Final step before limb lengthening: Consent form
INFORMED CONSENT FORM FOR LIMB LENGTHENING SURGERIES WITH HOLYFIX, LON, PRECICE 2.2 AND PRECICE STRYDE SYSTEMS AND ARM-LEG LENGTHENING
Dear patient/legal representative;
You have the right to be informed of any medical, surgical or diagnostic procedures recommended to you / your patient and their alternatives, benefits, risks or even possible damages related to your health condition / patient’s health condition and to refuse or accept all or some of them or even to stop the transactions at any stage. This document, that we want you to read and understand, is not intended to scare you or to keep you away from medical practices, but to determine your consent to these practices and to obtain your approval.
Height growth during childhood and adolescence occurs by growth of cartilage at the end plates of long bones (leg and arm bones), followed by endochondral bone formation. Physiologic growth is accelerated especially in the puberty and stop growing at around the age of 18 in a process called epiphyseal plate closure. Once the epiphyseal plates have closed there is simply no way for bone to grow in length without surgical procedures.
Lengthening surgery is used to lengthen both the arms and legs of individuals with short stature. Limb Lengthening Surgery is actually the surgical procedure of both leg bones (tibias or femurs). During bone lengthening the other leg tissues are stretching and in the result the individual increases his/her height.
Arm, leg and stature lengthening surgeries are performed by various methods for nearly 50 years.
Ilizarov circular fixator method is the oldest and widely used method. Patients undergo a general anesthesia and the surgeon makes a small incision in the leg, either the tibia or femur bone, whichever bone is opted to be lengthened is separated, thus fragmenting the bone into two. Furthermore, the surgeon drills screws into the top and bottom of the bones and 1.5-2 mm steel wires are attached into the bone separations, inserted from one side of the bone and extracted from the other side. At least, 8 wires are attached in this way; which are made of aluminum, steel or carbon; and fastened with 4 rings at minimum. The wires and screws are fastened into a metal frame that stabilizes the leg during and after the procedure. The body’s natural healing process, does the rest, by filling the gaps within bone tissue, thus lengthening the limb, in the process, naturally.
However, having said that, this system, does have its setbacks, as vascular nerve injury and infection are the most common and key complications. It is also the most troublesome methodology in terms of patient compliance and comfort.
Having said that, an improved version of this methodology is practiced by Wagner and De Bastiani, which consists of monolateral pin type fixator, whereby fixator-induced complications are less likely and patient compliance and comfort is superior to the original Ilizarov’s methodology.
The “HolyFix” method is a Monolateral pin type method which has been in application with success results, since 1997. It is an improved version of Wagner and De Bastiani methodology.
In other words, its formation happens by attaching to the bones one side, to the nails which, in turn are attached, from the exterior, to the “HolyFix” device. The nails are attached to the nearest and safest area, especially not near any vein and nerve, while the nail remains in the bone, thereby they do not cross. The chances of open wound infection are much rare and does not prevent or hinder completion of the lengthening process. This risk is significantly reduced to a minimum owing to the “Holy-Pin”, which is part of the “HolyFix” method, parcel.
The “HolyFix” apparatus is made-up of a specialty aluminum and titanium alloy, thus lighter in weight and is “MRI” and radiology compatible. Hence, making this biomechanical system extremely stable and safe; allowing the patient to walk during the treatment phase. This device makes the “Extension” process very practical and easy, allowing the patient to perform extensions on their own. In addition, “HolyFix” apparatus has such a superior design that it allows for accelerated bone formation and transfers the burden from the bone without any shortening (Dynamization).
Lengthening Over Nail (LON method)
During the 1st stage of the surgery, an intramedullary nail is inserted and embedded into the bone and an external fixator device is attached to the leg from the outside. Soon after, the lengthening period begins and the intramedullary nail helps in preventing any angular deformity, during this phase.
Once the lengthening phase has been completed, the external fixator can be removed with the completion of the internal fixation (screw insertion). This method was a groundbreaking development compared to the original methodology which only involved the use of an external fixator.
