Lumbar Degenerative Disc DiseasePhase 2NCT00878579
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
A Phase 2 study testing PDS System and Fusion in people with Lumbar Degenerative Disc Disease, run by Interventional Spine, Inc. at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- PDS System and Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Feb 2013
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of DDD (back pain with degeneration of the disc by patient history, physical exam, and radiographic studies and with one or more of the following factors:
- Osteophyte formation of facet joints or vertebral endplates
- Facet joint degeneration (no more than mild to moderate)
- Subjects with ≤50% collapse of disc as compared to the adjacent level
- Subjects with or without a contained herniated nucleus pulposus <5 mm and no free fragment
- Skeletally mature subjects aged between 18 and 70 years of age inclusive.
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- Subjects with primarily back pain associated with degenerative disc disease of the lumbar spine at one level or two adjacent levels from L3 through S1. Subjects may have a lesser degree of leg pain at the same level(s).
- Subjects who require surgical or minimally invasive intervention, who have failed to adequately improve following 6 months of non-operative therapy.
- Subject is a surgical candidate for a posterior approach to the lumbar spine and is suitable for fusion using pedicle screw systems
- Subjects with a minimum baseline Oswestry Score of 40% (20/50).
- Subjects with a minimum baseline VAS Score of 40/100 mm.
- MRI diagnostic for DDD within 3 months of the screening visit.
- Subjects who are mentally, physically and psychosocially able to cooperate with the study procedures and return for all required follow-up visits.
- Subjects who are able to understand this study and have given voluntary, written informed consent to participate in this study.
Who cannot join
- Subjects who have leg pain greater than back pain.
- Subjects with severe facet degeneration, radiographic findings of severe facet joint disease, degeneration or misshapen facet(s) or structural anomalies at the target level(s) that would preclude placement of the PDS device or pedicle screw systems.
- Subjects who require a pedicle screw smaller than 4.5 mm.
- Subjects with Modic 3 bone changes at the target level(s).
- Spondylolisthesis > Grade 1 and/or spondylolysis at the target level(s).
- Subjects with myelopathy or cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).
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- Subjects with fixed motor deficit and/or peripheral neuropathy.
- Subjects with prior discectomy at the target level(s).
- Subjects with prior spine surgery, trauma, metastatic disease, or spinal deformity due to scoliosis (Cobb angle > 15 degrees) or kyphosis (> 11 degrees) at any lumbar level.
- Subjects who have used any investigational drug or device within the past 30 days or have had an experimental spinal implant at any time.
- Subjects with active local or systemic infection.
- Subjects with osteoporosis. A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen subjects. If DEXA is required, exclusion will be defined as a DEXA bone density measured T scored < -1.0.
- Subjects with metabolic bone disease (e.g. osteomalacia, Paget's disease).
- Subjects with rheumatoid arthritis or other autoimmune spondyloarthropathies.
- Subjects with a systemic disease that compromises life expectancy (e.g. HIV, AIDS, hepatitis) or are on immuno-suppressive agents.
- Subjects who are taking any drug known to potentially interfere with bony/soft tissue healing, (e.g., steroids at any dose daily within the last 12 months).
- Subjects with active malignancy: A subject with a history of any invasive malignancy (except non-melanoma skin cancer), unless s/he has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.
- Subjects with a known allergy to titanium and/or polycarbonate urethane (PCU).
- Subjects who have existing conditions or pending litigation claims that could compromise their participation, follow-up care, or treatment outcomes (e.g., drug or alcohol abuse).
- Subjects with a BMI of ≥ 40 kg/m2 or weight > 275 pounds (125 kg).
- Subjects who are pregnant or are planning a pregnancy during the study period.
- Subjects who are prisoners.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Cincinnati, Ohio
Study site
Willow Grove, Pennsylvania
About this study
Official title: A Study to Evaluate the Safety and Effectiveness of the PDS System to Treat Back Pain Associated With Degenerative Disc Disease
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- PDS System, Fusion
- Keywords
- back pain, Spine, Spinal, Lower back pain, Lumbar, Lumbar Pain, DDD, Degenerative Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS SystemDevice
Percutaneous Dynamic Stabilization System
FusionDevice
Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws
| Study group | Role | What they receive |
|---|---|---|
| PDS System | Experimental | Not described Receives: Device: PDS System |
| Fusion | Active comparator | Not described Receives: Device: Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Oswestry Disability Index (ODI)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Sponsor Termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interventional Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878579
- Sponsor's protocol ID
- PDS-002-DDD
- Status last verified
- Feb 2013
- First submitted
- 7 Apr 2009
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Effectiveness of the PDS System to Treat Back Pain Associated With Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00878579
- Acronym / sponsor ID
- PDS-002-DDD
- Conditions
- Lumbar Degenerative Disc Disease
- Keywords
- back pain, Spine, Spinal, Lower back pain, Lumbar, Lumbar Pain, DDD, Degenerative Disc Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Termination
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Interventional Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Apr 2009 (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 objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDS System | Experimental | Device: PDS System |
| Fusion | Active comparator | Device: Fusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Confirmation of DDD (back pain with degeneration of the disc by patient history, physical exam, and radiographic studies and with one or more of the following factors:
- Skeletally mature subjects aged between 18 and 70 years of age inclusive.
- Subjects with primarily back pain associated with degenerative disc disease of the lumbar spine at one level or two adjacent levels from L3 through S1. Subjects may have a lesser degree of leg pain at the same level(s).
- Subjects who require surgical or minimally invasive intervention, who have failed to adequately improve following 6 months of non-operative therapy.
- Subject is a surgical candidate for a posterior approach to the lumbar spine and is suitable for fusion using pedicle screw systems
Key exclusion criteria (22 listed)
- Subjects who have leg pain greater than back pain.
- Subjects with severe facet degeneration, radiographic findings of severe facet joint disease, degeneration or misshapen facet(s) or structural anomalies at the target level(s) that would preclude placement of the PDS device or pedicle screw systems.
- Subjects who require a pedicle screw smaller than 4.5 mm.
- Subjects with Modic 3 bone changes at the target level(s).
- Spondylolisthesis > Grade 1 and/or spondylolysis at the target level(s).
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 |
|---|---|---|
| PDS SystemPercutaneous Dynamic Stabilization System | Device | PDS System |
| FusionTransforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws | Device | Fusion |
Primary outcome
Improvement in Oswestry Disability Index (ODI)
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: Sponsor Termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PDS System and Fusion in people with Lumbar Degenerative Disc Disease, run by Interventional Spine, Inc. at 2 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 14 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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Termination). Results are not available in the source record.
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?
Improvement in Oswestry Disability Index (ODI) (time frame: 2 Years). 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 21 Feb 2013.