BALTIMORE, Md. ( Ivanhoe Newswire) - You use one to flip through channels or even start your car, but there's a remote control that's helping people lengthen their legs.
Jason Carroll is getting back into the swing of things. When he was 11, a football injury shattered the growth plate in his right leg.
"I heard it break and then I just remember getting pulled into the ambulance," Jason Carroll, told Ivanhoe.
"As time went on he had more and more pain in the knee," Debbie Carroll, Jason's mom, told Ivanhoe.
The damage to his growth plate led to his right leg being an inch and a half shorter than his left.
"People would ask why are you limping and stuff like that," Jason said.
That's where new state-of-the-art technology comes in. PRECISE is the first FDA approved internal limb lengthening system designed with a remote control. Doctor Shawn Standard of Sinai Hospital is one of its developers.
"It's designed to be a lot smaller, can fit into more patients with different sizes of bones," Dr. Standard, head of pediatric orthopedics and international center for limb lengthening, said.
A telescopic titanium rod is placed inside the patient's thigh bone or shin. Then a remote control magnetic generator is put over the skin where the rod is implanted for a few minutes several times a day.
"And as you turn on the magnetic driver, the rod will actually pull apart and lengthen the bone," Dr. Standard said.
Patients can expect to grow an average of a millimeter a day or a little over an inch in one month with little pain.
"It was a lot easier than I expected, no pain with it," Jason Carroll said.
After legs are lengthened with the PRECISE system the titanium rods are removed. The remote-controlled treatment is not for everyone. The doctor said patients don't qualify if they're bones aren't long or wide enough for the device. People with significant deformities aren't candidates either.
BACKGROUND: While many people have slight differences in the length of one leg compared to the other, a significant difference between the two legs can cause problems. Leg length discrepancies can disturb the way a person walks, how his or her spine lines up and can strain hip joints. (Source: http://www.cedars-sinai.edu)
A limb length difference may simply be a mild variation between the two sides of the body. This is not unusual in the general population. For example, one study reported that 32 percent of 600 military recruits had a 1/5 inch to a 3/5 inch difference between the lengths of their legs. (Source: http://orthoinfo.aaos.org)
TYPES: There are two types of limb deficiencies.
Congenital discrepancy: This is when children are born with one leg longer than the other. In some cases one particular part of the leg is underdeveloped or absent.
Acquired discrepancy: This is when children are normal at birth but something happens to damage their growth plate, such as a severe fracture. The bone growth in that limb slows and results in a leg length discrepancy that increases as long as the child continues to grow. (Source: http://www.shrinershospitalsforchildren.org)
TREATMENT: There are two current treatments for this condition. The first is called epiphyiodesis, which is a surgical procedure that arrests the growth of one or more of the growth plates of the leg. When done at the right time, this procedure allows the short leg to "catch up" and reach equality just at maturity. It is the most simple and least risky treatment, but requires precise timing to avoid over or under correction. The second treatment is called Femoral shortening. In this procedure a part of the femur is surgically removed, and internal fixation is used to stabilize the femoral segments. It is used when there is enough growth remaining to allow epiphysiodesis to be effective. (Source: http://www.shrinershospitalsforchildren.org)
NEW TECHNOLOGY: To cater to the population with limb deficiencies more efficiently, a new procedure was introduced, called the PRECISE Limb Lengthening Device. Dr. Shawn Standard, MD, head of pediatric orthopedics at Sinai's International Center for Limb Lengthening (ICLL), and John Herzenberg, MD, ICLL director, performed the first tibial implantation using the Precice Limb Lengthening System at Sinai Hospital's Rubin Institute for Advanced Orthopedics, where limb lengthening specialists have now implanted eight of the devices.
The new system comprised of extension rods, a magnetic actuator, and a hand-held external remote controller, facilitates less-invasive leg lengthening through remote control adjustment of previously implanted rods. Engineers at Irvine, CA-based Ellipse Technologies invented the magnetic-powered device. Inside the rod, a miniature magnetic motor and gearbox create the force needed to lengthen the rod. The internal motor is powered by a magnetic field generator that is held next to the limb for a few minutes, several times a day. The PRECISE Limb Lengthening System, which can be used during lengthening of the tibia and femur bones, became the first remote-controlled internal limb lengthening system to receive approval from the FDA. (Source: http://www.lifebridgehealth.org and http://www.lowerextremityreview.com)
Shawn Standard, M.D., Head of Pediatric Orthopedics at the International Center for Limb Lengthening at Sinai Hospital of Baltimore, talks about how he's using a remote control device to help grow bone.
How common it is for a child to have a shorter limb?
Dr. Standard: Eighty percent of the population is off to some degree. There are only probably 20% to 25% of us that are actually perfectly equal. The way you measure that is with an x-ray. You can do all kinds of tape measurements and that is not going to really give you an accurate measurement.
