FDA Clinical Trials

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 are 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.