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| Sponsor: | AxioMed Spine Corporation |
|---|---|
| Information provided by (Responsible Party): | AxioMed Spine Corporation |
| ClinicalTrials.gov Identifier: | NCT00775801 |
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.
| Condition | Intervention |
|---|---|
|
Degenerative Disc Disease (DDD) |
Device: FLD Device: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
FLD
|
Device: FLD
Artificial lumbar disc
|
| Active Comparator: Control |
Device: Control
Artificial lumbar disc
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Janice Kim 310-248-7348 JKim@laspineinstitute.com | |
| Principal Investigator: Rick B. Delamarter, M.D. | |
| Sub-Investigator: Michael A. Kropf, M.D. | |
| Sub-Investigator: Hyun W. Bae, M.D. | |
| Sub-Investigator: Alexandre Rasouli, M.D. | |
| CORE Orthopaedic Medical Center | Recruiting |
| San Diego, California, United States, 92024 | |
| Contact: Farouk Awad 760-632-6719 ext 162 FAwad@CoreOrthopaedic.com | |
| Principal Investigator: Timothy Peppers, MD | |
| Sub-Investigator: Jaimeson Glenn, MD | |
| United States, Colorado | |
| The Spine Institute | Active, not recruiting |
| Loveland, Colorado, United States, 80538 | |
| United States, Georgia | |
| Resurgens Spine Center | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Renee Gaiter, RN, BSN 678-843-6051 rgaiter@sjha.org | |
| Principal Investigator: Paul R. Jeffords, M.D. | |
| United States, Louisiana | |
| Spine Institute of Louisiana | Recruiting |
| Shreveport, Louisiana, United States, 71101 | |
| Contact: Ajay Jawahar, MD 318-629-5555 ajawahar@louisianaspine.org | |
| Principal Investigator: Pierce D. Nunley, MD | |
| Sub-Investigator: David A. Cavanaugh, MD | |
| Sub-Investigator: Eubulus J. Kerr, MD | |
| Sub-Investigator: Ajay Jawahar, MD | |
| Sub-Investigator: Philip A Utter, MD | |
| United States, Nebraska | |
| Nebraska Spine Center, LLC | Recruiting |
| Omaha, Nebraska, United States, 68154 | |
| Contact: Kay Ryschon, M.S. 402-496-5513 kryschon@nebraskaspinecenter.com | |
| Principal Investigator: Timothy Burd, M.D. | |
| Sub-Investigator: Jonathan Fuller, M.D. | |
| Sub-Investigator: Howard R Woodward, M.D. | |
| Sub-Investigator: Michael Longley, M.D. | |
| Sub-Investigator: Eric Phillips, M.D. | |
| Sub-Investigator: John McClellan, M.D. | |
| Sub-Investigator: Brian Gill, M.D. | |
| United States, New York | |
| NYU/Hospital for Joint Diseases | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Jessie A Pierre, CCRC 212-263-3574 Jessie.Pierre@nyumc.org | |
| Principal Investigator: Jeffrey Goldstein, M.D. | |
| Sub-Investigator: Thomas J Errico, M.D. | |
| Sub-Investigator: John A Bendo, M.D. | |
| United States, North Carolina | |
| Carolina NeuroSurgery & Spine Associates | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Peggy Boltes, RN 704-831-4006 peggy.boltes@cnsa.com | |
| Principal Investigator: Domagoj Coric, MD | |
| Sub-Investigator: Frederick Finger, MD | |
| Sub-Investigator: Paul K Kim, MD | |
| Triangle Orthopaedic Associates, P.A. | Recruiting |
| Durham, North Carolina, United States, 27704 | |
| Contact: Crystal Hill, BSN 919-281-1870 chill@triangleortho.com | |
| Principal Investigator: David Musante, MD | |
| Sub-Investigator: Thomas A. Dimmig, MD | |
| Sub-Investigator: Ralph Liebelt, MD | |
| United States, Texas | |
| Central Texas Spine Institute | Recruiting |
| Austin, Texas, United States, 78731 | |
| Contact: Celeste Figg 512-795-2225 cfigg@pqrinc.com | |
| Principal Investigator: Randall F Dryer, M.D. | |
| Texas Back Institute | Active, not recruiting |
| Plano, Texas, United States, 76208 | |
| Gordon Spine & Brain Associates | Recruiting |
| Tyler, Texas, United States, 75701 | |
| Contact: Marolyn Stocks, RN BSN CCRC 903-363-1557 MarolynS@gordonspine.com | |
| Principal Investigator: Charles R Gordon, M.D. | |
| Sub-Investigator: Andy Redmond, M.D. | |
| Sub-Investigator: Brad Duhon, M.D. | |
| Sub-Investigator: Todd Raabe, M.D. | |
| Sub-Investigator: Guy O Danielson, M.D. | |
| Sub-Investigator: Michael Russell, M.D. | |
| Germany | |
| Westend Hospital | Active, not recruiting |
| Berlin, Germany, 14050 | |
| Klinikum-Goerlitz | Active, not recruiting |
| Gorlitz, Germany, 02828 | |
More Information
| Responsible Party: | AxioMed Spine Corporation |
| ClinicalTrials.gov Identifier: | NCT00775801 History of Changes |
| Other Study ID Numbers: | PR-125 |
| Study First Received: | October 13, 2008 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
|
Spinal Diseases Intervertebral Disk Degeneration Bone Diseases Musculoskeletal Diseases |