When you get to about ¾ inch (some people say ½ inch to ¾ inch), the discrepancy can become a functional issue. There are many reasons that people have a short limb. One is developmental, and we do not quite know why it happens. Some can be after trauma, where a bone is broken and the growth plate either stops growing or the bone is shortened during the treatment of the fracture. Infections can also destroy the growth areas of the bone. Some children are born with what is called congenital limb deficiency or bone dysplasia. Children with congenital limb deficiencies have one limb that is genetically programmed to grow at a different rate, which results in a limb length discrepancy. Children with dwarfism have a genetic defect in multiple growth plates, which makes the legs and arms equally short. These children have overall dysfunctional stature (not a leg length discrepancy). The causes of these genetic problems are unknown.
How does the limb lengthening device work?
Dr. Standard: Surgical limb lengthening started slightly more than a century ago. Dr. Ilizarov modernized limb lengthening and reconstruction in Russia in the 1950s, and this medical technology slowly came across the globe to us. It mainly utilized an external fixator, which is a device on the outside of the body that is attached to the bone through the skin with pins or wires. We cut the bone and slowly pull the bone apart with these apparatuses on the outside of the body. The holy grail of limb lengthening is to be able to achieve the same limb lengthening, but from within the bone (i.e., an internal device), and if you can do that, you can eliminate all the pin sites, which can be problematic. Use of an external fixator is still needed for certain types of deformity correction and lengthening. However, if you can do it without the pin sites, then it is a huge benefit for the patients. There have been several internal lengthening devices over the last couple of decades. They have their good points and bad points, but nothing has ever been the panacea of internal lengthening.
Over a 2-year period, Dr. Herzenberg, Dr. Green, and myself designed an internal lengthening rod that is for the bone in your thigh and a bone in your lower leg. The way the rod works is very similar to what we call an intramedullary rod or rod that is placed in a canal that is in the middle of your bone. What is special about the design of this rod is that it is a telescoping rod. It is a rod within a rod. Within that rod there is a magnetic mechanism that has gears and a drive shaft. You use a magnetic device on the outside of the body. The magnets rotate outside the body, and this magnetic field drives the internal drive shaft and makes the rod lengthen. When we insert the rod, we also cut the bone. This creates 2 bone segments, and the rod is attached to each end of the bone segment. As the magnetic driver turns, the rod will pull apart and lengthen the bone. The lengthening is activated with the remote control device that is located outside of the body.
What was the standard of care before this?
Dr. Standard: There are several internal limb lengtheners that are currently on the market. The one that is probably the most controlled is called the Fit Bone Device. It is a German design that is electronic. It has a little sensor or an antenna that is underneath the skin. It transmits an electronic signal that turns on an engine and lengthens the bone. One limitation of that rod is that it has a very big diameter. All of our bones have certain diameters. For me, being a pediatric orthopedic surgeon, children's thigh bones are smaller, so I need a smaller type design that can be used in young people. Unfortunately, the Fit Bone is not even available in the United States or FDA approved.
One FDA-approved device is called the internal skeletal kinetic distractor (ISKD) by a company called Orthofix. We have been using the ISKD for over a decade here. We have had many patients achieve successful results with the ISKD. For children with limb deficiencies, the ISKD can cause problems because the rod can either lengthen too fast or too slow. And, it is not 100% controllable. But, for a long time, it was the only FDA-approved internal lengthening device in the United States. It blazed the trail for this newer device, called the Precice rod (by Ellipse Technologies). The Precice rod is the second FDA-approved device in the United States. Its design is a lot smaller. It can fit into more patients and in different sizes of bones.
Besides being smaller, what else does it do?
Dr. Standard: The Precice rod offers more control. You can change the rate of lengthening and the rate of lengthening is very important. If you pull apart a bone too fast, it will not heal. If you pull it apart too slowly, it will heal too quickly and you cannot get anymore length. During limb lengthening, it is not only the bone that lengthens. The blood vessels, muscles, and nerves also have to elongate. Every patient is different. If a child is starts to have problems with the lengthening (e.g., the joints get tight, they have some nerve pain), you can slow this rod down to let the body accommodate. If you have to, you can even shorten the rod and reverse the lengthening to compress the bone. The compression aspect opens up this rod for another avenue of usage and that is in trauma, where people break their bones and sometimes healing does not occur. You can put this rod in and compress where the fracture is to try to induce it to heal. That is a completely different use for an internal rod that is very exciting.
Another advantage is that the bone healing with this rod has been fantastic. The patients state that the internal lengthening has caused far less pain and discomfort when compared with their previous treatments with external fixators.
How fast can the bone be stretched per day?
Dr. Standard: The average is about 1 millimeter a day, but you can pull the bone apart anywhere from a 0.5 millimeter to 1 millimeter a day. If you are going to do a 2-inch lengthening (50 mm), that is 50 days of using the rod to lengthen the bone.
I have achieved up to 3 to 4 inches of lengthening in one bone and that can be done safely, but it takes a team of experts, including surgeons, physical therapists, and clinical staff, to care for the patient and make sure all is going well. During lengthening, the team checks the joint motion, the muscles, the nerves, and the blood vessels to make sure that they are tolerating the lengthening. Issues with these soft tissues can become problematic or cause complications. If you just focus on the bone growth, then you can miss some other very important things and actually have a poor outcome.