The greatest advantage of the LON method is that the duration of the whole process is reduced, in comparison, to the classical methods, thereby vastly increasing the comfort of the patient and achieving positive results in much shorter periods of time. This positive outlook, generally, reflects more positively to patient psychology due to the fact of the quick removal of the devices. You don’t need to use a wheelchair for the first months like with a motorized nail. Patients usually begin to walk using support from the second day. The duration of the surgical operation is longer in comparison to classical surgeries. The experience of the surgeon is key in determining positive outcomes, thus plays a more significant role. Generally, prices and costs are a little higher more than classical methods, because of the usage of intramedullary nails.
You can get rid of the device in about 2 to 3 months, and overall recovery time lasts around 4 to 5 months; thereby enabling you to return to your normal life within 6 to 7 months. Most importantly, it is varied from patient to patient, as many factors determine the outcome, thus generally dependent upon the patient’s muscles, nerve structure and flexibility of their leg. Irrespectively, recovery times are significantly reduced if patients keep up with physiotherapy and continue the prescribed exercises, in a routinely fashion.
This new and improved method of applying a nail extending into the bone is the most preferable and comfortable method in terms of patient success and compliance. But this system is not applied and recommended in all patient cases. As this method, is relatively new, the data and feedback available, is generally limited. It is strictly advised that those patients who opt for this method, must use a wheelchair, and not to allow the patient to press or exert weight on the limbs, during the distraction phase.
Furthermore, in case of the patients contracting an infection, the procedure is halted, until the time that the infection is treated and subsides, which may halt the lengthening process. It must also be noted that this method is also one of the most expensive options available, currently.
Intramedullary nail is electromagnetic and motorized, thus allows for bone extensions with just a remote control; providing the patient more comfort and much shorter recovery times in total. Furthermore, the device is internally embedded into the patient’s bone, thus does not cause any discomfort and significantly limiting any risk of infections at minimum. Moreover, it reduces the total recovery period to just 2.5 – 3 months; but, it is a newer technology and currently much more expensive than “Ilizarov”, “Holy-Fix” & “LON” techniques. For bilateral lengthening, a wheel chair is required for mobilization until the radiographic evidence of bone consolidation. This system is not applied to every patient, because training process for this new technique has not been completed.
“PRECICE STRYDE” is the latest and most advanced limb lengthening system available, anywhere in the world. Largely, the “PRECICE STRYDE” is a newer and costlier version of “PRECICE 2” intramedullary nail system. It provides many innovations and benefits, including enhanced comfort of patients and extra weight bearing tolerance & capabilities.
It must be noted that both systems are theoretically the same; i.e. intramedullary nails, thus are internally embedded into the patient’s bones; either Femur or Tibia; thereby significantly reducing any chances of infections as the wounds are closed.
“PRECICE STRYDE” nails are made of stainless steel, which have been proven as being much stronger and sturdier than “PRECICE 2” intramedullary titanium-made nails. “PRECICE 2” system is not full weight bearing, as the titanium nails could only bear partial weight of patients thus the use of wheelchair is necessary to move around. However, with “PRECICE STRYDE” and its stainless steel nails can easily bear the full weight of the patients; thus with only a few weeks of crutch usage, then the patients are able to move around with easy and without any external support mechanism.
The Extension process consists of six phases:
- Inspection and Medical Examinations
- Lengthening Period
- Bone Strengthening (Consolidation)
- Removal of the System
- Inspection and Medical Examinations: Once the patient is admitted to our clinic. Radiological examinations, measurements and other necessary examinations are carried out. The patients are informed about everything, related to the lengthening process in detail. These inspections and examinations are planned and carried out on the day of surgery and soon the after surgery itself.
- Surgery: The patient will be called to the hospital at least one day before the operation in order to have pre-operative screening, meeting the Medical teams and the hospital and treatment team. The operation is performed under either a general anesthesia or a spinal anesthesia. The anesthesiologist and the patient have to decide this aspect together.
Our surgeries are performed with the help of tourniquet, hence bloodless; thereby the chances of bleeding are very rare. Thus, there is, generally, no need for any blood transfusions.
