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Questions

DOCTORS’ QUESTIONS AND OUR ANSWERS

WHAT IS EOT®II OR ORTHOKINE®II, RESPECTIVELY?

EOT®II and Orthokine®II are patented syringes by Orthogen Lab Services GmbH, available in several sizes:

  • EOT®II = 10 ml
  • Orthokine®II = 60 ml.

They are filled with a defined number of glass spheres, without chemical additives. They are used for the preparation of the Orthokine® serum in medical practice. EOT®II and Orthokine®II are registered trademarks for medical devices approved according to the European Medical Device Directive that are subject to constant monitoring by the authorities.

Are the terms ‘ORTHOKINE® SERUM’ and ‘ACS’ synonymous?

The acronym ACS stands for ‘Autologous Conditioned Serum’ and indicates that endogenous cytokines and growth factors are enriched from the blood by a defined treatment process using the EOT®II or Orthokine®II syringe. Since the acronym ACS is not legally protected and is used elsewhere in the medical field as well, the term ‘Orthokine® serum’ should be used.

How does the ORTHOKINE® therapy differ from PRP or ACP therapy?

The effectiveness of the Orthokine® therapy is based on the high concentration of endogenous signalling proteins (cytokines and growth factors) in the Orthokine®serum. Specifically, the anti-inflammatory interleukin-1 receptor antagonist is contained at high concentrations. The manufacturing process yields a cell-free serum without any risk of potentially harmful effects on cartilage.

The various PRP products are platelet concentrates (PRP = platelet-rich plasma) with high concentrations of various growth factors, depending on the system used. In this manufacturing process, cell-rich plasma is obtained.

It is scientifically proven that the combination of growth factors and cytokines and their antagonists is essential to influence complex regenerative processes, as in chondrogenesis1, 2, 3, 4.

Is testing for HIV and HEPATITIS necessary?

It is your responsibility whether or not to perform a test for HIV/hepatitis before Orthokine® therapy. It is important to comply with the hygiene regulations when obtaining and preparing the serum. Any risk of mix-up of the Orthokine® sera obtained from individual patients must be absolutely excluded.

We recommend performance according to our processing recommendation (QA Folder).

What legal aspects must I take into account when using the ORTHOKINE® therapy?

Treatment of your patients with the Orthokine® serum falls within the scope of therapeutic freedom. The serum obtained for Orthokine® therapy is an individual formulation (a pharmaceutical product), whose manufacture is regulated by the German Drugs Act (AMG). In accordance with § 67 II AMG, the production of individual formulations only needs to be reported by an informal notification to the competent authority.

You will find an appropriate form sheet and a list of addresses of authorities in your physicians’ folder.

Please note that each physician of a group practice who performs the Orthokine® therapy must file this notification once.

Does performance of the ORTHOKINE® therapy in my practice mandate compliance with special conditions or hygienic regulations?

For preparation of the Orthokine® serum, a practice room with closed windows and disinfected surfaces that is accessible only to the practice staff is sufficient. The working area including the equipment must be regularly and carefully cleaned and disinfected. By suitable quality assurance measures, which also include keeping a lab journal, it is to be ensured that all processing steps are carefully documented.

The applicable hygiene guidelines for blood collection and treatment must be complied with. The generally applicable hygiene plan adopted for the practice applies.

A detailed guidance for quality assurance of the Orthokine® therapy in practice is provided by ORTHOGEN Lab Services GmbH (QA Folder). In addition, ORTHOGEN Lab Services GmbH provides comprehensive training for the practice staff involved in the Orthokine® therapy.

Do I need to comply with the time prescibed for the incubation precisely?

Yes. By measurement series it could be shown that optimal concentrations of the endogenous active ingredients (in particular IL-1Ra) are present in the serum after the recommended incubation time of 6 – 9 hours.

How much ORTHOKIN® serum can I get from one EOT®II SYRINGE?

With optimum preparation, you can obtain up to 5 ml of serum per EOT®II syringe. The following should be considered:

  • Inform your patients that on the day before the blood sampling they should drink plenty of liquid (2 – 3 litres of water, juice, herbal tea). The higher the amount of liquid ingested, the higher the serum yield.
  • Aspirate the blood slowly to completely fill the syringe and to avoid haemolysis. The blood must not ‘foam’.
  • Aspirate the serum under visual control at the lowest point – this allows complete withdrawal of the serum.

Why has the ORTHOKINE® serum varying colours?

Varying colours of the serum can be caused by individual blood components (e.g. triglycerides, cholesterol, proteins), as well as by preparation and processing factors (e.g. haemolysis during sampling, unintended erythrocyte carry-over during serum extraction). They provide no indication of the effectiveness of Orthokine®serum.

How high is the risk of infection during treatment with the ORTHOKINE® serum?

The risk of infection from treatment with the Orthokine® serum corresponds to the risk basically associated with an injection. Again, compliance with the general rules for sterile blood collection and with the quality assurance recommendations is mandatory.

The Orthokine® serum is injected through a 0.2 μm filter to reduce the risk of infection.

In the past 10 years, about 400,000 injections were performed in 100,000 patients, and no increased risk of infections was observed (Orthogen Lab Services, internal data).

