Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD)
Primary Purpose
Degenerative Disc Disease (DDD)
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FLD
Control
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease (DDD)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Cedars-Sinai Medical Center
- CORE Orthopaedic Medical Center
- The Spine Institute
- Resurgens Spine Center
- Spine Institute of Louisiana
- Nebraska Spine Center, LLC
- NYU/Hospital for Joint Diseases
- Carolina NeuroSurgery & Spine Associates
- Triangle Orthopaedic Associates, P.A.
- Central Texas Spine Institute
- Texas Back Institute
- Gordon Spine & Brain Associates
- Westend Hospital
- Klinikum-Goerlitz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
FLD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00775801
First Posted
October 13, 2008
Last Updated
January 18, 2018
Sponsor
AxioMed Spine Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00775801
Brief Title
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
Acronym
FLD
Official Title
An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AxioMed Spine Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease (DDD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
FLD
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
FLD
Intervention Description
Artificial lumbar disc
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Artificial lumbar disc
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
CORE Orthopaedic Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
The Spine Institute
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Resurgens Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Nebraska Spine Center, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
NYU/Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Carolina NeuroSurgery & Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Triangle Orthopaedic Associates, P.A.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Central Texas Spine Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
76208
Country
United States
Facility Name
Gordon Spine & Brain Associates
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Westend Hospital
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Klinikum-Goerlitz
City
Gorlitz
ZIP/Postal Code
02828
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.axiomed.com
Description
AxioMed's Website
Learn more about this trial
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
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