Cervical Spinal Stenosis and Myelopathy

Cervical Spinal Stenosis and Myelopathy

M6-C Artificial Disc Investigational Device Exemption (IDE) Pivotal Study

Official Title: Prospective, Concurrently Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy

Purpose of the Study: The purpose of this study is to evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to Anterior Cervical Discectomy and Fusion (ACDF).  There are two arms of this study.  There are clinical sites that are investigating safety and effectiveness of the M6-C artificial cervical disc which is an investigational device (not approved by the U.S. Food and Drug Administration [FDA]).  There are other clinical sites that are evaluating Anterior Cervical Discectomy and Fusion (ACDF) which is a common treatment method for your neck/arm pain. 

Description:
The ACDF study arm is to provide a comparison group to see if the M6-C artificial cervical disc (an investigational or experimental device) is safe and effective (successful) in treating the continued neck/arm pain and nerve or spinal cord irritation that results from the discs (the spongy part between the bones in your neck called vertebral bodies) in your spine not working properly.  To determine if the M6-C device is safe and effective, the clinical results from the M6-C arm of the study will be compared to the results from subjects that undergo an Anterior Cervical Discectomy and Fusion (ACDF) procedure in the other arm of this study that is happening at the same time.

Eligibility Criteria: 

  • ≥ 18 years old and ≤ 75 years old
  • Degenerative cervical radiculopathy
  • No previous cervical spine surgery
  • Inadequate response to conservative treatment (e.g. injections, physical therapy, etc) over a period of at least 6 weeks

Study Status: Currently enrolling

Principal Investigator: Safdar Khan, MD

Contact: Kari Stammen, Clinical Research Coordinator, at 614-366-9138 or kari.stammen@osumc.edu

Funding/Study Sponsor: Spinal Kinetics

Efficacy of Riluzole in Patients with Cervical Spondylotic Myelopathy Undergoing Surgical Treatment. A Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study

Purpose of the Study: The primary objective of this study is to evaluate whether the sodium-glutamate antagonist riluzole in a dose of 50mg BID 14 days prior to the surgery and 28 days following the surgery is superior to placebo in achieving better neurological outcomes in patients undergoing surgical decompression for moderate or severe cervical spondylotic myelopathy. The study will also evaluate differences between the investigational and the control group as measured by pain, functional and quality of life outcomes, health utilities, and adverse events.

Description: CSM (cervical spondylotic myelopathy) is the most common cause of spinal cord impairment worldwide. The pathophysiology of CSM involves static and dynamic compression of the spinal cord which triggers ischemia and secondary cell death by a variety of mechanisms, including sodium influx and glutamatergic excitotoxicity. While the recently completed AOSpineNA prospective study suggests that surgical decompression is an effective treatment for CSM, it is clear that many patients have substantial residual neurological impairment. Moreover, while surgery is relatively safe, approximately 3% of patients sustain a neurological complication, of which C5 root palsy is the most common adverse outcome. Given this background and compelling evidence from preclinical models of non-traumatic and traumatic spinal cord injury (SCI), there is a strong rationale to consider the potential benefit of adding a neuroprotective drug which targets sodium/glutamate excitotoxicity to the treatment of patients with CSM undergoing surgical decompression. Riluzole, a potent sodium/glutamate antagonist has been widely studied in many models of neurotrauma and neurodegenerative disease. This drug is FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to CSM. Moreover, riluzole is currently under investigation for traumatic SCI. Given this background, there is a strong rationale to consider studying the potential neurological benefits of riluzole as an adjunctive treatment to surgical decompression in patients with CSM.

Eligibility Criteria: Adults ages 18 and 80 years diagnosed with symptomatic cervical spondylotic myelopathy and able to provide signed informed consent. Participants must be scheduled for an elective surgery for cervical spondylotic myelopathy and have a mJOA score between 8 and 14 at screening. Patients with previous CMS surgery, hypersensitivity to riluzole or its components, cervical trauma, symptomatic lumbar stenosis, or are on CYP1A2 inhibitors or inducers are not eligible. Women who are pregnant or may become pregnant, or are breastfeeding are not eligible. Other criteria and exclusions apply.

