Kineflex-C Artificial Disc System to Treat Cervical DDD

Status

Follow-up only. Study closed to enrollment.

Sponsor

SpinalMotion

Purpose

The Kineflex-C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF)in patients with single level degenerative disc disease at any cervical level from C3 toC7

Eligibility

Genders Eligible for Study: Both

Ages eligible for study: 18 Years to 60 Years

Inclusion Criteria: have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI; have radiculopathy symptoms in neck, one or both shoulders and/or one or both arms; have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose),the presence of progressive symptoms (e.g., increasing numbness or tingling) or signs of nerve root compression; have moderate disability neck disability index (NDI) score; be likely to return for all follow-up visits and be willing and able to provide Informed Consent for study participation.

Exclusion Criteria: marked cervical instability; non discogenic neck pain or non discogenic source of symptoms; radiographic confirmation of severe facet disease or facet degeneration; bridging osteophytes; prior surgery at the level to be treated; prior fusion at any cervical level; more than one neck surgery via anterior approach; previous trauma to the C3-C7 levels resulting in compression or bursting; documented presence of free nuclear fragment at any cervical level; severe myelopathy; any paralysis; history of chemical or alcohol dependence; active systemic infection; infection at the site of surgery; prior disc space infection or osteomyelitis in the cervical spine; any terminal, systemic or autoimmune disease; metabolic bone disease (e.g., osteoporosis , gout, osteomalacia, Paget’s disease); any disease, condition or surgery which might impair healing; known metal allergy; arachnoiditis; currently experiencing an episode of major mental illness; pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery; morbid obesity; use of spinal stimulator at any cervical level prior to surgery; currently a prisoner; currently involved in spinal litigation which may influence the subjects reporting of symptoms, lives more than 300 miles from study center or participation in any other investigational drug, biologic or medical device study within the last 30 days prior to study surgery.

A Randomized Study Evaluating Anular Repair utilizing the Xclose Tissue Repair System vs. Discectomy without Anular Repair

Status

Recruiting

Sponsor

Anulex Technologies

Purpose

To evaluate the benefits of anulus fibrosis repair utilizing the Xclose Tissue Repair System during a discectomy procedure compared to a standard discectomy without using the Xclose. The Xclose is FDA approved and in non-investigational for the purpose it is being used in this study.

Eligibility

Genders Eligible for Study: Both

Ages: Must be 18 years or older

Inclusion Criteria: candidate for a one or two level discectomy, positive imaging evidence of intervertebral disc herniation at location corresponding to patient’s radicular signs or symptoms, anular tear or slit incision and additionally deemed to include sufficient tissue for tissue reapproximation, persistent and predominant radicular pain, pre-operative leg pain score greater than or equal to 4cm on a 10cm Visual Analog Scale, leg pain unresponsive to conservative treatment for 6 or more weeks (exception: individuals suffering from acute and uncontrollable severe leg pain, patient is willing and able to comply with study requirements; willing and able to sign a study-specific informed consent form, complete necessary study paperwork, and return for required follow-up visits

Exclusion Criteria: age less than 18 years, prior or planned surgical procedure intended to fuse or stabilize the lumbar spine, previous surgery involving index level, Cauda Equina Syndrome, evidence of severe disc degeneration, greater than grade I spondylolisthesis or retrolisthesis at the affected level, no apparent annual defect and no indication to open the anulus at time of procedure, active local or systemic infection, active malignancy or other significant medical co-morbidities, current chemical dependency or significant emotional or psychosocial disturbance that would impact treatment outcome and study participation, patient or legal guardians who are unwilling or unable to cooperate or give written informed consent, women who are pregnant or with child bearing potential who are not on a reliable form of birth control, current fracture, tumor and/or deformity of the spine, documented history of allergy or intolerance to PET (suture material), patient is currently enrolled in other research that could confound the results of the studies.

Prospective Multi-Center Clinical Study of Patients with Degenerative Disc Disease treated with Anterior Cervical Decompression and Fusion using the Vectra-T Translational Cervical Plate

Sponsor

Synthes Spine

Status

Recruiting for three and four level fusions only. One and two levels are closed to enrollment.

Purpose

To evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using the Vectra-T Cervical Plate and the Advanced ACF or CorticoCancellous Allograft Spacer made by Synthes Spine Company. This is not an investigational study and no investigational or experimental devices or procedures are included in this study. The study is designed to gather information.

Eligibility

Genders eligible for study: Both

Ages: Must be 18 years or older

Inclusion Criteria: one to four levels (consecutive) cervical degenerative disc disease between C2 and C7 (defined at least one of the following: disc herniation, axial neck pain caused by spondylosis, functional deficit, neurological deficit which significantly limits patient’s normal living), one to four cervical levels to be plated, patient is skeletally mature and at least 18 years of age, patient signs consent form, patient is available for long tern (24 month) follow-up, etiology must be confirmed my MRI or CT

Exclusion Criteria: spondylolisthesis greater than grade I at either level(s) to be instrumented with no instability on flexion/extension radiographs, indications for complete corpectomy of any involved levels, posterior instrumentation is necessary at same levels, more than one previous failed anterior fusion attempt at the involved level(s), has had more than one previous open, posterior, spine surgical procedures at the involved level(s) with no pre-op instability on flexion/extension radiographs, pregnant or interested in becoming pregnant during the study follow-up period, had a know sensitivity to device materials, significant emotional or psychosocial disturbance, a prisoner, currently a participant in a study related to the treatment or cervical spinal disorders.

Cyclosporine in Traumatic Brain Injury

The UCSD Division of Neurosurgery, in conjunction with Medical College of Virgina and University of Kentucky is investigating the use of cyclosporine in Traumatic Brain Injury in severely head-injured patients. Collectively, these three institutions will enroll 1200 patients and assess the clinical benefit of the immune system suppressant in modulating the inflammatory response seen in the brain after trauma.

Patients are entered into this trial following admission to the hospital after trauma and informed consent is obtained from family members.

Corticorelin in the treatment of cerebral edema

Corticorelin is a synthetic preparation of the naturally-occurring peptide human corticotropin-releasing factor. This double blinded study examines the effectiveness of corticorelin in treating cerebral edema versus placebo. Dexamethasone is classically used to treat cerebral edema which is commonly seen in brain tumors and other pathological conditions. Corticorelin may have a benefit in terms of reduced side effects when compared to dexamethasone.

Please contact our office and speak with Dr. Alksne's assistant if you are interested in learning more about this trial.