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ROAD TO SPINAL FUSION IS BETTER WHEN ROUGH: MODIFIED TI ALLOY SURFACE SHOWS BETTER BONE FORMATION

Posted in Bone Disease and Musculoskeletal Disease, Uncategorized, tagged BMP, bone formayion, Interbody fusion, osteoblasts, PEEK, spine, Titan Spine, titanium on May 8, 2012| 1 Comment »

Curator: Ritu Saxena, Ph.D.

A recent news brief from Titan Spine company stated that a unique Ti surface manufactured by the company had a superior bone formation response as compared to both the smooth Ti surface and the PEEK (Polyetheretherketone) surface. The report is based on the research conducted by the Boyan et al, at the Georgia Institute of Technology published in the latest issue of Spine Journal Pubmed link- http://www.ncbi.nlm.nih.gov/pubmed?term=Osteoblasts%20exhibit%20a%20more%20differentiated%20phenotype%20and%20increased%20bone%20morphogenetic%20protein%20production%20on%20titanium%20alloy%20substrates%20than%20on%20poly-ether-ether-ketone

The research, although based on in-vitro data, holds promise as it shows that modifying only the surface of the material (in this case titanium alloy) works in the favor of better and faster bone formation by osteoblasts during the process of interbody fusion. The research is relevant for the patients with low back pain.

NEWS BRIEF:

SOURCE: Titan Spine, LLC

Titan Spine Announces the Release of Cellular Data on Its Surface Technology

Article in The Spine Journal Illustrates a Superior Bone-Production Response Versus PEEK

May 1, 2012, 11:00 a.m. EDT

MEQUON, Wis., May 01, 2012 (BUSINESS WIRE) — Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that an article published in The Spine Journal reports in-vitro data that demonstrates a superior bone-forming response to the company’s unique titanium implant surface when compared to smooth titanium and Polyetheretherketone (PEEK). In particular, the peer-reviewed data shows that Titan Spine’s surface, which features a proprietary, patent-protected combination of textures on the macro, micro, and nano levels, significantly increased osteoblast maturation and local production of bone morphogenetic proteins (BMP’s). The authors, led by Barbara Boyan, Ph.D., Professor of Biomedical Engineering at the Institute for Bioengineering and Bioscience, Georgia Institute of Technology, conclude that “modifying surface structure is sufficient to create an osteogenic environment that could enhance bone formation and implant stability, without addition of exogenous growth factors.”

“We are very pleased that this data set has been published,” commented Kevin Gemas, President of Titan Spine. “It clearly illustrates that our surface technology produces a superior environment for bone production over other common interbody fusion implant materials. This data, and others we hope will be published in the future, is helping to change the way spine surgeons and the rest of the spinal community think about interbody fusion implants. No longer should they be thought of as mere interbody spacers, but rather as active participants in the fusion process that promote the body to produce BMP’s naturally and avoid the need for the addition of BMP that was developed externally.”

The abstract of the article, titled, “Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic protein production on titanium alloy substrates than on poly-ether-ether-ketone,” can be viewed at

http://www.thespinejournalonline.com/article/S1529-9430 (12)00091-5/abstract.

About the Company — Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary 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. Visit http://www.titanspine.com to learn more and to view an animation that depicts the cellular response to the company’s surface technology.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50260191&lang=en

http://www.businesswire.com/news/home/20120501006437/en/Titan-Spine-Announces-Release-Cellular-Data-Surface

Concept :

Spinal fusion is a process using bone graft to cause two opposing bony surfaces to grow together. In medical terminology, this is called arthrodesis. Bone graft can be taken from the patient (termed autologous bone) during the primary surgical procedure or harvested from other individuals (termed allograft bone). Another option for some patients is bone morphogenetic protein (BMP). BMP stimulates the body to make bone.

