Lumbar Facet DiseaseNCT00887835
A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
A study testing PERPOS™ PLS in people with Lumbar Facet Disease, run by Interventional Spine, Inc..
Trial summary
The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Facet Disease
- What is being tested?
- PERPOS™ PLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2010
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males between 18 and 85
- Must have lumbar facet disease confirmed by:
- Documented pain relief with controlled lumbar facet block using local anesthetic or steroid administration; AND
- MRI or CT scan, with or without bone scan, obtained within 3 months of enrollment, confirming arthritic facet joints OR, must have lumbar facet disease (as confirmed above) and are contra-indicated for steroid injections, or non-compliant with conservative pain management treatments, or wish to avoid the side-effects of steroids or prescriptive pain medication treatment
- Must score at least 4 on a 10-point Visual Analog Scale (VAS) for back pain
- Must score at least 40% on the Oswestry Disability Index.
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- Must have less than 50% disc height loss
- Must have no greater than Grade I spondylolisthesis demonstrated on flexion and extension lumbar radiographs taken within 2 months of enrollment
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent.
Who cannot join
- Are within the first two PERPOS PLS System utilization experience of the investigator
- Have severe facet degeneration, radiographic findings of severe facet joint disease, degeneration of misshapen facet(s) or structural anomalies at the target fusion level that would preclude proper placement of the BONE-LOK Implant.
- Have evidenced malingering behavior related to workman's compensation claims
- Have had any significant prior intervention (greater than an injection) in the facet joint to be treated, or within two (2) levels above or two (2) levels below the facet joint to be treated
- Have had prior instrumentation of involved vertebrae at any time
- Have osteoporotic bone at the lumbar spine level to be treated based on the SCORE (Simple Calculated Osteoporosis Risk Estimation) screening questionnaire, (or a DEXA bone density measured T score <-1.0.).
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- Have scoliosis with lateral angulation >20 degrees
- Have an 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.
- Have a cyst in the canal associated with the facet
- Have neurologic deficit bowel or bladder dysfunction
- Have spinal canal or neural foramen compromise
- Have an infection (local or systemic)
- Have myelopathy
- Have abnormal coagulation time
- Have been or will be on anticoagulation therapy within 10 days of the study procedure
- Have radiculopathy
- Have cord compression or canal compromise requiring surgery for decompression
- Have disabling back pain secondary to another cause
- Have COPD that poses anesthesia risk
- Have severe cardiopulmonary deficiencies
- Have narcotic dependence or >90 days of narcotic pain medications
- Are morbidly obese (BMI >40)
- Have uncontrolled diabetes
- Have known allergies to implant materials, e.g., titanium.
- Are currently pregnant or lactating or considering becoming pregnant during the follow-up period
- Have been involved in an investigational drug or device study within the previous 30 days
About this study
The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.
Read the detailed description
The PERPOS™ PLS System involves a minimally invasive, percutaneous implant procedure via a small incision.
The PERPOS™ PLS is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
- Conditions
- Lumbar Facet Disease
- Being tested
- PERPOS™ PLS
- Keywords
- PERPOS fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERPOS™ PLSDevice
To stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.
| Study group | Role | What they receive |
|---|---|---|
| PERPOS™ PLS | Experimental | Minimally invasive transfacet fixation with PERPOS™ PLS as an aid to fusion Receives: Device: PERPOS™ PLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index and Visual Analogue Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Facet 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00887835
- Sponsor's protocol ID
- PLS-007-FUS
- Status last verified
- Apr 2009
- First submitted
- 23 Apr 2009
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
- ClinicalTrials.gov ID
- NCT00887835
- Acronym / sponsor ID
- PLS-007-FUS
- Conditions
- Lumbar Facet Disease
- Keywords
- PERPOS fusion
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Interventional Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (estimated)
- First posted
- 24 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 purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.
Detailed description
The PERPOS™ PLS System involves a minimally invasive, percutaneous implant procedure via a small incision.
The PERPOS™ PLS is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PERPOS™ PLS | Experimental | Device: PERPOS™ PLSMinimally invasive transfacet fixation with PERPOS™ PLS as an aid to fusion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females and males between 18 and 85
- Must have lumbar facet disease confirmed by:
- Must score at least 4 on a 10-point Visual Analog Scale (VAS) for back pain
- Must score at least 40% on the Oswestry Disability Index.
- Must have less than 50% disc height loss
Key exclusion criteria (26 listed)
- Are within the first two PERPOS PLS System utilization experience of the investigator
- Have severe facet degeneration, radiographic findings of severe facet joint disease, degeneration of misshapen facet(s) or structural anomalies at the target fusion level that would preclude proper placement of the BONE-LOK Implant.
- Have evidenced malingering behavior related to workman's compensation claims
- Have had any significant prior intervention (greater than an injection) in the facet joint to be treated, or within two (2) levels above or two (2) levels below the facet joint to be treated
- Have had prior instrumentation of involved vertebrae at any time
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 |
|---|---|---|
| PERPOS™ PLSTo stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. | Device | PERPOS™ PLS |
Primary outcome
Change in Oswestry Disability Index and Visual Analogue Scale
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PERPOS™ PLS in people with Lumbar Facet Disease, run by Interventional Spine, Inc..
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 10 inclusion and 26 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: withdrawn, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Oswestry Disability Index and Visual Analogue Scale (time frame: 1 year). 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 27 Apr 2012.