Full eligibility criteria:

Inclusion Criteria:

Adults ages 18 and 80 years diagnosed with symptomatic cervical spondylotic myelopathy and able to provide signed informed consent. Diagnosis of symptomatic cervical spondylotic myelopathy is defined as a combination of:

  • One or more of the following symptoms:
    • Numb hands
    • Clumsy hands
    • Impairment of gait
    • Bilateral arm paresthesiae
    • l’Hermitte’s phenomena
    • Weakness
  • Condurent with one or more of the following signs:
    • Corticospinal distribution motor deficits
    • Atrophy of hand intrinsic muscles
    • Hyperreflexia
    • Positive Hoffman sign
    • Upgoing plantar responses
    • Lower limb spasticity
    • Broad based, unstable gait
  • MRI evidence of cervical spondylotic myelopathy

Participants must be scheduled for an elective surgery for cervical spondylotic myelopathy and have a mJOA score ≥8 and ≤14 at screening.

Female participants must be:

  • Postmenopausal defined as amenorrhea for at least 2 years.
  • Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
  • Abstinent (at the discretion of the investigator)
  • Having other congenital or medical condition that prevents subject from becoming pregnant
  • Or if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), or male partner with a vasectomy. A double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel may be used as a birth control method.
  • Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test or a negative urine pregnancy test at screening before the first dose of study drug is received.

Exclusion Criteria:

  • Previous surgery for CSM.
  • Concomitant symptomatic lumbar stenosis.
  • CSM symptoms due to cervical trauma (at the discretion of the investigator).
  • Hypersensitivity to riluzole or any of its components.
  • Neutropenia measured as absolute neutrophil count (ANC) measured in cells per microliter of blood of <1500 at screening visit.
  • Creatinine level of  <1.2 mg/dl in males or > 1.1 mg/dl in females at screening visit.
  • Liver enzymes (ALT or AST) 3x higher than normal values at screening visit.
  • Subjects using any of the following medications which are classified as CYP1A2 inhibitors or inducers during the course of the drug regimen:
    • Inhibitors:
      • Ciprofloxacin
      • Enoxacin
      • Fluvoxamine
      • Methoxsalen
      • Mexiletine
      • Oral contraceptives
      • Phenylpropanolamine
      • Thiabendazole
      • Zileuton
    • Inducers*:
      • Montelukast
      • Phenytoin
        *Note: no washout period required; if these medications are discontinued, subjects are eligible to be enrolled in the trial
  • Systemic infection such as AIDS, HIV, and active hepatitis
  • Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years.
  • Recent history (<3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation.
  • Women breastfeeding at screening visit and who plan to continue breastfeeding during the course of the study drug.
  • Unlikely to comply with the follow-up evaluation schedule.
  • Unlikely to comply with investigational drug regime.
  • Participation in a clinical trial of another investigational drug or device within the past 30 days.
  • Is a prisoner.
  • Unable to converse, read or write English at elementary school level.

Study Status: Open to Accrual

Principal Investigator: H. Francis Farhadi, MD, PhD

Contact: Amy Minnema, Clinical Research Coordinator, at 614-685-9827 or amy.minnema@osumc.edu

Funding/Study Sponsor: AOSpine North America

Lumbar Spinal Stenosis

Lumbar Spinal Stenosis

Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System

Purpose of the Study: The purpose of this study is to create a repository of data from patients undergoing or who have undergone thoracic and/or lumbar spinal arthrodesis procedures supplemented by the Implanet Jazz SystemTM.  This comprehensive database will allow for the gathering of relevant information for potential future research use.

Description: To collect and organize data related to thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM from the patients of principal investigator H. Francis Farhadi, MD PhD and collaborating site investigators. This comprehensive database will provide relevant information for potential future research.  Any future research projects using data from this database will be submitted separately to the respective IRBs for their own separate approvals.

Eligibility Criteria: Patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar) supplemented by the Implanet Jazz System are eligible to participate in this study.

Study Status: Open to accrual

Principal Investigator: H. Francis Farhadi, MD, PhD

Contact: Amy Minnema, Clinical Research Coordinator, at 614-685-9827 or amy.minnema@osumc.edu

Funding/Study Sponsor: The Ohio State University Wexner Medical Center with funding provided by Implanet America, Inc.

Radiographic and Clinical Outcomes Following Unilateral or Bilateral Posterior Fixation in Minimally Invasive Transforaminal Lumbar Interbody Fusions

Purpose of the Study: To compare healing across three different screw placement strategies in patients two years after minimally invasive transforaminal lumbar interbody fusion(MI-TLIF) surgery.

Description:
Patients will be randomized to MI-TLIF followed by either stand-alone unilateral pedicle screw instrumentation, unilateral pedicle screw instrumentation with contralateral facet screw fixation, or bilateral pedicle screw instrumentation using Redcap (Research Electronic Data Capture), a web-based randomization process. All patients will undergo the following preoperative procedures: lumbar CT, lumbar MRI, lumbar x-rays, and medical evaluation including clinical history and physical examination. Post-operative follow-up will occur at 6 weeks and 3, 6, 12, and 24 months. CT scans will occur at the 24 month visit.

Primary Outcome: To compare bony fusion rates at two years between the three study arms, using the Brantigan, Steffee and Fraser scale.  Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspaces.

Secondary Outcomes: To compare clinical outcomes between the three study arms utilizing the VAS, ODI V2, and SF-36V2TM serially. Additionally, immediate and delayed medical and surgical (including neurological) complications between the three study arms will be compared.

Exploratory Outcomes: Bony fusion rates at 12 and 24 months between the three study arms, using an X-ray based classification scale (see appendix 2).

Eligibility Criteria: Patient 18-80 years, with symptomatic single-level lumbar disease including lumbosacral junction, unilateral leg-dominant pain non-responsive to conservative management with concordant imaging findings. These include degenerative spondylolisthesis (grade 1 or 2), facet arthropathy +/- lateral disc herniation, recurrent disc herniation, or large central disc herniation, back pain of confirmed discogenic origin (single level disease only), and failed conservative management for a minimum of 3 months.

Inclusion Criteria:

  • Age 18-80 years
  • Symptomatic single-level lumbar disease including lumbosacral junction
  • Unilateral leg-dominant pain non-responsive to conservative management with concordant imaging findings. These include degenerative spondylolisthesis (grade 1 or 2), facet arthropathy +/- lateral disc herniation, recurrent disc herniation, or large central disc herniation.
  • Back pain of confirmed discogenic origin (single level disease only)
  • Failed conservative management for a minimum of 3 months
  • Negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

  • Severe bilateral leg symptoms
  • Prior instrumented arthrodesis at any lumbar level
  • History of osteoporosis
  • Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate)
  • Severe co-morbidities (e.g., heart, respiratory, or renal disease)
  • Recent (<3 yrs) or co-incident spinal tumor or infection
  • Greater than single level symptomatic involvement
  • Associated thoracolumbar kyphotic or scoliotic deformity (> 10°)
  • Morbid obesity (BMI > 40)
  • History of metal sensitivity/foreign body sensitivity
  • Concurrent involvement in another investigational drug or device study that could confound study data
  • History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject’s ability to complete the protocol required follow-up
  • Subjects who are pregnant or plan to become pregnant in the next 24 months
  • Prisoner

Study Status: Open to accrual

Principal Investigator: H. Francis Farhadi, MD, PhD

Contact: 
Amy Minnema, Clinical Research Coordinator, at 614-685-9827 or amy.minnema@osumc.edu

Funding/Study Sponsor: OSUWMC

Spinal Cord Injury

Spinal Cord Injury

Glyburide Opportunity for Spinal Cord Injury Protection (GOSCIP)

Official Title: Pilot Study (#204): An Open-label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of RP-1127 (Glyburide for Injection) in Patients with Acute Traumatic Cervical Spinal Cord Injury (SCI)

Purpose of the Study:
To assess the safety of using intravenous glyburide (RP-1127) in patients with acute traumatic cervical spinal cord injuries (SCI).

