Frequently Asked Questions:
What is OSTEOARTHRITIS?
Osteoarthritis is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of your bones wear down over time. Although osteoarthritis can damage any joint, the disorder most commonly affects joints in your hands, knees, hips and spine.
What is the Gold Flex Therapy?
Gold Flex Therapy is a patented, safe, localized treatment that allows physicians to intervene and stop the progression of osteoarthritis, reduce or eliminate painful joints, restore mobility and significantly improve quality of life.
The Gold Flex Therapy treatment consists of proprietary gold microbeads being injected into the affected joint. A one-time procedure, the simple injection into an arthritic joint has proven to reduce or eliminate joint pain and greatly improve mobility.
What are the benefits of Gold Flex Therapy?
Gold Flex Therapy has proven to offer immediate (within days) and long lasting relief (years) for those who suffer chronic pain in one or two weight-bearing joints, such as knee or hip.
How does it work?
Gold salts have been used as a highly effective treatment for arthritic joint pain for over 100 years. The Gold Flex Therapy preserves the therapeutic effectiveness of gold while eliminating the systemic risks.
A small amount (20 mgs) of proprietary gold microbeads is injected into the interarticular space of the effected joint.
Once injected, your immune system goes to work “chewing” on the proprietary gold microbeads to release soluble ions. The released ions then suppress, or even stop, inflammatory signals in your joint. These ions are the same active metabolite of gold salts used in Auranofin and Myocrysine, the oldest drugs recognized as a “disease modifying anti-rheumatoid drug” (DMARD) by the American College of Rheumatologists.
The tiny amount of pure elemental gold locally implanted within the joint is less than the amount patients who were treated systemically received every week when taking oral Auranofin.
The level of response to the Gold Flex treatment depends on the amount of inflammation present. Your immune system interacting with the gold microbeads produces a time release, as needed, measured response to inflammation within the affected joint.
How soon is relief experienced and how long does it last?
Relief from the pain starts within days and lasts for years. Twenty-eight of 30 patients treated at the Orthopedic Clinic of the Aalborg University Hospital in Denmark, 2016-2017, enjoyed immediate pain relief. All 28 of them are still, pain free today.
Compare this to the temporary relief provided by oral NSAIDs or injected steroids.
What are the risks or adverse effects?
To date, we have not seen any adverse effects in more than 100 people treated with Gold Flex Treatment in Denmark.
As with any intra-articular injection, there may be minor discomfort due the injection for a few hours or days. Very rare complications and small risks may be a mild infection or acute post-injection flare within one week of injection. Our patients have not reported complications to date.
Is it safer than current treatment options?
Current treatments available for moderate to severe Osteoarthritis (OA) often require pharmacological treatment, intra-articular injections, and/or surgical treatments.
The Gold Flex Therapy specifically avoids these risks, while providing on demand, as needed, metered anti-inflammatory treatments to the affected joints.
Pharmacological treatments, such as oral NSAIDs, are associated with risks of gastrointestinal toxicity and complications. In fact, in the face of multiple risk factors, (advanced age, hypertension, concomitant aspirin use, past gastric ulcer) the use of NSAIDs should be avoided. Medical literature recommends that patients are not only informed of the potential cardiovascular, gastrointestinal, and other major risks of both nonselective NSAIDs and selective COX-2 inhibitors, but that the doses of these anti-inflammatories be limited to the minimal duration and dose necessary to control symptoms in order to minimize toxicity.
Medical guidelines recommend against routine use of intra-articular glucocorticoid injections for patients with knee OA. Serial injections are discouraged due to potential negative effects on the progression of cartilage damage in knee OA patients. *(1). A single glucocorticoid injection into the knee has been shown to provide short term pain reduction of small to moderate magnitude for up to six weeks post-injection. Afterwards, effects on knee pain and function are similar to that obtained with placebo. Intra-articular glucocorticoid injections like pharmacological solutions are not a long-term solution for OA.
Surgical treatment is dominated by total knee replacement which involves significant risk.
The Gold Flex Therapy can augment nonpharmocological treatments, replace pharmocologic treatments and delay or eliminate the need for surgical interventions. The Gold Flex Therapy provides on demand, as needed, metered anti-inflammatory treatment requiring only a single injection with lasting results.
Which joints can be treated?
Currently, the Gold Flex Therapy is offered only for treating weight bearing joints such as knees and hips. In the future, we may treat additionally affected joints.
Can I have more than one joint treated?
Yes, we can treat both knees or hips in a single visit.
Do I qualify for treatment?
Please complete and submit the form online prior to your initial consultation.
To determine if you qualify, we will interview you, take a medical history, and ask you a series of questions so that we can determine how OA is affecting your daily activities. Prior to treatment, a series of X-rays will be taken to determine the actual amount of OA damage within the joint. After our team reviews this information, we can determine if you are likely to benefit from the Gold Flex Therapy. If the damage is too severe, the Gold Flex Therapy may not be able to reduce or halt ongoing damage within the joint.
How much does it cost?
Cost is per joint. Special pricing for treating multiple joints will be provided following consultation with a Gold Flex representative. In addition to the treatment fee, the patient is responsible for their individual travel expenses, food, lodging and any incidentals.
Can my personal physician administer the Gold Flex Therapy?
Not at this time. FDA approval to treat patients in the United States with the Gold Flex Therapy is expected within the next two years. For now, the Playa Surgery Center, Playa del Carmen, Mexico, and the Orthopedic Clinic of the Aalborg University Hospital in Denmark are our approved treatment sites.
Where can I be treated?
The Gold Flex team is partnered with Playa Surgery Center in Playa del Carmen, Mexico and Orthopedic Clinic of the Aalborg University Hospital in Denmark where patients are administered the Gold Flex Treatment.
Why Denmark or Mexico?
The proprietary gold microbeads were invented in Denmark. Thus, we chose to develop the Gold Flex Therapy in partnership with our colleagues at the Orthopedic Clinic of the Aalborg University Hospital, in Denmark. In addition, we have a treatment center at Playa Surgery Center in Playa del Carmen, Mexico, in partnership with the Sani Medical Tourism Group in association with GEOSTAR Mexico, as a closer alternative.
When will it be available in the United States?
We expect FDA approval to treat patients in the United States with the Gold Flex Therapy within the next two years.
Is it covered by my insurance?
Gold Flex Therapy is not covered by insurance. This may change at a future date when the Gold Flex Therapy receives approval by the FDA for treatment within the United States.
How quickly can I be treated?
We are currently enrolling patients in the United States for treatment at the Playa Surgery Center in Playa del Carmen, Mexico and Orthopedic Clinic of the Aalborg University Hospital in Denmark. For a schedule of available treatment dates, please contact a Gold Flex representative. We are scheduling approximately 20 patients per quarter.
Please contact Robert McLauchlan at firstname.lastname@example.org or 512.339.4100
How to enroll?
Can you help arrange my travel?
Yes, we can! A Gold Flex representative will assist with travel arrangements upon request.