BeckerBetzInstitute Information Brochure ENG

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Dr. med. Axel Becker Specialist in Orthopaedics & Trauma surgery, specialist in Plastic, Aesthetic and Reconstructive surgery.

Specialization: minimally invasive limblengthening

Freiburg office: Kaiserstuhlstraße 28 79106 Freiburg – Germanyfreiburg@betzinstitute.com

Leg lengthening process

- First consultation with our leg lengthening specialists Dr. Axel Becker. The consults take place in our clinic in Freiburg (Kaiserstuhlstraße 28). The duration of which is about 2-3 hours:

- General information, presentation of different methods of leg lengthening, explanation of the principle of callus distraction.

- Medical history, physical examination, photo documentation, X-rays of the long bone and discussion of the X-rays. Personal photo simulation of an extension, creation of a preliminary operation plan with selection of an individually-optimal implant. Information about therapy procedures, rehabilitation options, accommodation options, treatment and any additional costs.

For legal purposes the surgical clarification must take place at least 48 hours before the surgery, otherwise it cannot take place at all. For this reason, the patient must be at the location of operation two days before the planned operation date.

- One day before the operation: Pre-op check-up and labs, anaesthesia clarification.

- Operation & First mobilisation on the evening of the day of the operation.

- Hospital stay for about 4 days with subsequent transfer to rehabilitation. Beginning of physiotherapeutic measures in the hospital.

- Rehabilitation phase

After moving to our rehabilitation center (Mooswaldklinikum), there is a phase of intensive physiotherapy and the beginning of clicking-mechanism under supervision.

Rehabilitation in the Mooswaldklinik is included with a stay of up to the 14th postoperative day. Afterwards, each patient is free to extend the rehabilitation at their own expense or to go home. We recommend to stay another 2 weeks in the rehab center to get fit and start the training to walk without crutches.

- Going home

Patients are not discharged to go home until they can safely use the lengthening or click mechanism on their own and have mastered the physical therapy and gait exercises. At home, physiotherapy and gait training must be performed every day. Swimming, massages, training on the ergometer etc. have a supporting effect. Safety, exercise discipline and personal consistency on the part of the patient are very important for the success of the treatment!

- Every six weeks an X-ray should be taken and sent to our institute. At the end of the extension phase, you will see our specialists again as an outpatient. If there are still functional deficits at this point, the physiotherapy plan is individually adjusted.

- If any problems or complications arise, it is crucial to contact our office in Freiburg at once.

- After one and a half to two years, the nail should be removed.

- An appointment can be done by mail or via phone call, after the last X-rays have been controlled. Check-in into the clinic is one day before the operation. The stay afterward is usually one to two days.

All information is provided without guarantee and without liability for the content of websites referred to here.

Surgical leg lengthening with fully implantable intramedullary distraction nails

Bone healing and callus formation

Bone is living tissue that is subject to constant remodelling and growth processes, even in adults.

In the case of a broken bone, what is known as primary bone healing only occurs if the fracture gaps have adapted to the finest of hairs and have been completely immobilised. This means that small tunnels of approx. 0.2 to 0.3 mm are resorbed by so-called osteoclasts. These so-called Haversian canals extend from one fragment end to the other. Subsequent so-called osteoblasts form concentric new bone deposits in these cavities and thus narrow the channels again. In this way, Haversian remodelling (the coordinated activity of osteoblasts and osteoclasts to resorb and replace existing cortical bone) spreads from one bone fragment to the next, resulting in a bridging of the bone fracture directly with that bone corresponding to the original bone in terms of structure and orientation.

However, normally, a broken bone cannot usually be set up in such a way that contact points are created everywhere. There are places with more or less fine gaps. If these gaps are supported by adjacent contact points, they are also subsequently immobilised. In such gaps, lamellar bone (bone substance arranged in layers) can initially form and later tubules are also formed, which grow through from one fracture end to the other and are built up with bone deposits.

In the case of larger crevices and gaps the so-called secondary fracture healing takes place. In the process of this bone healing, a so-called callus is formed. First of all, the action of the osteoclasts on the ends of the fractured fragment creates a rounded fragment end and temporarily widens the fracture gap. Starting from the periosteum, a so-called callus “sleeve” then grows at the fragment ends, which then gradually grows towards the fragment ends and at the same time widens, thus increasing the cross-section in the fractured area.

This precursor of bone tissue, the so-called callus, initially consists of the initial blood clot that formed due to the fracture of the bone, later it turns into granulation tissue, and eventually becomes connective tissue. A fibrocartilage framework develops in this connective tissue, which is further stiffened by the storage of lamellar bone in the meshes. The callus gradually bridges the hernial cleft. The fibrous cartilage that has formed in the fracture gap increasingly calcifies and is gradually built-up through the activity of osteoclasts and osteoblasts.

Principle of callus distraction:

Callus Distraction is when such a callus is stretched by controlled traction on the severed bone and results in length growth. The same processes of new bone formation takes place as it would in bone growth during childhood or in bone

healing after fractures. The possibility of callus distraction has been known since the middle of the 19th century, but it only gained importance with the Siberian doctor Prof. Ilizarov (1921-1992). He developed the ring/ external fixator, in which the leg or arm is pierced with thin wires and metal rings are stretched around the limb and connected by spindles, joints and rods. The treatment begins with cutting through the long bone to be lengthened from the outside with a bone chisel. Then the ring fixator is applied and fixed in both halves of the bone with pin wires that are passed through the skin, muscle and bone. The rings of the apparatus are then moved apart with the help of adjusting screws, so that the fracture gap widens. As long as a constant pull is maintained daily, new bone will be created.

The bone itself is not the limiting factor in callus distraction, but rather the soft tissue is. Muscles, blood vessels and nerves also grow with it, but the less stretchable tissues, such as ligaments and tendons, lead to, in the case of large lengthening distances, temporary functional losses. The worst case being displacements and stiffening in the adjacent joints.

When the distraction is too fast, this can also lead to damage to the nerves that are being stretched.

Lengthening with an external fixator causes considerable pain, ugly scars, and a high risk of infection due to the connection of the bone to the outside via the pin wires. This risk of infection exists not only for the duration of the lengthening phase itself, but also during the subsequent strengthening of the bone, which lasts for months.

The reason being that during this time the fixator ensures the sole stabilization of the healing bone and cannot be removed. The apparatus is heavy and cumbersome and prevents early and adequate physical therapy. Commonly, the patients suffer from significant limitations in joint functions. Nowadays there are also so-called monolateral external fixators. Although these fixators are usually somewhat more comfortable than the ring systems, they tend to lead to malposition such as bending,

twisting and axis deviations of the bone, basically due to their one-sided arrangement on the outside of the extremity (e.g., when used on the thigh in bending of the bone in the “O" sense). Attempts have since been made to solve this problem by additionally implanting a rigid intramedullary nail (LON=lengthening

Over Nail) to stabilize the bone. This procedure also allows the fixator to be removed after the end of the lengthening phase, thus reducing the risk of infection. Efficient all-encompassing physiotherapy is not possible with this procedure either.

Fully implantable intramedullary distraction nails:

In order to use the characteristics of callus distraction without having to accept the disadvantages of external fixators, fully implantable intramedullary distraction nails have been developed since the 1980s. Conventional intramedullary nails made of steel or titanium have been used in the treatment of fractures for over 50 years. All distraction intramedullary nails available on the world market today are based on such intramedullary nails. These have sophisticated inner workings that allow them to be distracted.

Electrical Nails

The Fitbone II® was developed by Prof. Dr. Med. Betz. It is a further development of the Fitbone I® developed by Prof. Dr. Med. Betz and Prof. Dr. Med. Baumgart. However, Fitbone I® is only rarely used. The nail is lengthened by an electric motor inside the nail, which is supplied with energy from the outside (a transmitter placed through the skin). Fitbone II® appears easy to use without active patient cooperation and is to date the only nail for simultaneous quadruple lengthening. The nail is expensive, stability and controllability are limited and frequent clinical, sonographic and X-ray controls are also required. It allows the shortest maximum distraction of all available intramedullary nails.

Mechanical Nails

The Albizzia® is a mechanical distraction nail developed by Drs. Guichet and Grammont in which lengthening is achieved by rotating the affected leg back and forth by 20 degrees until an audible click is heard. The nail used by Dr. med. A. Becker - the Betzbone®, is a further development or better said, a modification and improvement of the Albizzia®. The material of the nail is stronger and the interlocking in the bone has been better adapted to the anatomy of the bone. The Betzbone® has the highest stability and extension capacity (up to 12 cm) of all intramedullary distraction nails currently on the market. The high stability allows an early full-bearing load and unrestricted physiotherapy directly after the operation. It also allows a reliable feed with secure function and requires only a few clinical and

X-ray checks. The initial activation of the extension mechanism requires sensitive guidance from the surgeon.

The exact analysis of the leg geometry is based on X-rays of the whole leg and, if necessary, computer tomography. Based on this diagnostic imaging, the various treatment options are discussed with the patient and the operation is planned. Due to blood-saving, minimally invasive surgical techniques, blood transfusions are not necessary. The operation takes place under general anesthesia and lasts, with simultaneous application, several hours. The nail is inserted through a single small incision after the medullary cavity has been prepared. Long tubular bones have a solid, compact outer layer of bone. The inside consists of bone trabeculae near the joint, in the shaft area there is the marrow cavity for the bone marrow. These bone trabeculae enable a stable lightweight construction.

Betzbone® Operational procedure at Dr. med. A. Becker:

After drilling, the nail

During the preparation of the medullary canal to implant the lengthening nail, a small hollow needle, which is screwed into the lower part of the bone and which is later removed, prevents the pressure in the medullary canal from increasing too much thereby reducing the risk of bone meal and bone marrow washing into the bloodstream.

The artificial growth plate is done by using a special internal saw at the inside of the bone, i.e., via the same cavity into which the nail is then inserted. Usually, it is created from the outside with the help of bone saws or bone chisels, with the soft tissues at the site of the transection also having to be injured. This is what can be avoided by using an internal saw.

A single dose of antibiotics is administered intraoperatively to prevent infection. On the day of the operation, latest on the following day, the patient gets up for the first-time using support.

In the following post-operative rest phase, there are only isolated lengthening impulses.

Betzbone® in the thigh lateral view

After 5-7 days, the actual lengthening process begins with a distraction speed of up to 1 mm per day on the thigh and up to 0.5 mm on the lower leg. Careful and regular physiotherapy is essential for this process, possibly supported by individually adapted pain therapy.

