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

Lumbar Spinal Stenosis Clinical Trial

Official title:

A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03115983
• Other study ID #: LSS17001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Empirical Spine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 315
• Est. completion date: July 2025
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Spondylolisthesis
• Lumbar Spinal Stenosis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• LimiFlex
LimiFlex implantation at a single level after surgical decompression.
• 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 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).

Procedure:
• Decompression
Surgical decompression at one or two contiguous levels from L1 to S1.
• Fusion
Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	UHS Neurosurgery (Binghamton)	Binghamton	New York
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boulder Neurological & Spine Associates	Boulder	Colorado
United States	Indiana Spine Group	Carmel	Indiana
United States	University of Virginia Orthopaedic Surgery	Charlottesville	Virginia
United States	Rush University	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Norton Leatherman Spine Center	Louisville	Kentucky
United States	University of Miami, Dept of Neurological Surgery	Miami	Florida
United States	Hospital for Special Surgery	New York	New York
United States	Kaiser Permanente Division of Research	Oakland	California
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Texas Back Institue, Clincal Research, LLC-Plano	Plano	Texas
United States	Stanford University Medical Center	Redwood City	California
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Michigan Head and Spine Institute	Royal Oak	Michigan
United States	Kaiser Permanente Roseville Clinical Trials Program	Sacramento	California
United States	UC Davis Spine Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF Dept of Orthopaedic Surgery	San Francisco	California
United States	Kaiser Permanente (San Jose Medical Center)	San Jose	California
United States	The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration	Santa Monica	California
United States	Swedish Medical Center	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York
United States	BioSpine	Tampa	Florida
United States	Sonoran Spine Research and Education Foundation	Tempe	Arizona
United States	University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation	Worcester	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Empirical Spine, Inc.	Biomedical Statistical Consulting, MCRA, Medical Metrics Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 Months
Secondary	Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI)	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Neurological Status	Neurological Status	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Additional surgical interventions	Additional surgical interventions	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	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	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Estimated blood loss	estimated blood loss and units of blood transfused	Procedure
Secondary	Length of procedure	Length of procedure (skin to skin)	Procedure
Secondary	Hospital stay	Hospital stay	Immediately upon discharge
Secondary	Return to normal activities of daily living	Length of time for subject to return to his/her normal activities of daily living.	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Work status	Work status and days to return to work (as appropriate)	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Pain medication including narcotics usage	Medication use for pain, including narcotic, usage	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Visual analog scale (VAS) leg pain	Leg pain as measured on a Visual Analog Scale (VAS)	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Visual analog scale (VAS) back pain	Back pain as measured on a Visual Analog Scale (VAS)	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Zurich claudication questionnaire (ZCQ)	Zurich claudication questionnaire	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	SF-12 Quality of Life survey	SF-12 Health Survey	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Patient satisfaction	Patient satisfaction questionnaire	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Secondary	Radiographic fusion status	Radiographic fusion status	Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo