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.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00517751
First received: August 15, 2007
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
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
Device: X-STOP PEEK
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 Success Rate at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    Treatment success rate is reported as the percentage of participants who met all of the following criteria:

    1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline
    2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline
    3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5
    4. No additional surgery for lumbar stenosis performed
    5. Maintenance of distraction
    6. No dislodgement of the implant
    7. No device-related complications


Secondary Outcome Measures:
  • Treatment Success Rate at 60 Months [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

    Treatment success rate is reported as the percentage of participants who met all of the following criteria:

    1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline
    2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline
    3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5
    4. No additional surgery for lumbar stenosis performed
    5. Maintenance of distraction
    6. No dislodgement of the implant
    7. No device-related complications

  • Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.

  • Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.

  • Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.

  • Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.

  • Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment [ Time Frame: 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.

  • Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment [ Time Frame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.

  • Oswestry Disability Index (ODI) Score [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

  • General Health Status -- SF-36 PCS [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.

  • General Health Status -- SF-36 MCS [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    MCS score is between 0 and 100, with higher scores denoting better quality of life.

  • Back Pain in Numerical Rating Scales (NRS) [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

  • Left Leg Pain in Numerical Rating Scales (NRS) [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

  • Right Leg Pain in Numerical Rating Scales (NRS) [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]
    Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."


Other Outcome Measures:
  • Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.

  • Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.

  • Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.

  • Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.

  • Percent of Subjects Who Reported Implant-Related Adverse Events [ Time Frame: Overall study period ] [ Designated as safety issue: Yes ]
  • Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery [ Time Frame: Overall study period ] [ Designated as safety issue: Yes ]

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.
Device: X-STOP PEEK
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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00517751

  Hide Study Locations
Locations
United States, Alabama
The Kirklin Clinic - UAB Medical
Birmingham, Alabama, United States, 35249
United States, Arizona
Tucson Orthopaedic Institute-East Office
Tucson, Arizona, United States, 85712
Tucson Orthopaedic Institute-Northwest Office
Tucson, Arizona, United States, 85741
United States, California
Silicon Valley Spine Institute
Campbell, California, United States, 95008
UC Davis Spine Center
Sacramento, California, United States, 95818
UCLA Comprehensive Spine Center
Santa Monica, California, United States, 90404
United States, Colorado
Colorado Neurosurgery Associates, P.C.
Denver, Colorado, United States, 80220
Panaorama Orthopedics and Spine Center
Golden, Colorado, United States, 80401
United States, Connecticut
Yale School of Medicine, Dept. of Orthopaedics
New Haven, Connecticut, United States, 06520
United States, District of Columbia
George Washington University Hospital Medical Facility Associates
Washington, District of Columbia, United States, 20037
United States, Georgia
Pinnacle Orthopedics
Marietta, Georgia, United States, 30060
United States, Illinois
Orthopaedic Center of Southern Illinois
Mt. Vernon, Illinois, United States, 62864
United States, Kentucky
University of Kentucky, Dept of Neurosurgery
Lexington, Kentucky, United States, 40536-0298
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Missouri
Drisko, Fee & Parkins, P.C.
Kansas City, Missouri, United States, 64116
United States, New York
UpState Orthopedics
East Syracuse, New York, United States, 13057
United States, Ohio
Mayfield Clinic
Cincinnati, Ohio, United States, 45219
United States, Oregon
The Center Orthopedic & Neurosurgical Care & Research
Bend, Oregon, United States, 97701
NeuroSpine Institute
Eugene, Oregon, United States, 97401
United States, Pennsylvania
OrthopaediCare
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
Texas Back Institute
Plano, Denton, Mansfield, Texas, United States, 75093, 76208, 76063
Neurosurgical Associates of San Antonio
San Antonio, Texas, United States, 78258
Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation
Temple, Texas, United States, 76508
Sponsors and Collaborators
Medtronic Spine LLC
Investigators
Principal Investigator: Jim Malcolm, MD Pinnacle Orthopedics
  More Information

Publications:
Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00517751     History of Changes
Other Study ID Numbers: LSS-006-COA 
Study First Received: August 15, 2007
Results First Received: December 1, 2015
Last Updated: January 14, 2016
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
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 25, 2016