FDA Clinical Trials

LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis and Spinal Stenosis


Principal Investigator:  Alan T. Villavicencio, MD
Sub-Investigators:  Sharad Rajpal, MD, Kara Beasley, DO, Andrew Bauer, MD
Sponsor:  Empirical Spine, Inc.
Status:  Enrolling patients

Purpose:  The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.

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Inclusion Criteria:

  • Male or female patients ages 25-80
  • Lumbar degenerative spondylolisthesis (Grade I per Meyerding classification), at one level from L1 to S1, with radiographic confirmation using X-ray
  • Lumbar spinal stenosis, at the level diagnosed with degenerative spondylolisthesis, and confirmed radiographically using CT or MRI
  • Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain as evidenced by patient history
  • Persistent symptoms despite at least 6 months of conservative treatment that may include but is not limited to physical therapy, medications, and/or epidural injections
  • A pre-operative Visual Analog Scale (VAS) leg pain score of ≥50 on a 100 mm scale
  • A pre-operative Oswestry Disability Index (ODI) score ≥35 points on a 100-point scale
  • Candidate for surgical decompression and stabilization at only one level between L1-S1
  • Posterior element anatomy is appropriate for interspinous fixation including prediction of presence of spinous processes of segment to be instrumented following decompression (investigational AND control groups) and a prediction of >50% of facet joints present following decompression
  • Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements
  • Patient reads, understands and signs a written Informed Consent form prior to participating in the study or undergoing any study-mandated procedure

Exclusion Criteria:

  • A primary and predominate diagnosis of discogenic back pain
  • A primary and predominate diagnosis of facet-mediated back pain
  • Back or non-radicular leg pain of unknown etiology
  • Significant peripheral vascular disease causing vascular claudication
  • Significant peripheral neuropathy caused by conditions other than spinal stenosis
  • Greater than Grade I, per Meyerding classification, spondylolisthesis at the affected level or levels adjacent to the affected level, OR less than 10% anterolisthesis at the affected level in standing lateral x-rays
  • At any level in the lumbosacral spine except the level planned for decompression and stabilization: History of any previous surgery* except for a discectomy or decompression
  • At the level planned for decompression and stabilization: History of any previous surgery (previous surgery includes spinal stimulator placement but does NOT include epidural injections)
  • Isthmic spondylolisthesis or spondylolysis (pars fracture) at any level in the lumbar spine;
  • Clinically significant compromise of vertebrae at L1 to S1 levels due to osteoporotic vertebral compression fracture or any traumatic, neoplastic, metabolic or infectious pathology or congenital abnormality;
  • Spinous process fracture(s) or other posterior element fracture(s) of the segment to be instrumented;
  • Spinous process insufficiency or deformity that would preclude secure fixation of the LimiFlex Device to the spinous process including spinous process length <10 mm from lamina to dorsal tip or other significant deformities due to trauma, or congenital abnormality such as spina bifida occulta at the planned instrumented level;
  • The estimated distance between the LimiFlex Device strap attachment points (midpoint of the cranial edge of the cranial spinous process and the midpoint of the caudal edge of the caudal spinous process) is <30mm on pre-operative lateral standing radiographs at the segment to be instrumented;
  • Degenerative lumbar scoliosis with a Cobb angle >10° at the affected motion segment;
  • Symptomatic lumbar stenosis that is not amenable to a direct decompression
  • Anklyosed motion segment at the target operative level
  • Severe osteoporosis, defined as a history of fragility fracture and DXA T-score <-2.5 or QCT T-score < -2.5. History of a fragility fracture requires that a DXA scan or QCT scan is completed;
  • Planned hip or knee replacement surgery;
  • Documented allergy to titanium or polyethylene;
  • Active local or systemic infection;
  • Receiving immunosuppressive or long-term steroid therapy;
  • Known history of bone metabolic disorder, including Paget’s disease, hyperparathyroidism, renal osteodystrophy, and osteomalacia;
  • Disease or condition that would preclude accurate clinical evaluation of the safety and effectiveness of the study treatment or any significant medical conditions which would place the patient at excessive risk for surgery, such as:
    1. severe rheumatoid arthritis or other autoimmune diseases
    2. active hepatitis (viral or serum) or HIV positive
    3. unstable cardiac disease
    4. uncontrolled diabetes
    5. renal failure
    6. severe muscular, neural or vascular diseases that endanger the spinal column
    7. cauda equina syndrome
    8. severe neurologic disorders including paralysis
    9. systemic lupus erythematosus;
  • Morbid obesity defined as BMI >40;
  • History of malignancy within the last five years;
  • Women who are pregnant or are interested in becoming pregnant within the study period;
  • Currently seeking or receiving worker’s compensation for back pain or spinal condition;
  • Currently involved in spinal litigation that potentially is associated with secondary financial gain;
  • Current involvement in a study of another investigational product for similar purpose;
  • Demonstrates three or more Waddell’s Signs of Inorganic Behavior;
  • Active treatment of a major psychiatric condition, such as major depression, anxiety disorder, bipolar disorder, schizophrenia, personality disorder, that could prevent accurate completion of self-reporting assessment scales;
  • Current history (within 12 months) of substance abuse, including alcohol abuse; or
  • A prisoner

Pharmacogenomic Test Assessment for Medication Management in the Advancement of Personalized Medicine

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Sharad Rajpal, MD; Kara Beasley, DO; Andrew Bauer, MD; Alan D. “Tripp” Nanney, MD
Sponsor: MD Global, Inc.
Status: Enrolling patients

Purpose: Pharmacogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variations.

