Clinical trial: The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery (NCT01067014)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 57-year-old man comes to the emergency department due to constipation.  His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain.  There is no history of trauma. The pain is not relieved with over-the-counter pain medications.  His vital signs are within normal limits.  Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg.  Pinprick in the perianal area does not cause rapid contraction of the anal sphincter.  The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI.

Patient description (patient's own words): I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI.

Does the patient match the trial criteria? Contradiction