Patient Name:

Operation:
Date Clicks
Clicks right
Nail Type: 1 Click = Operative gap: left Right
left leg
leg

Cost breakdown of the length lengthening procedure

First consult with Dr. Axel Becker

Anamnesis, physical examination, X-rays, X-ray analysis, operation planning, photo simulation, detailed information about the optimal procedure, alternatives, rehabilitation, and organization.

Possible additional costs for pain therapy, alternative methods and/ or naturopathic treatment

Individual additional costs, e.g. use of a swimming pool, medication, telephone, internet, laundry, taxi, car rental, language course, excursions & food and accommodation for companions, etc. as and when required.

If unforeseen complications occur, further costs may be added.

The prices can change at short notice. The information provided is without guarantee.

If necessary, please contact the office of Dr. Becker for further information.

Duration 2-3 Hours. 500,00 € Implants (e.g. 2 Betzbone nails) incl. VAT ca. 19.000,00 € Surgery Costs: Thigh both sides incl. VAT ca. 18.600,00 € Surgery costs: Lower leg both sides incl. VAT ca. 21.600,00 € Clinic costs for a stay of 5-14 days incl. VAT ca. 16.000,00 € Medications in the course of treatment ca. 800,00 €
on demand If needed, clicking under anesthesia ca. 350,00 € Removal of metal; surgery and clinic costs ca. 7.200,00 €

Stretching exercises in preparation for leg lengthening

The following exercises are used for muscle and tendon stretching before a planned leg lengthening process. This preparation reduces muscle resistance and simplifies the first few centimeters of lengthening. It is important not to spring back when stretching, but to hold the tension for about 120 seconds and then go 30 seconds deeper in the tension. After that slowly release the tension again. Please carry out these exercises on a daily basis. This will make the post-operative phase easier. After the implantation of the distraction nail, these stretching exercises should built the basic foundation for the muscles to catch up with the distraction of the bone. And should be done in repeated cycles for at least 3-4 hours a day. This counteracts the relative shortening of the musculature and to thus ensure that the soft tissue grows in a gentle manner. This in turn relieves the adjacent joints. However, when performing the stretching exercises after the operation, please make sure not to put your full body weight on your legs and to protect your joints.

1. Stretching of the Achilles tendon

Lie one leg on the bed or table and put the other leg on the floor. The bed or table supports your body weight. Now bend your upper body forward over the horizontal leg until you feel a pull on the back of your leg. Hold this position for about 120 seconds. Repeat this exercise 3-5 times.

2. Quadriceps stretching exercises

Stand on one leg and bring the heel of the other leg to buttock-height. You may hold on to a wall or stable chair with one hand. With the other hand, grasp the heel of the leg to be stretched, or use a towel to stretch more gently. Now pull your heel up When you feel a pull, hold this position for 120 seconds and repeat 3-5 times. Be sure to keep your pelvis straight, your knees together, and your supporting leg slightly bent.

3. Stretching the hamstrings, outer thighs and glutes

Sit up straight and bend one leg crossing it over the other extended leg. Put your foot down at thigh level. Support yourself with one arm and press the bent leg as close as possible to your upper body with the other arm. Hold this position for 120 seconds and then slowly release the tension. Repeat the exercise 3-5 times.

4. Stretching of the deep hip flexors

Take a long lunge forward while keeping your upper body upright. You can place your hands on the thigh of the front leg for support. Hold this position for 120 seconds and then release the tension. Repeat the exercise 3-5 times.

5. Stretching of the hamstrings and glutes

Lie on the floor with your legs stretched flat. Bend one leg and pull the knee to your chest with your hands. The other leg remains stretched out on the floor. Hold the stretch for about 120 seconds and then slowly relax. Repeat the exercise 3-5 times.

6. Stretching the adductors and inner thigh muscles I

From a wide straddle position with your upper body upright, bend one leg and shift your body weight to the bent leg. The feet remain parallel and the toes point forward. You can either raise your arms or support yourself with them on your thighs. Hold the stretch for 120 seconds, then slowly release. The exercise is repeated 3-5 times.

7. Stretching the adductors and inner thigh muscles II

Sit on the floor and place the soles of your feet together. Pull your feet close to your body with your hands, keeping your knees as close to the floor as possible. Hold the stretch your individual pain threshold for 120 seconds and slowly release the tension. The exercise is repeated 3-5 times.

8. Stretching the adductors and inner thigh muscles III

Sit upright on the floor and spread open your stretched legs. The toes should be drawn up and the knees should be fully locked. With a straight torso lean forward towards the floor. Hold the position at your individual pain threshold for 120 seconds and then slowly release the tension. The exercise is repeated 3-5 times.

Stand about 30 cm away from a wall and lean against it with your hands. Make sure that you do not put too much body weight on your legs after the operation. Now slowly let your body fall diagonally towards the wall by bending your arms and leaning against the wall. The wall carries most of your body weight. Keep your heels on the floor, knees locked and hips locked. When you feel a pull in your calf, hold this position for 120 seconds and repeat 3-5 times.

