Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
Public ClinicalTrials.gov record NCT00405691. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multi-Center Clinical Study to Assess the Saftey and Effectiveness of the Impliant TOPS System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00405691
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2006 (Type not available)
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- May 18, 2011
Started 2006
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Institute for Advanced Spinal Research In California | Beverly Hills | California | 90211 | — |
| Century City Doctors Hospital | Beverly Hills | California | 90212 | — |
| Seton Medical Center | Daly City | California | 94015 | — |
| Yale University - School of Medicine | New Haven | Connecticut | 06519 | — |
| The Orthopaedic & Sports Medicine Ctr. | Trumbull | Connecticut | 06611 | — |
| Florida Orthopaedic Institute | Tampa | Florida | 33637 | — |
| Illinois Neuro Spine Center | Ogden | Illinois | 60504 | — |
| Saint Joseph Medical Center & Orthopaedic Associates | Baltimore | Maryland | 21204 | — |
| The Boston Spine Group | Boston | Massachusetts | 02120 | — |
| New England Neuro Assoc. | Springfiled | Massachusetts | 01104 | — |
| Columbia Orthopedic Group | Columbia | Missouri | 65201 | — |
| Orthopedic Spine Care of Long Island | Huntington Station | New York | 11746 | — |
| Buffalo Spine Surgery | Lockport | New York | 14094 | — |
| Carolinas Medical Center Hospital - Neurosurgery & Spine Associates | Charlotte | North Carolina | 28204 | — |
| NeuroSpine Center of Wisconsin | Appleton | Wisconsin | 54913 | — |
| Milwaukee Spinal Specialists | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00405691, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 18, 2011 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00405691 live on ClinicalTrials.gov.