Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)

The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.

Study Overview

• Status: Unknown
• Conditions: Radiculopathy; Lumbar Spinal Stenosis; Spondylolisthesis
• Intervention / Treatment: Procedure: Decompression using the iO-Flex® system

Detailed Description

This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical study enrolling 100 subjects following a pre-specified protocol with no site enrolling more than 30 subjects. All eligible subjects providing written informed consent and meeting study eligibility criteria will receive a facet preserving decompression using the FDA cleared iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using a precision estimate assuming a 55% positive response rate.

In addition to baseline characteristics and procedural parameters, subject outcomes will be assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase with annual follow-up contact through 5 years to evaluate retreatment for the original indication at these late time points.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Castro Valley, California, United States, 94546
      • Eden Medical Center
    • Los Angeles, California, United States, 90036
      • Olympia Medical Center
    • Mission Viejo, California, United States, 92691
      • Orange County Neurological Associates
    • Orange, California, United States, 92868
      • University California Irvine
    • Van Nuys, California, United States, 91405
      • Southern California Orthopedic Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University
  • Florida
    • Odessa, Florida, United States, 33556
      • Medical Center of Trinity
    • Temple Terrace, Florida, United States, 33637
      • Florida Orthopaedic Institute
  • Georgia
    • Cumming, Georgia, United States, 30041
      • Resurgens Orthopaedics
  • Illinois
    • Bartlett, Illinois, United States, 60103
      • Suburban Orthopedics
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Texas
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital
  • Virginia
    • Richmond, Virginia, United States, 23219
      • VCU Medical Center
    • Richmond, Virginia, United States, 23226
      • Tuckahoe Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult (> 18 years of age)
2. Leg/buttock pain, with or without back pain
3. Grade 1 degenerative spondylolisthesis (≤25% slippage)
4. NRS pain score for leg pain of 4/10 or greater
5. ODI score of 30/100 or greater
6. Failed non-operative medical management for a period of at least 6 months
7. Confirmed clinical diagnosis of lumbar spinal stenosis
8. Confirmation of central and/or lateral recess stenosis with or without foraminal stenosis, at one level or at two adjacent levels from L2-S1, with concordant symptoms. Subjects with central and/or lateral recess stenosis and spondylolisthesis at one level, may have symptomatic central, lateral recess or foraminal stenosis treated at one adjacent level. A "below-the pedicle" pass to decompress a third segment can be completed provided laminotomies are performed at no more than 2 levels. Subjects that, following an intraoperative decision, have a 3-level laminotomy and decompression will not be considered enrolled. Confirmation of spinal stenosis is shown on MRI or CT scan with evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
9. Ability to give voluntary, written informed consent to participate in this clinical investigation and ability to participate in follow up examinations and complete patient questionnaires

Exclusion Criteria:

1. Back pain only
2. Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
3. History of pathologic fractures of the vertebrae
4. Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
5. Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
6. Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
7. Prior surgery of the lumbar spine
8. Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
9. Spondylolysis (pars fracture) at any level in the lumbar spine
10. Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
11. Vascular claudication in the lower extremities
12. Cauda equina syndrome
13. Evidence of active (systemic or local) infection at time of surgery
14. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
15. Tumor in the spine or a malignant tumor except for basal cell carcinoma.
16. Prisoner or transient
17. Any significant psychological disturbance past or present, psychotic or neurotic that could impair the consent process or ability to complete subject self-report questionnaires
18. Involved in pending litigation of the spine or worker's compensation related to the back
19. Inability to communicate clearly in the English language
20. Morbid obesity (BMI > 40)
21. Pregnant, nursing, or planning on becoming pregnant.
22. History of narcotic abuse
23. Current involvement in another drug or device clinical trial
24. Uncontrolled diabetes
25. Irreversible coagulopathy or bleeding disorder (patients on anticoagulant therapy may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.)
26. Plans to relocate in the next 2 years
27. Subject unwilling to undergo a blood transfusion, if necessary

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery; Decompression using the iO-Flex® system	Procedure: Decompression using the iO-Flex® system; Decompression using the iO-Flex® system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	Responder analysis	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative success	Achieving intended decompression using the iO-Flex® System. The number of neural foramen in which the iO-Flex® System was used for decompression compared to the number in which an attempt was made but not completed.	Operative (day 1)
Oswestry Disability Index (ODI)	Responder analysis	6, 12, 36, 48 and 60 months
Oswestry Disability Index (ODI)	Comparison of ODI scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits	6, 12, 24, 36, 48 and 60 months
Numerical Rating Scale (NRS)	Comparison of NRS scores for back and leg pain between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits	6, 12, 24, 36, 48 and 60 months
Zurich Claudication Questionnaire (ZCQ)	Comparison of ZCQ scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits	6, 12, 24, 36, 48 and 60 months
SF-36 Health Survey	Comparison of SF-36 scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits	6, 12, 24, 36, 48 and 60 months
Treatment survival rate	To characterize longevity of the treatment effect of a decompression using the iO-Flex® System.	Ongoing out to 60 months

Collaborators and Investigators

• Sponsor: Baxano Surgical, Inc.
• Investigators: Principal Investigator: Sylvain Palmer, M.D., Neurological Surgery Medical Associates

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: April 21, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: spondylolisthesis; lumbar spinal stenosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Radiculopathy; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: CP-1967