Those suffering from painful degenerative or herniated discs in their necks might find relief in two newly launched clinical studies at the Beverly Hills-based Advanced Disc Replacement Spinal Restoration Center | Lanman Spinal Neurosurgery, operated by leading spinal surgeon and spine medicine innovator, Dr. Todd Lanman.
Earlier this year, the practice has begun enrollment on two new clinical research trials, featuring artificial cervical disc devices by Centinel Spine and Synergy Spine Solutions.
For those experiencing continued symptoms from arm or neck pain after trying non-operative conservative treatments such as physical therapy and medication, they may find themselves to be candidates for a motion-preserving alternative to spinal fusion in a new FDA clinical study using the prodisc C Vivo and SK.
The 2-to-1 randomized clinical trial is investigating the treatment of two-level symptomatic cervical disc disease, comparing both the Vivo and SK to the Mobi-C in those between the ages of 18-69. The Mobi-C device is used as the control to determine the safety and efficacy of the two prodisc C discs to treat disc disease at two levels of the cervical spine.
For every two patients receiving a prodisc C Vivo or SK, a third will receive a currently marketed and approved TDR (total disc replacement) Mobi-C device.
Both prodisc devices are low profile, which allow for stacking (or multilevel application) at two adjacent levels of the cervical spine, and have a ball and socket design, allowing for physiological range of motion and stability. The C Vivo incorporates a “teeth” fixation, while the SK uses low-profile keels for fixation.
During the surgery, for those receiving the prodisc, Dr. Lanman will select the appropriate design correlating with the patient’s anatomic needs.
For those patients needing a single-level disc replacement, the Synergy Cervical Disc Investigational Device (IDE) Clinical Trial might be a better suited option.
The Synergy Disc trial is a historically-controlled study designed to demonstrate that the Synergy device is as safe and effective as conventional anterior cervical discectomy and fusion in patients experiencing symptomatic degenerative disc disease in one level of their cervical spine. What is also unique about this trial is that patients who have had a prior cervical fusion at one level can be in the Synergy Disc trial. You may qualify for this trial if you have a single degenerative disc in your neck or need a disc replacement after having had a fusion in your neck. All patients who qualify for that study will receive the Synergy Disc.
Synergy was founded by Dr. Neil Duggal, M.D., a Canadian neurosurgeon who has dedicated his neurosurgery practice to advancing the treatment of patients with symptomatic cervical degenerative disc disease and myelopathy. Synergy has received more than 55 patents, protecting its novel design elements and features of alignment and motion restoration.
The Synergy Disc is a cervical disc prothesis that is intended for reconstruction of a disc between C3-C7 after a single level discectomy, in order to provide restoration of motion and alignment to the functional spinal unit.
For nearly three decades, Dr. Lanman has been at the forefront of innovation in the world of spine medicine, particularly when it pertains to motion preservation and advanced disc replacement. He has served as principal investigator on a majority of clinical trials for artificial disc replacement devices, leading to their FDA approvals.
Dr. Lanman has served as an associate professor at UCLA for more than 20 years and has published numerous peer-reviewed articles and book chapters. He serves as a medical educator and expert contributor and is sought after by patients from around the world, including high-profile celebrities and business leaders. His practice, Lanman Spinal Neurosurgery, is affiliated with Cedars-Sinai Medical Center’s Institute for Spinal Disorders and UCLA Medical Center.
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