Description: This will be a prospective multi-center single arm open-label pilot study of intravenous glyburide (RP-1127) in patients with acute traumatic cervical spinal cord injuries (SCI). The study population consists of subjects with acute traumatic ASIA A, B or C cervical spinal cord injuries, age 18-70 years, and able to start RP-1127 within 6 hours of injury. The study will enroll and treat up to a maximum of 10 patients who will be matched in a 1:3 ratio with historical controls collected from the North American Clinical Trials Network database.

Eligibility Criteria: Patients, 18-70 with acute cervical SCI, ASIA Impairment A, B or C, without other life-threatening injuries, evidence of sepsis, and with non-penetrating SCI at neurologic level from C4 to C8. Patients must be able to provide informed written consent. Patients must be able to receive first RP-1127 bolus within 6 hours of injury. Additional exclusion criteria apply.

Inclusion Criteria:

  • Age: ≥ 18 years and ≤ 70 years
  • Written informed consent by patient
  • No other life-threatening injury
  • No evidence of sepsis
  • Acute cervical SCI with ASIA Impairment Scale grade A, B or C
  • Non-penetrating SCI at neurologic level from C4 to C8
  • No cognitive impairment that would preclude an informed consent, including moderate or severe traumatic brain injury (GCS < 13)
  • Initiation of RP-1127 bolus within 6 hours of injury

Exclusion Criteria:

  • Unable to receive RP-1127 intravenously
  • Inability to undergo MRI (pacemaker or other metallic implant)
  • Concomitant traumatic head injury with GCS < 13
  • Acute cervical SCI with ASIA Impairment Scale grade D or E
  • Associated bilateral cervical facet dislocation or other fracture pattern associated with > 50% canal compromise (as seen on CT)
  • Currently involved in another non-observational SCI research study or receiving another investigational drug
  • History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
  • Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator)
  • Unable to commit to the follow-up schedule
  • A recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject’s participation in the study
  • Any condition likely to result in the patient’s death within the next 12 months
  • Prisoner
  • Severe renal disorder from the patient’s history (e.g. dialysis) or eGFR of < 30 mL/min/1.73 m2
  • Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin > 2 times upper limit normal. Subjects may be randomized if liver function tests have been drawn but are not yet available and the subject has no known history of liver disease; however, treatment with RP-1127 will be discontinued at ≤ 3 hours if liver function tests indicate ALT >3 times upper limit of normal or bilirubin > 2 times upper limit of normal
  • Blood glucose <55 mg/dL at enrollment or immediately prior to administration of RP-1127, or a clinically significant history of hypoglycemia
  • Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc>520 ms, and/or known history of cardiac arrest  (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months
  • Known treatment with Bosentan within past 7 days
  • Known G6PD enzyme deficiency
  • Pregnancy: Women must be either post-menopausal, permanently sterilized or, if ≤ 50 years old, must have a negative test for pregnancy obtained before enrollment
  • Breast-feeding women who do not agree to stop breast-feeding during RP-1127 infusion and for 7 days following the end of RP-1127 infusion
  • Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented)

Study Status: Open to accrual

Principal Investigator: H. Francis Farhadi, MD, PhD

Contact: Amy Minnema, Clinical Research Coordinator, at 614-685-9827 or amy.minnema@osumc.edu

Funding/Study Sponsor: OSUWMC- IND Holder: Remedy Pharaceuticals, Inc.

Spine Sprains, Strains and Fractures

Spine Sprains, Strains and Fractures

Radiographic and Clinical Outcomes Following Non-operative versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial with an Observational Component

Purpose of the Study: This study compares patient outcomes following surgery plus bracing versus bracing alone for AO Type A3 fractures.

Description:
This is a randomized interventional study to determine if surgery plus bracing or bracing alone provides better outcomes for patients with AO type A3 (A3.1-A3.3) burst fractures. Patients will be followed for 10 years during with X-ray and clinical outcomes, and data on immediate and delayed medical and surgical side effects will be collected.

