SpondylolisthesisDSSNCT01461005
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
A study testing Dynamic Stabilization System (DSS) in people with Spondylolisthesis and Neurologic Deficits, run by Paradigm Spine at 1 site in United States.
Trial summary
The purpose of the Post-Market Surveillance study is to evaluate safety. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Spondylolisthesis, Neurologic Deficits, Kyphosis
- What is being tested?
- Dynamic Stabilization System (DSS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2016
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is skeletally mature (21-85 years old).
- Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
- Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
- Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.
Who cannot join
- The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
- Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
- Acute or chronic systemic, spinal or localized infections.
- Active, severe systemic and metabolic diseases.
- Obesity defined as Body Mass Index > 35.
- Subject is pregnant or interested in becoming pregnant in the next 36 months.
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- Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
- Lack of patient cooperation.
- Foreign body sensitivity to the implant material.
- Degenerative scoliosis greater than 25 degrees.
- Grade 4 degenerative spondylolisthesis (>75% slip).
- Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
- Soft tissue deficit not allowing wound closure.
- Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
- Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
- Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
- Pars defect.
- Clinically compromised vertebral bodies at affected level due to current or past trauma.
- Prisoner or ward of the state.
- Currently in litigation regarding a spinal condition.
- Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
- Is currently involved in a study of another investigational product for similar purpose.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95816
About this study
Official title: A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
Read the detailed description
Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Being tested
- Dynamic Stabilization System (DSS)
- Keywords
- Spondylolisthesis, Neurologic impairment, Kyphosis, Pseudarthrosis
- Medical subject headings
- Spondylolisthesis, Neurologic Manifestations, Kyphosis, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Stabilization System (DSS)Device
Dynamic Stabilization System
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Stabilization System | Experimental | Dynamic Stabilization System (DSS) System Receives: Device: Dynamic Stabilization System (DSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated.
Measured: 6 months
Secondary outcomes (5)
Measurement of Lower Back Pain as Assessed by Visual Analog Scale
Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Measured: 6 months
Measurement of Right Leg Pain as Assessed by Visual Analog Scale
Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Measured: 6 months
Measurement of Left Leg Pain as Assessed by Visual Analog Scale
Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Measured: 6 months
Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline.
The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
Measured: Pre-Op, 6 weeks, 6 months, 12 months, and 24 months
Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).
ODI is a questionnaire that provides information on back and the affects on managing every day life by diving questions into 10 sections. The total possible score for each section is 0-5. The scores are then converted into percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: FDA reclassified so all 522 studies were stopped,
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpondylolisthesisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paradigm Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Gitela Gandelman, Study director, Paradigm Spine LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461005
- Sponsor's protocol ID
- Dynamic Stabilization System
- Acronym
- DSS
- Status last verified
- Feb 2020
- First submitted
- 18 Oct 2011
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)
- ClinicalTrials.gov ID
- NCT01461005
- Acronym / sponsor ID
- DSS / Dynamic Stabilization System
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Keywords
- Spondylolisthesis, Neurologic impairment, Kyphosis, Pseudarthrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA reclassified so all 522 studies were stopped,
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Paradigm SpineIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Post-Market Surveillance study is to evaluate safety.
Detailed description
Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Stabilization System | Experimental | Device: Dynamic Stabilization System (DSS)Dynamic Stabilization System (DSS) System |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is skeletally mature (21-85 years old).
- Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
- Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
- Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.
Key exclusion criteria (22 listed)
- The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
- Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
- Acute or chronic systemic, spinal or localized infections.
- Active, severe systemic and metabolic diseases.
- Obesity defined as Body Mass Index > 35.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Stabilization System (DSS)Dynamic Stabilization System | Device | Dynamic Stabilization System |
Primary outcome
Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
Time frame: 6 months
The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated.
5 secondary outcomes
Measurement of Lower Back Pain as Assessed by Visual Analog Scale
Time frame: 6 months
Measurement of Right Leg Pain as Assessed by Visual Analog Scale
Time frame: 6 months
Measurement of Left Leg Pain as Assessed by Visual Analog Scale
Time frame: 6 months
Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline.
Time frame: Pre-Op, 6 weeks, 6 months, 12 months, and 24 months
Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gitela Gandelman study director
Paradigm Spine LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Stabilization System (DSS) in people with Spondylolisthesis and Neurologic Deficits, run by Paradigm Spine 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 4 inclusion and 22 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 19 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2019). 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?
Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure. (time frame: 6 months). 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 19 Feb 2020.