be greatest in tibial fracture patients which factors that tend to prolong healing time.
Older patients and women tend to have greater times to healing than younger patients and men, and the reduction in time to healing from SAFHS tended to be greater in older patients and in women.
Healing times tended to be greater with larger fracture gaps, and spiral and oblique fractures tended to take longer to heal than transverse fractures. The effect of SAFHS in reducing the time to complete healing of tibial fractures tended to be greater where there was what is a bone growth stimulator used for larger fracture gap, and also in patients with spiral or what is a bone growth stimulator used for fractures.
The greatest reductions in healing time occurred in patients with oblique and what is best buy return policy fractures who also had the largest fracture gaps. The magnitude of the benefit of SAFHS was also affected by the location of the fracture on the tibia, with the greatest reduction in fracture healing time occurring in patients with fractures of the distal portion of the tibial diaphysis.
The what is a bone growth stimulator used for of prereduction displacement also appeared to have an effect on time to complete what is a bone growth stimulator used for and on the amount of reduction of fracture healing time with SAFHS.
Patients with less than 20 percent prereduction displacement tended to have less time to a healed fracture and less reduction in fracture healing time than patients with prereduction displacement of 20 percent or more. Long-term follow-up of trial participants was done at the request of the FDA to determine whether all healed fractures in both groups remained healed at a minimum of two years after the injury. Fifty-five patients 56 fractures of the 66 patients 67 fractures who had been enrolled in the protocol were contacted, and all of the 56 fractures were still healed up to four years after fracture.
The conclusions about the effectiveness of low-intensity pulsed ultrasound on fracture healing from this study are limited to new fractures of the tibial diaphysis that are closed or open grade I.
Excluded from the study were patients with severe fracture complications Also excluded from the study were patients with pathological fractures fractures due to bone diseases or malignancy.
Although SAFHS low-intensity pulsed ultrasound has been demonstrated to accelerate the time to radiologic healing of fresh closed Colles' wrist fractures, it has not been shown to significantly reduce the time to clinical healing of these fractures. Kristiansen, et al.
The study only included patients with closed Colles' fractures in which the primary fracture line was predominantly transverse and occurred within the distal 1. The fracture was required to be satisfactorily reduced, based upon radial length, radial angle, and volar tilt. Eighty five fractures were entered into the study, with 40 fractures randomly assigned to the ultrasound treatment, and 45 fractures assigned to the placebo device.
Patient's were treated with ultrasound or the placebo device for 20 minutes each day for 10 weeks, starting within 7 days of fracture. Three of these fractures were lost to follow-up, and 21 were excluded because of lack of adherence to protocol the latter group were included in an intention-to-treat analysisso that 61 fractures remained in the study to its conclusion. The what are the tax rates in the uk examined in this study were similar to those examined in the study of tibial fractures described above: measures of clinical healing, radiographic healing, and time to complete healing were reported.
Colles' fractures were considered clinically healed when the fracture site was solid and free of tenderness and pain upon palpation. In contrast to the study of SAFHS and tibial fractures, the time to cast removal was not reported in this study.
Time to endosteal healing and time to cortical healing were measured. Colles' fractures were considered radiographically healed when all cortices were bridged. Time to complete healing, defined as the time to full clinical and radiographic healing, was also measured.
Because clinical healing of fractures usually occurs well before radiographic healing, the time to complete radiographic and clinical healing was primarily a factor of the time to radiographic healing. Thus, the time to radiographic healing and the time to complete healing were approximately equal.
Both patients treated with low-intensity pulsed ultrasound what time did the first world trade center collapse patients receiving placebo were healed by the end of the study; there was no difference in the final healing rates between the treatment and control groups Kristiansen, et al.
There was a statistically significant difference time to radiographic healing between patients receiving active treatment what is a bone growth stimulator used for The authors noted, however, that the measurement of clinical healing was complicated by the subjectivity of the clinical assessment.
Furthermore, clinical healing was assessed when the initial cast was removed, and the initial cast removal did not occur at the same time following fracture in each patient. The failure to find a significant reduction in the time to clinical healing of Colles' fractures with SAFHS, however, calls into question whether the reductions in healing time reported in this study were of clinical significance.
