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

Primary Purpose

Degenerative Spondylolisthesis, Lumbar Spinal Stenosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LimiFlex
Fusion Instrumentation
Decompression
Fusion
Sponsored by
Empirical Spine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 requiring decompression at up to two contiguous levels from L1 to S1, inclusive of 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 radiculopathy 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 3 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;

    * Leg pain includes hip and/or buttock pain on the same side

  6. A pre-operative Oswestry Disability Index (ODI) score ≥35 points on a 100-point scale;
  7. Candidate for surgical decompression at a single level or two contiguous levels, with 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, rhizotomy or nerve ablation.
  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 that would preclude secure fixation of the LimiFlex Device to the spinous process;
  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 that would preclude secure fixation of the LimiFlex Device to the spinous process;
  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 <80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed;
  18. Planned hip or knee replacement surgery, severe osteoarthritis or other musculoskeletal pathology of the hip or leg that could preclude reliable patient self reporting assessment scales and/or that would likely progress to surgery during study period;
  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 severe 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
  24. Morbid obesity defined as BMI >40;
  25. Active malignancy or history of metastatic 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.

Sites / Locations

  • Sonoran Spine Research and Education Foundation
  • Kaiser Permanente Division of Research
  • Stanford University Medical Center
  • UC Davis Spine Center
  • Kaiser Permanente Roseville Clinical Trials Program
  • UCSF Dept of Orthopaedic Surgery
  • Kaiser Permanente (San Jose Medical Center)
  • The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration
  • Boulder Neurological & Spine Associates
  • University of Miami, Dept of Neurological Surgery
  • BioSpine
  • Emory University
  • Rush University
  • Indiana Spine Group
  • Norton Leatherman Spine Center
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation
  • Beaumont Hospital
  • Michigan Head and Spine Institute
  • Washington University School of Medicine
  • UHS Neurosurgery (Binghamton)
  • Hospital for Special Surgery
  • SUNY Upstate Medical University
  • The Ohio State University
  • University of Pennsylvania Hospital
  • Texas Back Institue, Clincal Research, LLC-Plano
  • University of Virginia Orthopaedic Surgery
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LimiFlex

Fusion

Arm Description

Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band

Transforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation

Outcomes

Primary Outcome Measures

Composite Clinical Success
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

Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Neurological Status
Neurological Status
Additional surgical interventions
Additional surgical interventions
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Estimated blood loss
estimated blood loss and units of blood transfused
Length of procedure
Length of procedure (skin to skin)
Hospital stay
Hospital stay
Return to normal activities of daily living
Length of time for subject to return to his/her normal activities of daily living.
Work status
Work status and days to return to work (as appropriate)
Pain medication including narcotics usage
Medication use for pain, including narcotic, usage
Visual analog scale (VAS) leg pain
Leg pain as measured on a Visual Analog Scale (VAS)
Visual analog scale (VAS) back pain
Back pain as measured on a Visual Analog Scale (VAS)
Zurich claudication questionnaire (ZCQ)
Zurich claudication questionnaire
SF-12 Quality of Life survey
SF-12 Health Survey
Patient satisfaction
Patient satisfaction questionnaire
Radiographic fusion status
Radiographic fusion status

Full Information

First Posted
March 31, 2017
Last Updated
January 6, 2023
Sponsor
Empirical Spine, Inc.
Collaborators
Biomedical Statistical Consulting, Medical Metrics Diagnostics, Inc, MCRA
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1. Study Identification

Unique Protocol Identification Number
NCT03115983
Brief Title
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
Official Title
A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Empirical Spine, Inc.
Collaborators
Biomedical Statistical Consulting, Medical Metrics Diagnostics, Inc, MCRA