9. Hamstring and calf stretching exercises I

10. Hamstring and calf stretching exercises II

Take a big backward lunge step with one leg. The heel is completely on the ground. Keep your back leg straight. Bend your front leg and keep your torso upright. As soon as you feel a pull, hold this position 120 Seconds and repeat the exercise 3-5 times.

Important muscle groups when doing limb lengthening

In this packet you will find the important stretching exercises leading up to your surgery and how to execute them properly.

Stretching

Limb lengthening is not only lengthening of the bone, but the soft tissue surrounding the bone as well. Therefore, the flexibility of your muscles and tendons play a crucial role in limb lengthening.

It is strongly recommended to carry out stretching exercises throughout the entire procedure. Patients may also benefit greatly by doing stretching exercises before the operation.

The main muscle groups that require your attention are listed below in the order of priority;

1. Hip Flexor (Very important)

2. Quadriceps (Very important)

3. Hamstring (Very important)

4. Calves

5. Adductors

6. Buttocks

On the following pages we will go through how to stretch each muscle group. Please read the text on each page before executing the exercises.

Basic rules of stretching

Warm up first. Stretching muscles when they're cold increases your risk of injury, including pulled muscles. Warm up by walking while gently pumping your arms, or do a favourite exercise at low intensity for five minutes. Always use the opportunity to stretch after you exercise (when your muscles are warm and more receptive to stretching).

Stretching exercise: Every area (ventral/dorsal/lateral/medial) should be stretched in two cycles. Begin with the ventral area. Do the stretching exercise until the tension hurts and hold this for 2 min. Then go a bit further for another 30 sec. After that change to the next area. Once the cycle is finished (stretching was done in all four areas), start the second cycle.

How often: As a general rule, always stretch whenever you exercise. Prior to the surgery, try to do at least one session of stretching (all muscle groups) 4-5 times per week. Remember; the more flexible you are before the surgery the easier your lengthening will be

1. Hip Flexor / 2. Quadriceps Exercise 1 Exercise 2

Exercise 1.2.3: Push your hip forward in order to increase the tension while maintaining a straight back.

Exercise 1 can also be performed lying on your stomach.

3. Hamstring

Exercise 3 Exercice 1

Exercise 2

Exercise 3

Exercise 1: Keep your legs completely straight. In time, try to stand on something elevated while trying to touching the floor. The goal is to try and increase your flexibility at a distance that represents the amount of centimetres/ inches gained.

Exercise 2: In order to increase the tension; try to stretch the knee of the elevated leg and bring your head towards the knee. Keep the other knee completely stretched.

Exercise 3: Move your upper body towards the foot while maintaining a straight knee

4. Calves

Exercise 1: Keep the knee straight. Try also to arch your back while moving your upper body downwards

Exercise 2: Keep the knee completely stretched while pulling the foot towards your upper body.

Exercise 1 Exercise 2 Exercise 3

Exercise 3: Keep your knees stretched while moving your upper body towards your feet

5. Adductors

Exercise 2

Exercise 1:

Exercise 1

In order to increase the tension; increase the distance between your feet and bring your hips closer to floor by bending the flexed knee more – keep the other knee completely straight.

Exercise 2: Keep your feet close to your body and try to lean forward with your upper body.

6. Buttocks

Exercise 1 Exercise 2 Exercise 3

Exercise 1: Lean forward putting all pressure on the bent leg on the table. Turn slowly to the opposite side to isolate the buttocks muscles.

Exercise 2: Make sure that the straight leg is lying on the floor and that the knee is straight.

Exercise 3: Cross the leg being stretched while pulling the opposite leg to your chest.

Dr. med. Axel Becker

Specialist in Orthopaedics & Trauma surgery, specialist in Plastic, Aesthetic and Reconstructive surgery.

Specialization: minimally invasive limblengthening

Freiburg office: Ärzte am alten Zollhof

Kaiserstuhlstraße 28 79106 Freiburg 0761 489 72 31

Patients name:

Informed Consent for cosmetic surgery without medical indication

Date of birth:

_____/______/___________

Physician:

Attendees:

Indication for surgery:

Without any medical necessity, I would like to increase my leg-length by approx. mm and if possible more.

Desired and planned intervention:

Limb-lengthening using the so-called Ilisarov principle (see below for a more detailed explanation) using intramedullary force carriers (nails) on both thighs. The bone is distracted by the telescopic mechanism of the nail system.

The above-mentioned patient, _________________________________________, born on ____/______/________, received an informative discussion about the various possibilities of limb lengthening for the first time on ____/______/________. He/ she described that he/ she has been suffering from height issues since he/ she was years old. Visits to numerous clinics have taken place. All possibilities of extension have been repeatedly discussed with _____________________________. Leading to a final interview and presentation in this clinic.

Mr./Mrs. has a height of cm and currently weighs kg. His/her father is cm tall, his/her mother is cm. Mr. / Mrs. has /does not have any siblings.

He/ She would like to be approximately cm taller.

There is symmetry on both thighs and lower legs as well as in both the upper and lower arms.

stature, thigh shape.

The X-rays were taken on ____/______/________:

Long leg images of the right and left leg from 2 planes as well as both legs from hip to ankle on an X-ray plate.

The various systems were discussed again, especially when measuring the recordings and the desired result.

