ClinicalTrials.gov

History of Changes for Study: NCT00775801
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD)
Latest version (submitted January 18, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 17, 2008 None (earliest Version on record)
2 January 16, 2009 Contacts/Locations and Study Status
3 February 10, 2009 Contacts/Locations and Study Status
4 March 4, 2009 Study Status and Contacts/Locations
5 June 26, 2009 Study Status and Contacts/Locations
6 July 20, 2009 Study Status, Contacts/Locations and Eligibility
7 September 9, 2009 Contacts/Locations and Study Status
8 September 10, 2009 Contacts/Locations and Study Status
9 November 24, 2009 Contacts/Locations and Study Status
10 February 4, 2010 Study Status and Contacts/Locations
11 June 2, 2010 Contacts/Locations and Study Status
12 July 14, 2010 Contacts/Locations and Study Status
13 August 23, 2010 Study Status and Contacts/Locations
14 December 3, 2010 Contacts/Locations and Study Status
15 January 13, 2011 Study Status and Contacts/Locations
16 March 4, 2011 Study Status and Contacts/Locations
17 April 4, 2011 Study Status and Contacts/Locations
18 January 18, 2012 Contacts/Locations, Sponsor/Collaborators and Study Status
19 May 2, 2013 Study Status and Contacts/Locations
20 April 25, 2014 Study Status
21 May 27, 2014 Recruitment Status, Study Status and Contacts/Locations
22 July 28, 2016 Study Status
23 July 19, 2017 Study Status
24 January 18, 2018 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT00775801
Submitted Date:  October 17, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: PR-125
Brief Title: Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD)
Official Title: An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2008
Overall Status: Recruiting
Study Start: September 2008
Primary Completion: September 2012 [Anticipated]
Study Completion: December 2012 [Anticipated]
First Submitted: October 13, 2008
First Submitted that
Met QC Criteria:
October 17, 2008
First Posted: October 20, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 17, 2008
Last Update Posted: October 20, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AxioMed Spine Corporation
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Degenerative Disc Disease (DDD)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment
FLD
Device: FLD
Artificial lumbar disc
Active Comparator: Control Device: Control
Artificial lumbar disc
Open or close this module Outcome Measures
Primary Outcome Measures:
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.
[ Time Frame: 24 Months ]

Secondary Outcome Measures:
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.
[ Time Frame: 24 Months ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 34.5 mm in the mediallateral and/or 27 mm in the anterior-posterior directions.
  • Subjects not able to meet follow-up requirements.
  • Any previous or current litigation related to the spine.
Open or close this module Contacts/Locations
Central Contact Person: Burkhard Rischke, Dr. Med.
Telephone: 49016090716123
Email: b-rischke@hamburg.de
Study Officials: Burkhard Rischke, Dr. Med.
Principal Investigator
Westend Hospital
Locations: Germany
Westend Hospital
[Recruiting]
Berlin, Germany, 14050
Contact:Principal Investigator: Burkhard Rischke, Dr. Med.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: AxioMed's Website
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services