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

Not Applicable

Active, not recruiting

• Conditions: Degenerative Spondylolisthesis; Lumbar Spinal Stenosis

• Registration Number: NCT03115983
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Study Start: 2017-07-17
• Primary Completion: 2022-06-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite Clinical Success	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

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