The ratio of thigh to lower leg falls within the normal range. In terms of proportions, the torso length allows for an extension of the desired amount. As part of the photo simulation carried out, the possible proportions after lengthening were presented. A discussion regarding the lengthening of the thighs and lower legs with respect to maintaining proportions was also carried out.

In addition to several telephone calls and emails, the informational discussion took place on ______________. At this point it was clear that any medical insurance company would not contribute to the costs of the treatment. Irrespective of these financial requirements, Mr./Ms.

was determined to have the extension carried out at their own expense. He/She is aware of the scope of the operation and its complications, e.g. an infection.

The operation was requested to be held on the ______/_______/________ .

On Mr./Ms. will be admitted to the private clinic Praxisklinik2000 in Freiburg to carry out the limb lengthening procedure.

As part of the initial consultation, the options for limb lengthening were discussed in detail:

- External fixator

- Monolateral fixator in combination with a rigid intramedullary nail

- Distraction intramedullary nail (Betzbone®,Precice®, Fitbone®).

The various approaches were discussed, in particular the following:

- Treatment period

- Workplace

- Professional/ occupational circumstances

- Risks

- Treatment complications of the specific procedures and possible late damage.

Comparison to alternative methods/ choice of implant

According to the current state of medical research, only the so-called callus distraction (Ilisarov principle, see above) is a sensible method of lengthening measures, a procedure in which, after bone has been severed, continuous stretching of the bones is stimulated to form new bones and thus gradually - with a 0.7-1 mm gain in length per day - regains its normal shape through an uncomplicated course.

This method of callus distraction is carried out worldwide with external fixators, which are in turn associated with a considerable risk of infection due to the unavoidable long periods of stationary time and usually with a poor cosmetic result due to multiple scarring. In this case, the phase of bone expansion alone takes up to a period of approx. days per limb with a daily extension distance of approx. 1mm on the thigh followed by a rest phase of 6 days. In addition, there is a solidification phase of at least 9-12 months, which would increase the risk of infection exponentially if stabilization were only carried out with the help of an

external system (Ilisarov apparatus). In addition, the question remains open whether the complete length compensation that is desired can be achieved at all during a single therapy phase. The stabilizing system must of course be left in place until the bone has regained its sufficient load-bearing capacity. The wearing time, and thus the reduction of the risk of infection in external systems, cannot be shortened by using immobilizing bandages. In addition, any external systems used on the thigh lead to considerable immobilization of the patient (pure ring fixator systems, including open ring forms), while smaller fixator assemblies (so-called monolateral systems) allow more functionality, but almost always do not prevent axis misalignments that can be influenced (in particular in the sense of the varus deformation - inward angulation - on the thigh) in the course of stretching.

In addition to the more favorable biomechanical conditions, stabilization with the help of an intramedullary nail results in an enormous increase in patient comfort and a reduction in the risk of infection when compared to the external fixator, primarily because the connections between the body surface and the bone through a fixator are missing. There is no need to extend the length of time the fixator is in place during the solidification phase as this would only increase the risk of infection.

For these reasons, as a stabilizing and transport system, a so-called telescopic intramedullary nail of the type with a caliber of mm and a hub of mm at the thigh/ lower leg will be used.

In this particular case, an extension route of a total of cm of hollow bone is expected. This long extension leads to an increased tension on the neighboring joints and thus a minimal temporary loss of function, which eventually requires intensive drug, physical treatment and pain therapy measures (e.g. through peridural catheters).

The overall treatment of an uncomplicated process is structured as follows:

" First surgery: bone cutting and implantation of the stabilizing and transporting intramedullary nail on the thigh. It is planned to insert the nail into the thigh/ lower leg via a single small opening of the tissue through the skin. If possible, the bone cutting is made from the outside at the osteotomy site by means of a special inner saw without any soft tissue trauma. In addition, there are the stab incisions for locking; on the outside of the thigh, or on the inside of the lower leg and an additional hole in the lower (distal) area of the bone to compensate for the pressure difference during the drilling of the medulla. This is done to minimize the risk of bone particles or bone marrow seeping into the bloodstream. In the case of lower leg extensions, the fibula must also be cut from the outside, here minimal soft tissue trauma is unavoidable, since it cannot be reached with the inner saw.

• The operation is followed by a rest period of about 6 days with only a few clicks a day.

• After the resting phase, the lengthening phase begins with 0.7 - 1 mm advancement on the thigh/lower leg, i.e. 0.7 - 1 mm per limb per day (with Betzbone corresponding to 15 or 20 rotational movements = clicks), corresponding to a clear extension-time of approximately 60-100 days. During this time, in addition to extension, the focus is on a physiotherapy exercise regiment of the adjacent joints in order to suffer from as little functional loss as possible, especially during the stretching phase. Continuation of the intensive physiotherapy exercises to regain normal mobility, since functional losses in the joint area occur almost regularly during the stretching phase, and also to strengthen the muscles during the entire course of treatment. Intensive gait training straight after the first operation and increase of the load until full load is achieved after about 8-12 weeks after the end of the stretching regimen.

• Second operation: removal of the metal implants. All metal parts can be removed after the final bone solidification.