Different materials such as titanium, titanium-alloy, stainless steel, or non-metallic are implanted by surgery into the spine. Medical implants are specially designed and come in many shapes and sizes. Typically these include rods, hooks, braided cable, plates, screws, and interbody cages. Cages are simply structures that support bones (either between bones or in place of them) while new bone growth occurs through and around them.

http://www.spineuniverse.com/treatments/surgery/what-spinal-instrumentation-spinal-fusion

Interbody fusion is a kind of spinal fusion that involves removing damaged intervertebral disc and inserting a bone graft that promotes bone growth. An intervertebral device is placed between the vertebra to maintain spine alignment and disc height and is made of either plastic or titanium. Bone growth leads to the fusing of the vertebrae. Fusing the bones together can help make a particular area of the back more stable, reducing problems related to nerve irritation.

RESEARCH:

Extensive research has been conducted on the kind of materials that could be used for interbody fusion using surgery. A lot of other researchers have focused on testing the biomechanics of the material used and most importantly, their compatibility and bone forming potential during the interbody fusion.

Polyetheretherketone (PEEK) was reported as a biomaterial for spinal applications by Turner et al. Threaded lumbar interbody spinal fusion devices (TIBFD) made from titanium have been reported to be 90% effective for single-level lumbar interbody fusion, although radiographic determination of fusion has been intensely debated in the literature. Using blinded radiographic, biomechanic, histologic, and statistical measures, the group evaluated a radiolucent polyetheretherketone (PEEK) threaded interbody fusion device packed with autograft or rhBMP-2 on an absorbable collagen sponge in 13 sheep at 6 months. Radiographic fusion, increased spinal level biomechanical stiffness, and histologic fusion were demonstrated for the PEEK cages filled with autograft or rhBMP-2 on a collagen sponge. No device degradation or wear debris was observed. Only mild chronic inflammation consisting of a few macrophages was observed in peri-implant tissues. Based on these results, Turner et al (2006) stated that the polymeric biomaterial PEEK might be a useful biomaterial for interbody fusion cages due to the polymer’s increased radiolucency and decreased stiffness.

http://www.ncbi.nlm.nih.gov/pubmed/16115677

Few groups have focused on testing new materials or altering the already existing materials as potential implants for spinal interbody fusion. Studies include testing the biomechanics of the material used and most importantly, their compatibility and bone forming potential during the interbody fusion process.

For example Nakamura et al from the University of Kyoto, Japan, tested a porous bioactive titanium implant for spinal interbody fusion in canine model. Histological examination demonstrated a large amount of new bone formation with marrow like tissue in the bioactive implants and primarily fibrous tissue formation in the non-treated implants.

http://www.ncbi.nlm.nih.gov/pubmed/17933320

The same group published a study of human clinical trials in 2011 using porous titanium treated with bioactive surface. The objective of this study was to establish the efficacy and safety of porous bioactive titanium metal for use in a spinal fusion device, based on a prospective human clinical trial. A high-strength spinal interbody fusion device was manufactured from porous titanium metal. A bioactive surface was produced by simple chemical and thermal treatment. Five patients with unstable lumbar spine disease were treated surgically using this device in a clinical trial approved by our Ethics Review Committee and the University Hospital Medical Information Network. Clinical and radiological results were reported at the minimum follow-up period of 1 year. The optimal mechanical strength and interconnected structure of the porous titanium metal were adjusted for the device. The whole surface of porous titanium metal was treated uniformly and its bioactive ability was confirmed before clinical use. Successful bony union was achieved in all cases within 6 months without the need for autologous iliac crest bone grafting. Two specific findings including an anchoring effect and gap filling were evident radiologically. All clinical parameters improved significantly after the operation and no adverse effects were encountered during the follow-up period. Although a larger and longer-term follow-up clinical study is mandatory to reach any firm conclusions, the study results show that this porous bioactive titanium metal is promising material for a spinal fusion device.

http://www.ncbi.nlm.nih.gov/pubmed/21369760