Must theequipment (incubator, centrifuge) be serviced regularly?

No regular maintenance is prescribed by the manufacturers (see also QA Folder).

How do I store the SYRINGES with the ORTHOKINE® serum, and how long can they be stored?

The syringes with the Orthokine® serum must be stored at -18 °C (-1 °F) or colder and can be stored for seven months. Later use may result in reduced efficacy. Experience has shown that brief thawing once, e.g. overnight in case of power failure, does not result in loss of efficacy of the Orthokine® serum. Although there are no measurement results available, we advise against repeated freezing and thawing of the serum. For packaging, we recommend using the storage packaging included in the supply and marked by you with the patient data. Any different packaging, provided it is explicitly suitable for frozen storage, is the responsibility of the practice.

What indications are eligible for ORTHOKINE® therapy?

In clinical trials it has been shown that in patients with knee or hip osteoarthritis and back pain the Orthokine® therapy alleviates pain. A positive effect of Orthokine® serum on sports injuries and tendinitis (e.g. Achilles, meniscus) has also been reported.

You will find a list of selected publications in the physicians’ folders and on our literature list.

Are the dosage recommendations per re-injection and treatment intervals binding?

These recommendations are based on prospective, randomised studies, clinical observations and many years of experience of Prof. (USA) Dr. med. Wehling, Düsseldorf, and other users (see Recommendations for indication and dosage).

In everyday practice, deviations from the recommended treatment frequency may result. A treatment break of maximally of two weeks should not be exceeded.

Can I treat multiple joints simultaneously?

Simultaneous treatment of multiple joints is basically possible.

Are adjunctive therapies to the ORTHOKINE® therapy expendient?

Combination of Orthokine® therapy with other methods is possible and can be useful. In particular, methods such as acupuncture or accompanying physical therapy can support the success of the Orthokine® therapy. Data from Spain (2013) document that Orthokine® therapy followed by standardised physiotherapy has led to long-lasting pain relief in patients with knee osteoarthritis5.

Can I use cortisone or hyaluronic acid during the therapy?

Yes. The arthritic joint causes complaints of various kinds. In activated osteoarthritis with severe, acute pain and simultaneous effusion, use of corticosteroid-containing drugs may be expedient in the acute phase. It should be noted that crystalline corticosteroids cannot pass through filters and therefore need to be injected separately from the Orthokine® serum.

There are no clinical studies that would caution against combination of these agents with the serum. By contrast, according to the current guidelines of the AAOS (American Academy of Orthopaedic Surgeons), July 2013, use of hyaluronic acid in osteoarthritis of the knee is no longer recommended due to lack of efficacy.

In which stage of osteoarthritis is ORTHOKINE® therapy useful?

The present study data and user reports show that Orthokine® therapy is promising especially in mild to moderate osteoarthritis (stages I – III) and leads to significant improvement in quality of life (pain reduction, improvement in function). This effect is often long-lasting.

In patients with stage IV osteoarthritis, implantation of an artificial joint replacement is frequently performed. If surgery is not possible or is refused by the patient, the Orthokine® therapy represents a conservative treatment.

New, published study results5 indicate that the Orthokine® therapy can potentially delay or prevent joint surgery. In these studies, the Orthokine® therapy was effective even in the terminal osteoarthritis stage IV. Due to the advanced stage of osteoarthritis, however, the patient should be advised of possibly lower effectiveness of the Orthokine® therapy. It is recommended to document that the patient currently refuses a surgical procedure and wants, at his or her own request, to have an Orthokine® therapy carried out.

Can I additionally use a local anaesthetic?

At present, nothing seems to argue against subcutaneous use, e.g. before painful injections.

Can I mix the ORTHOKINE® serum with a local anaesthetic?

Orthokine® serum should not be mixed with other components, to avoid causing any dilution effect. Local anaesthetics seem to have a negative effect on the cytokines present in the serum.

How much does an ORTHOKINE® therapy cost?

The cost of an Orthokine® therapy depends on the indication, the selected dosage and the frequency of injections. Generally, a distinction is made between expenditures on material and medical services. Overall, the costs of an Orthokine® therapy amount to about € 150 – € 750 (1 – 4 EOT®II syringes, blood collection, processing, local anaesthesia, injection). It is important to inform the patient in a briefing about billing and resulting costs, and to obtain his/her written consent to carry out the therapy. For a current price list of Orthogen Lab Services GmbH and billing examples, please see the physicians’ folder.

Are the costs of an ORTHOKINE® therapy reimbursed by health insurance providers?

The Orthokine® therapy has not been included into the list of regular services by the statutory and private health insurance yet. The Orthokine® therapy is an individual health service that is not covered by the statutory health insurance and must be paid by the patient.

Privately insured patients can clarify the reimbursement of costs with their health insurance before treatment. Basically, detailed documentation of the previously conducted therapy and proof that except for surgery there are no other options anymore are helpful. In addition, information on the Orthokine® therapy should be annexed.

In the recent past, the Federal Administrative Court has repeatedly ruled in favour of patients, due to which the insurance company had to reimburse the Orthokine® therapy.

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