Physiotherapy:

An indispensable prerequisite for the desired treatment success is regular and adequate physiotherapy before, during and after the lengthening phase. Essential elements are: stretching exercises for muscles and tendons, as well as swimming. It is very important that the selected physiotherapy exercises are done in consultation with Dr. Becker and carried out in order to achieve optimal protection of the soft tissue. Lengthening that is gentle on the joints and soft tissue is only possible with regular and correct physiotherapy. In this way, you can minimize the risk of joint function loss and subsequent pain.

To prevent the occurrence of a thrombosis and/or embolism, early and regular movement of the legs (physiotherapy, standing up, walking) and drug-based thrombosis prophylaxis, initially with low molecular weight heparin during the hospital stay, and later with a preparation to be taken orally (Xarelto 10 mg per day) is necessary.

Drug thrombosis prophylaxis using heparin is associated with an increased risk of bleeding, the risk of a reduction in blood platelets (HIT type 2), a risk of osteoporosis, or a possible delay in bone formation and the risk of developing an allergy, hence the early switch to Xarelto after about 5-7 days.

I declare that I was present on the ____/______/______ for the initial examination in the before mentioned clinic/ hospital, on the occasion of the telephone call from ______________________, and if it were necessary, the renewed presentation on the ____/______/___ as well as the telephone calls from and about the type, course of events, importance, possible consequences and risks of the intended cosmetic operation or treatment, as well as the expected result of the operation and the expected permanent scars which were explained in detail. In addition to the detailed verbal explanation, I also received written informational material:

- Process of a leg lengthening at Dr. Becker

- Surgical leg lengthening with fully implantable intramedullary distraction nails

- Accommodations/ Rehab/ Procedure

- Cost breakdown of the leg lengthening procedure

- Stretching exercises

- Informed consent to the surgery

- Follow-up information for the postoperative phase

I have completely understood this detailed explanation, was able to ask all the necessary questions that interested me and received comprehensive answers. Dr. Becker repeatedly and emphatically pointed out to me during the consultation that there was no medical indication for the operation The operation to be performed is not necessary from a medical point of view. Rather, the intended limb lengthening serves exclusively my own aesthetic image. The realization of this aesthetic image is so important to me that I urged Dr. Becker to carry out this farreaching physical intervention. I am aware that this is not a routine operation, but an extraordinary and also very difficult operation. Dr. Becker informed me that previously unknown risks can materialize when performing such operations. It can therefore happen that, despite all medical efforts, damage to my health occurs and

I have to endure considerable pain. Nevertheless, I expressly wish to go forward with this operation. I accept the surgical risks that have been communicated to me, as well as previously unknown surgical risks that could have a negative impact on my health.

By all accounts, I ask and instruct Dr. Becker to perform the desired operation I requested.

After careful consideration, I expressly desire to have the planned cosmetic procedure and also agree to the necessary examinations including X-rays, pathology and other parallel interventions as well as the pain numbing measures. I also hereby agree to any inevitable changes or enhancements that could arise in addition to the implementation of the planned procedure. I am aware that the doctor and his vicarious assistants cannot guarantee that the desired cosmetic result of the medical efforts will be achieved. In addition to the uncertainty of the success of the treatment, I was also informed about the effects of the medications. I understand that any surgery or anesthesia method may involve the risk of temporary or lifelong disability and even death I have also been informed about the types and occurrences of possible risks, also of a general nature, which are not explicitly listed below, such as thrombosis, embolism, intolerance reactions to medication, etc. In particular, I was made aware of the possibility of specific complications and risks of the procedure.

I will comply with the medical orders of Dr. Becker and do whatever is necessary to achieve the desired outcome of the treatment. I am aware that Prof. Dr. Betz can perform the operation for me, but the actual extension requires my own cooperation. In particular, I am willing to pre-stretch my muscles and tendons with physiotherapy exercises before the operation, to refrain from wearing high heels in the last 6 weeks before the operation, and to refrain from injury-prone and stressful sports after the operation and to carry out the necessary physiotherapy exercises

regularly and correctly. In order not to overload the implants and thus avoid implant breakage, I will use crutches during the lengthening phase and also for 8-12 weeks afterwards. Smoking impairs bone formation. I know that I should stop smoking to ensure the success of the therapy.

I am not aware of any allergies I may have, nor am I aware of a risk of allergies within my family.

I suffer from the following allergies:

I suffer from the following diseases:

I take the following medications regularly:

I am aware that drugs that affect bone metabolism and drugs that affect blood clotting must be specified enough time before the operation and, if necessary, discontinued.

To prove that I have thoroughly been informed, I will tick each risk mentioned individually:

Vascular, nerve, muscle or tendon damage e.g. through surgery, the extension or by an infection, or by positioning damage during the operation

Hematomas and bleeding

Infections of the skin, subcutaneous fatty tissue and muscles

Infection of bones (including marrow cavity infection) and joints (empyema, arthritis)

Joint injuries, joint dislocations, loss of joint function, joint stiffness e.g. by increasing the load on the adjacent joints/ by increasing the tissue tension during lengthening

Thrombosis, embolism (lung)

Compartment syndrome

Bone healing disorders resulting in repeated operations such as renewed bone separation and/or transplant of the body's own bone or bone from a donor.

- Delayed, insufficient or absent new bone formation,

- False joint formation (pseudarthrosis),

- Premature bony union

Axis misalignment ("X", "O"), antecurvation = bending forward, recurvation = bending backwards, rotation error.