First, the total healing time and reduction in healing time with SAFHS of Colles' fractures were much smaller than that of tibial fractures. This is because trabecular bone heals much more rapidly than cortical bone due to its greater surface area, cellularity, and vascularity. Among fractures of cortical bone, tibial fractures are particularly likely to be slow-healing.
Second, radiographic healing is an outcome of questionable clinical relevance, given that the primary reason to accelerate fracture healing is to reduce the duration of morbidity due to pain and loss of function.
There was evidence that the greatest reductions in time to complete healing with SAFHS what is a bone growth stimulator used for achieved by older patients and female patients -- patients who also tend to have longer healing times.
Actively treated patients age 50 or older healed 40 days sooner than placebo what is a bone growth stimulator used for of the same age, whereas actively treated patients less than 50 years old healed only 29 days sooner than their counterparts in the placebo group. Similarly, the reduction in time to complete healing of Colles' fractures tended to be greater in women 40 days what is lactic acid build up than men 30 days saved.
Excluded from the study were patients with nonunions, pathologic fractures, or patients with fractures requiring open reduction, skeletal fixation, or surgical intervention. Thus, evidence of healing was limited to patients with fresh closed distal radius Colles' fractures that can be managed with closed reduction and cast immobilization.
At the request of the FDA, attempts were made to contact all clinical trial participants two or more years after fracture to determine whether their fractures were still healed. Over 92 percent of the patients were contacted and all remained healed. Children were excluded from both clinical trials because the effects of low intensity pulsed ultrasound on the immature skeleton are unknown. SAFHS is most likely to result in clinically significant benefits when applied to fresh fractures with poor vascularity that are slow to heal and at high risk of non-union.
Tibial fractures that are open or segmental are notorious for prolonged healing and a high incidence of delayed union and non-union.
Healing of femur fractures is also prolonged, and the femur is the second most common site of fracture nonunion. However, repair of femur fractures requires open surgery.
Fractures of the scaphoid carpal navicular and the fifth metatarsal Jones fracture are uncommon, but when they occur, they are at high-risk of delayed union and non-union. Literature from the manufacturer suggests that low intensity pulsed ultrasound could be targeted to patients who are likely to have a slow healing fractures, either because of fracture characteristics, comorbid conditions, or because of age.
Fractures involving trabecular bone tend to heal much more rapidly than fractures of cortical bone, and comparison of clinical trials of SAFHS in patients with fractures of the tibia comprised primarily of cortical bone and Colles' fractures involving primarily trabecular bone suggest that the reduction in healing time with SAFHS is greatest in fractures involving cortical bone.
Smokers tend to have longer times to fracture healing. A subsequent analysis of the SAFHS tibial fracture study showed that greater reductions in fracture healing time were achieved in patients with a history of smoking, with the greatest reductions in fracture healing time occurring in current smokers Cook et what is a bone growth stimulator used for, There is evidence that patients receiving steroids or anticoagulants tend to have prolonged fracture healing times. Patients with circulatory problems e.
Open fractures and severe fractures are susceptible to delayed healing. However, patients with the most severe fracture complications were excluded from study participation. Patients with pathologic fractures fractures occurring through what colors match army green bone due to tumor, infection, Paget's disease, etc.
Moreover, it is uncertain whether SAFHS would significantly accelerate healing in patients with pathologic fractures due to malignancy unless the underlying neoplasm is treated. Obese patients and patients with diabetes tend to have delayed fracture healing. However, there are no clinical studies that demonstrate that SAFHS results in a greater reduction in fracture healing time in these patients compared to other patients.
There are no contraindications to the use of low intensity pulsed ultrasound, and no known side effects. SAFHS will not correct or alter post reduction aspects of a fracture, such as displacement, angulation, or malalignment. It does not obviate the need for open reduction and internal fixation in fractures where this is indicated. Ultrasonic bone growth stimulation has also been studied for accelerating healing of stress fractures. In a prospective, randomized, double-blind clinical trial, Rue what is the worst disease in the world today al ascertained if pulsed ultrasound reduces tibial stress fracture healing time.
