Condition of Approval Study

Stopped early · Phase 4

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID: NCT00517751
Run by: Medtronic Spine LLC
People needed: 176
Starts: 2007-08-01
Expected to finish: 2015-04-01
Last updated by the study team: 2018-01-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
is physically and mentally willing and able or has a caregiver who can comply with the postoperative and routinely scheduled clinical and radiographic evaluations
lives in the immediate area and has no plans to relocate to another geographic area before completion of the study or lives outside the immediate area and will comply with the scheduled postoperative visits with a prearranged and designated physician

You may not qualify if…

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
has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
has an ankylosed segment at the affected level(s);
has significant scoliosis (Cobb angle is greater than 25 degrees)
has an acute fracture of the spinous process or pars interarticularis
has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips
has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in the spine or hip more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures
has Paget's disease at the involved segment(s) or metastasis to the vertebrae
has had any surgery of the lumbar spine
has significant peripheral neuropathy demonstrated by nerve conduction velocity tests
has acute denervation secondary to radiculopathy, as shown by EMG
has significant peripheral vascular disease characterized by diminished dorsalis pedus or tibial pulses
has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2
has an active systemic infection or infection localized to the site of implantation
has an active systemic disease such as AIDS, HIV, hepatitis, etc.
has a medical condition that may interfere with postoperative management and follow-up, or may result in patient death prior to study completion (e.g., Alzheimer's disease, unstable cardiac disease, active malignancy)
has a recent history of narcotic abuse (i.e., within last 3 years)
has a known allergy to titanium,titanium alloy, or polyetheretherketone

Where it is running

The Kirklin Clinic - UAB Medical — Birmingham, Alabama, United States
Tucson Orthopaedic Institute-East Office — Tucson, Arizona, United States
Tucson Orthopaedic Institute-Northwest Office — Tucson, Arizona, United States
Silicon Valley Spine Institute — Campbell, California, United States
UC Davis Spine Center — Sacramento, California, United States
UCLA Comprehensive Spine Center — Santa Monica, California, United States
Colorado Neurosurgery Associates, P.C. — Denver, Colorado, United States
Panaorama Orthopedics and Spine Center — Golden, Colorado, United States
Yale School of Medicine, Dept. of Orthopaedics — New Haven, Connecticut, United States
George Washington University Hospital Medical Facility Associates — Washington D.C., District of Columbia, United States
Pinnacle Orthopedics — Marietta, Georgia, United States
Orthopaedic Center of Southern Illinois — Mount Vernon, Illinois, United States
University of Kentucky, Dept of Neurosurgery — Lexington, Kentucky, United States
Spine Institute of Louisiana — Shreveport, Louisiana, United States
Drisko, Fee & Parkins, P.C. — Kansas City, Missouri, United States
UpState Orthopedics — East Syracuse, New York, United States
Mayfield Clinic — Cincinnati, Ohio, United States
The Center Orthopedic & Neurosurgical Care & Research — Bend, Oregon, United States
NeuroSpine Institute — Eugene, Oregon, United States
OrthopaediCare — Willow Grove, Pennsylvania, United States
Texas Back Institute — Plano, Denton, Mansfield, Texas, United States
Neurosurgical Associates of San Antonio — San Antonio, Texas, United States
Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation — Temple, Texas, United States

Full record on ClinicalTrials.gov

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