Expired Study
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Austin, Texas 78731


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

PR-125


NCT ID:

NCT00775801


Secondary ID:


Study Acronym:

FLD


Brief Title:

Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease


Official Title:

An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AxioMed Spine Corporation


Oversight Authority:

  • Germany: Federal Institute for Drugs and Medical Devices
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Study Dates

Start Date:September 2008
Completion Date:July 2018
Completion Type:Anticipated
Primary Completion Date:July 2018
Primary Completion Type:Anticipated
Verification Date:January 2018
Last Changed Date:January 18, 2018
First Received Date:October 13, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:FLD
Description:Artificial lumbar disc
Arm Name:Treatment
Intervention Type:Device
Name:Control
Description:Artificial lumbar disc
Arm Name:Control

Study Arms

Study Arm Type:Active Comparator
Arm Name:Control
Study Arm Type:Experimental
Arm Name:Treatment
Description:FLD

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AxioMed Spine Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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