Our vision is to improve the lives of those with neck and back pain and with your support, we can give hope. We do this through data-driven research, focused on educating patients on treatments that work, reducing the need for invasive treatments, and improving surgical outcomes. We aim to prove that more efficient and less invasive alternatives to traditional treatments exist, often resulting in faster recovery times and improved quality of life.
- Robotic Assisted Spine Surgery Outcomes Retrospective.
An analysis of specific outcome measures, such as surgical complications, need for revisions, radiation exposure, and accuracy of screw placement. We are currently in the development phase of a prospective, multi-center study where we collect the same clinical outcomes (plus a lot more), but also add in patient reported outcomes.
- Patient Expectation Survey.
We are one center in this multi-center study based out of Norton-Leatherman Spine Center. It looks at how well we prepare patients for the recovery process after lumbar fusion surgery.
- Stem Cell Study. We are tracking patient reported outcome measures after having an intradiscal stem cell/regenerative medicine procedure.
- Enhanced Recovery After Surgery (ERAS)
ERAS will help patients get better and stronger faster, and out of the hospital more quickly after surgery. This patient-centered research is based on evidence discovered after observing a patient’s response to surgical procedures. Our work has shown a reduction in the length of hospital stays, narcotic usage, earlier ambulation, and earlier restoration of bladder and bowel function. Currently, we are combining our data with HCA hospitals around the country to continue making progress with a larger data pool, which will help us make great progress.
- Augmented Reality Assisted Spine Surgery Outcomes
With augmented reality, we are looking prospectively at clinical and patient reported outcomes in new technology. We take a retrospective analysis of specific measures and configure what needs revision and enhancement. Augmented reality in spine health is becoming more and more important as technology expands.
- Discogenic Pain Study
This study aims to look at patients with only discogenic pain as a diagnosis. How can surgery effectively treat this when non-operative treatments have failed? Many insurance companies and physicians/surgeons do not recognize discogenic pain as a reason to have surgery yet, so it’s extremely important to continue research on this issue and ensure patients have access to the tools and treatments they need.
- Spine Registries.
We are enrolling many patients into a cervical or thoracolumbar registry to track their outcome if they don’t fall into another study category.
- Cervical BMP
BMP is a bone growing protein that is helpful in fusions. It is approved for use in the lumbar spine, but VSI also uses this in the cervical spine “off-label” and track their patients to show that when dosed appropriately, the use of BMP is safe and effective at achieving fusion in patients who otherwise are at risk for a failed fusion. This is controversial because when dosed inappropriately (too high), then there are higher incidences of complications with swallowing and breathing after surgery.
- Artificial Intelligence (AI)
Adapted to measure spinopelvic parameters. We have partnered with a company in Germany to help facilitate validation of their AI algorithm to make precise measurements of the spine that are critical in understanding spinal alignment problems and used to calculate corrections needed during surgery.
- Simplify Medical
We are part of a large FDA/industry study. Simplify Medical is a company that created a new artificial disc for the neck (cervical spine). Their one level implant has recently been FDA approved and their two level implant is well on its way. We’ve been tracking our patients for 3 years now as part of this clinical trial.
- Artificial Disc Replacement
Artificial disc replacement (ADR) was developed as an alternative to fusion surgeries as a method to preserve some motion and reduce stress on adjacent discs. ADR surgery is minimally invasive, with the goal of simulating normal disc function while increasing mobility and alleviating pain. There are a variety of artificial discs currently on the market. The Foundation is investigating those composed from a combination of materials including ceramic, titanium, polyurethane, and polyether ether ketone (PEEK). All of these available artificial discs have a ‘moveable’ core, which allows for flexation and rotation once implanted. The Foundation is collaborating with industry partners to help identify the benefits of artificial discs and track the recovery progress of patients using them.
- Robotic Guided Surgery
Many of The Foundation’s research partners are currently utilizing navigation and various robotic-guidance platforms for surgery planning and hardware implantation, demonstrating greater accuracy than traditional surgery or fluoscopic-guided (x-ray) techniques. Robotic-guided surgery provides the ability to create an extremely detailed preoperative plan, enabling the surgeon to prepare for the entire procedure before ever making an incision. The surgeon has an opportunity to work through a cannula tube, leaving only two degrees of freedom: depth and rotational direction. This allows for more precise screw implantation and less complications versus the traditional freehand method. The system also allows for less radiation exposure for both the patient and the surgical team as well as greater accuracy of hardware placement, ultimately reducing recovery times. The Foundation is currently gathering outcome data on patients who have undergone robotic-guided surgery and hopes to use these data to identify the optimal robotic-guided system for the individual patient.
