Texas Back Institute Clinical Research
Pioneers for Advancing Spine Care
At Texas Back Institute (TBI), our physicians are dedicated to engaging in industry and physician-initiated studies and feel it is vital that discoveries translate into treatments and interventions that will improve the care for our patients.
Founded over 4 decades ago, our TBI physicians have proven their ability to keep up with patients’ varied needs, constantly adapting to remain at the forefront of innovated treatments that get our patients back to life. At TBI, we are committed to providing the highest quality treatments and services to our patients. One way we stay in the forefront of the latest advances in technology and treatment is through our clinical research program. With a dedicated research team, our patients receive benefit from some of the latest clinical spine studies, information gleaned from peer-reviewed research papers and the latest technology in motion-preserving procedures, minimally invasive procedures, and robotic technology for spine surgery.
Clinical studies at TBI help advance the field of spine care and patients gain access to technologies that often aren’t available to the public for several years. Our surgeons at TBI have been pioneers and champions in the advancement of spine surgery and are diverse in that we cover everything from trauma and deformity to tumors and the degenerative changes in the neck and spine that occur as part of the aging process.
Clinical studies involve patients and help doctors and researchers find new ways to improve treatments and the quality of life for people with spine disease, injury or deformity. In clinical studies, researchers methodically test drugs, medical devices, screening approaches, behavioral modifications and other interventions.
Clinical studies are used to answer many different clinical questions which can help you stay healthy and get better sooner. Participating in a clinical study at TBI can get you the most advanced treatment and help further spine research in our own community. Clinical studies are important for discovering new ways to detect, diagnose and treat spine conditions. Clinical studies can show researchers what does and doesn’t work and adds to overall medical knowledge to best treat the medical condition of patients.
Clinical studies vary from study to study but there are many similar benefits to participating in clinical studies:
- The potential of getting a newer and better treatment.
- Contributing to the advancement of medicine for a family member or friend and knowing that the knowledge gained by your participation may benefit others in the future.
- Getting the same high-quality treatment you would get with any treatment provided by TBI.
- Receiving additional care and attention from a research coordinator who works with the study doctor.
In order to participate in a clinical study, you must meet a strict set of criteria. These criteria are necessary in order to ensure you are the right patient for the study and to protect your safety. Your study doctor at TBI must always follow the study criteria for each specific study and must feel that in his/her medical opinion, you will benefit from the study treatment.
There are potential risks to participating in a clinical study. The risks may include:
- You may have to spend more time at your doctor’s office for research-related procedures and follow-ups which may not be required if you were not participating in a study.
- You may experience a side effect of the treatment.
- You may not receive any immediate benefit.
Your study doctor and study team will explain to you all the risks and benefits of participating in a study.
Your health and protection are our top priority. All studies are reviewed and approved by an Institutional Review Board (IRB). An IRB is a group of outside physicians, nurses, lay people and members of the community who are tasked with protecting all patients who consent to a clinical study. Studies are continuously monitored to ensure they are ethical and safe.
Before you can begin a clinical study, you will be asked to sign an informed consent form. This informed consent form is study-specific and will outline the clinical study and provide all the information we can give so that you can make an informed decision on your participation.
TBI is committed to providing the best possible care to you in an environment of innovation, research and education. TBI is truly unique in that they combine the expertise of fellowship-trained orthopedic surgeons and neurosurgeons who will work together to find the best treatment for you. Together, the research today may become the standard tomorrow.
The Spine Biomechanics Laboratory at Texas Back Institute exists to investigate the biomechanical and neuromuscular risk factors associated with spinal ailments in an effort to define the most appropriate and effective treatment options.
This lab is a critical component in bridging the basic science of biomechanics and engineering, with the clinical science of treating patients suffering from spinal ailments.
The clinicians and scientists involved with the lab are uncompromising in furthering the biomechanics related to the treatment of spinal pathology. They will make every effort to further the science and translate that knowledge into clinical advances which will benefit the patients we serve.
