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.
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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. improvement of at least 20 mm in leg pain at 24 months compared to baseline using a VAS pain scale;
3. maintenance or improvement of neurological status;
4. no revisions, supplemental fixation, and removals;
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. absence of spontaneous fusion in the investigational group and lack of fusion in the control