Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00878579 |
Recruitment Status :
Terminated
(Sponsor Termination)
First Posted : April 9, 2009
Last Update Posted : February 21, 2013
|
Sponsor:
Interventional Spine, Inc.
Information provided by (Responsible Party):
Interventional Spine, Inc.
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | April 7, 2009 | ||
First Posted Date ICMJE | April 9, 2009 | ||
Last Update Posted Date | February 21, 2013 | ||
Study Start Date ICMJE | March 2009 | ||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Improvement in Oswestry Disability Index (ODI) [ Time Frame: 2 Years ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease | ||
Official Title ICMJE | A Study to Evaluate the Safety and Effectiveness of the PDS System to Treat Back Pain Associated With Degenerative Disc Disease | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | Lumbar Degenerative Disc Disease | ||
Intervention ICMJE |
|
||
Study Arms ICMJE |
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
20 | ||
Original Estimated Enrollment ICMJE |
292 | ||
Actual Study Completion Date ICMJE | February 2013 | ||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00878579 | ||
Other Study ID Numbers ICMJE | PDS-002-DDD | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Interventional Spine, Inc. | ||
Original Responsible Party | Bita Ghadimi, Director of Clinical Research, Interventional Spine, Inc. | ||
Current Study Sponsor ICMJE | Interventional Spine, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Interventional Spine, Inc. | ||
Verification Date | February 2013 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |