nanoLOCK® FAQ

Back Pain Background

Q: What causes back pain?

 A: Back pain can be caused by a variety of problems with the muscles, nerves, bones, discs or tendons in or around the spine. Most cases can be linked to a general cause—such as muscle strain, injury, or overuse—or can be attributed to a specific condition of the spine—including herniated disc, degenerative disc disease, spondylolisthesis, spinal stenosis or osteoarthritis. In many cases, whether because of injury, age or disease, there is instability in the spine that leads to pain.

Q: What is the prevalence of back pain?

 A: According to the American Chiropractic Association, 8 out of every 10 (80%) Americans will experience back problems at some point in their lives. In addition, lower back pain is the single-leading cause of disability worldwide and ranks #3 (behind diseases of the respiratory system and disease of the nervous system, respectively) among the top reasons why people visit their doctor.

Q: What are the treatment options for back pain sufferers?

 A: Treatment options for back pain range from minimally invasive options, such as medication and physical therapy, to more invasive options such as surgery. Spinal fusion is a common surgical approach to treating spine instability and associated pain.

Spinal Fusion Background

Q: What is spinal fusion?

A: The purpose of spinal fusion is to permanently connect two or more vertebrae in the spine, eliminating motion between them in order to relieve symptoms associated with instability. Surgeons will often use surgical implants—such as screws, rods or small devices called interbody devices that are placed between the two vertebrae they want to connect—to help stabilize the vertebrae as the fusion takes place. The goal is that bone will grow through and around the implant over time, creating a strong fusion that will stabilize the spine and relieve pain. Each year, more than 450,000 spinal fusion surgeries are performed in the U.S.

Q: What are interbody devices?

A: Interbody devices are small implants designed to restore the spacing between the vertebrae following the removal of the intervertebral disc during interbody fusion surgery. These devices are also used to house biological material that helps the fusion occur. Titan Spine has developed interbody devices that participate in the fusion process as well. 

Q: Who is a candidate for spinal fusion surgery?

A: Patients who meet one or more of the following criteria may be appropriate candidates for spinal fusion surgery: 

1. They are skeletally mature with one or more of the following spinal conditions:

     o Degenerative disc disease (DDD) at one or two lumbar levels from L2-S1 or one cervical level from C3-C7

     o Spondylolisthesis (when one vertebra slips forward over the vertebra below it) or retrolisthesis (when one vertebra slips backward over the vertebra below it) at the involved level(s)

     o Spinal stenosis

     o Herniated disc

     o Infections, tumors, fractures, scoliosis or deformity

     o Neck pain (with or without arm pain, sometimes called cervical radiculopathy)      or back pain (with or without leg pain, sometimes called sciatica)

2. Have received at least six months of non-operative treatment for a spine-related lower back/lumbar issue or 6 weeks of non-operative treatment for a spine-related neck/cervical issue. Non-operative treatment includes treatments such as pain medication, physical therapy, chiropractic care, and injections. 

3. Are a candidate for one or more of the following spinal fusion procedures:

     o Anterior Lumbar Interbody Fusion (ALIF), with or without supplemental posterior instrumentation

     o Transforaminal Lumbar Interbody Fusion (TLIF)

     o Posterior Lumbar Interbody Fusion (PLIF)

     o Anterior cervical Disectomy and Fusion (ACDF)

     o Single or multi-level fusions

Q: What are the risks of spinal fusion surgery?

A: As with all surgical procedures and implantable medical devices, there are associated risks, contraindications, warnings, and precautions. Patients should consult with their physician to determine if they are an appropriate candidate and to discuss all potential risks.

nanoLOCK®, A New Innovation in Spinal Fusion Surgery

Q: What is nanoLOCK®? How does it work?

A: nanoLOCK® is a proprietary surface technology only available on Titan Spine interbody fusion devices that is designed to promote natural bone growth and speed the healing process for those undergoing spinal fusion. Spinal implants featuring nanoLOCK® surface technology are made with titanium, a material with a long history of success in orthopedics due to its high strength, low weight and ability to promote bone growth for firm and lasting fixation. Titan Spine's patented subtractive manufacturing process—similar to “sandblasting”—creates a roughened surface on the titanium at the macro, micro and nano levels (MMNTM). This surface serves both to hold the implant firmly in place and to create an environment in which the body begins to signal stem cells around the implant to turn into bone-forming cells, produce natural bone morphogenetic proteins (BMPs, a bone growth protein) and inhibit inflammation,4,5 all of which creates an environment for faster patient healing.

Q: How does the nanoLOCK® surface compare to other surfaces on the market?

A: Common materials, like plastic, are smooth at the micro and nano levels and have been shown in published studies to promote fibrious tissue formation and inflammation rather than the desired bone formation.4,5 In contrast, nanoLOCK® has been shown to promote bone growth. There are other titanium implants on the market, but none of them have the same roughened nano-architecture as nanoLOCK® and are not backed by as much, if any, published research.

Q: Is nanoLOCK® available in the U.S.? What is it approved to treat?

A: Spinal implants with nanoLOCK® are the first and only FDA-cleared interbody fusion devices featuring nanotechnology. These devices are commercially available in the U.S. and indicated for use in spinal fusion procedures. Titan Spine is the only interbody spine fusion device manufacturer offering this product line.

Q: What scientific data supports the use of nanoLOCK®?

A: The benefits of nanoLOCK® surface technology are supported by five studies published in scientific journals. These publications can be found here.

Q: Who developed nanoLOCK®?

A: nanoLOCK® is developed and manufactured by Titan Spine, a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary nanoLOCK® textured surface in the U.S., portions of Europe, and Australia through its sales force and a network of independent distributors.

1Medline Plus. Back Pain: http://www.nlm.nih.gov/medlineplus/backpain.html 2Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. “The global burden of low back pain: estimates from the Global Burden of Disease 2010 study.”
2Ann Rheum Dis. 2014 Jun;73(6):968-74. Centers for Disease Control (CDC): http://www.cdc.gov/nchs/data/ahcd/combined_tables/AMC_2009-2010_combined_web_table01.pdf
3Institute of Medicine Report: Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. http://www.painmed.org/patientcenter/facts_on_pain.aspx
4Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

5Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.