- Regenerative Medicine
Regenerative medicine is a natural treatment option using living and functional tissues to repair or replace damaged or diseased tissue. Regenerative therapy uses the patient’s own cells or tissues to initiate the healing process. Regenerative treatments are currently performed using either 1) the patient’s own natural stem cells, mesenchymal stem cells (MSC), harvested from the patient’s hip bone, 2) the patient’s own natural growth factors and proteins, platelet rich plasma (PRP), extracted from their blood, or 3) cells extracted from the patient’s adipose tissue, or fat. Once extracted, the stem cells are injected into the affected area (degenerative discs, facet joints, etc.) in order to help facilitate the healing process and reduce pain, without the need for invasive surgery. The Foundation is tracking patient-reported outcomes for those who undergo regenerative treatments and preliminary results indicate a significant improvement in quality of life metrics compared to pre-treatment reports.
Past Research Projects
Bone Morphogenetic Protein
Bone morphogenetic protein (BMP) is a naturally occurring protein within our bodies that stimulates bone growth and is essential for broken bones to heal. Recombinant human bone morphogenetic protein (rhBMP) has long been recognized for its remarkable potential as a bone graft substitute; The Foundation and Virginia Spine Institute (VSI) oversaw the first surgical use of rhBMP in fusion surgeries. During spinal fusion surgery, the surgeon uses rhBMP, in the form of a sponge soaked with the rhBMP at the surgical site in order to cause the adjacent bones to fuse together. Traditional treatments currently use an autograft, consisting of the painful step of harvesting bone from the patient’s hip. The Foundation has found that use of rhBMP has resulted in patients obtaining higher rates of fusion, less revision surgeries, less complications, and faster recovery times.
Chronic spinal pain affects more than 80% of the population and is the leading cause for physical and emotional suffering, disability, and missed work days. One non-surgical treatment option for alleviating this pain is targeted electrical stimulation of spinal nerves, also known as spinal cord stimulation (SCS). When leads are implanted onto target nerves in the spine, they elicit a low-voltage electrical signal to prevent pain signals from reaching the brain. These electrical pulses can be controlled wirelessly via Bluetooth. After an initial trial period (~15 days) a pulse generator, the size of a pocket lighter, which provides the electrical signals, is permanently implanted into the patient’s lower back. Permanent implantation allows for pain- and worry-free movement. Data from partner clinics and patients using SCS is currently being collected by The Foundation in order to educate current and potential patients on the dramatic decrease in spinal pain due to electrical stimulation.
Discogenic pain refers to pain originating from a damaged vertebral disc, commonly due to degenerative disc disease, a naturally occurring process due to aging. Discogenic pain can normally be treated with non-surgical treatments; however, it is sometimes so severe that it requires surgery. The Foundation is currently gathering patient-driven data on fusion surgeries to treat discogenic pain, which may be a viable alternative to their current treatment plan.
The Foundation collaborates with a number of different medical device and biologics industry partners to help push new and novel treatments as standard of care. The US Food and Drug Administration (FDA) requires large amounts of data in order to determine if a new device or treatment is safe and effective for human use. Because of The Foundation’s reputation and the reputation of its collaborators, device and biologic companies are eager to cooperate with The Foundation. The Foundation assists in obtaining both physician and patient data on devices and biologics that are set for review by the FDA. These large data sets are compiled for the industry partner by The Foundation’s staff, researchers, and collaborators, with hopes of obtaining FDA approval and eventual translation into humans. Read more about The Research Institute or our SpineOnline® initiative.
October 7, 2020
Jazini E, Haines C, Schuler TC, Sohail O, Orosz L, Roy R, Carreon LY, Good CR. Adoption of Enhanced Recovery After Surgery (ERAS) Protocol for Adult Spinal Deformity (ASD) Surgery Decreases In-Hospital and 90-day Post-operative Opioid Consumption. 2020 North American Spine Society (NASS).
Jazini E, Haines C, Orosz L, Bharara N, Schuler TC, Sohail O, Roy R, Carreon LY, Good C, Johnson N. Adoption of Enhanced Recovery After Surgery (ERAS) Protocol for Lumbar Fusion Decreases In-Hospital Post-operative Opioid Consumption. 2020 North American Spine Society (NASS).
