A Clinical Study of the Dynesys(R) Spinal System
Tracking Information | |
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First Received Date ICMJE | September 23, 2008 |
Last Updated Date | June 26, 2012 |
Start Date ICMJE | March 2003 |
Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status) [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00759057 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | A Clinical Study of the Dynesys(R) Spinal System |
Official Title ICMJE | A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization |
Brief Summary | This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion. |
Detailed Description | The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system. |
Study Type ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Condition ICMJE |
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Intervention ICMJE | Device: Posterior Pedicle Screw System
Implantation of Posterior Pedicle Screw System |
Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Terminated |
Enrollment ICMJE | 399 |
Estimated Completion Date | December 2015 |
Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 20 Years to 80 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00759057 |
Other Study ID Numbers ICMJE | G020291 |
Has Data Monitoring Committee | No |
Responsible Party | Zimmer, Inc. |
Study Sponsor ICMJE | Zimmer, Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Zimmer, Inc. |
Verification Date | June 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |