Degenerative Disc Disease (DDD)FLDNCT00775801
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
A study testing FLD in people with Degenerative Disc Disease (DDD), run by AxioMed Spine Corporation at 14 sites in 2 countries.
Trial summary
This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Degenerative Disc Disease (DDD)
- What is being tested?
- FLD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Sep 2008to Jul 2018
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level, degenerative disc disease at L3 to S1, inclusive.
- Minimum of 6 months of unsuccessful conservative treatment.
- Subject is a surgical candidate for an anterior approach to the lumbar spine (<3 abdominal surgeries).
- Back pain at the operative level only (by discogram, if necessary).
- Leg pain and/or back pain due to disc space settling, with or without radicular symptoms related to foraminal narrowing.
- Subject must understand and sign the written Informed Consent.
Who cannot join
- Prior fusion at any lumbar level.
- Clinical evidence of adjacent lumbar segment disease.
- Previous trauma to the L3, L4, L5, or S1 levels (in compression or burst).
- Non-contained or extruded herniated nucleus pulposus.
- Congenital stenosis or central/lateral stenosis (mid-sagittal stenosis of <8mm by CT or MR) secondary to acquired degenerative disease requiring treatment that destabilizes the spine (requiring fusion), or for subjects in whom increased motion may increase symptoms.
- Retro- or spondylolisthesis of ≥ 2.5 mm which is either fixed or present on flexion/extension films, and slippage of vertebral body where the listhesis is due to disc space settling in the absence of degenerative facets or a pars interarticularis defect.
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- Significant kyphosis (>11ْ sagittal plane deformity).
- History of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).
- Acute or chronic infection (local or systemic).
- Instability or facet joint arthrosis, clinically significant.
- Arachnoiditis.
- Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
- Radiographic findings of a fused or total collapsed disc.
- Subject using medications or drugs known to potentially interfere with bone or soft tissue healing (high-dose of steroids, osteoclast inhibitors, etc.).
- Systemic disease affecting the spine, including rheumatoid arthritis, autoimmune disease, AIDS, HIV, or hepatitis.
- Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed separately).
- Psychosocial disorders (e.g. evidence or drug or alcohol abuse).
- Morbid (extreme) obesity (BMI ≥ 40 kg/m2).
- Bone growth stimulator use in spine.
- Investigational drug or device use within 30 days.
- Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan if poor bone quality is suspected (T-score < -1.0).
- If female of childbearing potential, pregnant or interested in becoming pregnant in the next three years.
- Type 1 diabetes, and uncontrolled (or poorly controlled) Type 2 diabetes.
- Subjects with a history of implant rejection.
- Provocative discography with non-concordant pain at the operative level.
- Incarcerated subjects.
- Myelopathy.
- Significant leg pain of a radicular or neurogenic claudication nature.
- Involved vertebral endplates dimensionally smaller then 39 mm in the mediallateral and/or 32 mm in the anterior-posterior directions.
- Subjects not able to meet follow-up requirements.
- Lumbar scoliosis > 11 degrees.
- Any previous or current litigation related to the spine.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Resurgens Spine Center
Atlanta, Georgia, 30342
Central Texas Spine Institute
Austin, Texas, 78731
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, 28204
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27704
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Spine Institute
Loveland, Colorado, 80538
NYU/Hospital for Joint Diseases
New York, New York, 10003
Nebraska Spine Center, LLC
Omaha, Nebraska, 68154
Texas Back Institute
Plano, Texas, 76208
CORE Orthopaedic Medical Center
San Diego, California, 92024
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Gordon Spine & Brain Associates
Tyler, Texas, 75701
About this study
Official title: An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.
Read the detailed description
The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This is a prospective, multi-center, randomized, controlled trial. Subjects with DDD will be randomized to disc arthroplasty with the FLD device or a control device. The overall purpose (objective) of this trial is to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device.
- Conditions
- Degenerative Disc Disease (DDD)
- Being tested
- FLD, Control
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLDDevice
Artificial lumbar disc
ControlDevice
Artificial lumbar disc
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | FLD Receives: Device: FLD |
| Control | Active comparator | Not described Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success will be determined by a composite of measures regarding subject self-assessment of function (disability), low back pain, neurological function and device implantation status.
Measured: 24 Months
Secondary outcomes (1)
The improvement of subject self-assessment of function (disability), low back pain, patient satisfaction, neurological function and device implantation status at the 24 month follow-up compared to baseline.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease (DDD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AxioMed Spine Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775801
- Sponsor's protocol ID
- PR-125
- Acronym
- FLD
- Status last verified
- Jan 2018
- First submitted
- 13 Oct 2008
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00775801
- Acronym / sponsor ID
- FLD / PR-125
- Conditions
- Degenerative Disc Disease (DDD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AxioMed Spine CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 20 Oct 2008 (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.
This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.
Detailed description
The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This is a prospective, multi-center, randomized, controlled trial. Subjects with DDD will be randomized to disc arthroplasty with the FLD device or a control device. The overall purpose (objective) of this trial is to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: FLDFLD |
| Control | Active comparator | Device: Control |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Single level, degenerative disc disease at L3 to S1, inclusive.
- Minimum of 6 months of unsuccessful conservative treatment.
- Subject is a surgical candidate for an anterior approach to the lumbar spine (<3 abdominal surgeries).
- Back pain at the operative level only (by discogram, if necessary).
- Leg pain and/or back pain due to disc space settling, with or without radicular symptoms related to foraminal narrowing.
Key exclusion criteria (32 listed)
- Prior fusion at any lumbar level.
- Clinical evidence of adjacent lumbar segment disease.
- Previous trauma to the L3, L4, L5, or S1 levels (in compression or burst).
- Non-contained or extruded herniated nucleus pulposus.
- Congenital stenosis or central/lateral stenosis (mid-sagittal stenosis of <8mm by CT or MR) secondary to acquired degenerative disease requiring treatment that destabilizes the spine (requiring fusion), or for subjects in whom increased motion may increase symptoms.
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 |
|---|---|---|
| FLDArtificial lumbar disc | Device | Treatment |
| ControlArtificial lumbar disc | Device | Control |
Primary outcome
Overall success will be determined by a composite of measures regarding subject self-assessment of function (disability), low back pain, neurological function and device implantation status.
Time frame: 24 Months
1 secondary outcome
The improvement of subject self-assessment of function (disability), low back pain, patient satisfaction, neurological function and device implantation status at the 24 month follow-up compared to baseline.
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- AxioMed's WebsiteLink provided by the sponsor.
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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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLD in people with Degenerative Disc Disease (DDD), run by AxioMed Spine Corporation at 14 sites in 2 countries.
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 6 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany. 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?
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?
Overall success will be determined by a composite of measures regarding subject self-assessment of function (disability), low back pain, neurological function and device implantation status. (time frame: 24 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 23 Jan 2018.