New FDA Approved Drug-Free Treatment for Painful Diabetic Neuropathy

New FDA Approved Drug-Free Treatment for Painful Diabetic Neuropathy

HFX

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What is Diabetic Neuropathy? 

Diabetic Neuropathy is chronic nerve damage in the upper and lower extremities caused by constantly high blood sugars. It is a chronic debilitating condition which can interfere with a person’s sleep, their functionality, and their overall quality of life.

Around 34 million Americans have diabetes (CDC, 2020) and roughly half of all adults with diabetes will suffer from Diabetic Neuropathy in their lifetime (Hicks, 2019). Of those, it’s estimated approximately 2.3 million will suffer from Painful Diabetic Neuropathy (PDN) with no relief by using current treatments and conventional medical management (Schmader, KE., 2020).

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What are the Typical Symptoms of Painful Diabetic Neuropathy (PDN)? 

Those who suffer from Painful Diabetic Neuropathy typically have daily continuous pain. Typical symptoms of include tingling, numbness, and pain in the extremities. This nerve damage can make patients more vulnerable to falls, burns, infections, ulcers, and long-term complications.

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What Treatment Options are there to Relieve Chronic Pain from Diabetic Neuropathy?

Current treatment options aim to relieve the chronic pain that is frequently seen with Diabetic Neuropathy. These treatments often include pain medicines such as Tylenol or Aspirin. NSAIDS such as Ibuprofen or Advil, however, are not recommended for diabetic patients. Some patients with Diabetic Neuropathy are also treated with nerve medications including Neurontin (Gapapentin), Lyrica, and Topomax.  When patients don’t respond to these medications, narcotics or opioids are often used.

Although narcotics can lessen pain, they have significant long term consequences including dependence, decreased benefit over time, and abuse.  New federal guidelines aimed at reducing opioid misuse and abuse have resulted in many physicians denying or limiting opioid therapy for some chronic pain patients. Physicians are constantly looking to improve clinical and interventional tools to treat complex chronic pain. One of these advancements includes the development of Spinal Cord Stimulation (SCS).

Digital Image of Spinal Cord Stimulator calming Diabetic Neuropathy pain signals to the brain

Spinal cord stimulation has been available since the 1960s and uses a device called a Spinal Cord Stimulator to treat chronic pain. This small device is placed on the spinal cord to calm the spinal nerves and suppress the pain responses to the brain. As a result, pain lessens for the patient. Each device is programable to the individual patient’s needs. Additionally, Spinal Cord Stimulation allows for patients to go through a weeklong trial period to test their response to the device before permanent implantation.

There are many types of Spinal Cord Stimulators and the technology and programming options that come with them have made many advancements in recent years. These advancements have shown to provide better pain relief for many chronic pain conditions. Most recently, Spinal Cord Stimulation for Painful Diabetic Neuropathy (HFX™ for PDN) developed by Nevro, received FDA indication and approval to treat Painful Diabetic Neuropathy.

Who is HFX™ for PDN for and what does Spinal Cord Stimulator Surgery entail?

Graphic Illustrating where a spinal cord stimulator is placed on the low back to treat Diabetic Neuropathy

Patients suffering from Painful Diabetic Neuropathy specifically, who have not responded well to conventional medicine treatments are typically good candidates for a Nevro HFX™ for PDN Spinal Cord Stimulator trial. During this trial period, a temporary version of the stimulator is placed through a needle without undergoing surgery. The patient will then use this device for one week and monitor their pain levels, activity level improvements, and their need for pain medicine. At the end of the trial, the device is removed.  Ninety percent (90%) of patients who go through the trial have enough to success to make the decision to move forward with a permanent stimulator (Diabetes Care, 2021).

Once this decision has been made, a permanent spinal cord stimulator can be implanted with a quick outpatient surgery. With any outpatient surgery, the patient is able to go home and recover the same day as surgery. The permanent implant procedure is done through two small incisions. After the incisions are made, a paddle with metal contacts is placed against the spinal cord and a rechargeable battery is placed below the skin.

What is the Average Recovery Time from Spinal Cord Stimulator Surgery?

Moderate activity is limited, and strenuous activity is restricted for approximately six weeks post-surgery. This recovery time ensures that the device is received well, and the body has time to heal. However, despite this dedicated recovery time, many patients can feel pain relief in as little as a few days after their operation.

Recovery is quick with approximately eighty six percent (86%) of patients with Painful Diabetic Neuropathy experiencing substantial, long-term relief after 12-months (JDST, 2021). Additional details of the study can be found here.

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Stay tuned, ongoing studies are showing great success using Spinal Cord Stimulation (SCS) to help treat additional types of Neuropathy such as Peripheral Neuropathy.

