Bone Growth Stimulator

Everything There Is to Know About Bone Growth Stimulators

The osseous cells form as part of the human body through a process called osteogenesis. From birth until adolescence, the cells keep growing until they reach a maximum height. In a circumstance when the bone is injured or fractured, it must undergo repair. The repair process takes quite a while, depending on the type of injury sustained. Seventy to eighty-five percent of injuries will heal after surgery or through sufficient time, proper stabilization, and adequate blood supply. The other 15-30% of patients that do not heal themselves have a unique condition called "non-union" and require an orthopedic specialist's assistance. The orthopedic specialist has many ways to deal with a non-union. These include internal fixation, external fixation, surgery, or the use of the latest device called the Bone Growth Stimulator. It works to provide extra energy by pulsed electromagnetic or ultrasound waves to speed up the union process between two bony fragments. The stimulator helps patients recover without any invasive procedure, helping the bone to fuse faster than the average time would take. This technology is quite expensive and ranges between $500-$5000 depending on the manufacturer and the required area. 

History

The bone growth stimulator comes from early 1841, but its use did not progress until the 1950s. Yasuda did the first experiment on the rabbit's femur. This trial lasted for about three weeks and showed the osseous formation within the cathode's vicinity. Yasuda proved that the electrical potentials in it and the use of such a modality with electric potentials could assist osseous re-formation. Following this, more and more scientists and doctors around the world began studying the effects of electricity on these cells. By 1976, more than 119 articles were published on the impact of different forms of currents on these cells. These investigations led to the invention of a variety of electrical stimulation devices. These devices proved to be beneficial in treating those patients whose bodies do not have the tendencies to heal or repair themselves. This modality has become essential in almost all hospital settings to treat patients suffering from this condition worldwide. 

Indications to use the device

The bone growth stimulator is a device used to promote cell formation after fractures that are difficult to heal independently. This modality applies electrical or ultrasonic currents on the fracture site to provide energy for healing. The electrical bone growth stimulator provides electrical stimulation to augment ossification. This procedure is non-invasive, which makes it a therapy of choice amongst medical professionals. The stimulator emits low-intensity pulsed ultrasound waves with the aid of a coupling gel to stimulate fusion. 

The bone growth stimulator can be applied from the outside or inside of the body, but health care professionals prefer the non-invasive technique. An external power source attached to a coil or electrodes that the doctor places on the skin of the cast over the fracture site characterizes the non-invasive electrical stimulator.

During treatments, the doctor must prescribe an increased dose of daily vitamin intake, Vitamin D, vitamin C, and calcium. These measures encourage the production of osseous and new cells that help in the healing process. 

Many professionals say that the bone growth stimulator is mainly helpful to treat non-unions, which are parts that are broken and do not tend to heal on their own. Non-union may occur when there is a lack of nutrition, decreased blood flow, or even both. Infections are also a significant factor in a resulting non-union. 

The effectiveness of using osseous growth stimulators in the healing of bones remains unclear. There have been mixed results on whether these devices prove beneficial or not. The use of Electrical bone growth stimulator by professionals is possible for the following conditions (keep in mind that they are still under investigation for some health issues): 

  • All types of osseous fractures 
  • Fresh fractures
  • Slowly healing fractures or non-healing fractures
  • Corrective osteotomy 
  • Shin splints
  • Charcot arthropathy
  •  Avascular necrosis of the hip 
  • Charcot's foot 
  • Comminuted toe fracture
  • Fractures of the scapula or the pelvis
  • Loosened hip or knee prosthesis
  • Lunate, odontoid fractures
  • Sacroiliac fusion
  • Spondylolysis
  • Stress fracture

The identification of the need for surgery is made by testing whether the procedure should occur to decrease the risk of further health issues to the patient. 

