Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designe… (NCT00405691) | Clinical Trial Compass
CompletedPhase 3
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
United States450 participantsStarted 2006-09
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* Moderate to Severe lumbar spinal stenosis at a single level\* between L3 - L5, with radiographic confirmation of any one of the following on CT, MRI, plain x-ray or myelography:
* Evidence of thecal sac and/or cauda equina compression
* Evidence of nerve root impingement by either osseous or non-osseous elements;
* Evidence of hypertrophic facets with canal encroachment Moderate/severe spinal stenosis is further defined radiographically as;
* moderate canal stenosis is a 25-49% reduction in the A/P dimension of the central and/or lateral foramen when compared to adjacent (cephlad) level
* Severe canal stenosis is defined as 50% or greater reduction in the A/P dimension of the central and/or lateral foramen when compared to the adjacent (cephlad) level \*\*Patients which require minimal decompressive surgery at an adjacent level, may have a laminonotmy or soft tissue resection as long as the decompression does not compromise the stability of the adjacent segment.
* At least six (6) months of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage; administration of epidural/facet injections.
* Age 40-75 years old (male or female).
* Up to one prior surgery without instrumentation implanted at any lumbar vertebral level limited to the following:
* IDET,
* laminotomy,
* laminectomy,
* foraminotomy
* Discectomy (that occurred at least three years ago …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary safety and effectiveness to determine patient success are: 1 .15% ODI improvement vs baseline at 24 mos; 20 mm leg and back pain VAS improvement vs baseline at 24 mos.
2
2. improvement of at least 20 mm in leg pain at 24 months compared to baseline using a VAS pain scale;
3
3. maintenance or improvement of neurological status;
4
4. no revisions, supplemental fixation, and removals;
5
5. absence of major device-related complications (device component degradation or breakage, device component separation or disassembly, device component loosening (including screw loosening)) requiring revisions, supplemental fixation, and removals;
6
6. absence of spontaneous fusion in the investigational group and lack of fusion in the control