Click Here for additional Data on Nevro’s HFX™ for PDN or visit https://www.hfxforpdn.com/

Dr. Roger Sung, MD Colorado Springs Orthopaedic Group

Roger D. Sung, MD

Dr. Sung is a Fellowship-Trained and Board-Certified Orthopedic Surgeon who specializes in Cervical, Thoracic, Lumbar, and Sacroiliac surgery, Microsurgery, and Minimally Invasive Spine Surgery techniques. He also performs complex spine reconstruction using minimally invasive techniques.

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Cartilage Restoration: Innovative Treatment for Knee Pain in Active Individuals

Cartilage Restoration: Innovative Treatment for Knee Pain in Active Individuals

What is Cartilage?

Articular (or hyaline) cartilage is a tissue in the body that lines the ends of the bones, providing a smooth surface for movement of the joint.  It also serves as a shock absorber during activities.  When there is an injury to the cartilage in a joint, it does not heal on its own as there is no direct blood supply to aid in this process.  Instead, cartilage continues to deteriorate over time, especially with continued activity.  This leads to a disease called Osteoarthritis.  Fortunately, there are now procedures available to restore the cartilage in a joint without having to go through a joint replacement.  The most common joint for a Cartilage Restoration procedure is the knee.

Treatment Options for Cartilage Disorders

There is a spectrum of treatment options for treating cartilage disorders including palliative, reparative, resurfacing, and reconstruction.  Palliative treatment is known as Chondral Debridement, where the uneven surface of damaged cartilage is smoothed out during arthroscopic surgery.  This does not replace injured cartilage but may relieve pain as there is no longer a loose flap of tissue moving abnormally in the joint.  This may be an option for a patient with only a partial thickness cartilage injury or an older patient who does not participate in demanding activities.  The recovery time for this procedure is minimal.  The patient can be full weight bearing and does not have any range of motion restrictions after surgery.

When there is a very small, focal lesion of missing cartilage, the patient may be a candidate for a reparative procedure known as Marrow Stimulation.  This procedure is sometimes referred to as Microfracture.  With this procedure, holes are made directly into the lesion allowing bone marrow to escape into the defect.  This allows for healing of the lesion with a substance known as Fibrocartilage, which acts similarly to innate articular cartilage when in a small area.  This is a simple arthroscopic procedure but does require some restrictions during subsequent rehabilitation to allow the Fibrocartilage to develop and heal.

Cartilage Restoration for Active Individuals

When we think of true “Cartilage Restoration” procedures, there are really two different types – Resurfacing and Reconstruction.

Resurfacing: “Repaving the Street”

When the lesion is too large for microfracture but still only involves the surface of the bone, then a resurfacing procedure is warranted.  There are several ways to resurface the end of the bone with new cartilage.  One technique is to take the patient’s own unused cells out during an arthroscopic procedure and send them to a lab to be grown into new cartilage cells, which would then be placed over the lesion that is missing cartilage.  This process is known as Autologous Chondrocyte Implantation and requires two surgical procedures – one to harvest the cells and another to put them into the defect.  The benefits of this procedure are that it uses the patient’s own cells and is able to resurface a large area of damage.  The recovery depends on where in the knee these cells are placed, but generally range of motion is encouraged early as cells adhere to the bone and proliferate right away.  Patients are able to ride a bike within weeks and even start running after just a few months.

Another resurfacing technique is done by Allograft Implantation.  Rather than two separate surgeries, this can be done in one arthroscopic or minimally invasive procedure.  The defect is debrided, and the donor cells are pasted into place and fixated with a type of biologic glue.  Similarly, patients progressively return to their normal activities within several weeks as the cells grow into real articulating cartilage.

Pre Cartilage Resurfacing Of The Patella

Pre Cartilage Resurfacing Of The Patella

Post Cartilage Resurfacing Of The Patella

Post Cartilage Resurfacing Of The Patella

Reconstruction: “Filling the Pothole”

When a cartilage defect extends beyond the surface to involve the underlying bone, a structural graft is necessary in a reconstructive procedure to restore the cartilage.  The size of the injured cartilage determines whether the cartilage can be obtained from the patient or must come from a donor.  If it is a smaller lesion, then a cartilage plug (includes underlying bone) may be taken from a place in the joint that does not need it and placed into the defect.  This procedure is called Osteochondral Autograft Transplantation and is typically done with a minimally invasive open incision.  However, when the size of the defect is too large to take it from another place, donor tissue is required.  In this case, a plug can be made to fit the size of the void after the missing cartilage and damaged underlying bone is removed.  Even an oval shaped plug can be fashioned to fill a large, long defect over the weightbearing surface of the knee, which is termed a BioUni.  These procedures are called Osteochondral Allograft Transplantations and may be an alternative to partial or total joint replacement for the right patient.  Although they do take longer to heal compared to a cartilage resurfacing procedure, the patients generally return to activity within a few months and have excellent outcomes.