Clinical Research Articles
- “Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial” posted in the Journal Neurosurgery Spine (Dr. Zigler)
- “Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial” posted in the Journal Neurosurgery Spine (Drs. Hisey and Rashbaum)
- “Prospective, Randomized Comparison of Cervical Total Disc Replacement vs. Anterior Cervical Fusion: Results at 48 Months Follow-up” posted in Journal of Spinal Disorders and Techniques (Dr. Hisey)
- “Comparison of 2 Lumbar Total Disc Replacements: Results of a Prospective, Randomized, Controlled, Multicenter Food and Drug Administration Trial With 24-Month Follow-up” posted in the Spine Journal (Dr. Guyer)
- “Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease” posted in The Spine Journal (Dr. Zigler)
- “Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial” posted in the European Spine Journal (Drs. Blumenthal, Zigler, and Guyer)
- “Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease” posted in the Journal Neurosurgery Spine (Dr. Zigler)
- “Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion” posted in the Journal Neurosurgery Spine (Dr. Zigler)
- “Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared with Circumferential Arthrodesis for the Treatment of Two-Level Lumbar Degenerative Disc Disease” posted in the Journal of Bone and Joint Surgery (Dr. Zigler)
- “A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion” posted in the Spine journal (Dr. Blumenthal)
- “Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE´ artificial disc versus lumbar fusion: Five-year follow-up” posted in The Spine Journal (Dr. Guyer)
- “A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion” posted in the Spine Journal (Drs. Guyer and Blumenthal)
- “Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc -L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease” posted in the Spine Journal (Dr. Zigler)
Spine Biomechanics Lab
- Haddas R, Cox J, Belanger T, Boah AO, Ju KL, Derman PB. (2019) Characterizing Gait Abnormalities in Patients with Cervical Spondylotic Myelopathy: A Neuromuscular Analysis. The Spine Journal; 16(11): 1803-08. DOI: 10.1016/j.spinee.2019.06.005
- Haddas R, Lieberman IH. (2019) The Change in Sway and Neuromuscular Activity in Adult Degenerative Scoliosis Patients Pre and Post Surgery Compared to Controls. Spine; 44(15): E899-907. DOI: 10.1097/BRS.0000000000003009
- Haddas R, Xu M, Lieberman IH, Yang J. (2019) Finite Element Analysis of Pre and Post Lumbar Fusion for Adult Degenerative Scoliosis Patients. Spine Deformity; 7(4): 543-52. DOI: 10.1016/j.jspd.2018.11.008
- Xu M, Yang J, Lieberman IH, Haddas R. (2019) Finite Element Method-Based Study of Pedicle Screw-Bone Interaction. Medical Engineering & Physics; 67: 11-21. DOI: 10.1016/j.medengphy.2019.03.004
- Haddas R, Lieberman IH, Kakar R. (2019) A Comparison of Muscular Activity during Gait between Walking Sticks and a Walker in Patients with Adult Degenerative Scoliosis. Spinal Deformity; 7:454-466. DOI: 10.1016/j.jspd.2018.09.067
- Xu M, Yang J, Lieberman IH, Haddas R. (2019) The Effect of Surgical Alignment in Adult Scoliotic Spines on Axial Cyclic Vibration: A Finite Element Study. Journal of Computing and Information Science in Engineering; 19(2): 021006. DOI: 10.1115/1.4042326
