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The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
Sponsor: Medicrea International
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).
Official title: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
77
Start Date
2018-05-17
Completion Date
2024-05-22
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
PASS LP implants
Thoraco lumbar arthrodesis
PASS DEGEN
Thoraco lumbar arthrodesis
PASS TULIP PRIME
Thoraco lumbar arthrodesis
Locations (4)
Clinique du Dos Bordeaux - Terrefort
Bruges, France
Clinique des Cèdres
Cornebarrieu, France
CHRU Tours, Hôpital de Bretonneau
Tours, France
Hôpital Pitié-Salpêtrière AP-HP
Paris, Île-de-France Region, France