Currently Dr. Pazmiño is an investigator for four clinical trials, soon to be adding 2 more. We are currently evaluating the latest artificial disc technology, for the Lumbar Spine (Kineflex-Lumbar), and for the Cervical Spine (Kineflex-Cervical).
Dr. Pazmiño is also conducting a trial that focuses on a minimal invasive device for lumbar fusions (Optimesh 1500s). We are also evaluating new interspinous spacer for lumbar spinal stenosis.
What is a Clinical Trial?
It is a research study designed to answer definitive questions about new drugs, treatments, or medical therapies. Clinical trials are carried out to determine if a new treatment is safe and effective. In clinical trials the drug or treatment is offered to volunteers before the U.S Food and Drug Administration (FDA) determines if it will become available to the general public.
Why should patients participate in a clinical trial?
Patients who participate in a clinical trial have the opportunity to play an active role in their health care, and gain access to new treatment options that are not available to the general public. Although there are no guarantees of the results, participation in trials does help to advance the science of medicine and potentially help future patients with the same problem or disease.
For information on clinical trials contact:
Clinical Research Coordinator
Santa Monica CA 90403
Tel: (310) 270-6676
Fax: (310) 496-2077
Current Clinical Trials
Coflex Clinical Trial
We are currently enrolling patients in a new FDA clinical trial. Approximately 400,000 Americans suffer from spinal stenosis. And as the majority of the baby boom generation moves into its 50s and beyond, the number of patients being diagnosed with this degenerative disease will increase. The coflex provides an effective alternative treatment option for patients with lumbar spinal stenosis who have failed to achieve sustained relief with conservative care.
There is a choice.
The Coflex® Dynamic Interspinous Device is intended to provide dynamic stabilization to the affected lumbar region and is currently being evaluated in an IDE trial in the U.S. This could be an important treatment alternative in patients with lumbar spinal stenosis, even after having prior back surgeries.
Paradigm Spine, LLC has begun enrollment in a FDA pivotal trial of its coflex® Interspinous Stabilization Device. The coflex device is a U- shaped implant indicated for use in one- and two-level lumbar stenosis from L1-L5. The coflex is a single, U- shaped component, fabricated from medical grade titanium alloy (Ti6A14V), a material with a long history of safe use in implantable orthopedic products.
In addition to the benefits of dynamic stabilization, the coflex interspinous device provides similar advantages with regard to maintenance of neural foraminal height as compared to traditional pedicle screw fixation.
1. Arnoldi CC, Brodsky AE, Cauchoix J, et al: Lumbar spinal stenosis and nerve root entrapment syndrome. Definition and classification. Clin. Orthrop 1976; 115:4-5.
2. Treatment of Degenerative Lumbar Spinal Stenosis. Summary, Evidence Report/Technology Assessment: Number 32. AHRQ Publication No. Ol-E047, March 200l.
3. Deyo RA, Rainville J, Kent DL. What can the history of physical examination tell us about low back pain? JAMA 1992; 268:760-5.
4. Yone K, et al. Indication of fusion for lumbar spinal stenosis in the elderly patients and its significance. Spine, Jan 1996; 21: 242-8.
5. Knaub MA, Won DS, McGuire R, Herkowitz HN. Lumbar spinal stenosis: indications for arthrodesis and spinal instrumentation. Instr. Course Lect., Jan 2005; 54: 313-9.
6. Kong DS, Kim, ES, Eoh W. One year outcome ecalitation after interspinous implantation for degenerative spinal stenosis with segmental instability. Unpublished paper from the Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
M6 Cervical Arthroplasty
We are currently enrolling a select group of patients in a new cervical arthroplasty trial featuring a viscoelastic polymer core. The M6 Artificial Disc is designed to replicate the anatomic structure and biomechanical performance of a natural disc. Its innovative design incorporates an artificial nucleus to allow axial compression and a woven fiber annulus for controlled range of motion in all 6 degrees of freedom.
Discover Cervical Arthroplasty
We are currently enrolling a select group of patients in a new cervical arthroplasty featuring the Discover Artificial Cervical Disc Replacement. This multi-center, prospective, randomized controlled trial is designed to evaluate the safety and effectiveness of the DISCOVER™ Artificial Cervical Disc when compared to ACDF for the treatment of cervical Degenerative Disc Disease. This study will also explore potential advantages of the DISCOVER™ Artificial Cervical Disc over ACDF.