ARM OR LEG EXTENSIONS:
If the length of bone which is to be extended or lengthened is up to 5 cm at one level, it is extended over 5 cm, two level cuts are surgically made. Two or three nails are applied to both sides of the area which is to be cut before the bone is separated; this is mainly dependent on the body weight (BMI) of the patient. Henceforth, a suitable “HolyFix” fixator is prepared and applied.
During the surgery, an incision is made on the skin section at about 3 to 4 cm at each level and the device is aesthetically internally planted and hence there are no stitches which need to be removed. Single-zone single arm-leg lengthening surgery takes an average 40 minutes; on the other hand a double-zone single arm-leg lengthening takes about 60 minutes.
Height lengthening is a process of both legs extension. Whereby, both the legs are lengthened at the same time, thus the patient’s height is increased, simultaneously. Length lengthening surgeries, generally, take about 90 minutes for single level (up to 5 cm), 2-2.5 hours for a double level (up to 10 cm).
3.HOSPITALIZATION: The hospitalization is in a single room to accommodate one person.
If the patient’s singular arm or leg is to be lengthened, they would have to reside at the hospital for 2 to 3 days; in case, of stature or both leg lengthening is to be achieved, their stays would last between 4 to 7 days. During this period, the patients are informed about the treatment and the lengthening process, in total. Walking with crutches and nail care and maintenance is thoroughly taught. Physiotherapy training is given to the patient and exercises are taught and the lengthening process is taught, practically.
- Lengthening Period:Normally, this process of limb lengthening starts at the hospital. The lengthening is taught to the patient and who may extend the limb lengthening by a total of 1 mm per day in four equal parts (4 × 0.25 mm) at each lengthening level.
The patient is discharged after this time and may return to their homes. However, patients who would like to reside in our care more often can stay in our hospital or at accommodation centers close to our clinic. During this time, the patient can function movement with the help of crutches. Throughout this journey of the patient, our physiotherapy team are with them; helping with exercises and teaches them stretching, muscle and joint movements during this lengthening period. The patient should perform these exercises during the entire course of the treatment. The patients are also taught nail care and maintenance. From the second week of the surgery; (except in special and rare cases), the patient can bath during the treatment. Clinical and radiological examinations are performed after every 15 to 30 days, periods.
- Bone Strengthening (Consolidation):After the lengthening process is completed, the elongated bone area is strengthened and consolidated at becoming load bearing.
Full Recovery of the bone after Limb Lengthening:
The recovery period is approximately one month for each approximate centimeter gained, within the lengthening period. Whereby, regular medical examinations, are necessary, after every 20 to 30 days period. Patients living outside the city or country could easily perform regular checks by sending their X-rays and, if necessary, photographs.
- Removal System:After the lengthening and consolidation periods are completed, the system is removed; easily and painlessly under local anesthesia or general anesthesia at our hospital. Our medical professionals, make sure that no other materials are left in the patient’s body. Long walks, heavy exercises and sports are, generally prohibited, until the time that the bones have fully recovered to normality, subsequent to the removal of the devices. However, ample swimming is a recommended exercises. Generally, most physical activities are allowed, as long as the bones are of the same quality and integrity to the other bones, of the patient.
Complications of Limb Lengthening Surgery
LLS carries some post-op complications like any other type of surgery. Patients undergo a general or spinal anesthesia. Patients have some clinical examinations and tests before the operation and then the anesthesiologist gives detailed information about anesthesia procedures and possible complications.
Surgical site is marked before surgery. Check marking surgical sites and be sure to have the right bone segment marked.
Complications that may occur during the surgery: skin, muscle, tendon, vascular and nerve injuries. Also tourniquet applications may involve vascular, skin, nerve and soft tissue injuries. Also undesirable fractures of the bone tissue may occur. In this case you may have additional surgeries in the same session for correction. According to the pathology that may occur, specialist doctors in that field may be called for surgery. You may have surgery on the same day or later due to complications. You may experience permanent problems as a result of these injuries. You will be informed about these possible situations.
You may also experience complications related to medications, serums, and wound dressings.
