Emerging Soft Tissue Regeneration System Impacts O

Written by Dr. Bob Baravarian, DPM, FACFAS

Over 20 years in practice, I have spent a great deal of time looking for a modality that could treat the majority of foot and ankle ailments we see in our practices. 

When I was in residency, almost all care was surgically-based. If a patient had a thickened and damaged Achilles tendon with tendinopathy, you could “clean up” the damage in surgery. If a patient had plantar fasciitis, he or she had cortisone injections and physical therapy. If it didn’t work, we would perform surgery to release the fascia.

When I started at UCLA, I was very interested in the potential of treating patients in a more holistic and less surgical manner, but my options were limited. I began a clinical trial utilizing the TOPAZ (Smith & Nephew) procedure, which was surgical but minimally invasive. We would make about 20 holes through the skin and use the TOPAZ microdebrider coblation wand to fenestrate the damaged tendon or fascia with a burst of radiofrequency energy, which would release the damaged scar tissue, cause a minor injury that alerted the body to the region of concern, and subsequently start the healing process. 

I also began to use high-intensity extracorporeal shockwave therapy (ESWT) to treat plantar fasciitis. In my experience, the treatment was very expensive, had to be done with the patient under sedation and was sometimes very painful for the patient. However, it worked. Over time, though, the cost and difficulty of this type of extracorporeal shockwave treatment made it obsolete for my practice.

My mother is a career-long clinical researcher. When I started describing my attempts to find a holistic treatment approach that enabled the body to heal itself, she suggested looking at platelet-rich plasma. This process requires us to draw and spin the patient’s blood, separating the different blood materials into layers. We then separated the buffy coat and platelet-rich material, and injected it into the region of injury to facilitate the development of healing cells in the affected area. This was a revolution and I am proud to say the University Foot and Ankle Institute was one of the first organizations in the United States to treat foot and ankle ailments with platelet-rich plasma.

About 10 years ago, we began treating wounds with amniotic membrane products. The ulcers were healing so well that we asked the company we used to make the amniotic membrane in a liquid format so we could consider the modality for injections to treat tendon and fascia injuries. We found amniotic membrane to be a great addition to our treatment options. Amniotic membrane injections offer concentrated healing cells that are drawn out from processed amniotic fluid, umbilical cord and membrane. I found that this material promoted multiple healing benefits including decreased inflammation, reduced pain and increased stem cell regeneration in the area of injury.

All was going well but drawing blood, using amniotic material from a foreign source and giving patients injections was still more problematic and painful to the patient than what I wanted. I began looking for a better option and that is how I discovered SoftWave® (Tissue Regeneration Technologies) unfocused electrohydraulic shockwave therapy.

What Are The Ideal Features Of A Foot And Ankle Treatment Modality?

Over the years, I began to make a list of my ideal attributes for treatment options for soft tissue and bone injury healing. The ideal modality would need to be as non-invasive as possible, provide immediate relief and long-term repair, be non-painful, and not cost an arm and a leg.

I was also looking for a treatment that was successful for more than just one indication. For example, it could not just be for wounds or tendinitis or fracture healing. Was there a modality I could employ to treat all of these conditions? How could I treat it all? With studies on the treatment of conditions ranging from tendinopathies and fasciopathies to calcifications, non-unions and ulcer care, the OrthoGold-100™ (Tissue Regeneration Technologies) seems to fit this description.1-4

From my perspective, while the the OrthoGold-100 device is very much in line with traditional ESWT and its burst of energy, this appears to be an improved modality as it combines a burst of energy with a sound wave and a light wave. In my experience, this is the ideal platform for any form of tissue healing. 

A Closer Look At The Technology And Science Behind An Emerging Treatment Option

Extracorporeal shockwave therapy has been around for decades. With the initial ESWT devices used for kidney stone treatment and the use of focused, high-intensity shockwave, we found issues with tissue damage and some cases of bruising, hematoma and bone edema. With the low intensity and radial devices, we found there was unsatisfactory penetration and, although the modalities worked in some cases, there was a lack of consistent outcomes. 

While the OrthoGold-100 device is similar to past shockwave devices, the unfocused treatment can penetrate as deep as a high-intensity machine without causing tissue damage. Use of this modality does not require anesthesia and treatments are relatively pain-free in my clinical experience. The OrthoGold-100 device does require multiple treatments with three to six treatments being ideal. We currently perform five treatments over one month for ideal outcomes and adjust as necessary. 

SoftWave technology is fairly simple. There is a combination of acoustic impedance, mechanotransduction and cavitation that produces tissue healing. The acoustic impedance results in a transverse and a longitudinal wave of energy. This energy causes cavitation within the affected region. Extreme pressure differences created by the cavitation produces a biological effect, releasing the body’s own healing factors in the region. 

The mechanotransduction occurs by a combination of the sound wave, light wave and shock wave tissue “shaking,” which results in the release of energy into an electrical and chemical signal response to the tissue injury. Following stimulation of the cell nucleus via the excited cytoskeleton, there is an enzymatic tissue response and expression and release of transcription factors, cytokines and growth factors that initiates the healing cascade responsible for tissue repair. 

This healing cascade includes the expression of vascular endothelial growth factor (VEGF), endothelial nitric oxide synthase (eNOS), bone morphogenetic protein (BMP), proliferating cell nuclear antigen (PCNA), stromal-derived factor 1 (SDF-1), insulin-like growth factor 1 (IGF-1), fibroblast growth factor B (FGF-B), transforming growth factor B (TGF-B), tumor necrosis factor, adenosine triphosphate and interleukins (IL-1, IL-6, IL-8, IL-10). These are similar to the healing factors found in bone marrow aspirate, adipose-derived stem cells, platelet-rich plasma and amniotic membrane-derived injections. However, the SoftWave treatment is far less painful and far easier for the patient in my experience. 

An Overview Of Practical Treatment Applications And Results

In my practice, we are currently using the OrthoGold-100 device to treat the following conditions: 

• acute injuries, such as sprains, after the first week;

• plantar fasciitis/fasciosis;

• Achilles tendonitis/tendinopathy;

• posterior tibial tendonitis/tendinopathy;

• peroneal tendonitis/tendinopathy;

• capsular inflammation/early plantar plate injury; 

• early osteoarthritis;

• delayed healing with fractures;

• non-healing surgical wounds or bone regions; and

• wounds.

Anecdotally, the initial treatments have been exceptional. We have found a reduction of pain with each treatment and an eventual resolution of pain in over 90 percent of our patients with chronic tendon and fascia ailments six weeks after our one-month treatment regimen. We also saw a dramatic reduction in time to wound healing, multiple cases of delayed- or non-union bone fracture healing and a case of a multi-year, non-fused ankle that resolved and fused with 10 treatments over the course of two months. 

Final Notes

The treatment of foot and ankle ailments has dramatically improved in the past decade. Much of the advances in treatment are geared to facilitate the body’s own reparative processes. The body has a very strong ability to heal damaged tissue and constantly utilizes its own anti-inflammatory cytokines and stem cells to heal damaged and inflamed tissue regions. Much of what we surgically treated in the past in the foot and ankle can now benefit from tissue regeneration options such as the OrthoGold-100 device.

Dr. Baravarian is an Assistant Clinical Professor at the UCLA School of Medicine. He is the Director and Fellowship Director at the University Foot and Ankle Institute in Los Angeles.