Leg length discrepancies: the greater the extension, the more likely it is to occur. Fractures (breaks) during implant installation and after surgical metal removal. Also during lengthening. Re-fractures, e.g. occurrence of a bend or break in the area of newly formed bone after metal removal

Scarring

Pain. In addition to the pain caused by the operation; pain in the course of lengthening is to be expected both in the soft tissue and in the area of the joints. Paralysis, temporary or permanent, due to damage of the nerves as a result of tissue stretching

Material breakage

Material failure, e.g. bone transport failure

Material-related intolerances and infections

Transfusion risks, e.g. HIV, hepatitis, syphilis etc.

Unforeseen follow-up interventions (e.g. changing implants, clicking under anaesthesia, spongioplasty, renewed osteotomy (bone cutting), e.g. in the case of premature callous bridging, fractures of all kinds, as well as correction of axis misalignments, joint subluxations and joint luxations, etc.

Femoral-head necrosis

Allergies, even serious ones

The implant is a medical product and is only intended and approved for single use.

I agree that the medical device will be disposed of professionally after the metal has been removed.

I,________________________________, born on _____/_______/___________, hereby authorise the attending physician, Dr. Becker to perform the above operation. I can revoke this consent for surgery at any time. If my consent is withdrawn up to 2 weeks before the agreed upon date of operation between myself and Dr. Becker, I will have to pay a cost of €5000.00.

Changes in my state of health should be treated during the operation depending on the assessment and knowledge of the doctor. With my signature, I give the doctor my consent to treat unexpected changes in my condition.

I consent to photo documentation being made before, during and after the treatment. These documents are the property of and can be used for medical purposes and advertising without providing the patient's name in an anonymous form.

This clarification took place in the presence of _________________________________, secretary at , and Mr./Mrs.

Should a risk materialise, I release the doctor from any allegations if the procedure fails.

Freiburg, the _______/_______/____________ .

(Patients signature)

My second signature confirms that:

a) I have read and understood the text and that the text has been translated

b) that I have received all the information requested from me regarding the operations and procedures and their alternatives (including anaesthesia).

c) that the complete above information sheet was discussed verbally with me in detail. This informational discussion extended over a period of

I confirm that the complete all of the information sheets were discussed with me and that the handwritten entries in the text were filled in before I signed the individual pages.

............................................
............................................ Name
Name
............................................
............................................
............................................
............................................
Patient signature
in block letters Doctor signature
in block letters
Translator signature
Name in block letters
Witness signature
Name in block letters

I have had ample opportunity to ask further questions. I have no additional questions.

Specialist in orthopaedics & trauma surgery, specialist in plastic, aesthetic and reconstructive surgery.

Specialization: minimally invasive limblengthening

Patient Information

on the postoperative phase of leg lengthening using intramedullary distraction nails

Patient’s name:

Date of Birth:

Informing physician:

Others present:

In order not to jeopardise the success of the operation and to achieve a successful leg lengthening with few complications, it is essential that the patient complies to certain behaviour patterns and cooperates constructively.

Before the operation, it is essential to state all medications currently being taken. Dr. Becker then discusses with the patient which medications may need to be discontinued or replaced with other preparations. Neither before nor after the operation and especially not during the entire extension and consolidation phase are drugs or other preparations, e.g. bought online or brought with you, allowed to be taken without consulting Dr. A. Becker be taken. Drug interactions with the necessary medicines prescribed by Dr. Becker cannot be ruled out. Such medications and interactions can also have serious negative effects on blood clotting and new bone formation and endanger the health and life of the patient. In order not to negatively impact bone formation, smoking should strictly be avoided.

Leg lengthening with implanted intramedullary distraction nails requires careful medical supervision to avoid complications and to achieve a satisfactory result. This means that the patient, after the operation, can only leave the clinic after consultation with. The patient is not allowed to leave/ go home early, this contradicting the agreement. The daily extension distance is determined in consultation with Prof. Dr. med. Betz and must not be slowed down or accelerated on ones own authority otherwise it can lead to bone healing disorders and premature bony union.

Sports that are prone to injury and associated with maximum loads (e.g. team sports and all sports involving jumps) should be avoided when the implants are in place and also for about three to five months after the metal has been removed. Care should be taken not to over-stress the implants thus avoiding material fatigue and consequent breakage or bending of the implants and the fixing screws. This requires maximum dissipation of the body load over the shoulder girdle and the arms using crutches. The forearm crutches are to be used from the operation

day until at least 6 weeks after the end of the stretching phase, or until sufficient regeneration can be seen in the X-ray images. The decision as to when one can stop using the crutches is made by Dr. Becker based on the X-ray images. The patient is not allowed to stop using the crutches without prior agreement. If the implants are overloaded, they can bend or break, or the fixing screws can break. This in turn results in a loss of extension or for example axis deviations of the bone which can also occur when the nail is bent. If the screw breaks, the defective screw must be surgically removed and replaced. This will involve additional costs for the patient. If the implant breaks, the intramedullary distraction nail must be removed and replaced with a new intramedullary distraction nail or, if necessary, a solid nail. This would all need to occur in another operation. In addition to the renewed risks of an operation, this would also create additional costs for the patient. However, there is also a positive aspect to the introduction of a solid intramedullary nail. The patient can immediately bear full weight with the solid intramedullary nail and can do without crutches. This means faster rehabilitation and reintegration into working life. If, after the end of the lengthening phase, i.e. after the desired lengthening has been achieved, immediate full weight bearing without forearm crutches is desired, the implants can be surgically removed and replaced with solid titanium nails at an additional cost.

