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LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT03115983
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Morley Research Consortium
Biomedical Statistical Consulting
Medical Metrics, Inc
Information provided by (Responsible Party):
Empirical Spine, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Degenerative Spondylolisthesis Lumbar Spinal Stenosis Device: LimiFlex Device: Fusion Instrumentation Procedure: Decompression Procedure: Fusion

Detailed Description:
The LimiFlex™ Paraspinous Tension Band is a new stabilization option for patients being treated with surgical decompression for degenerative spondylolisthesis. The LimiFlex does not require pedicle screws to anchor to the spine; instead, two dynamic rods are attached by screws to pedicle-sparing straps which encircle adjacent spinous processes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-center, prospective, concurrently controlled, non-blinded study. Balance between groups will be achieved through sub classification using propensity scores.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: LimiFlex
Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band
Device: LimiFlex
LimiFlex implantation at a single level after surgical decompression.
Other Name: LimiFlex Paraspinous Tension Band
Procedure: Decompression
Surgical decompression of a single level L1-S1.
Active Comparator: Fusion
Transforaminal lumbar interbody fusion and concomitant posterolateral fusion with pedicle screw instrumentation
Device: Fusion Instrumentation
Titanium alloy top-loading, polyaxial pedicle screws and cylindrical, titanium alloy rod instrumentation using autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only), and/or a synthetic bone graft extender that is on-label for these indications (i.e., decorticated posterolateral gutter only). The TLIF requires a single PEEK TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).
Procedure: Decompression
Surgical decompression of a single level L1-S1.
Procedure: Fusion
Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.



Primary Outcome Measures :
  1. Composite Clinical Success [ Time Frame: 24 Months ]

    Individual success for patients in the investigational LimiFlex or control fusion arm is assessed with Composite Clinical Success (CCS) criteria. To be considered a success, a subject must demonstrate all of the following:

    • 15 point improvement in Oswestry Disability Index (100 point scale)
    • Absence of a new or worsening, persistent neurological deficit
    • Absence of additional surgical intervention
    • Absence of device integrity failures


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  2. Neurological Status [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  3. Additional surgical interventions [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  4. Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  5. Estimated blood loss [ Time Frame: Procedure ]
  6. Length of procedure [ Time Frame: Procedure ]
  7. Hospital stay [ Time Frame: Immediately upon discharge ]
  8. Return to normal activities of daily living [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  9. Work status [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  10. Pain medication including narcotics usage [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  11. Visual analog scale (VAS) leg pain [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  12. Visual analog scale (VAS) back pain [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  13. Zurich claudication questionnaire (ZCQ) [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  14. SF-12 Quality of Life survey [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  15. Patient satisfaction [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]
  16. Radiographic fusion status [ Time Frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo; Investigational group only: 36 mo, 48 mo, 60 mo ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (patients must meet ALL of the following criteria to be eligible for participation in the study):

  1. Lumbar degenerative spondylolisthesis (Grade I per Meyerding classification), at one level from L1 to S1, with radiographic confirmation using X-ray;

    a. Grade I spondylolisthesis per Meyerding classification includes up to 25% anterior translation of a vertebra relative to the superior endplate of the subjacent vertebra at the index level. A patient is considered to have spondylolisthesis with a minimum 10% anterolisthesis at the affected level in a lateral x-ray image.

  2. Lumbar spinal stenosis, at the level diagnosed with degenerative spondylolisthesis, and confirmed radiographically using CT or MRI;

    a. At the index level, lumbar spinal stenosis is at least moderate lumbar canal stenosis, defined as more than 25% reduction of the cross-sectional area compared with the next adjacent normal level, with nerve root crowding compared with the normal level, as determined by the investigator on CT Scan or MRI.

  3. Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain as evidenced by patient history;
  4. 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;
  5. A pre-operative Visual Analog Scale (VAS) leg pain score of ≥50 on a 100 mm scale;
  6. A pre-operative Oswestry Disability Index (ODI) score ≥35 points on a 100-point scale;
  7. Candidate for surgical decompression and stabilization at only one level between L1-S1;
  8. 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 (investigational group only);
  9. 25-80 years of age and skeletally mature;
  10. 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; and
  11. Patient is willing to provide Informed Consent for study participation.

