The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:

The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01067014
• Other study ID #: CP-1318
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2010
• Last updated: September 19, 2013
• Start date: February 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2013
• Source: Baxano Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

1. Age =18 years

2. Leg/buttock pain with or without back pain

3. Failed nonoperative medical management

4. A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)

5. Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region

6. Able and willing to give voluntary, written informed consent to participate in this clinical study

Exclusion Criteria

Candidates will be excluded from the evaluation if ANY of the following apply:

1. Back pain only

2. A diagnosis of central stenosis only

3. More than two levels requiring decompression

4. Fixed motor deficit

5. Significant instability of the lumbar spine as defined by = 4mm translation between standing flexion and extension lumbar spine plain film radiographs

6. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips

7. Primary disc pathology and/or patients who will undergo a discectomy

8. Prior surgery of the lumbar spine at the level(s) of planned treatment

9. Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4)

10. Spondylolysis (pars fracture) at any level in the lumbar spine

11. Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25°

12. Symptomatic vascular claudication in the lower extremities

13. Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction)

14. Evidence of active (systemic or local) infection at time of surgery

15. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease

16. Tumor in the spine or a malignant tumor except for basal cell carcinoma

17. Prisoner or transient

18. Recent history of known narcotic abuse

19. Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires

20. Involved in pending litigation of the spine or worker's compensation related to the back

21. Inability to communicate clearly in the English language

22. Morbid obesity (BMI > 40)

23. Plans to relocate within the next 2 years

24. Pregnant or planning to become pregnant

25. Irreversible coagulopathy or bleeding disorder

a. Subjects on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.

26. Subject unwilling to undergo blood transfusion, if necessary

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Baxano iO-Flex® System
Decompressive lumbar surgery using Baxano iO-Flex® System

Locations

Country	Name	City	State
United States	Suburban Orthopedics	Bartlett	Illinois
United States	Rothman Institute	Bensalem	Pennsylvania
United States	Neurospine Solutions, PC	Bristol	Tennessee
United States	Eden Medical Center	Castro Valley	California
United States	Triangle Orthopaedic Associates	Chapel Hill	North Carolina
United States	Resurgens Orthopaedics	Cumming	Georgia
United States	Easton Hospital	Easton	Pennsylvania
United States	Moses Cone Hospital	Greensboro	North Carolina
United States	Carolina Neurosurgery & Spine Center	Greenwood	South Carolina
United States	Spine Midwest, Inc.	Jefferson City	Missouri
United States	McCune-Brooks Regional Hospital	Joplin	Missouri
United States	Caldwell Memorial Hospital	Lenoir	North Carolina
United States	Buffalo Spine Surgery	Lockport	New York
United States	Olympia Medical Center	Los Angeles	California
United States	Spine Works Institute	North Richland Hills	Texas
United States	Tuckahoe Orthopaedic Associates	Richmond	Virginia
United States	University of Utah	Salt Lake City	Utah
United States	Watsonville Community Hospital	Watsonville	California

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	Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points		6 months	No
Primary	Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30%		6 months	No
Primary	Re-operation at the treatment level(s) at one year post-procedure		One year	No
Primary	Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects		Hospital discharge	Yes
Secondary	Changes in Visual Analog Scale scores compared to baseline		6 weeks, 3 months, 6 months, 12 months, 24 months	No
Secondary	Changes in Zurich Claudication Questionnaire scores compared to baseline		6 weeks, 3, 6, 12, and 24 months	No
Secondary	Changes in Oswestry Disability Index scores compared to baseline		6 weeks, 3, 6, 12, and 24 months	No
Secondary	Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months		6, 12, and 24 months	No
Secondary	Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems		Through 2 years	Yes