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Inclusion Criteria:

  • Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on a voluntary agreement with a thorough explanation of the patient’s participation will be provided to them.
  • Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days (“index PGx test assessment”);
  • Patient was receiving at least one medication known to be associated with allelic variation at the time of the (“index PGx test assessment”), including over-the- counter medications;
  • Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment or has experienced inadequate efficacy from a target drug.

Exclusion Criteria:

  • Patients will be excluded from the Study if any of the following criteria apply:
    • Patient is currently hospitalized;
    • Patient’s medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
    • Patient is unable to provide an accurate history due to mental Incapacity;
    • Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Staphylococcus Aureus 4-Antigen Vaccine (SA4Ag) in Adults Undergoing Elective Posterior Instrumented Lumbar Spinal Fusion Procedures

Principal Investigator:  Alan T. Villavicencio, MD
Sub-Investigators:  E. Lee Nelson, MD, Sharad Rajpal, MD
Sponsor:  Pfizer
Status:  Enrolling Patients

The purpose of the clinical trial is to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

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Primary Outcome Measures

  • Subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective open posterior spinal fusion procedures with multilevel instrumentation
  • Safety and tolerability of a single vaccination of SA4Ag in adults aged 18 to <86 years undergoing elective open posterior spinal fusion procedures with multilevel instrumentation, by measuring local reactions, systemic events, and AEs.
Arms Assigned Interventions
Active Comparator: SA4Ag Staphylococcus aureus 4-antigen Vaccine Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine administered via IM injection once 10 to 60 days prior to surgery
Placebo Comparator: Placebo Diluent (sterile water) Other: Placebo Vaccine excipients administered via IM injection given 10 to 60 days prior to surgery

Eligibility 

Ages Eligible for Study: 18 to 85 years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria

  • Subject must be scheduled to undergo an elective open posterior spinal fusion procedures with multilevel instrumentation, 10 to 60 days after study vaccination.
  • Subject must be available for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary for 10 days after study vaccination.
  • Aged 18 to <86 years old.

Exclusion Criteria

  • Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure).
  • Surgical indication of malignancy, infection or acute or emergency trauma.
  • History of major surgery within 3 months prior to enrollment, or anticipated major surgery other than the Index Surgical Procedure between study enrollment and completion of study participation.
  • History of any spinal surgery performed within 6 months prior to study enrollment.
  • History of any previous spinal surgery resulting in postoperative BSI or SSI.
  • Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies within a year of enrollment or the use of systemic corticosteroids for > 14 days within 30 days prior to enrollment.
  • History of leukemia, lymphoma, underlying bone marrow disorder or history of bone marrow transplant.

Facet Replacement System to Treat Spinal Stenosis

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Alexander Mason, MD; Sharad Rajpal, MD; Kara Beasley, DO; David Shafer, MD
Sponsor: Globus Medical Inc
Status: Enrollment Completed

The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

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Outcome Measures

Primary Outcome Measures

  • Improvement in Zurich Claudication Questionnaire Physical Function and Symptom Severity Scores
  • Lack of device-related serious adverse events
  • Maintenance or improvement in Neurological status.
  • No device failures requiring revision, removal, re-operation or supplemental fixation.

Secondary Outcome Measures

  • Improvement in pain as measured by Visual Analog Scale
  • Radiological evidence of fusion in Investigational Group

Arms Assigned Interventions
Experimental: Investigational surgical treatment using the ACADIA® Facet Replacement system Device: ACADIA® Facet Replacement System used for the treatment of lumbar spinal stenosis
Active Comparator: Control surgical treatment using an instrumented posterolateral fusion Device: Control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Eligibility

Ages Eligible for Study: 21 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria

  • 21-85 years of age and skeletally mature;
  • Have undergone 6 months of non-operative treatment prior to surgery;
  • Lateral, lateral recess and/or central canal stenosis;
  • Disc height measuring ≥ 4 mm at the operative level;
  • Persistent leg, thigh and/or buttock symptoms, including pain, numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;
  • A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate;
  • A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score;
  • A candidate for a decompression with full facetectomy at the operative level
  • Candidate for a posterior lumbar fusion;
  • Physically and mentally willing and able to comply evaluations;
  • Lives in the immediate area and has no plans to relocate;

Exclusion Criteria

  • Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;
  • Previous lumbar fusion or disc replacement procedure;
  • Osteoporosis;
  • Greater than Grade I spondylolisthesis or retrolithesis;
  • Spondylolisthesis at levels other than at the operative level;
  • Scoliosis of the lumbar spine (defined as more than 11 deg sagittal deformity);
  • Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease;
  • Acute traumatic pars fracture at the operative/adjacent level vertebral body;
  • Spinal stenosis at more than three lumbar segments;
  • Acute trauma to the lumbar spine within the last 24 months;
  • Active infection at the operative level, or a systemic infection;
  • Physically / mentally compromised;
  • Systemic disease that would affect the patient’s welfare or the research study.
  • Immunologically suppressed or immunocompromised;
  • Insulin-Dependent Diabetes Mellitus (Type I Diabetes);
  • Currently undergoing long-term steroid therapy;
  • Metabolic bone disease;
  • Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years;
  • Known allergy to cobalt chromium or titanium;
  • Used any investigational drug or device within the past 30 days;
  • Pending litigation or receiving Workers Compensation related to back pain or injury;
  • Is a prisoner.