Exclusion Criteria:

  1. A primary and predominate diagnosis of discogenic back pain;
  2. A primary and predominate diagnosis of facet-mediated back pain;
  3. Back or non-radicular leg pain of unknown etiology;
  4. Significant peripheral vascular disease causing vascular claudication;
  5. Significant peripheral neuropathy caused by conditions other than spinal stenosis;
  6. History of fixed or permanent neurological deficit related to spinal cord injury;
  7. History of any previous surgery* at any level in the lumbosacral spine except for a discectomy or decompression;
  8. History of any previous surgery* at the level planned for treatment;

    • previous surgery includes spinal stimulator placement but does NOT include epidural injections
  9. Isthmic spondylolisthesis or spondylolysis (pars fracture) at any level in the lumbar spine;
  10. 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;
  11. Spinous process fracture(s) or other posterior element fracture(s) of the segment to be instrumented;
  12. 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 deformity due to trauma, or congenital abnormality such as spina bifida occulta at the planned instrumented level;
  13. 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;
  14. Degenerative lumbar scoliosis with a Cobb angle >10° at the affected motion segment;
  15. Symptomatic lumbar stenosis that is not amenable to a direct decompression
  16. Anklyosed motion segment at the target operative level
  17. Severe osteoporosis, defined as 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;
  18. Planned hip or knee replacement surgery;
  19. Documented allergy to titanium or polyethylene;
  20. Active local or systemic infection;
  21. Receiving immunosuppressive or long-term steroid therapy;
  22. Known history of bone metabolic disorder, including Paget's disease, hyperparathyroidism, renal osteodystrophy, and osteomalacia;
  23. 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 disease
    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;
  24. Morbid obesity defined as BMI >40;
  25. History of malignancy within the last five years;
  26. Women who are pregnant or are interested in becoming pregnant within the study period;
  27. Currently seeking or receiving worker's compensation for back pain or spinal condition;
  28. Currently involved in spinal litigation that potentially is associated with secondary financial gain;
  29. Current involvement in a study of another investigational product for similar purpose;
  30. Demonstrates three or more Waddell's Signs of Inorganic Behavior;
  31. 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;
  32. Current history (within 12 months) of substance abuse, including alcohol abuse; or
  33. A prisoner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115983


Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Ma Agnes Ith    650-721-7600    Mith@stanford.edu   
Principal Investigator: Ivan Cheng, MD         
United States, Colorado
Boulder Neurological & Spine Associates Recruiting
Boulder, Colorado, United States, 80303
Contact: Boulder Neurological Associates    303-938-5700    info@bnasurg.com   
Principal Investigator: Alan Villavicencio, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Lauren Glenney    404-778-6857    lauren.glenney@emory.edu   
Principal Investigator: Timothy Yoon, MD         
United States, Indiana
Indiana Spine Group Recruiting
Carmel, Indiana, United States, 46032
Contact: Sheetal Vinayek    317-715-5897    svinayek@indianaspinegroup.com   
Principal Investigator: Rick Sasso, MD         
United States, Michigan
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Lisa Motowski    248-551-6679    lisa.motowski@beaumont.org   
Principal Investigator: Jeffery Fischgrund, MD         
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Tina Craig    315-464-8618    craigt@upstate.edu   
Principal Investigator: William Lavelle, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Elizabeth Sheridan    614-293-6131    elizabeth.sheridan@osumc.edu   
Principal Investigator: Elizabeth Yu, MD         
United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Marie Kerr    215-829-6700    marie.kerr@uphs.upenn.edu   
Principal Investigator: William Welch, MD         
Sponsors and Collaborators
Empirical Spine, Inc.
Morley Research Consortium
Biomedical Statistical Consulting
Medical Metrics, Inc
Investigators
Principal Investigator: Rick Sasso, MD Indiana Spine Group
Principal Investigator: William C Welch, MD Pennsylvania Hospital Neurosurgery

Responsible Party: Empirical Spine, Inc.
ClinicalTrials.gov Identifier: NCT03115983     History of Changes
Other Study ID Numbers: LSS17001
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Spondylolisthesis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis