Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
FLD
An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
1 other identifier
interventional
300
2 countries
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 13, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJanuary 23, 2018
January 1, 2018
9.8 years
October 13, 2008
January 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
24 Months
Study Arms (2)
Treatment
EXPERIMENTALFLD
Control
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
CORE Orthopaedic Medical Center
San Diego, California, 92024, United States
The Spine Institute
Loveland, Colorado, 80538, United States
Resurgens Spine Center
Atlanta, Georgia, 30342, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Nebraska Spine Center, LLC
Omaha, Nebraska, 68154, United States
NYU/Hospital for Joint Diseases
New York, New York, 10003, United States
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, 28204, United States
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27704, United States
Central Texas Spine Institute
Austin, Texas, 78731, United States
Texas Back Institute
Plano, Texas, 76208, United States
Gordon Spine & Brain Associates
Tyler, Texas, 75701, United States
Westend Hospital
Berlin, 14050, Germany
Klinikum-Goerlitz
Görlitz, 02828, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2008
First Posted
October 20, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
January 23, 2018
Record last verified: 2018-01