As a result of clotting during and after surgery patient may face various organ injuries. If these injuries occur in vital organs it can result with vital risks and death.
Specific risks and complications associated with Limb Lengthening Surgery are: poor bone healing (non-union), premature consolidation, muscle contractures, osteomyelitis (bone infection), injury to blood vessels, nerve injury, joint stiffness (contractures), pin loosening in the anchor sites, destruction of cartilage and most common serious risk is infection of the pin sites or wires going through the bone that may result in further bone or skin infections. Pain and difficulty sleeping are other problems that arise during limb lengthening period. Pain is very subjective and the pain threshold vary among people. Each person deals with it in different ways.
Premature consolidation can occur with any method if the patient is a very rapid bone healer. The patient in these cases is able to make bone faster than the speed at which the bone is being lengthened. The only way to prevent this is to speed up the lengthening intentionally for a week or two. The Precice nail with its rate control allows the surgeon to do this. If premature consolidation does occur it requires an outpatient small surgery to re-break the bone through a tiny incision.
You must follow the advice of your doctor after the surgery. You should visit your doctor for regular checkups. In case of undesired situations, please inform your doctor or go to the nearest hospital.
You will be informed about distraction process. Please learn every detail carefully. Incorrect, incomplete or over-distraction may cause problems, such as premature consolidation, bone deformation, joint dislocation and also vascular, nerve, tendon and skin injuries. You may have to have multiple surgeries in cases of premature consolidation, poor bone healing or non-union.
We may have problems with the extension device. If we face problems with the device, we may do device replacement surgery.
You can experience bone deformation during distraction period as a result of bending, breaking or micro-movement of nails holding the bones. In this case, you can have device correction, device replacement and nail replacement surgeries.
You can experience infection, especially pin site infections, immediately after the surgery, as well as during post-op period. You may have surgeries due to these infections. You may experience permanent infections as a result of these possible infections.
There is a risk of bone fracture, deformation, infection and shortening of bone in the early period after the devices are removed. You should follow all the warnings and precautions.
You may have some psychological problems during the treatment process and therefore may require treatment.
Apart from the above-mentioned complications, you are also at risk of experiencing different complications.
As a result of all these possible complications, the planned treatment can be terminated and a decision can be made to maintain the current situation. Your lengthening may be terminated.
As a result of all these complications, beside the doctor’s fees you will have to pay for hospital and treatment costs and the treatment process will be prolonged. Therefore, you should take necessary precautions before the surgery.
I have read and understood the explanations mentioned above. I know that surgery is not a result of the disease, but purely because of the aesthetic and psychological need. I agree with the consequences of possible risks.
I certify that I have read this consent and have been informed by the undersigned doctor. I was informed about the purpose, risks and complications of the medical or surgical intervention and a copy of this form was given to me. I confirm this process without the need for any further explanation, under any pressure and consciously.
I authorize the person named ___________________________________________to give consent and to receive any information about my treatment when my consciousness is lost in any way in my attempts regarding my treatment or when I am unable to give my consent.
________________________________________________________ fill in with natural handwriting “I agree with I have read and understood.”
The patient’s attorney / legal representative*
|Name-Surgery (handwriting)______________________________ |
* The person mentioned in the last paragraph must sign
Sufficient and satisfactory explanations about the disease, the intervention to be performed, the cause and benefits of this intervention, the care required after the intervention, the expected risks, if necessary, the type of anesthesia to be applied and the risks and complications of the anesthesia mentioned above have been explained by me to the patient / patient relative. The patient / his / her relatives signed and approved this form with their consent that they were sufficiently informed about the intervention.
If the patient has language / communication problems;
I translated the explanations made by the doctor to the patient. In my opinion, the information I have translated has been understood by the patient.
Name Surname (handwriting)________________________________
You can apply to the Patient Relations Department during the day and Night Directorate at night about all your complaints about medical practices, or anything you want to mention.
Legal representative: guardian for guardianship, parents for minors, 1st degree legal heirs in the absence of these. Signing this consent form does not invalidate the patient’s legal rights.