Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

Lumbar Spinal Stenosis Clinical Trial

— STRiDE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01338766
• Other study ID #: CP-1967
• Status: Active, not recruiting
• Phase: N/A
• First received: April 18, 2011
• Last updated: April 21, 2014
• Start date: April 2011

Study information

• Verified date: April 2014
• Source: Baxano Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Radiculopathy
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• Decompression using the iO-Flex® system
Decompression using the iO-Flex® system

Locations

Country	Name	City	State
United States	Suburban Orthopedics	Bartlett	Illinois
United States	Indiana Spine Group	Carmel	Indiana
United States	Eden Medical Center	Castro Valley	California
United States	Resurgens Orthopaedics	Cumming	Georgia
United States	Olympia Medical Center	Los Angeles	California
United States	Orange County Neurological Associates	Mission Viejo	California
United States	Medical Center of Trinity	Odessa	Florida
United States	University California Irvine	Orange	California
United States	Tuckahoe Orthopedics	Richmond	Virginia
United States	VCU Medical Center	Richmond	Virginia
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Florida Orthopaedic Institute	Temple Terrace	Florida
United States	Southern California Orthopedic Institute	Van Nuys	California
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Baxano Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	Responder analysis	24 Months	No
Secondary	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)	No
Secondary	Oswestry Disability Index (ODI)	Responder analysis	6, 12, 36, 48 and 60 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment survival rate	To characterize longevity of the treatment effect of a decompression using the iO-Flex® System.	Ongoing out to 60 months	No