A total of 26 midshipmen 43 tibial stress fractures were randomized to receive pulsed ultrasound or placebo treatment.
Improving spinal bone healing in at-risk patients
Oct 24, · Bone stimulators are often used to treat nonunions, which are broken bones that fail to heal. Nonunions may occur when there’s a lack of stability, blood flow, or both. Infections are also a . Electrical bone growth stimulators are a supplemental form of therapy to help enhance the body’s bone healing process a process that is absolutely essential for the success of any type of spinal fusion surgery. Human bone is actually a living tissue and, like skin, has the inherent ability to heal itself when broken or injured. A bone growth stimulator is a small device that administers either electrical, electromagnetic, or ultrasonic pulses (depending on the type or brand) to the fractured area in order to promote healing.
Bone growth stimulation BGS is a therapy your surgeon may prescribe following a spinal fusion procedure. A bone growth stimulator is a supplemental device worn following cervical neck or lumbar low back spine surgery.
BGS may be utilized to help spinal bone fuse after a fusion procedure or as a treatment for failed fusion. Naturally, you have questions about this technology. Bone growth stimulation may be utilized to help spinal bone fuse after a fusion procedure or as a treatment for failed fusion.
Photo Credit: RF. Gerard J. Having been a study center for this technology, I have used bone growth stimulation in the majority of my post-operative cervical and lumbar patient cases. Not every patient is a candidate for bone growth stimulation.
The patient evaluation criteria I use includes:. Spinal fusion is performed to stop movement of the spine and help prevent neurologic deficit. During the procedure, 2 or more vertebral bodies are joined together using instrumentation and bone graft. Bone graft may include your own bone autograft , donor bone allograft , or other types of graft. Post-operative image of a neck cervical surgery using spinal instrumentation. Spinal instrumentation creates an internal cast, which allows the inflammatory process to stimulate bone healing.
With time, new bone grows into and around the implanted instrumentation healing into a solid construct. Some patients are at-risk for spinal fusion to not heal properly or fail.
A failed fusion is also called pseudarthrosis or non-union. Pseudarthrosis and non-union are medical terms your surgeon may use to define a fusion problem. A BGS sends low level electrical signals to the fusion site. The electrical signals activate the body's natural bone healing process, which may be impaired in at-risk patients. Over 50 years ago, scientists discovered that low-level electrical fields stimulate the body's bone-healing process.
Other advances that include finding different types of energy that stimulate bone growth, electromagnetic coil technology and simply better devices— supported by scientific and clinical research—have improved bone healing in patients who undergo spinal fusion.
All bone growth stimulators are different. Certain types are designed to be surgically implanted internal BGS and other stimulators are worn outside the body external BGS. Other differences include the type of electrical current or magnetic field generated by the device and how stimulation is transmitted to the spine.
The types of bone growth stimulation devices approved by the U. Food and Drug Administration FDA use direct current 1 , capacitive coupling 2 , combined magnetic fields 3 , or pulsed electromagnetic fields. References 1.
Kane WJ. Direct current electrical bone growth stimulation for spinal fusion. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions.
A double-blind, randomized, placebo-controlled study. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. The Spine Journal. Thacker I.
Pseudarthrosis after lumbar spine fusion: non-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics. Mooney V.
The patient evaluation criteria I use includes: Patients who smoke Multi-level fusions; more than 1 level of the spine is fused Co-morbidities risk factors that could hinder bone healing and growth About Spinal Fusion Spinal fusion is performed to stop movement of the spine and help prevent neurologic deficit. Bone graft helps stimulate new bone to grow through 3 stages: Inflammatory stage: Cells begin to form new tissue Repair stage: Small blood vessel ingrowth starts Remodeling stage: Bone structure becomes strong Post-operative image of a neck cervical surgery using spinal instrumentation.
View Sources References 1. Always consult your doctor about your medical conditions or back problem. SpineUniverse does not provide medical advice, diagnosis or treatment. Use of the SpineUniverse. Sign up for our newsletter, and get this free sanity-saving guide to life in the time of corona. Continue Reading:. Bone healing is the process necessary for a successful spinal fusion. Learn about risk factors that could cause a spinal fusion to fail.