What would be the downside?
Dr. Standard: You might not be a candidate for the rod. You need to have a bone canal that is big enough to get the rod in. Second, the ability to correct a bone that is curved or bent is limited with an internal lengthening device. If you have a very deformed (i.e., curved) bone and this bone is also short, it would still require an external fixator device to not only lengthen the bone but to straighten the deformity as well.
Another limitation is that at this point in time, the Precice's external remote control device is FDA-approved only for use by medical caregivers. Currently, patients come to Sinai Hospital twice a day so that the external remote control device can be used and the rod lengthened. In other cases, we have designated medical caregivers near the patient's home to use the external remote control device. When the company receives FDA-approval for the home use of the remote control device, patients will be allowed to lengthen their bone at home.
But the hope is to allow a person to be in the comfort of their home and do this?
Dr. Standard: Yes, the parents will be able to take this remote control device home and then place it on the leg 3 or 4 times a day and hit the button. When they hit the button, the device makes a little noise as the magnet rotates. As it rotates, the magnet drives the shaft inside the rod, which lengthening the rod and bone.
The external remote control device is currently being reviewed by the FDA. After it goes through this routine review, it will become a home device just like a wrench that is used to adjust external fixators.
Could this be used cosmetically for those that wanted to gain a few inches?
Dr. Standard: It can. Cosmetic lengthening is a very controversial subject. I think lately there has been some national news about cosmetic lengthening. Cosmetic lengthening at our institute is performed by my partner, Dr. Janet Conway. It is a pretty stringent process.
The low average height of an adult male is about 5 foot 4 inches and for the adult female it is 5 foot 2 inches. Where you fall amongst those averages as well as other criteria help us decide if a patient is a candidate for the surgery. You have to really understand what you are getting into. It is completely different from the children and even adults who are dealing with limb length discrepancies that cause functional issues.
Cosmetic limb lengthening is a journey that requires a significant time investment and financial investment. It takes about a year to complete the process, so it is a huge amount of time for an adult to be in treatment. You undergo the lengthening process and physical therapy for the better part of 4 to 6 months. Then you have more physical therapy for another 3 to 6 months. You have to consider loss of independence for that period of time as well as the support network that you need to have in place to get through the year of treatment. Also, it requires a significant financial investment because insurance companies will not cover stature lengthening.
What's the biggest risk for those people?
Dr. Standard: Cosmetic lengthening is not only a biological or medical decision, it is also an ethical and personal decision. From a personal point of view, I view it as a surgery and there are always surgical risks. There are nerve and muscle complications that can occur, but we are very good at what we do, so we have minimal complications.
Can you talk a little bit about Jason and his journey?
Dr. Standard: Jason is a 16-year-old young man who unfortunately had an injury several years ago that damaged his growth plate in his thigh bone. His one side grew a little bit slower and the other normal side continued, leaving him with over an inch and a half discrepancy in his legs. Eventually, when you have a significant leg length discrepancy, it can give you hip, back and/or knee pain.
We were pretty much set on using an external fixator device, but it was just about the time when the FDA approved the Precice rod. I presented it to Jason as an option. He was very excited, and his family was very supportive. We then moved ahead and did the internal lengthening with the Precice rod, and he has done fantastic. He told me the other day that his friends could not believe that he had surgery because he was on crutches and going to the basketball games at his high school. No one knew that his leg was actually being lengthened at the same time with the remote control device. He has been a great patient with physical therapy, which is really a huge requirement. His leg has now completely lengthened. He has equal leg lengths at this point in the healing process and is doing really well. His mother was nervous before Jason went in for surgery, but she has said that the process was very, very easy. I think he has had fantastic success.
Who are the best candidates for this particular leg lengthening system?
Dr. Standard: Anyone with a leg length difference whose leg is already straight (i.e., not deformed or curved) and whose bone canal is large enough to accommodate the Precice rod is a candidate. If a patient does have an angular deformity in their bone, the deformity may be able to be corrected with an external fixator either before or after limb lengthening with the Precice rod. Patients who are projected as infants to have anywhere from 15 to 20 cm of leg length discrepancy at maturity undergo 3 limb lengthenings during their first 14 to 16 years of life. For those children, being able to avoid external fixation during their second or third lengthening would be a huge benefit and a huge change.
What is 15 to 20 cm?
Dr. Standard: That is about 6 to 8 inches of leg length discrepancy at maturity, which is a moderate-to-severe problem. The very severe cases would be anywhere from 12 to 16 inches of discrepancy and would require multiple lengthenings.
Jason, you said was about an inch and a half.
Dr. Standard: He was an inch and a half, which is a significant leg length discrepancy. Once you get to ¾ inch, the way your back has to compensate when you walk can cause problems.
What is the most extreme discrepancy you have seen in your career?
Dr. Standard: I would have to say it is probably between 14 and 16 inches over a period of time. It is amazing when parents send me an old picture of their kid standing in the kitchen with a bunch of books underneath the short leg. It can take a huge stack of books to make the short leg appear level with the normal leg. Just seeing what the leg looked like before treatment and after treatment is pretty amazing.
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