S. Tim Yoon, Darrel Brodke, María Alvarez Sánchez (KF Manager), Jeff Wang, Zorica Buser, Jong-Beom Park, and Patrick Hsieh attending KF Steering Committee and Associates meeting (Buenos Aires, Argentina, 2015).

 

AOSpine KF Degenerative/

Biologics in search of evidence – raising the bar

 

The current evidence in biologics is severely lacking and there are no reliable comparative studies to guide surgeons' decisions. To increase accountability on a global level, the Knowledge Forum (KF) Degenerative/Biologics has been focusing on biologics for its first four years of existence. Now it is moving into developing the first ever biologics Classification.

 

Realizing there is a lack of evidence surrounding decision making about biologics, the first Chairperson of KF Degenerative/Biologics, Jeff Wang, inspired the study group to cover the full spectrum: past, present, and future. The past meant looking at existing large databases collected by other groups and analyzing the currently available data. The present, includes publishing the "We are really trying to raise the bar, to understand the effect of biologics on spine surgery outcomes and to increase awareness of evidence; or rather the lack of it." (S. Tim Yoon)evidence generated from these databases and from conducting health technology assessment reviews. For the future, the group is looking to establish an international multicenter prospective biologics database through the DegenPRO study, to be able to understand which biologics work and which don't, with a strong focus on patient reported outcomes.

 

"We are really trying to raise the bar, to understand the effect of biologics on spine surgery outcomes and to increase awareness of evidence; or rather the lack of it", explains the newly elected Chairperson Tim Yoon. "There is such a big discrepancy in the amount of evidence supporting the use of one biologic versus the other. It is frustrating, how many of our colleagues are unaware of the differences."

 

Making the best choice

According to Yoon, AOSpine has no competition in this area. The foundation has been laid to take research to the next level and to ramp up the data collection from all over the world. "Something like this requires a global group like AOSpine", Wang confirms. Companies are creating new biologic products that sound good and may be more effective, but cost much more, raising health care costs without sufficient evidence to support that these new products are any better. "What makes it worse is that surgeons are using these products without understanding the therapeutic benefit and the evidence or lack of it."

 

Increased accountability is the wider social impact the KF is seeking. "It's not that you should pick based on cost, you should always think what is best for the "In a translational field like spine you really need both, basic science fundamentals and clinical evidence." (Zorica Buser)patient", Wang explains. "But how can you choose what is best when you don't have the evidence? We may be wasting healthcare dollars, but we don't know." The ethical question of using human allograft tissue adds to the need of acquiring more evidence. "Someone has donated their body, and you are creating a commercial product out of their bone. We owe it to them to create the best possible products, so that surgeons can pick the most effective one."

 

There are several new biologics coming out, and Wang hopes the public, the patients, and especially the surgeons who make the decisions will demand to see the evidence, to prove the products are effective and safe. "We are basing other treatment decisions on evidence, whether to do surgery, what surgery to do, so why not biologics? This will be the measure of our success, to see people demanding evidence."

 

​Launching the KF Degenerative/Biologics with Dan Riew, Jim Youssef, Jeff Wang, Hans Jörg Meisel, S. Tim Yoon, Jong-Beom Park and Niccole Germscheid (Los Angeles, CA, USA, 2013).The KF working meeting at the Global Spine Congress (Buenos Aires, Argentina, 2015).The group emphasizes the importance of globalization from the start. S. Tim Yoon discussing on-going research projects (Los Angeles, CA, US, 2014).Jong-Beom Park and Hans Jörg Meisel. The meeting topics included publication strategy and Knowledge Transfer (Los Angeles, CA, US, 2014).First discussions on the DegenPRO study with Jeffrey Wang, Darrel Brodke, and Hans Jörg Meisel (Los Angeles, CA, US, 2014).The KF Degenerative Steering Committee members Jong-Beom Park, Hans Jörg Meisel, Darrel Brodke, Jeff Wang, and S. Tim Yoon.The fellows joined Hans Jörg Meisel, Jong-Beom Park, Peter Langer, Jeremiah Cohen, Darrel Brodke, Patrick Hitpold, Jeff Wang, Dmitri Sofianos, S. Tim Yoon, and Elizabeth Lord in a working meeting (Los Angeles, CA, USA, 2014).S. Tim Yoon, Darrel Brodke, María Alvarez Sánchez (KF Manager), Jeff Wang, Zorica Buser, Jong-Beom Park, and Patrick Hsieh attending KF Steering Committee and Associates meeting (Buenos Aires, Argentina, 2015).3 - 8<>