In order to prevent joint problems and contractures in the lengthening process, special physiotherapy must be carried out. The patient receives help and instructions from Dr. Becker and by the physiotherapists in the clinic. During the first consultation, the patient is given the relevant information in writing as part of an extensive information folder. In principle, one can choose between inpatient and outpatient postoperative physiotherapy. However, not every physiotherapist chosen by the patient is able to meet the special requirements of postoperative physiotherapy for leg lengthening using intramedullary distraction nails. Therefore, the choice of physiotherapist has to be discussed and recommended by Dr. Becker.

.

The postoperative physiotherapy covers the entire lengthening phase and continues thereafter until all joint functions have been fully restored. It must be individually adapted and carried out in a way that is gentle on the soft tissue in order to avoid contractures and damage to the muscles, tendons, nerves and vessels. The lengthening of the bone increases the tension in the adjacent joints. In order to prevent permanent joint damage, it is therefore necessary to carry out the learned physiotherapy exercises every day. The nerves are also stretched by the lengthening. In order to protect them, and thus prevent sensory failures or even paralysis, the daily increase in extension distance must be slow and continuous. The stretching exercises during physiotherapy can help prevent damage here. The patient must take it upon him/herself to carry out the learned exercises independently and carefully several times a day. Regular physiotherapy is also essential for thrombosis prophylaxis. The elongation of the soft tissues can lead to micro-tears in the inner layer of the blood vessels. Although these micro tears are reversible and will heal again, they pose a risk of developing thrombosis (blood clot) throughout the lengthening phase. Should a so called thrombus find itself in the blood stream, it may lead to a life-threatening pulmonary embolism. Therefore, adequate thrombosis prophylaxis must be ensured during the entire extension phase. This consists of regular exercise and physiotherapy on the one hand and the consistent wearing of compression stockings on the other. At times, this is supplemented by medicinal thromboembolism prophylaxis with low molecular weight heparin (risk: bleeding complications, reduced blood platelets, osteoporosis). How long the use of heparin has to be continued after the operation is determined individually by Dr. Becker. Administration of heparin can inhibit new bone formation to some extent, but is necessary if the patient's movement is significantly restricted. Only after having discussed it with Dr. Becker can the heparin treatment be stopped. Under no circumstances should it be stopped arbitrarily. The medicinal therapeutic measures to manage pain that are inevitable in individual

cases can have side effects, such as allergies, gastrointestinal problems, delayed bone formation, restricted driving ability, addiction, etc. Once the patient has returned home, regular e-mails should be sent every two weeks to Dr. Becker about the condition of the patient and a briefing from the attending physiotherapist.

In the extension phase, if the course is uncomplicated - i.e. without any problems with clicking, largely free joint function in the knee, hip and ankle, no feeling of instability, no disturbances in sensitivity, no signs of paralysis, as well as free exercise with adequate pain therapy - have X-rays taken every 6-8 weeks and the pictures sent to Dr. Becker via e-mail or by post. In the event of problems or complications, such as a click stop, a feeling of heaviness or problems when clicking, an increase in resistance, intensification of pain, a fall or other accident or significant joint function deficits that lead to significant mobility restrictions, send an e-mail to Dr. A. Becker describing the problem (info@betzinstitute.com) immediately. If you have specific questions or problems, an appointment can be made during the consultation hours of Dr. Becker (by telephone or e-mail).

Patient information and informed consent

I acknowledge receipt of a copy of the information sheet I have just signed.

Patient signature

Facharzt für Orthopädie&Unfallchirurgie, Facharzt für Plastische, Ästhetische und Rekonstruktive Chirurgie

Spezialisierung: Minimalinvasive Extremitätenverlängerungen

Date: Limitation of liability

Mr / Mrs would like to undergo a limb lengthening by Dr. Becker.

Dr. A. Becker has agreed to carry out this limb lengthening procedure in the private clinic "Praxisklinik2000" in the period from ____/_____/______ to ____/_____/______.

It has been expressly agreed between Mr. / Ms. and Dr. Becker that all legal issues arising in connection with this operational measure are to be assessed according to German law. This relates both to the operation itself and to any necessary follow-up measures. The parties therefore agree on the exclusive application of German law.

The parties further agree that only the German courts have jurisdiction, namely the court responsible for the location of the surgical intervention, namely the court responsible for the "Praxisklinik2000".

Mr / Mrs expressly declares that he/she is fully aware of the legal consequences of this agreement. He/She expressly declares that all legal issues related to the operation shall not be judged according to foreign law, nor shall foreign courts have jurisdiction. Mr. Mrs guarantees Dr. Becker that lawsuits will not be asserted or filed in any foreign courts.

Furthermore, the parties agree that the liability of Dr. Becker is limited to the amount that Dr. Becker, namely the AXA-insurance company covers. Mr./Mrs. will not claim more than is already covered by the above mentioned insurance.

Dr. Becker is insured on a case-by-case basis, i.e. for each insured event, in the amount of EUR 5,000,000.

Physician

Patient

Date

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