JPNI Clinical Trials

The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia after Anterior Cervical Discectomy and Fusion Surgery

Principal Investigator: E. Lee Nelson, MD
Sub-Investigators: Alan T. Villavicencio, MD; Sharad Rajpal, MD; Kara Beasley, DO; David Shafer, MD
Study Design: Prospective, Randomized, Double­Blind Clinical Study
Status: Enrolling
Condition: Patients undergoing anterior cervical discectomy and fusion
Intervention: Bupivacaine hydrochloride 0.5%

Purpose

The main objective of this study is to analyze the effects of local anesthetic application into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence rates in patients undergoing anterior cervical discectomy and fusion. The patients will be randomly assigned into one of the two groups to receive either bupivacaine hydrochloride 0.5% solution if they are randomized to the treatment group or 0.9% NaCl solution if they are randomized to the control group.
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Outcome Measures

Primary Outcome Measures

  • Reduction in dysphagia scores
  • Swallowing
  • Quality of Life Questionnaire.
  • Time frame: 3 months.

Estimated Enrollment: 60
Study Start Date: March 2015
Estimated Study Completion Date: March 2016

Eligibility

Inclusion Criteria

  • Patients older than 18 y.o.
  • Patients undergoing one- or two-level anterior cervical discectomy and fusion surgery for radiculopathy or myelopathy symptoms
  • Patients are wiling and able to sign informed consent and complete questionnaires

Exclusion Criteria

  • More than 2-level ACDF surgeries
  • Previous cervical spine surgery
  • Surgeries for trauma, infection or tumor
  • Known hypersensitivity reactions to bupivacaine hydrochloride or other amino-amide anesthetics (e.g. lidocaine)
  • Known history of swallowing issues (e.g. dysphagia, odynophagia)

Prospective, Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation with Surgical Leads

Principal Investigator: Kara Beasley, DO
Sub-Investigators: E. Lee Nelson, MD
Co-Sponsored by: Justin Parker Neurological Institute and Medtronic
Study Design: Prospective Randomized Feasibility Study
Status: Enrolling patients
Condition: Chronic refractory low back and leg pain

Purpose

The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type leads experience position-related variations in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.

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Outcome Measures

Primary Outcome Measures: Stimulation amplitude changes in response to postural

Secondary Outcome Measures: Sleep quality improvement

Other Outcome Measures

  • Disability score improvement
  • Pain scores
  • Patient satisfaction

Estimated Enrollment: 20
Study Start Date: June 2013

Arms Assigned Interventions
Active Comparator: The RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months Device: RestoreSensor neurostimulator
Active Comparator: The RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months. Device: RestoreSensor neurostimulator

Detailed Description

A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.

Eligibility

Ages Eligible for Study: 18 years to 70 years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Study Population

Boulder Neurosurgical & Spine Associates patients

Criteria

Inclusion Criteria

  • Skeletally mature adults between 18 and 70 years old
  • Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
  • > 50% pain reduction during the trail period
  • Willing and able to comply with the requirements of the protocol including
  • follow-up requirements
  • Willing to sign a study specific informed consent

Exclusion Criteria

  • Previous spinal cord stimulation treatment
  • Surgically remediable spinal condition
  • Active local or systemic infection

PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Alexander Mason, MD; Sharad Rajpal, MD; Kara Beasley DO; David Shafer, MD
Study Design: Prospective Randomized Clinical Study
Status: Enrolling
Condition: Cervical or lumbar degenerative disc disease
Intervention: Cervical or Lumbar Fusion

Purpose

The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either PEEK or cortical allografts.

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Outcome Measures

Primary Outcome Measures

  • Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.

Secondary Outcome Measures

  • Assessment of Neck or Lower Back Disability Scores;
  • Assessment of SF-36 Health Survey;
  • Assessment of restoration of vertebral height, sagittal alignment, and graft subsidence;
  • Assessment of fusion rates;

Estimated Enrollment: 240
Study Start Date: July 2011
Estimated Study Completion Date: July 2014

Arms Assigned Interventions

Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages or allograft spacers.
Procedure: Lumbar or cervical fusion

Detailed Description

Following surgery study subjects will be evaluated at the following intervals: 3 (+ 2 weeks), 6 (+ 1 month), 12 (+ 2 months), 24 (+ 2 months) months.

Eligibility

Ages Eligible for Study: 18 – 70 years old
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Lumbar Fusion Patient Group

Inclusion Criteria

  • Skeletally mature adults between 18 and 70 years old
  • Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
  • Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
  • Willing and able to comply with the requirements of the protocol including follow-up requirements
  • Willing and able to sign a study specific informed consent.

Exclusion Criteria

  • More than 3 intervertebral levels to be fused
  • Posterior fixation used at more than 1 level for 1-level intervertebral fusion
  • Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
  • Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
  • Any additional approaches, e.g. anterior, XLIF
  • Active local or systemic infection
  • Prior interbody fusion surgery at the index level
  • Prior fusion at the adjacent levels
  • Previous known allergy to polyetheretherketone (PEEK) or titanium alloy

Cervical Fusion Patient Group

Inclusion Criteria

  • Skeletally mature adults between 18 and 70 years old
  • Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels
  • Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
  • Willing and able to comply with the requirements of the protocol including follow-up requirements
  • Willing and able to sign a study specific informed consent

Exclusion Criteria

  • More than 3 vertebral levels to be fused
  • Any additional approaches, e.g. posterior cervical fusion
  • Active local or systemic infection
  • Prior interbody fusion surgery at the index level
  • Prior fusion at the adjacent level
  • Previous known allergy to polyetheretherketone (PEEK) or titanium alloy