- Haddas R, Lieberman IH, Arakal R, Boah A, Belanger T, Ju KL. (2019) Effect of Cervical Decompression Surgery on Gait in Adult Cervical Spondylotic Myelopathy Patients. Clinical Spine Surgery; 31(10): 435-40. DOI: 10.1097/BSD.0000000000000719
- Xu M, Yang J, Lieberman, IH, Haddas R. (2019) Comparisons of Stress Distributions in Vertebral Bone and Pedicle Screw and Screw-Bone Load Transfers among Different Fixation Methods of Lumbar Spine Fusion Surgery: A Finite Element Study. Medical Engineering and Physics, 63, 2019, 26-32. DOI: 10.1016/j.medengphy.2018.10.003
- Haddas R, Lieberman IH, Boah A, Arakal R, Belanger T, Ju KL. (2019) Functional Balance Testing in Cervical Spondylotic Myelopathy Patients. Spine; 44(2): 103-109. DOI: 10.1097/BRS.0000000000002768
- Haddas R, Ju KL. (2018) Gait Alteration in Cervical Spondylotic Myelopathy Elucidated By Ground Reaction Forces. Spine; 44(1): 25-31. DOI: 10.1097/BRS.0000000000002732
- Xu M, James Y, Lieberman IH, Haddas R. (2019) Stress Distribution in Vertebral Bone and Pedicle Screw and Screw-Bone Load Transfers among Various Fixation Methods for Lumbar Spine Surgical Alignment: A Finite Element Study. Medical Engineering & Physics; 63: 26-32. DOI: 10.1016/j.medengphy.2018.10.003
- Haddas R, Lieberman IH, Block A. (2018) The Relationship between Fear-Avoidance and Neuromuscular Measures of Function in Patients with Adult Degenerative Scoliosis. Spine; 43(23): E1412-21. DOI: 10.1097/BRS.0000000000002719
- Haddas R, Patel S, Arakal R, Boah AO, Belanger T, Ju KL. (2018) Spine and Lower Extremity Kinematics during Gait in Cervical Spondylotic Myelopathy Patients. The Spine Journal; 18(9): 1645-1652. DOI: 10.1016/j.spinee.2018.04.006
- Haddas R, Ju K, Lieberman IH. (2018) The Use of Gait Analysis in the Evaluation of Patients Afflicted with Spinal Disorders. European Spine Journal; 27(8): 1712-1723. DOI: 10.1007/s00586-018-5569-1
- Haddas R, Lieberman IH. (2018) A Method to Quantify the “Cone of Economy”. European Spine Journal; 27(5): 1178-1187. DOI: 10.1007/s00586-018-5475-6
- Haddas R, Lieberman IH, Block A. (2018) The Relationship between Fear-Avoidance and Objective Biomechanical Measures of Function in Patients with Adult Degenerative Scoliosis. Spine, 46 (9): 647-653. DOI: 10.1097/BRS.0000000000002381
- Aghyarian S, Hu X, Haddas R, Lieberman IH, Kosmopoulos V, Kim HKW, Rodrigues DC. (2017) Biomechanical behavior of novel composite PMMA-CaP bone cements in an anatomically accurate cadaveric vertebroplasty model. Journal of Orthopaedic Research; 35(9); 2067-2074. DOI: 10.1002/jor.23491
- Haddas R, Belanger T. (2017) Clinical Gait Analysis on a Patient Undergoing Surgical Correction of Kyphosis from Severe Ankylosing Spondylitis. International Journal of Spine Surgery; 11(3): 138-144. DOI: 10.14444/4018
- Haddas R, Hu X, Lieberman IH. The Correlation of Spinopelvic Parameters with Biomechanical Parameters Measured by Gait and Balance Analyses in Patients with Adult Degenerative Scoliosis. Clinical Spine Surgery; In Press.
- Haddas R, Ju KL, Boah AO, Kosztowski T, Derman PB. The Effect of Surgical Decompression on Functional Balance Testing in Patients with Cervical Spondylotic Myelopathy. Clinical Spine Surgery; In Press. DOI: 10.1097/BSD.0000000000000889
- Haddas R, Samocha Y, Yang J. Effects of Volitional Spine Stabilization on Trunk Control during Asymmetric Lifting Task in Patients with Recurrent Low Back Pain. Global Spine Journal; In Press. DOI: 10.1177/2192568219885898