Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00775801
Other study ID # PR-125
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 13, 2008
Last updated January 18, 2018
Start date September 2008
Est. completion date July 2018

Study information

Verified date January 2018
Source AxioMed Spine Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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 (>11? 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 Design


Intervention

Device:
FLD
Artificial lumbar disc
Control
Artificial lumbar disc

Locations

Country Name City State
Germany Westend Hospital Berlin
Germany Klinikum-Goerlitz Gorlitz
United States Resurgens Spine Center Atlanta Georgia
United States Central Texas Spine Institute Austin Texas
United States Carolina NeuroSurgery & Spine Associates Charlotte North Carolina
United States Triangle Orthopaedic Associates, P.A. Durham North Carolina
United States Cedars-Sinai Medical Center Los Angeles California
United States The Spine Institute Loveland Colorado
United States NYU/Hospital for Joint Diseases New York New York
United States Nebraska Spine Center, LLC Omaha Nebraska
United States Texas Back Institute Plano Texas
United States CORE Orthopaedic Medical Center San Diego California
United States Spine Institute of Louisiana Shreveport Louisiana
United States Gordon Spine & Brain Associates Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
AxioMed Spine Corporation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT02171169 - Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures N/A
Not yet recruiting NCT06011551 - HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs N/A
Terminated NCT00374413 - Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD) N/A
Active, not recruiting NCT01551901 - Luna Interbody System for Fusion Trial N/A
Recruiting NCT05489822 - PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
Active, not recruiting NCT03737461 - Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive Phase 2/Phase 3
Enrolling by invitation NCT05536453 - Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine
Completed NCT01972256 - A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures N/A

External Links