Condition of Approval Study (COAST)

This study has been terminated.
(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.)
Information provided by (Responsible Party):
Medtronic Spine LLC Identifier:
First received: August 15, 2007
Last updated: May 15, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Lumbar Spinal Stenosis
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients

Resource links provided by NLM:

Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:
  • Treatment response rates equivalent to overall success reported in the IDE pivotal trial as measured by improvement in ZCQ scores, no additional surgery for LSS, maintenance of distraction, no dislodgement of the implant or device related complications. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints: SF-36, ODI, and NRS scores, Adverse event rate,device failures, MRI evaluation of adjacent levels and secondary surgeries. [ Time Frame: Two to Five years ] [ Designated as safety issue: No ]
  • Treatment response rates at 5 years as measured by ZCQ, no additional LSS surgery, maintenance of distraction, no dislodgement or device complications. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: August 2007
Study Completion Date: April 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X-STOP PEEK
In this arm, patients will undergo X-STOP PEEK surgery.
Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.

Detailed Description:

This prospective, multicenter longitudinal five-year study of X-STOP PEEK implant 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. This post-approval study will enroll 240 patients at up to 8 clinical sites where all participating spine surgeons have completed a company-sponsored physician training program. The clinical sites recruited to participate in this study comprise a geographically diverse mix of academic, referral, and/or community based sites.

Safety and effectiveness data will be assessed at baseline and annually through five (5) years postoperatively. Office visits will be scheduled preoperatively, and at 6 weeks, 1, 2, 3, 4, and 5 years postoperatively. Clinical/neurological and radiographic examination will be performed during each office visit. A baseline patient history (including medication usage) will be taken, and concomitant medications will be recorded at each postoperative follow-up visit. In addition, patients will be asked to complete the following questionnaires prior to consultation with their physicians or their staff: Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and SF-36 Health Survey. At the 2-, 3-, 4- and 5-year office visit, patients will also be asked two questions assessing the value of surgery and the overall improvement in the quality of life postoperatively.

The primary study endpoint in this study is treatment success. Secondary endpoints will include scores from the SF-36, ODI, and NRS, as well as incidence rates of adverse events, device failures, and secondary surgeries.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. has a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
  2. is 50 years old or older
  3. 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.
  4. can sit for 50 minutes without pain
  5. can walk 50 feet or more
  6. 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
  7. 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
  8. has signed a patient informed consent document
  9. is physically and mentally willing and able or has a caregiver who can comply with the postoperative and routinely scheduled clinical and radiographic evaluations
  10. 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

Exclusion Criteria:

  1. has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
  2. cannot sit for 50 minutes
  3. cannot walk more than 50 feet
  4. has unremitting pain in any spinal position
  5. has axial back pain only without leg/buttock/groin pain
  6. has a fixed motor deficit
  7. has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
  8. has severe symptomatic lumbar spinal stenosis at more than two levels
  9. 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)
  10. has an ankylosed segment at the affected level(s);
  11. has significant scoliosis (Cobb angle is greater than 25 degrees)
  12. has an acute fracture of the spinous process or pars interarticularis
  13. has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips
  14. 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
  15. has Paget's disease at the involved segment(s) or metastasis to the vertebrae
  16. has had any surgery of the lumbar spine
  17. has significant peripheral neuropathy demonstrated by nerve conduction velocity tests
  18. has acute denervation secondary to radiculopathy, as shown by EMG
  19. has significant peripheral vascular disease characterized by diminished dorsalis pedus or tibial pulses
  20. has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2
  21. has an active systemic infection or infection localized to the site of implantation
  22. has an active systemic disease such as AIDS, HIV, hepatitis, etc.
  23. 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)
  24. has a recent history of narcotic abuse (i.e., within last 3 years)
  25. has a known allergy to titanium,titanium alloy, or polyetheretherketone
  26. is immunologically suppressed, or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
  27. is currently involved in a study of another investigational product that may affect the outcome of this study
  28. is pregnant or planning to become pregnant during the study period
  29. cannot undergo MRI or tolerate closed MRI scanning.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00517751

  Show 23 Study Locations
Sponsors and Collaborators
Medtronic Spine LLC
Principal Investigator: Jim Malcolm, MD Pinnacle Orthopedics
  More Information

Responsible Party: Medtronic Spine LLC Identifier: NCT00517751     History of Changes
Other Study ID Numbers: LSS-006-COA 
Study First Received: August 15, 2007
Last Updated: May 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spine LLC:
Lumbar Spinal Stenosis
X-STOP Spacer
Interspinous process decompression
Neurogenic Intermittent Claudication

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases processed this record on February 09, 2016