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| Sponsor: | Interventional Spine, Inc. |
|---|---|
| Information provided by: | Interventional Spine, Inc. |
| ClinicalTrials.gov Identifier: | NCT00878579 |
Purpose
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Lumbar Degenerative Disc Disease |
Device: PDS System Device: Fusion |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Safety and Effectiveness of the PDS System to Treat Back Pain Associated With Degenerative Disc Disease |
| Estimated Enrollment: | 292 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PDS System |
Device: PDS System
Percutaneous Dynamic Stabilization System
|
| Active Comparator: Fusion |
Device: Fusion
Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Confirmation of DDD (back pain with degeneration of the disc by patient history, physical exam, and radiographic studies and with one or more of the following factors:
Exclusion Criteria:
Contacts and Locations| Contact: Carol Roche | croche@i-spineinc.com |
| United States, Ohio | |
| Recruiting | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Recruiting | |
| Willow Grove, Pennsylvania, United States | |
More Information
| Responsible Party: | Carol Roche, Clinical Research, Interventional Spine, Inc. |
| ClinicalTrials.gov Identifier: | NCT00878579 History of Changes |
| Other Study ID Numbers: | PDS-002-DDD |
| Study First Received: | April 7, 2009 |
| Last Updated: | February 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
back pain Spine Spinal Lower back pain |
Lumbar Lumbar Pain DDD Degenerative Disc Disease |
|
Spinal Diseases Intervertebral Disk Degeneration Bone Diseases Musculoskeletal Diseases |