Schroerlucke SR, Harris EN, Roy R. Improvements in Screw Placement and Accuracy With Newer Generation Robotic-Assisted Minimally Invasive Instrumented Lumbar Fusions. 2020 North American Spine Society (NASS).
April 2, 2020
Jazini E, Haines C, Orosz L, Bharara N, Schuler TC, Sohail O, Roy R, Carreon LY, Good C. Adoption of Enhanced Recovery After Surgery (ERAS) Protocol for Lumbar Fusion Decreases In-Hospital Post-operative Opioid Consumption. 2019 Lumbar Spine Research Society (LSRS).
April 1, 2020
Jazini E, Haines C, Schuler TC, Sohail O, Orosz L, Roy R, Carreon LY, Good CR. Adoption of Enhanced Recovery After Surgery (ERAS) Protocol for Adult Spinal Deformity (ASD) Surgery Decreases In-Hospital and 90-day Post-operative Opioid Consumption. 2020 Scoliosis Research Society (SRS).
Jazini E, Haines C, Schuler TC, Sohail O, Orosz L, Roy R, Carreon LY, Good CR. Adoption of Enhanced Recovery After Surgery (ERAS) Protocol for Adult Spinal Deformity (ASD) Surgery Decreases In-Hospital and 90-day Post-operative Opioid Consumption. 2019 International Meeting on Advanced Spine Techniques (IMAST).
March 24, 2020
Early Adoption of Enhanced Recovery After Surgery (ERAS) Protocol Following Adult Spinal Deformity (ASD) Surgery is Not Associated with Decreased Total In-hospital Opioid Use.2020 American Academy of Orthopaedic Surgeons (AAOS)
February 27, 2020
Human Bone Marrow Concentrate-Derived Mesenchymal Stem Cells for Treatment of Low Back Pain: Patient Reported Outcomes Through One Year.2020 International Society for Advancement of Spine Surgery (ISASS)
The Use of rhBMP-2 in Cervical Arthrodesis for Patients with Cervical Degenerative Disc Disease. 2020 International Society for Advancement of Spine Surgery (ISASS)
September 25, 2019
Gorini C, Haines CM, Good CR, Woodlief S, Padin B, Jazini E. Early adoption of enhanced recovery after surgery protocol following ASD surgery is not associated with decreased in-hospital opioid use. 2019 North American Spine Society Meeting (NASS). Podium presentation
June 6, 2019
Haines CM, Good CR, Schuler TC, Bharara N, Nguyen TT, Gorini C. Use of Human Bone Marrow Concentrate-Derived Mesenchymal Stem Cells for Treatment of Low Back Pain: Patient Reported Outcomes Through One Year. 2019 The Orthobiologics Institute (TOBI). Poster presentation
September 21, 2017
Schroerlucke SR, Wang MY, Cannestra A, Good CR, Lim JY, Hsu VW, Zahrawi F, Villalobos HJ, Ramirez PM, Sweeney T . Complications and revision rates in robotic-guided vs. fluoro-guided minimally invasive lumbar fusion surgery – report from MIS ReFRESH prospective comparative study. 2017 North American Spine Society Meeting. Podium Presentation
January 13, 2015
Subach BR, Copay AG. The use of a dehydrated amnion/chorion membrane allograft in patients who subsequently undergo reexploration after posterior lumbar instrumentation. Adv Orthop. 2015;2015:501202. doi: 10.1155/2015/501202. Epub 2015 Jan 13.
November 22, 2012
Copay AG. Commentary: the proliferation of minimum clinically important differences. Spine J. 2012 Dec;12(12):1129-31. doi: 10.1016/j.spinee.2012.11.022
February 10, 2010
Copay AG, Martin MM, Subach BR, Carreon LY, Glassman SD, Schuler TC, Berven S. Assessment of spine surgery outcomes: inconsistency of change amongst outcome measurements. Spine J. 2010 Apr;10(4):291-6. doi: 10.1016/j.spinee.2009.12.027. Epub 2010 Feb 19
Subach BR, Copay AG, Martin MM, Schuler TC, Romero-Gutierrez M. An unusual occurrence of chondromyxoid fibroma with secondary aneurysmal bone cyst in the cervical spine. Spine J. 2010 Feb;10(2):e5-9. doi: 10.1016/j.spinee.2009.11.016.
January 16, 2008
Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16
September 2, 2007
Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007 Sep-Oct;7(5):541-6. Epub 2007 Apr 2. Review.