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 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: 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: stature, thigh shape.

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.

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

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.

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.

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

Dr. med. Axel Becker

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

Dr. med. Axel Becker

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".