AzTrials
AzTrials

Lumbar Spinal StenosisNCT00534092

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

An observational study of Lumbar Spinal Stenosis, run by Medtronic Spine LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). 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® Interspinous Process Decompression System
Type of treatment
Medical device
How many people
69 participants
Where
5 sitesUnited States
Study dates
Dec 2006to Jun 2010
Phase
Observational
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

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.

Who may be able to join

  • A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:
  • 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.
  • Is willing and able to provide Informed Consent
  • Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.

Who cannot join

  • A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:
  • Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
  • Participated in the CAP or COS programs, but the device has been removed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University Hospital

    Madison, Wisconsin, 53792

  • Neurological Specialist

    Norfolk, Virginia, 23510

  • St. Mary's Spine Center

    San Francisco, California, 94117

  • Neurological & Spine Associates

    Scarborough, Maine, 04074

  • Greater Baltimore Spine Care

    Timonium, Maryland, 21093

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
X STOP® Interspinous Process Decompression System
Keywords
Lumbar Spinal Stenosis, X STOP
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® Interspinous Process Decompression SystemDevice

    The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.

What is being measured

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

  1. Treatment Success Rates (At ≥ 5 Years)

    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.

    Measured: 3+ years following first 2 years post-X-STOP implant through IDE study

Secondary outcomes (3)

  1. Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)

    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.

    Measured: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

  2. Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)

    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.

    Measured: 3+ years following first 2 years post-X-STOP implant through IDE study

  3. Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)

    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.

    Measured: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

Timeline

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

  1. First posted24 Sep 2007 (estimated)
  2. Study startDec 2006
  3. Study completionJun 2010

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00534092
Sponsor's protocol ID
LSS-004-LTO
Status last verified
Mar 2015
First submitted
20 Sep 2007
Last updated
5 Jan 2021
Data monitoring committee
No

Publications

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spinal Stenosis, run by Medtronic Spine LLC at 5 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2011). 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 Rates (At ≥ 5 Years) (time frame: 3+ years following first 2 years post-X-STOP implant through IDE study). 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 NCT00534092, which also lists 2 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 5 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in