At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.
In Brief
An observational study evaluating PASS LP implants, PASS DEGEN, and 1 other intervention for Thoracolumbar Disc Degeneration and 3 related conditions. Completed, enrolled 77 participants across 4 sites.
Detailed Summary
The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).
Study Details
Timeline
Interventions
Thoraco lumbar arthrodesis
Thoraco lumbar arthrodesis
Thoraco lumbar arthrodesis