Large Cartilage Defect Of The Medial Femoral Condyle

Large Cartilage Defect Of The Medial Femoral Condyle

Cartilage Graft Being Placed Into Defect

Cartilage Graft Being Placed Into Defect

Cartilage Graft Placed Into Defect

Cartilage Graft Placed Into Defect

Small Cartilage Defect Of The Medial Femoral Condyle

Small Cartilage Defect Of The Medial Femoral Condyle

Harvested Cartilage Graft Ready for Placement

Large Cartilage Defect Of The Medial Femoral Condyle

Cartilage Graft Placed Into Defect

Large Cartilage Defect Of The Medial Femoral Condyle

Reconstruction Innovation

There is a very exciting new procedure using the Osteochondral Allograft Transplantation concept to replace the entire undersurface of the patella (kneecap).  The patella cartilage is especially vulnerable to injury in athletes, specifically runners.  Here in Colorado Springs, we see many patients with this problem who are told that their only options are to stop being active, live with the pain, or get a partial or total knee replacement.  This procedure provides an opportunity to restore their cartilage and get them back to activities within a matter of months.  We are excited to announce that Dr. Jamie Friedman is the first orthopaedic surgeon to bring this technology to the state of Colorado.  The first patient to undergo this procedure here in Colorado Springs is currently doing his physical therapy and has registered to run a marathon this coming June.

Pre Total Biologic Resurfacing Of The Patella

Pre Total Biologic Resurfacing Of The Patella

Pre Total Biologic Resurfacing Of The Patella

Pre Total Biologic Resurfacing Of The Patella

Donor Patella Ready For Placement

Donor Patella Ready For Placement

Post Total Biologic Resurfacing Of The Patella

Post Total Biologic Resurfacing Of The Patella

Cartilage Restoration and Joint Deformity: Knocked-Kneed and Bowlegged

Finally, one aspect of Cartilage Restoration that is often overlooked is the alignment of the joint itself.  Many people are born either knock-kneed or bowlegged, but if there is too much of this deformity in the joint, it puts additional pressure on one side of the knee.  If the underlying problem of leg malalignment isn’t addressed, it can cause continued damage to the existing cartilage and a cartilage restoration procedure may fail.  In this case, the patient may be a candidate for realignment surgery to balance out the knee joint in conjunction with restoring the damaged cartilage.  If the patient is too knock-kneed (Genu Valgum), then they may need what is called a Distal Femoral Osteotomy.  This is when the bottom end of the thigh bone (Femur) is cut and straightened out with an opening wedge.  If the patient is too bowlegged (Genu Varum) then they may need what is called a High Tibial Osteotomy.  This procedure involves cutting the top end of the shin bone (Tibia) to straighten out the joint with an opening wedge.  Although these deformity correction procedures require the longest recovery (several months), they save the patient from a joint replacement and have great long-term outcomes.

Valgus Malalignment Pre Distal Femoral Osteotomy Surgery For Knocked Knee

Valgus Malalignment Pre Distal Femoral Osteotomy Surgery For Knocked Knee

Valgus Malalignment Post Distal Femoral Osteotomy Surgery For Knocked Knee

Valgus Malalignment Post Distal Femoral Osteotomy Surgery For Knocked Knee

Varus Malalignment Pre High Tibial Osteotomy Surgery For Bow Legged Knee

Varus Malalignment Pre High Tibial Osteotomy Surgery For Bow Legged Knee

Varus Malalignment Post High Tibial Osteotomy Surgery For Bow Legged Knee

Varus Malalignment Post High Tibial Osteotomy Surgery For Bow Legged Knee

Is Cartilage Restoration right for you?

So, who is the right candidate for a Cartilage Restoration procedure?  The ideal patient is young, active, and motivated.  These patients are typically considered too young for a partial or total knee replacement (18-45 years old) and are still involved in an active lifestyle such as team sports, running, hiking, biking, skiing, etc.  Patients who currently have pain in their knee with these activities are first assessed in the clinic and with x-ray images.  Typically, advanced imaging with an MRI is necessary to fully characterize the cartilage and the underlying bone.  If the surgery does not require a donor graft, then the surgical procedure can be scheduled right away.  If a donor graft is necessary, then this graft must be ordered, and surgery is not scheduled until a match is found, which usually takes 4-8 weeks.

Cartilage Restoration Recovery

Cartilage Restoration procedures do take some time to recover from – weeks to months – but the patients who are determined to follow the rehabilitation protocols have great outcomes.  The goal of Cartilage Restoration is to get patients back to the activities that they love to do without having a joint replacement.

Developed by the Colorado Springs Orthopaedic Group Sports Medicine Team

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