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Lumbar Spinal StenosisPhase 4COASTNCT00517751

Condition of Approval Study

A Phase 4 study testing X-STOP PEEK in people with Lumbar Spinal Stenosis, run by Medtronic Spine LLC at 23 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Lumbar Spinal Stenosis
What is being tested?
X-STOP PEEK
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
23 sitesUnited States
Study dates
Aug 2007to Apr 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • is immunologically suppressed, or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
  • is currently involved in a study of another investigational product that may affect the outcome of this study
  • is pregnant or planning to become pregnant during the study period
  • cannot undergo MRI or tolerate closed MRI scanning.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • The Center Orthopedic & Neurosurgical Care & Research

    Bend, Oregon, 97701

  • The Kirklin Clinic - UAB Medical

    Birmingham, Alabama, 35249

  • Silicon Valley Spine Institute

    Campbell, California, 95008

  • Mayfield Clinic

    Cincinnati, Ohio, 45219

  • Colorado Neurosurgery Associates, P.C.

    Denver, Colorado, 80220

  • UpState Orthopedics

    East Syracuse, New York, 13057

  • NeuroSpine Institute

    Eugene, Oregon, 97401

  • Panaorama Orthopedics and Spine Center

    Golden, Colorado, 80401

  • Drisko, Fee & Parkins, P.C.

    Kansas City, Missouri, 64116

  • University of Kentucky, Dept of Neurosurgery

    Lexington, Kentucky, 40536-0298

  • Pinnacle Orthopedics

    Marietta, Georgia, 30060

  • Orthopaedic Center of Southern Illinois

    Mount Vernon, Illinois, 62864

  • Yale School of Medicine, Dept. of Orthopaedics

    New Haven, Connecticut, 06520

  • Texas Back Institute

    Plano, Denton, Mansfield, Texas, 75093, 76208, 76063

  • UC Davis Spine Center

    Sacramento, California, 95818

  • Neurosurgical Associates of San Antonio

    San Antonio, Texas, 78258

  • UCLA Comprehensive Spine Center

    Santa Monica, California, 90404

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101

  • Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation

    Temple, Texas, 76508

  • Tucson Orthopaedic Institute-East Office

    Tucson, Arizona, 85712

  • Tucson Orthopaedic Institute-Northwest Office

    Tucson, Arizona, 85741

  • George Washington University Hospital Medical Facility Associates

    Washington D.C., District of Columbia, 20037

  • OrthopaediCare

    Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
X-STOP PEEK
Keywords
Lumbar Spinal Stenosis, X-STOP Spacer, Interspinous process decompression, Neurogenic Intermittent Claudication
Medical subject headings
Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X-STOP PEEKDevice

    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.

Study groups in NCT00517751
Study groupRoleWhat they receive
X-STOP PEEKExperimentalIn this arm, patients will undergo X-STOP PEEK surgery.
Receives: Device: X-STOP PEEK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Success Rate at 24 Months

    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

    Measured: 24 months

Secondary outcomes (13)

  1. Treatment Success Rate at 60 Months

    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

    Measured: 60 months

  2. Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)

    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.

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  3. Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)

    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.

    Measured: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

  4. Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)

    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.

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  5. Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)

    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.

    Measured: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

  6. Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment

    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.

    Measured: 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  7. Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment

    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.

    Measured: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

  8. Oswestry Disability Index (ODI) Score

    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).

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  9. General Health Status -- SF-36 PCS

    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.

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  10. General Health Status -- SF-36 MCS

    MCS score is between 0 and 100, with higher scores denoting better quality of life.

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  11. Back Pain in Numerical Rating Scales (NRS)

    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."

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  12. Left Leg Pain in Numerical Rating Scales (NRS)

    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."

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

  13. Right Leg Pain in Numerical Rating Scales (NRS)

    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."

    Measured: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionFeb 2015
  4. Study completionApr 2015

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00517751
Sponsor's protocol ID
LSS-006-COA
Acronym
COAST
Status last verified
Jan 2016
First submitted
15 Aug 2007
Last updated
2 Jan 2018
Data monitoring committee
No

Publications

  • Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1.

    PubMed 15959362

  • Hsu KY, Zucherman JF, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Cauthen JC, Ozuna RM. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006 Dec;5(6):500-7. doi: 10.3171/spi.2006.5.6.500.

    PubMed 17176013

  • Kondrashov DG, Hannibal M, Hsu KY, Zucherman JF. Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech. 2006 Jul;19(5):323-7. doi: 10.1097/01.bsd.0000211294.67508.3b.

    PubMed 16826002

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing X-STOP PEEK in people with Lumbar Spinal Stenosis, run by Medtronic Spine LLC at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success Rate at 24 Months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00517751, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.

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Condition of Approval Study (NCT00517751) | AzTrials