Bone Morphogenetic Protein
Bone morphogenetic protein (BMP) is a naturally occurring protein within our bodies that stimulate 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; NSHF 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. NSHF has found that use of rhBMP has resulted in patients obtaining higher rates of fusion, less revision surgeries, less complications, and faster recovery times.
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. NSHF 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. NSHF 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 NSHF’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. NSHF 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 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. NSHF 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.
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 NSHF 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. NSHF is currently gathering patient-driven data on fusion surgeries to treat discogenic pain, which may be a viable alternative to their current treatment plan.
NSHF 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 NSHF’s reputation and the reputation of its collaborators, device and biologic companies are eager to cooperate with NSHF. 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 NSHF staff, researchers, and collaborators, with hopes of obtaining FDA approval and eventual translation into humans.
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. Podium presentation
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. The Orthobiologics Institute. Poster presentation
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
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.
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
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.
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.
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.
American Academy of Orthopaedic Surgeons (AAOS): 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. Submitted
International Society for Advancement of Spine Surgery (ISASS): Human Bone Marrow Concentrate-Derived Mesenchymal Stem Cells for Treatment of Low Back Pain: Patient Reported Outcomes Through One Year. Submitted
International Society for Advancement of Spine Surgery (ISASS): The Use of rhBMP-2 in Cervical Arthrodesis for Patients with Cervical Degenerative Disc Disease. Submitted