The neurosurgeons of Orange County Neurosurgical Associates are dedicated to providing proven surgical and non-surgical treatments for brain and spinal disorders. Additionally, we lead and participate in current research and clinical trials. Clinical trials allow us to advance the science of neurosurgery, and allow us to offer the most modern, up-to-date treatments for our patients. Some of our current clinical trials/studies are listed below. Darin Johnson, PA is our research coordinator and can answer additional questions regarding ongoing trials.
Mobi C cervical disc replacement for degenerated or herniated cervical discs versus fusion/instrumentation for one or two level cervical disc degeneration. www.ldrmedical.com/mobi-c.php?Langue=en
The treatment goal of the Mobi C prosthesis, is to restore the normal dynamic function of the spine and to significantly reduce pain. This is achieved through the re-establishment of the disc height, as maintained by the prosthesis. The goal of the intervertebral disc prosthesis is to maintain mobility at the affected intervertebral disc and to reduce the extra loading on the adjacent intervertebral discs. National prospective multicenter trial, follow-up ongoing, enrollment closed.
Anterior cervical discectomy and fusion study using PEEK/Infuse. Safety and efficacy of Infuse/PEEK in the treatment of cervical spinal degeneration and cervical rdaiculopathy. Bone morphogenic protein (BMP-2, or, also known as Infuse™) has been one of the most significant advances in spine surgery in the last decade. Its ability to promote bone growth has increased success rates of fusion in patients who were once deemed too risky for surgical fusion (smokers, patients with rheumatoid arthritis, etc). Fusion with BMP-2 may become the gold-standard for fusion over hip autograft harvest. In careful concentrations and dosing, BMP-2 will be able to provide excellent fusion rates for patients undergoing anterior cervical fusion. However, the nature of BMP-2 to recruit cells to the region of desired fusion also makes it prone to transient inflammation and swelling. Single level study follow-up ongoing, enrollment is completed. Multilevel study enrollment to be announced.
Synthes Prodisc C disc replacement for cervical disc degeneration or herniated cervical disc. Clinical outcomes study as compared to control group of cervical fusion. The treatment goal of the Synthes Prodisc C is to restore the normal dynamic function of the spine and to significantly reduce pain. This is achieved through the re-establishment of the disc height, as maintained by the prosthesis. The goal of the intervertebral disc prosthesis is to maintain mobility at the affected intervertebral disc and to reduce the extra loading on the adjacent intervertebral discs. Ongoing outcome study. Contact Darin Johnson, PA. http://www.synthesprodisc.com/html/fileadmin/user_upload/content/cervical/pdfs/patinfo/036.000.441.pdf
Anterior lumbar discectomy and fusion with ROI- A PEEK cage and plate system. http://www.ldrholding.com/products/en/roi-a/index.html
Outcome study to assess safety and efficacy of lumbar discectomy and fusion with zero profile PEEK cage and screw construct in the treatment of disc space collapse, lumbar pain. Enrollment open, contact Darin Johnson, PA.
Anterior lumbar discectomy and fusion with Solitaire PEEK cage and plate system.http://www.biomet.com/spine/products.cfm?pdid=3&majcid=14&prodid=220
Outcome study to assess safety and efficacy of lumbar discectomy and fusion with zero profile PEEK cage and screw construct in the treatment of disc space collapse. Enrollment open, contact Darin Johnson, PA.
Superion interspinous spacer versus Xstop interspinous spacer for the treatment of Lumbar spinal stenosis. http://superionstudy.com
To qualify for this study you must be diagnosed with moderate lumbar spinal stenosis and be at least 45 years of age. Your symptoms must include persistent leg, buttock and/or groin pain that is relieved by sitting or bending forward. Study candidates will have experienced these symptoms for at least 6 months and cannot have a history of prior surgery of the lumbar spine.
The Superion™ Interspinous Spacer (ISS) (Figure 1) is an investigational medical device designed to relieve chronic pain caused by moderate lumbar spinal stenosis and may offer a minimally invasive alternative to traditional spinal surgery. This may avoid the need for a large incision, and minimizing bleeding and trauma to the body. Enrollment open, contact Darin Johnson, PA.
Superion™ ISS is implanted between the spinous processes (Figure 2) through a small skin incision. Once in place the device can act as a support column to open the passageways that contain the spinal cord and nerve roots. This reduces the compression on the nerves, resulting in potential pain relief and return to a more active lifestyle.
Phase II Consensus Multi-Institutional trial of Cyberknife Radiosurgery to the Operative Cavity in Patients with Resected Brain Metastases
Trial of stereotactic radiosurgery following resection of cerebral metastases utilizing Cyberknife stereotactic radiosurgery.
- CK Brain Mets-01– A Phase II consensus multi-institutional trial of CyberKnife Radiosurgery to the operative cavity in patients with resected brain metastases.
- Sex: Male or Female
- Age: 18 years of age and older
- Histology: Brain metastases of malignant epithelial cell origin, excluding small cell carcinoma, lymphoma, germ cell tumors, leukemia, and multiple myeloma.
- Number of Brain Mets: 1-3
- Size of Planning Target Volume: less than or equal to 5.0 cm
- KPS: greater than or equal to 70
- Surgery: All patients will have undergone craniotomy with a gross total resection per the attending neurosurgeon’s assessment and confirmed by a CyberKnife planning brain MRI.
- Radiation: Prior whole-brain XRT or prior stereotactic radiosurgery to the resection cavity area are exclusion criteria. Prior stereotactic radiosurgery to other parts of the brain is NOT an exclusion criterion.
- Number of Subjects: 20
- ACCP001.0– Prospective evaluation of CyberKnife Stereotactic Radiosurgery for low and intermediate Risk Prostate Cancer.
- Sex: Male
- Histology: Confirmed Histology, adenocarcinoma of prostate
- Clinical Stage: T1b-T2b, NX-0, MX-0
- Gleason score: 2-6 and PSA less than 20
- ECOG Performance Status: 0-1
- No prior prostate radiation or definitive therapy
- Sample size: 289 patients