Advantages:

  • Low complication rates 
  • Implantable devices allow constant stimulation.
  • Non-invasive technique available
  • Less pain
  • Speedy recovery 
  • Fast osseous joining 

Disadvantages

  • High cost 
  • Not 100% reliable 
  • Pain
  • Difficulty

Complications

Till now, bone growth stimulators have not caused any side effects on the patients. Some side effects may or may not be directly related to the use of this device such as: 

  • Increase in pain 
  • Numbness 
  • Headache 
  • Migraine 
  • Tingling at point of contact 
  • Nausea

These modalities have not yet shown any adverse effects in people, but Podiatry Today cautions that these devices must not be used in the following cases:

  • If the fracture gap is >50% of the total diameter
  • In pseudoarthrosis joints
  • Where Magnetic implants are present in the bod
  • Pregnant women
  • Patients having skeletal immaturity 
  • In patients with pacemakers and defibrillators

Alternative procedures 

Using the bone growth stimulator modality is not the only option available for treating non-unions. In addition to a balanced diet full of protein, calcium, vitamins C, and D, the doctor may suggest other methods to treat the fracture. These alternative procedures include: 

  • Surgical osseous graft 
  • Internal/external fixation

Surgical osseous graft

The osseous graft might be necessary if the non-surgical procedures are not working. The osseous grafts provide new bony cells and encourage healing. This procedure uses a scaffold or an area on which the new skeletal formation can occur. 

Surgical internal or external fixation:

The internal fixation method involves attaching metal plates and screws to the outer part of the bone and placing a nail in the canal at the inner part to stabilize the union.

The external fixation method uses a rigid frame attached to the outside of the injured limb using wires and pins. Bone growth stimulation is the method used to reduce instability.

General specifications 

  • A patient unit which produces an electromagnetic signal is 9-volt 
  • Flat spool with Velcro makes it easily applicable to any fracture
  • There is a particular double-sided flat spool for osseous stimulation on both sides of the breakage
  • Cylindrical spool is used for fractures in a cast  

Osseous stimulators are available in a wide variety depending on fracture and the health care professional. They are available as units that come with the complete setup. These electrodes connect the device and deliver current to the skin and deep bony tissues that are not healing correctly. There is another modality present like a brace or belt that the patient can wear. Also, the patient can sit in a reclined position. 

The typical treatment time is 4-6 hours a day for 3-9 months to be effective. Patient compliance plays a critical role in producing favorable results. The units used are relatively comfortable, safe, and lightweight. They do not need much adjustment because the current is negligible and causes no discomfort to the patient. 

How they work

The device itself is not very complicated to use at all, and there are two types of osseous stimulators in the market—external and internal.

Usage:

External:

  • The patient unit is used as a sleeve and applied to the area of treatment 
  • Velcro secures it as it is already a part of the unit 
  • The modality has a fixed intensity for a fixed duration of time 
  • It is usually used for about 4-6 hours a day, based on the doctor's prescription

Internal: 

  • The internal bone growth stimulator's use is for those areas in which there is no use for the external device, such as a fracture of the spine 
  • A small incision is made at the site of fracture
  • The device has a program at a fixed intensity
  • In the soft pocket of tissue under the skin is the implantation site of the small device
  • The incision made gets sutured afterward

Market leaders

Due to this device being common nowadays, retailers selling the product flood the market, making for high competition. The top 10 market leaders are:

  • Arthrex, INC
  • Bioventus LLC
  • Depuy Synthes
  • DJO Finance LLC
  • Harvest Technologies
  • Isto Biologics
  • Medtronic PLC 
  • Orthofix International N.V 
  • Stryker Corp.
  • Zimmer Biomet Holding INC.

The cost of the device varies from $4000 to $5000 in retail. But the total cost for making this device is way less than this, and that is about $50 to $100.

Conclusion

The invention of an osseous growth stimulator has proven to be of much use in the medical world. These devices are very helpful in treating patients that have almost lost every hope of moving their body normally again. Although it is a very expensive modality, its use is worldwide because of its unique properties to heal a non-union without any invasive procedure. Nowadays, this is one of the few promising devices that produce excellent results and positive feedback. Without the osseous growth stimulator, the only option that orthopedic doctors would be left with is an invasive surgery that can be very painful and slow healing—both effects go against the comfort of the patient. This device has shown to be free of side effects, and with the cooperation of the patient, it can lead to a road of recovery and a healthy lifestyle in no time.

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