Branching out

The next immediate goal for the KF is to rapidly expand both in scope and numbers. Gathering momentum for his three-year term, Yoon envisions developing the KF Degenerative/Biologics into a research group where several sub-"No matter if you are in the middle of Alaska or from a major city – as long as you are up to it and you are a member of AOSpine – learn about what we are doing, and once you start entering patients, you can become a member of the KF." (Jeff Wang)studies could be performed in subsets of degenerative patients focusing on cervical, minimally invasive surgery, and so on. The area is broad, and the expertise needed is wide.

 

With the results from the DegenPRO study, the group hopes to contribute meaningful evidence to the research community. In parallel, in the footsteps of the AO pioneers, the KF is also developing the first ever Osteobiologics Classification, hoping it will become the standard like the other AO Classifications. Developing treatment guidelines through the DegenPRO study and the Osteobiologics Classification would enable more tailored treatment procedures to the patients and reduce the need for revision surgeries.

 

Zorica Buser, Associate Member of the KF, reminds that lower back pain is a leading cause of disability worldwide both in developed and developing countries. "We are constantly advancing our knowledge in spine care. However, we still see an increase in the number of spine fusion procedures, for example, with the growing aging population. Biologics really play an instrumental role in the surgical success."

 

Creating the best mix

The Knowledge Forum is a mix of surgeons and non-surgeons, research driven clinicians and clinically driven researchers. The associate members play a key role and Buser brings crucial basic science and translational knowledge to the "It's not that anything out there that is not tested is bad, we just don't know how good or bad it is. Ten years from now, we'll have set the standard. Any biologics product that comes out will have been tested and put in its place." (Jeff Wang)table. "In a translational field like spine you really need both, basic science fundamentals and clinical evidence." She is impressed by the huge potential of the group and the way it works. "Everyone brings in ideas and contributes to all steps. It's a collection of great minds."

 

AOSpine members benefit widely from the KF studies, from the evidence, the ideas, the classifications. Any AOSpine member can also get directly involved in the KF Degenerative/Biologics. "You don't have to be a leader of AOSpine in your country, you don't have to be an officer, it's all based on merit and accountability", Wang assures. "We have the cream of the crop, but we are moving into new topics and must include more members of AOSpine from around the world", Wang says.

 

Together with Yoon, Wang welcomes dedicated new people to participate. People who can demonstrate they share the vision, are able to contribute, and provide patient data to their degenerative studies. "AO is an organization with no limits. You can do great things through this organization", Wang concludes.

 

This article concludes a series on the AOSpine Knowledge Forums. The full story of the Knowledge Forums is now available on the AOSpine Research website ​ www.aospine.org/kf

 

 

 

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QUICK FACTS

• KF Degenerative/Biologics launched in 2013, the youngest of the AOSpine Knowledge Forums, first chaired by Jeffrey C. Wang
• Chairperson S. Tim Yoon leads a Steering Committee of 5 members; serves as a member of the AOSpine International Research Commission
• Wang continues in the AO Foundation Board and as a KF Steering Committee member
• Associate member structure in development, will provide wider regional representation
• Published 11 peer-reviewed journal articles and 7 presentations

 

STUDY HIGHLIGHTS

• DegenPRO database. Prospective study on Osteobiologics, now opening to members
• Osteobiologics Classification. Evaluates the level of evidence supporting use of bone grafts
• For more information see www.aospine.org/kf-degen