The study period for each subject will be a minimum of 60 months. The anticipated enrollment for this study is 12 months. The resultant study follow-up to completion is 60 months. A sample size of 790 subjects at 30 investigative sites in North America combined in the 1-level and 2-level applications will be accrued. The next nearest site in the study is in Texas.
- Five Year Follow-up
- Multiple x-ray studies
- Four Axial CT scans
- Patient agrees to randomization. Study will be in a 2:1 ratio, stratified separately within 1- and 2-level applications, favoring the artificial disc.
- Follow-up appointments at 2 and 6 weeks, 3, 6, 12, 24, 36, 48, and 60 months
- Patient 21 to 70 years of age
- Cervical disc disease in 1 or 2 adjacent vertebral levels between C3-C7 defined as:
- upper extremity radicular pain
- subjects with myelo-radiculopathy
- Failed non-surgical treatment of at least 6 weeks, or subject has progressive symptoms of nerve root or spinal cord compression
- Minimum neck disability index score of ?30% (15/50)
- Must understand and sign ethics committee / institutional review board approved informed consent form
- Able to meet follow-up schedule requirements and post-operative management program
- If required, bone mineral density T-score of ? –1.5 SD as confirmed by DEXA
Laminoplasty versus Laminectomy
Expansive (“open-door”) laminoplasty has been shown to be an effective treatment for multilevel cervical spinal cord decompression. An open-door laminoplasty is performed by creating a channel through one side of the lamina and a hinge on the other side of the lamina so that the posterior elements can be rotated to provide decompression of the spinal cord. This procedure has proven effective in the treatment of ossification of the posterior longitudinal ligament, cervical spondylosis, and congenital stenosis1,2,3,4.5. Historically, laminectomy has been the standard procedure for posterior decompression, but has resulted in segmental cervical spine instability, kyphotic deformity, and in some cases, late neurologic deterioration. Laminoplasty was developed in Japan as an alternative to laminectomy procedures to avoid the described complications.
The goal of laminoplasty is to maximize spinal canal decompression while preserving stability and range of motion without disruption of the posterior elements. Several authors have described different laminoplasty techniques; all preserve the lamina but expand the size of the spinal canal by placing the freed or partially freed lamina in a more posterior position.
The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to laminoplasty using the Laminoplasty fixation System with ODL allograft bone spacers.
The primary study hypothesis is that, in regard to key clinical outcomes, the treatment group (laminoplasty with Laminoplasty fixation) is not inferior to the control group (laminectomy) based on the patient’s clinical and radiographic findings at 12 months post-surgery. All patients will be evaluated preoperatively, intraoperatively and postoperatively at 6 weeks, 6 months, 12 months and 24 months. Outcome measures include maintenance of alignment, stability of the cervical spine, severity of myelopathy, evaluation of neck pain, neurological function, and independent radiographic findings.
2.2 Protocol & Treatment Summary
This is a multi-center, prospective, randomized controlled clinical study for the treatment of patients with multiple level cervical spinal canal stenosis from C3 to T1. Patients meeting the inclusion/exclusion criteria will be randomized (1:1) within each investigational site to one of two groups:
- Hirabyashi K, Satomi K. Operative procedure and results of expansive open-door laminoplasty. Spine. 1998;13:870-876.
- Hasegawa K, Homma T, Chiba Y, et al. Effects of surgical treatment for cervical spondylotic myelopathy in patients ? 70 years of age: A retrospective comparative study. J Spinal Disord. 2002;15:458-460.
- Sani S, Ratliff JK, Cooper PR. A critical review of cervical laminoplasty. Neurosurg Q. 2004;14:5-16.
- Park AE, Heller JG. Cervical Laminoplasty. Use of a novel titanium plate to maintain canal expansion – surgical technique. J Spinal Disord. 2004;17:265-271.
- Edwards CC, Riew KD, Anderson PA et al. Cervical myelopathy: current diagnostic and treatment strategies. Spine J. 2003;3:68-81.