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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 to pedicle-sparing straps which encircle adjacent spinous processes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis, Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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. Prospective patient sample supplemented with retrospective and/or historical control subjects.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LimiFlex
Arm Type
Experimental
Arm Description
Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band
Arm Title
Fusion
Arm Type
Active Comparator
Arm Description
Transforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation
Intervention Type
Device
Intervention Name(s)
LimiFlex
Other Intervention Name(s)
LimiFlex Paraspinous Tension Band
Intervention Description
LimiFlex implantation at a single level after surgical decompression.
Intervention Type
Device
Intervention Name(s)
Fusion Instrumentation
Intervention Description
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 or Titanium TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).
Intervention Type
Procedure
Intervention Name(s)
Decompression
Intervention Description
Surgical decompression at one or two contiguous levels from L1 to S1.
Intervention Type
Procedure
Intervention Name(s)
Fusion
Intervention Description
Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.
Primary Outcome Measure Information:
Title
Composite Clinical Success
Description
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
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Oswestry Disability Index (ODI)
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Neurological Status
Description
Neurological Status
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Additional surgical interventions
Description
Additional surgical interventions
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Description
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, 36 mo, 48 mo, 60 mo
Title
Estimated blood loss
Description
estimated blood loss and units of blood transfused
Time Frame
Procedure
Title
Length of procedure
Description
Length of procedure (skin to skin)
Time Frame
Procedure
Title
Hospital stay
Description
Hospital stay
Time Frame
Immediately upon discharge
Title
Return to normal activities of daily living
Description
Length of time for subject to return to his/her normal activities of daily living.
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Work status
Description
Work status and days to return to work (as appropriate)
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Pain medication including narcotics usage
Description
Medication use for pain, including narcotic, usage
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Visual analog scale (VAS) leg pain
Description
Leg pain as measured on a Visual Analog Scale (VAS)
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Visual analog scale (VAS) back pain
Description
Back pain as measured on a Visual Analog Scale (VAS)
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Zurich claudication questionnaire (ZCQ)
Description
Zurich claudication questionnaire
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
SF-12 Quality of Life survey
Description
SF-12 Health Survey
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Patient satisfaction
Description
Patient satisfaction questionnaire
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Title
Radiographic fusion status
Description
Radiographic fusion status
Time Frame
Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (patients must meet ALL of the following criteria to be eligible for participation in the study): 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. Lumbar spinal stenosis requiring decompression at up to two contiguous levels from L1 to S1, inclusive of 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. Neurogenic claudication or radiculopathy 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 3 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; * Leg pain includes hip and/or buttock pain on the same side A pre-operative Oswestry Disability Index (ODI) score ≥35 points on a 100-point scale; Candidate for surgical decompression at a single level or two contiguous levels, with 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 (investigational group only); ≥25-80 years of age and skeletally mature; 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 Patient is willing to provide Informed Consent for study participation. 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; History of fixed or permanent neurological deficit related to spinal cord injury; History of any previous surgery* at any level in the lumbosacral spine except for a discectomy or decompression; History of any previous surgery* at the level planned for treatment; previous surgery includes spinal stimulator placement but does NOT include epidural injections, rhizotomy or nerve ablation. 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 that would preclude secure fixation of the LimiFlex Device to the spinous process; 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 that would preclude secure fixation of the LimiFlex Device to the spinous process; 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 history of fragility fracture and DXA T-score <-2.5 or QCT T-score <80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed; Planned hip or knee replacement surgery, severe osteoarthritis or other musculoskeletal pathology of the hip or leg that could preclude reliable patient self reporting assessment scales and/or that would likely progress to surgery during study period; 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: severe rheumatoid arthritis or other severe autoimmune disease active hepatitis (viral or serum) or HIV positive unstable cardiac disease uncontrolled diabetes renal failure severe muscular, neural or vascular diseases that endanger the spinal column cauda equina syndrome severe neurologic disorders including paralysis Morbid obesity defined as BMI >40; Active malignancy or history of metastatic 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Sasso, MD
Organizational Affiliation
Indiana Spine Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William C Welch, MD
Organizational Affiliation
Pennsylvania Hospital Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonoran Spine Research and Education Foundation
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Kaiser Permanente Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Stanford University Medical Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
UC Davis Spine Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Kaiser Permanente Roseville Clinical Trials Program
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
UCSF Dept of Orthopaedic Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Kaiser Permanente (San Jose Medical Center)
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Boulder Neurological & Spine Associates
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
University of Miami, Dept of Neurological Surgery
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
BioSpine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Norton Leatherman Spine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Michigan Head and Spine Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UHS Neurosurgery (Binghamton)
City
Binghamton
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Texas Back Institue, Clincal Research, LLC-Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia Orthopaedic Surgery
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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