Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®

December 10, 2020 updated by: Medtronic Spine LLC

Long-term Outcomes Among Patients With Lumbar Spinal Stenosis Treated With the X STOP® Interspinous Process Decompression System: Five-Year Follow-up of IDE Patient Cohorts

The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE. These patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to X-Stop implantation (as determined by a baseline score >2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score <=2.0 in the PF domain of the Zurich claudication questionnaire (ZCQ), through the fifth postoperative year. Clinical examination will be performed at each office visit to confirm the absence of neurological complications. X-ray films (AP/lateral views) taken during the fifth postoperative year will, be analyzed to confirm A) maintenance of distraction and B) the absence of radiological evidence of device-related complications. Secondary endpoints will include mean scores from the SF-36, and incidence rates of adverse events, device failures, and secondary surgeries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94117
        • St. Mary's Spine Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Neurological & Spine Associates
    • Maryland
      • Timonium, Maryland, United States, 21093
        • Greater Baltimore Spine Care
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Neurological Specialist
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who received implants and completed participation in the Pivotal, CAP, or COS studies and has the implant intact and is willing and able to provide consent and return to the clinic for evaluation or complete study questionnaires.

Description

Inclusion Criteria:

A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:

  1. Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study.
  2. Is willing and able to provide Informed Consent
  3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.

Exclusion Criteria:

A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:

  1. Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
  2. Participated in the CAP or COS programs, but the device has been removed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Success Rates (At ≥ 5 Years)
Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study
Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.
3+ years following first 2 years post-X-STOP implant through IDE study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)
Time Frame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). 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 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.
Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)
Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.
3+ years following first 2 years post-X-STOP implant through IDE study
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)
Time Frame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.
Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study
Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study
The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.
3+ years following first 2 years post-X-STOP implant through IDE study
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study
Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study
3+ years following first 2 years post-X-STOP implant through IDE study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Spine LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSS-004-LTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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