NCT04670536

The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)

The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: Medicrea International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Thoracolumbar Disc Degeneration
• Thoracolumbar Spondylolisthesis
• Spinal Deformity
• Spinal Degeneration

Interventions

Type	Name	Description
DEVICE	PASS LP implants	Thoraco lumbar arthrodesis
DEVICE	PASS DEGEN	Thoraco lumbar arthrodesis
DEVICE	PASS TULIP PRIME	Thoraco lumbar arthrodesis

Timeline

• Start date: 2018-05-17
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2020-12-17
• Last updated: 2025-01-13

Locations

4 sites across 1 country: France