Condition of Approval Study (NCT00517751) | Clinical Trial Compass
TerminatedPhase 4
Condition of Approval Study
Stopped: Due to Medtronic's voluntary withdrawal of PMA P040001 for X-STOP systems; post-approval study costs outweighed business benefits for marketing X-STOP in US.
United States176 participantsStarted 2007-08
Plain-language summary
This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline (i.e., an "indicated" population) who elect to undergo X STOP PEEK surgery.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. has a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
✓. is 50 years old or older
✓. has leg/buttock/groin pain with or without back pain NOTE: Leg/buttock/groin pain must be completely relieved when flexed such as when sitting in a chair. If back pain is also present, it must be partially relieved when flexed.
✓. can sit for 50 minutes without pain
✓. can walk 50 feet or more
✓. has a confirmed diagnosis of neurogenic intermittent claudication secondary to lumbar spinal stenosis, with X-Ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing
✓. has completed at least six months of conservative care therapy which may include but is not limited to physical therapy, bracing, systemic or injected medications
✓. has signed a patient informed consent document
. has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
✕. cannot sit for 50 minutes
✕. cannot walk more than 50 feet
✕. has unremitting pain in any spinal position
✕. has axial back pain only without leg/buttock/groin pain
✕. has a fixed motor deficit
✕. has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
✕. has severe symptomatic lumbar spinal stenosis at more than two levels