Spinal StenosisNCT01485289
Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
An observational study of Spinal Stenosis, run by Rachiotek LLC at 1 site in United States.
Trial summary
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc . Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spinal Stenosis
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Any patient that after having met all of the inclusion/exclusion criteria identified for the Stabilimax Investigational Device Exemption study had enrolled in the Stabilimax Investigational Device Exemption study and were implanted with the Stabilimax NZ or the control device.
Who cannot join
- Any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. This applies only if the patient was formally withdrawn from the study at that time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan. No additional patient treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval for a new study and the information collected in this study is essential for supporting the new Investigational Device Exemption application.
- Conditions
- Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Stabilimax | Not described | |
| Control, Posterolateral Fusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Leg Pain
Patient demonstrates a reduction in leg pain from baseline of at least 20 mm on a 100 mm visual analog scale (VAS)
Measured: Minimum 24 months post procedure
Zurich Claudication Questionnaire (ZCQ)
Clinically significant improvement from baseline defined by a minimum decrease of .5 as measured by the Zurich Claudication Questionnaire for both Symptom Severity(SS) and Physical Function (PF) scores
Measured: Minimum 24 months post procedure
Major Device Related (MDR) Complications
Patient experiences no major device-related complications
Measured: Minimum 24 months post procedure
Revision, Reoperation, or Removal
The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.
Measured: Minimum 24 months post procedure
Secondary outcomes (4)
Oswestry Disability Index (ODI)
Changes from baseline in function scores (Oswestry Disability Index)
Measured: Minimum 24 months post procedure
Presence (control) or Absence (Stabilimax)of fusion
Presence (control patients) or absence (Stabilimax NZ® patients) of fusion at 24-months post procedure
Measured: Minimum 24 months post procedure
Adverse Events (AE)
safety will be assessed by quantification of the incidence of all adverse events observed during the study period by type.
Measured: Minimum 24 months post procedure
Physician Satisfaction Scale
Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales.
Measured: Immediately post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachiotek LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485289
- Sponsor's protocol ID
- MLucey
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2011
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
- ClinicalTrials.gov ID
- NCT01485289
- Acronym / sponsor ID
- MLucey
- Conditions
- Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Rachiotek LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan. No additional patient treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval for a new study and the information collected in this study is essential for supporting the new Investigational Device Exemption application.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Stabilimax | – | – |
| Control, Posterolateral Fusion | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Any patient that after having met all of the inclusion/exclusion criteria identified for the Stabilimax Investigational Device Exemption study had enrolled in the Stabilimax Investigational Device Exemption study and were implanted with the Stabilimax NZ or the control device.
Key exclusion criteria (1 listed)
- Any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. This applies only if the patient was formally withdrawn from the study at that time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale (VAS) for Leg Pain
Time frame: Minimum 24 months post procedure
Patient demonstrates a reduction in leg pain from baseline of at least 20 mm on a 100 mm visual analog scale (VAS)
Zurich Claudication Questionnaire (ZCQ)
Time frame: Minimum 24 months post procedure
Clinically significant improvement from baseline defined by a minimum decrease of .5 as measured by the Zurich Claudication Questionnaire for both Symptom Severity(SS) and Physical Function (PF) scores
Major Device Related (MDR) Complications
Time frame: Minimum 24 months post procedure
Patient experiences no major device-related complications
Revision, Reoperation, or Removal
Time frame: Minimum 24 months post procedure
The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.
4 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Minimum 24 months post procedure
Presence (control) or Absence (Stabilimax)of fusion
Time frame: Minimum 24 months post procedure
Adverse Events (AE)
Time frame: Minimum 24 months post procedure
Physician Satisfaction Scale
Time frame: Immediately post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis, run by Rachiotek LLC at 1 site 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 1 inclusion and 1 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) for Leg Pain (time frame: Minimum 24 months post procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.