Eligibility Criteria: Patients, 18-65 years with acute AO type A3.1-A3.3 fracture of T10-L2, otherwise neurologically intact, with TLICS score of 4. Women who are pregnant or will become pregnant, patients with prior history, severe poly-trauma or other ongoing spine trauma or spine conditions are not eligible. Other eligibility and exclusion criteria apply.

Study Status: Open to Accrual

Principal Investigator: H. Francis Farhadi, MD, PhD

Contact: Amy Minnema, Clinical Research Coordinator, at 614-685-9827 or amy.minnema@osumc.edu

Funding/Study Sponsor: OSUWMC


Other Conditions

Other Conditions

Neurosurgical Specimen Collection Protocol

Purpose of the Study: This protocol is for the collection and storage of tissue and/or fluids from patients of Ohio State University Wexner Medical Center’s Department of Neurological Surgery diagnosed with neurological conditions requiring surgery or other treatments for future research purposes.

Description: During the course of standard care, neurological patients submit tissue and fluid (i.e. blood, cerebral spinal fluid [CSF], urine) samples for diagnostic tests or other clinical care purposes. Often the amount collected exceeds the amount needed. Rather than be discarded, this protocol proposes that the excess be collected and stored for future neurological research.  Clinical data recorded in medical records will be collected and associated with the specimens. All future research projects will be submitted to the IRB for their own separate IRB approval. 

Eligibility Criteria: Patients, 18 years or older, with a neurological condition requiring surgery or other procedure (i.e. diagnostic lumbar punctures) as determined by an OUWMC Department of Neurological Surgery physician. Participant must be able to provide informed consent. Patients with a neurological condition not requiring surgery or other procedures, inability to provide informed consent or prisoners are not eligible.

Study Status: Open to accrual

Principal Investigator: Russell Lonser, MD

Contact: Amanda McGill, Clinical Research Coordinator, Amanda.McGill@osumc.edu

Funding/Study Sponsor: OSUWMC

Ohio State University Comprehensive Spine Center Data Registry

Purpose of the Study: To establish a prospective registry of validated outcome measures from patients treated at the Ohio State University Comprehensive Spine Center (OSUCSC). The registry will provide the investigators an immediate internal database to prospectively track and report on the quality of both the non-surgical and surgical care (including the most common spinal procedures) provided at the OSUCSC.

Description: To establish a prospective registry of validated outcome measures from patients treated at OSUCSC. The registry will provide the investigators an immediate internal database to prospectively track and report on the quality of both the non-surgical and surgical care (including the most common spinal procedures) provided at the OSUCSC.

Specifically, this registry will:

  • Allow for comparison of validated outcomes at the OSUCSC against established risk-adjusted national quality benchmarks for common spinal procedures
  • Allow OSU practitioners to review their own individual morbidity and clinical outcomes in real-time
  • Generate both quality and efficiency data with respect to spinal procedures
  • Assess the comparative effectiveness of spinal procedures
  • Generate comparative cost data for non-operative versus operative care of common spinal conditions
  • Allow for gathering of relevant information for potential future spine-related research use. This research may include multi-center trials and other cooperative clinical studies. Any future research projects using data from this database will be submitted to the OSU Institutional Review Board (IRB) for their own separate IRB approvals.

Eligibility Criteria: We will include any patient that presents to the OSUCSC for evaluation. Patients may go on to receive conservative care or pursue surgical options for treatment. There is not an experimental treatment involved with this registry. This registry is collecting information regarding patients’ natural, standard course of care. Patients will be excluded if they do not speak English, have cognitive disabilities which may impact their capacity to provide informed consent, or are a prisoner.

Study Status:
Approved, not yet recruiting

Principal Investigator: Albert Timperman, MD

Contact: Kathy Jelinek, Clinical Research Manager, Kathryn.Jelinek@osumc.edu

Funding/Study Sponsor: OSUWMC

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