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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

August 15, 2007
January 14, 2016
August 2007
February 2015   (final data collection date for primary outcome measure)
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
Treatment response rates equivalent to the 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 and Five years ]
Complete list of historical versions of study NCT00517751 on ClinicalTrials.gov Archive Site
  • 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."
Secondary endpoints will include scores from the SF-36, ODL, and VAS, as incidene rates of adverse events, device failures, and secondary surgeries. [ Time Frame: Five years ]
  • 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 ]
Not Provided
 
Condition of Approval Study
Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients
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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lumbar Spinal Stenosis
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.
Experimental: X-STOP PEEK
In this arm, patients will undergo X-STOP PEEK surgery.
Intervention: Device: X-STOP PEEK

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
176
April 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00517751
LSS-006-COA
No
Not Provided
Not Provided
Medtronic Spine LLC
Medtronic Spine LLC
Not Provided
Principal Investigator: Jim Malcolm, MD Pinnacle Orthopedics
Medtronic Spine LLC
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP