Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
|First Received Date ICMJE||November 29, 2006|
|Last Updated Date||May 17, 2011|
|Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00405691 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis|
|Official Title ICMJE||A Prospective, Multi-Center Clinical Study to Assess the Saftey and Effectiveness of the Impliant TOPS System|
|Brief Summary||The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal claudication, that results from moderate or severe lumbar spinal stenosis at one vertebral level between L3 and L5.|
This study is being conducted to evaluate a new surgical implant (TOPS™ System, Impliant). The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the affected vertebral level following decompression surgery to alleviate pain stemming from moderate/severe lumbar spinal stenosis while maintaining range of motion.
When non-surgical treatment is ineffective, decompression (including laminectomy and medial facetectomy) and fusion of the spinal segments with moderate/severe lumbar spinal stenosis has been used to stabilize the motion segment and to alleviate the patient's clinical symptoms. Spinal fusion surgery using metal instrumentation is designed to stop motion at a painful, unstable spinal segment by permanently fusing the segment. While fusion may decrease pain generated at the treated segment, the procedure also eliminate motion at the implanted level and transfers and thus increases loads on the adjacent segments.
The TOPS System is intended to provide stabilization following decompression in patients with disease at one level from L3 to L5. The ideal goal of stabilization is to preserve mobility but eliminate abnormal motion and prevent deformity. By using the TOPS System, it may be possible to preserve load-bearing dynamics and spinal biomechanics, and thereby maintaining motion at the treated segment.
The TOPS surgical technique, utilizing a standard top loading pedicle screw-based system, is the same as a standard posterior spinal fusion with the exception of the placement of the TOPS motion segment. Therefore, the surgeon will be executing the steps of surgical exposure, decompression, insertion of pedicle screws (with attention to proper placement/alignment) and closure in the same manner as he/she would in a standard posterior spinal fusion.
The objective of the clinical investigation is to compare the safety and effectiveness of the TOPS System to a control group of patients undergoing posterior spinal fusion with pedicle screws and local autograft bone in the treatment of back and leg pain that results from moderate/severe lumbar spinal stenosis at a single vertebral level between L3 to L5.
Prior to entering the study, patients will be evaluated by the investigator according to the inclusion/exclusion criteria. Patients recruited to the study will be randomized in a 1:1 ratio to undergo implantation of the TOPS System or the control spinal fusion procedure. Patient follow-up will be evaluated immediately post-operatively and at discharge, 6 weeks, 3 months, 6 months, 12 months, and 24 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Intervention ICMJE||Device: "TOPS System" - Total Posterior Arthroplasty Implant|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||450|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Note: Additional inclusion/exclusion criteria are applied. Please contact Impliant for further details.
|Ages||40 Years to 75 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00405691|
|Other Study ID Numbers ICMJE||TOPS-US-IDE-002|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Dan Finan, Impliant, Inc.|
|Study Sponsor ICMJE||Impliant, Ltd.|
|Collaborators ICMJE||Not Provided|
|PRS Account||Impliant, Ltd.|
|Verification Date||January 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP